Pfizer
Skin & localized to injection site symptom reports
Female, 60 - 75 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 60 | 2020-12-31 | rash |
I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Ligh...
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I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Lightheaded , some dizziness that night. Forced the water intake. 12-30-2020, went to work, as the day went on the rash on my face and neck into upper chest increased and Hypertension. I went to the ER Dept at Hospital. IV Fluids and IV Benadryl and oral Prednisone and Prednisone to be taken at home. Face and neck rash goes away and comes back as of Jan 1 2021.
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| 60 | 2020-12-31 | itchy rash, rash |
Patient was discharged at 1:25 came back at 1:36 with itchy rash on forearm, given Benadryl 50mg IM....
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Patient was discharged at 1:25 came back at 1:36 with itchy rash on forearm, given Benadryl 50mg IM. Assessed by doctor working clinic at 2:15, rash was fading and itching resolved. No breathing or airway issues, was discharged.
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| 60 | 2021-01-02 | injection site pain |
No symptoms or pain with initial injection. I came home about 2 hours after the injection and took ...
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No symptoms or pain with initial injection. I came home about 2 hours after the injection and took one 200mg ibuprofen and one 500mg acetaminophen and put an ice pack on the site briefly. Later that afternoon I developed pain at the injection site that progressively got worse over the course of the evening so bad that I could not raise my left arm of touch the site. I put an ice pack on again and that night I slept with a heating pad on. I would rate the pain 8/10. When I woke the next day the pain was still there, but not as severe. I got in the shower and let the hot water beat on the injection site and that seems to help a lot. The pain gradually lessened over the course of the day to a 2/10. By the following day (3rd day post injection) the pain had completely subsided. There was no redness or swelling at the site and I did not have any other symptoms other than the intense injection site pain.
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| 60 | 2021-01-03 | injection site pain |
* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, ...
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* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight
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| 60 | 2021-01-03 | redness, rash |
12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. ...
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12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. 12/20/20 loose bowel movement, rash on back and disappeared face red lips swollen. 12/21/20 symptoms continued medications taken Benadryl. Imodium; rash resolved and loose bowel movements later in the day. Abd discomfort, pain and nausea present since vaccine given.
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| 60 | 2021-01-03 | hives | Hives |
| 60 | 2021-01-04 | injection site bruising, injection site hardening, injection site swelling |
Immediately after injection into patient's left deltoid, site swelling and felt firm. Some bruising...
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Immediately after injection into patient's left deltoid, site swelling and felt firm. Some bruising noted. Ice applied and patient monitored for over 30 minutes. Patient did complain of scratchy throat while being monitored, but refused Benadryl at this time. Patient will notify her physician of this reaction to the vaccine.
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| 60 | 2021-01-04 | injection site pain, injection site swelling | Injection site pain and swelling the day after vaccination |
| 60 | 2021-01-04 | redness, itchy rash, rash |
Red, itchy rash to both upper and lower extremities and upper back. Started 1/01/2021 to present. T...
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Red, itchy rash to both upper and lower extremities and upper back. Started 1/01/2021 to present. Treated with prednisone 60 mg x 5 days and trimcinolon 0.025% topically
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| 60 | 2021-01-04 | itchy rash, rash with redness, rash | Red, itchy rash to upper back, both upper and lower extremities. |
| 60 | 2021-01-04 | vaccination site pain |
Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a...
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Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.
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| 60 | 2021-01-04 | vaccination site rash, itchy skin |
Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm c...
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Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm cough; Bronchospasm cough; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Spasm; she has a lot of allergies; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 to 23Dec2020 at 0.3 mL single on left deltoid to prevent getting the COVID vaccine, for protection. Medical history included ongoing asthma diagnosed in her mid twenties, in the 80s, she had asthma when she was a child, then it stopped and resurfaced in her mid twenties, ongoing eczema diagnosed years already, a long time ago and unspecified allergies with medications. There were no concomitant medications. She received the vaccine on 23Dec2020. She has a lot of allergies in Dec2020, and had some side effects, and she got through it ok. Her side effects were some swelling of arm, a rash developed, like 5cm x 4cm at site of injection, chills and shivers, and a bronchospasm cough on 24Dec2020. Arm swelling event started 24 hours later, no more, it was stable for 24 hours, and the 3rd day, went down, was a little raised, the next day was flat but still red. She had recovered completely. The 4th day was a good day. The patient stated she had some allergy shots she had to go through before, this was no different. Rash was no more, it was gone by 27Dec2020. She was still able to go to work. Chills and shivers started 24 hours later, and took for 48 hours intermittently, she had since recovered completely. The patient stated this was all nothing different than getting like the flu shot. Bronchospasm cough event only took another 48 hours, the difference was, even when she calls it bronchospasm, it was close to when she had an asthma attack, but no chest tightness, shortness of breath, she just would cough, spasm in Dec2020 and stop. She had recovered completely. The patient stated she had no symptoms at all before the vaccine, she was healthy, she made sure nothing was going on, that she was not tired, had no cold, she took no medications for this, as she wanted to know how her body reacted and if it can handle it. They says it was ok to take paracetamol (TYLENOL), but she did not, but the second dose she would, now that she knows and she was comfortable through it. She did have some mild eczema flare ups, itchiness and sores that came up in Dec2020, but nothing to run to the hospital to the doctor for. Clarifies this occured after she received the vaccine. The outcome of the event allergies, mild eczema flare ups, itchiness and sores were unknown. The outcome of rash at site of injection was recovered on 27Dec2020. The outcome of other events was recovered in Dec2020. The causality between Pfizer COVID vaccine with some swelling of arm, rash developed 5cm x 4cm at injection site, chills and shivers, bronchospasm cough was related (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection). Information on the lot/batch number has been requested.
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| 60 | 2021-01-05 | rash macular | BLOTCHES OVER ENTIRE BODY NO OTHER SYMPTOMS. TREATED WITH BENADRLY OBSRVED 30 MIN AND RASH RESOLVED |
| 60 | 2021-01-05 | redness |
Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in b...
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Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.
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| 60 | 2021-01-05 | vaccination site redness, vaccination site swelling, vaccination site itchiness |
Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling belo...
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Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; This is a spontaneous report from a contactable other-HCP (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included pulmonary embolism and known allergies: penicillin. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), vitamin b complex (VITAMIN B), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), tocopherol (VITAMIN E), received within 2 weeks of vaccination. Facility that the most recent COVID-19 vaccine administered was in Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 14:45, the patient experienced golf ball size swelling below the injection site. Arm was red and itchy. No treatment received for the adverse event. Outcome of the events was recovering. This report was assessed as non-serious. Information about Lot/batch number has been requested.
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| 60 | 2021-01-05 | injection site redness, itchy skin |
INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINES...
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INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.
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| 60 | 2021-01-05 | itchy skin |
Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nu...
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Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (Batch/lot number: EK5730) intramuscular at Left arm, on 31Dec2020 at single dose for covid-19 immunisation. Medical history included mild Hypertension (HTN), Hypothyroidism, Anxiety, Gastrooesophageal reflux disease (GERD), Hyperlipidemia. Known allergies included Shellfish, SSRI, Demerol, Codeine. The patient did not have covid prior vaccination. Patient had no other vaccine in four weeks. Concomitant medication included lisinopril, levothyroxine, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), bupropion hydrochloride (WELLBUTRIN), atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), vitamin c [ascorbic acid], calcium, linum usitatissimum seed oil (FLAX SEED OIL), glucosamine, curcuma longa (TURMERIC), ubidecarenone (COQ 10), collagen. The patient experienced itching but no hives, slight headache, dizziness on 31Dec2020 15:30. The patient received Benadryl 25mg for the events. The patient did not have covid tested post vaccination. The outcome of events was recovering.
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| 60 | 2021-01-05 | itchy skin |
hand was swollen and itchy on the same arm where the injection was; back of hand was swollen and itc...
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hand was swollen and itchy on the same arm where the injection was; back of hand was swollen and itchy on the same arm where the injection was; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration (Deltoid Right) from 26Dec2020 15:00 at single dose for Covid-19 immunization. The patient's medical history included chronic pain and insomnia. Concomitant medications included hydrocodone and temazepam. The patient reported, "On 26Dec2020 I got my first immunization for COVID and today (30Dec2020) I woke up and the back of my hand was swollen and itchy on the same arm where the injection was". The patient further stated "It never have happened before I don't have any reaction at the injection site but it was kind of odd that it kind of showed up on the back of my hand, it feels like an allergy kind of thing." The patient tried the Voltaren Gel to try and get the inflammation down, but it didn't help, and she took some Benadryl it doesn't seem to help much. The patient's next shot is due on "12Jan2021". The outcome of events was unknown.
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| 60 | 2021-01-06 | redness, injection site pain |
30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some a...
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30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some advil. Over next two days on and off hot flashes tingling numbness on hands and feet. Very cold feet couldn't get warmed up till wrapped up on heating pad. Ño fever but felt chills. Sore arm site of injection.
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| 60 | 2021-01-06 | injection site pain |
APPROXIMATELY 24 HOURS AFTER THE INJECTIONS I RAN A FEVER OF 100.7, BODY ACHES OVER ALL JOINTS, EXT...
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APPROXIMATELY 24 HOURS AFTER THE INJECTIONS I RAN A FEVER OF 100.7, BODY ACHES OVER ALL JOINTS, EXTREME FATIGUE AND HEADACHE ADN THE INJECTION SITE WAS PAINFUL. I HAD THE COVID VIRUS DIAGNOSED 10/23/2020 WITH THE EXACT SAME SYMPTOMS EXCEPT I RAN A HIGHER TEMP
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| 60 | 2021-01-06 | injection site pain |
Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. wit...
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Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. without any issues. Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite. The body aches, fatigue continued the following day, appetite returned slightly. Thankful these were my scheduled days off from work. Third day after injection body aches dissipating able to go out of the house to do errands.
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| 60 | 2021-01-06 | injection site swelling | Single raised bump at inject site - no redness or pain |
| 60 | 2021-01-06 | skin irritation, skin hardening, itchy rash, redness |
intensely pruritic rash, starting around neck initially and then presenting in perianal area, moving...
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intensely pruritic rash, starting around neck initially and then presenting in perianal area, moving up lower back with sharp linear demarcations, also perinasal bilat . Also on eyelid with periorbital edema rt>lt. Typical appearance of contact derm with raised indurated intensely pruritic lesion except almost exact opposite in distribution (flexoral/internal aspects of skin) and no known exposures. Now day two and rash is becoming more well demarcated, more red and inflamed and spreading in distribution face, neck and lower back. There is no logical explanation for this rash.
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| 60 | 2021-01-07 | vaccination site swelling |
Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This...
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Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), via an unspecified route of administration on 30Dec2020 at 09:15 (at the age of 60-years-old) as a single dose, in the right arm for COVID-19 vaccination. Medical history included lymphedema, lipedema, depression, osteoporosis, osteoarthritis, hypothyroid, malabsortion with vitamin deficiencies, anemia, and allergy to latex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, however it was reported the patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took thimerisol and influenza vaccine both from unknown dates to unknown dates for unknown indications and experienced allergy. On 30Dec2020 at 10:00, the patient experienced sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site. The patient did not receive any treatment for the events. The clinical outcome of the events sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 60 | 2021-01-07 | itchy rash, rash |
arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on he...
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arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach; inherited some type of reaction like a rash, its itchy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1685, Expiry Date: Mar2021, via an unspecified route of administration on left arm from 29Dec2020 to 29Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypertension (verbatim: Blood Pressure High), thyroid disorder (verbatim: Thyroid), cholesterol. The patient's concomitant medications were not reported. The patient stated she got her vaccination on 29Dec2020, that's Tuesday and her arm was sore the next day (30Dec2020) but she have inherited some type of reaction like a rash, its itchy, her hands are itching like crazy, she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach that's not so itchy it's the hands that's itchy. The patient was asking what should she do. The outcome of the events was unknown. When asked for treatment for the events, the patient stated, "I was doing some, I take an Aleve, Aspirin and then I was taking some Benadryl capsule for allergy."
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| 60 | 2021-01-07 | rash, hives |
chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, o...
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chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, on right arm, under left foot; This is a spontaneous report from a contactable nurse (patient). A 60-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via intramuscular route of administration in the right arm on 28Dec2020 at 05:30 AM (at the age of 60 years-old) as a single dose for COVID-19 vaccination. Medical history included diabetic and asthma. The patient's allergies included sulfa, iodine, shellfish and latex/rubber. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 28Dec2020 at 06:30 AM, the patient experienced chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The report was reported as non-serious. The patient was not treated for chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The clinical outcome of chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 60 | 2021-01-07 | vaccination site mass, vaccination site redness, vaccination site pain |
very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt real...
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very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021. Information about lot and batch number was requested.
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| 60 | 2021-01-08 | itchy rash, rash with redness, rash |
Approximately 24 hrs after injectio rash occurred to groin area & lower abdomen. Then appeared in mu...
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Approximately 24 hrs after injectio rash occurred to groin area & lower abdomen. Then appeared in multiple patchy areas. Over next 10 days rash appeared on right of mid sternum, right upper ribs, coccyx area, nap of neck. Rash was small red bumps any extremely pruritic
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| 60 | 2021-01-08 | rash with redness, rash, itchy rash, rash papular |
Had initial vaccine on 12/21/2020. Broke out in rash reported in a previous report file. After 2nd i...
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Had initial vaccine on 12/21/2020. Broke out in rash reported in a previous report file. After 2nd injection, at some of the exact locations of healing rash from 1st, new eruptions of red raised pruritic rash occurred. Lower abdomen, top of right ribs and nape of neck.
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| 60 | 2021-01-08 | injection site pain | Headache very fatigue, soreness at injection site Narrative: stayed home from work |
| 60 | 2021-01-08 | rash | SkinRash & NauseaVomiting |
| 60 | 2021-01-08 | itchy skin |
c/o itching and pressure in her head. Narrative: c/o of itching and pressure in head. Staff gave Di...
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c/o itching and pressure in her head. Narrative: c/o of itching and pressure in head. Staff gave Diphenhydramine HCL VS 178/85, 72, 18, 98% O2sat. at 1340 states she felt better.
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| 60 | 2021-01-10 | blister, redness, injection site pain, skin warm |
1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to t...
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1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to touch, swelling 3" x 3", small raised blisters. 01/11/2021: symptoms are subsiding; pink, warm to touch, swelling 2" x 2", blisters fading
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| 60 | 2021-01-10 | injection site pain | Injection site slightly sore to the touch, very slight sore throat and very slight headache |
| 60 | 2021-01-10 | rash, skin burning sensation |
On the 3rd day after the injection I felt a burning sensation on the skin of my neck then with in 10...
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On the 3rd day after the injection I felt a burning sensation on the skin of my neck then with in 10 minutes the feeling spread over my whole body. Not an itch just a burning and slight red patches on my: Neck, upper back and inner side of my arms. It wasn't like a hot flash I was expecting hive welts but that didn't happen.
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| 60 | 2021-01-10 | injection site pain |
Patient reported soreness/painful up into clavicle area of right side where injection occurred. Pati...
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Patient reported soreness/painful up into clavicle area of right side where injection occurred. Patient also reports swollen and painful lymph nodes on right side where injection occurred.
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| 60 | 2021-01-10 | injection site pruritus, injection site redness | Redness and itch at injection site for 48 hours |
| 60 | 2021-01-11 | vaccination site pain |
Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point;...
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Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took amoxicillin and had allergies. On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering. No follow-up attempts possible. No further information expected.
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| 60 | 2021-01-11 | itchy skin, rash, redness |
Patient developed a rash on her neck beginning on the right side and continued to increase around he...
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Patient developed a rash on her neck beginning on the right side and continued to increase around her neck. She is still experiencing redness today. She also has some itching of her scalp. She did not require intervention.
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| 60 | 2021-01-12 | vaccination site pain |
Her arm was a little sore; The soreness at the injection site lasted 2 days; This is a spontaneous r...
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Her arm was a little sore; The soreness at the injection site lasted 2 days; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (arm left) on 08Dec2020 (lot unknown) at SINGLE DOSE; and second dose via an unspecified route of administration on 06Jan2021 at SINGLE DOSE (lot number EJ1685) for COVID-19 immunization. The patient medical history was not reported. The patient was taking unspecified concomitant medications (same medications that she usually takes and has not started anything new). Patient reported that she was fine after the first shot. Her arm was a little sore on Dec2020 and that was it. The soreness at the injection site lasted 2 days and then recovered completely. She has no breathing difficulties or anything similar. Outcome of the event "Her arm was a little sore" was unknown while recovered for " The soreness at the injection site lasted 2 days" on Dec2020.
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| 60 | 2021-01-12 | rash papular, rash with redness, rash |
Initially, sore throat, body aches and headache, then on 1/11/21 she developed red raised rash on he...
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Initially, sore throat, body aches and headache, then on 1/11/21 she developed red raised rash on her neck and chest. Denies difficulty breathing however she reports her throat is very painful, scratchy, dry and irritated. For treatment patient took a zyrtec 24 hour 10 mg tablet on 1/11/21 which reduced some inflammation of rash, however still present 1/12/21. Has increased fluids, is taking tylenol and tea with honey. These were self care done by patient. MD suggested to Zyrtec every 6-8 hours as needed for symptom control. Ibuprofen / tylenol as needed for headache if no provider has told you not to use these in the past. If any progressive Sx than you should be seen at URI clinic.
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| 60 | 2021-01-12 | itchy skin |
Pfizer-BioNTech COVID-19 vaccine EUA - Client reports "after 45 minutes post injection, started hav...
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Pfizer-BioNTech COVID-19 vaccine EUA - Client reports "after 45 minutes post injection, started having mild itching in my trunk, arms and left Hand. itching increased so took Benadryl 50 mg PO, stayed for 15 minutes then left work to go home. Once home itching increased, eyes started swelling and started losing my voice. Husband took me to the ER at Hospital, arrived approx. 6.10 pm. Treated with Benadryl, Solu medrol and Pepcid, all thru IV. Condition improved and client sent home with script for Pepcid, Medrol dose pack and Atarax.
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| 60 | 2021-01-12 | injection site rash, rash macular, rash with redness |
Received Pfizer vaccine on January 7 at approximately 5:20PM. This morning on January 13 at 5:20 AM...
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Received Pfizer vaccine on January 7 at approximately 5:20PM. This morning on January 13 at 5:20 AM, I noticed a rash on my left upper arm/deltoid at the vaccine site. Rash is flat and red, approximately 8 cm x 8 cm, but not circular.
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| 60 | 2021-01-13 | shingles |
4 days after receiving Covid shot in left arm, shingles appeared on right scapula area, 3 days late...
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4 days after receiving Covid shot in left arm, shingles appeared on right scapula area, 3 days later shingles appeared on right upper lateral arm form shoulder to forearm
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| 60 | 2021-01-13 | itchy skin |
Patient received her first dose of COVID-19 vaccine at 9:27 am. Around 9:40, the patient complained ...
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Patient received her first dose of COVID-19 vaccine at 9:27 am. Around 9:40, the patient complained of head tingling and body itchiness.
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| 60 | 2021-01-14 | itchy skin |
10 minutes after receiving vaccine pt. c/o severe itching on face and neck. No hives, shortness of ...
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10 minutes after receiving vaccine pt. c/o severe itching on face and neck. No hives, shortness of breath or distress noted. Pt. declined to take Benadryl or Epinephrine - requested to go to hospital for evaluation.
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| 60 | 2021-01-14 | hives |
About 15 minutes after injection c/o mild tingling to lips. No other symptoms. VSS (BP 103/68, O2 99...
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About 15 minutes after injection c/o mild tingling to lips. No other symptoms. VSS (BP 103/68, O2 99%, RR 17, HR 68). no wheezing, SOB, swelling, chest pain, dizziness, abd pain, NV. about 15 minutes later, lip tingling improved but began c/o generalized urticaria with mild erythema to left upper chest. patient well appearing at that time, A&Ox3, no increased WOB, SOB, hives, facial swelling, facial redness. Patient reports she experienced same urticaria about 24-48 hours after 1st COVID vaccine dose, treated at home with po benadryl with improvement. Placed on continuous monitoring and administered 25 mg Benadryl po with improvement in symptoms. About 30 min after benadryl administration symptoms resolved. Offered ER evaluation to which patient declined. She works within hospital and agrees to seek emergency medical care should symptoms return or worsen. can continue to take benadryl at home and monitor closely.
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| 60 | 2021-01-14 | injection site pain, itchy skin |
Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus,...
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Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.
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| 60 | 2021-01-14 | itchy skin |
I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in...
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I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in the morning I had high fever, chills, and a very bad headache, and shooting pain like a shock in legs and arms (I had the same when had covid around 04/2020 and was out of work until June 2020 - I developed double pneumonia). It lasted until 11AM the next day. Got a covid test around noon and it was negative and on the 25th I started feeling better. Got second dose on 01/13/2021 had the same symptoms but not as severe.
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| 60 | 2021-01-14 | injection site redness |
Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection...
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Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.
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| 60 | 2021-01-15 | itchy skin, rash | Arm and joint pain, itching, rash |
| 60 | 2021-01-15 | injection site pain |
Soreness at injection site x 48 hours--no treatment Slight twitching in left eyelid x 48 hours--no t...
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Soreness at injection site x 48 hours--no treatment Slight twitching in left eyelid x 48 hours--no treatment--still have a little twitching in the eye but seems to be getting better
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| 60 | 2021-01-15 | injection site pain | soreness at site x 24-48 hours--no treatment slight twitching of left eye x 1 week--no treatment |
| 60 | 2021-01-17 | rash | Clammy, sweating and rash to BUE and chest. Patient will be seeing PCP for treatment. |
| 60 | 2021-01-17 | injection site pain, injection site redness, injection site warmth |
I received the Pfizer COVID-19 vaccine on 1/7/21 which resulted in slight redness and soreness at th...
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I received the Pfizer COVID-19 vaccine on 1/7/21 which resulted in slight redness and soreness at the site. This gradually dissipated over a few days, but not completely. On Friday, 01/15/21 a couple hours after exercising (elliptical and hand weights) at the site of vaccination was redness, soreness, and heat. Upon waking up Saturday, 01/16/21, the redness, soreness, and heat had increased - area was 6cm x 7cm - contacted pcp and was advised to go to Urgent Care, which I did and was prescribed Doxycycline for possible cellulitis. Today, 01/18/21, sx's have much improved.
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| 60 | 2021-01-17 | itchy skin | PATIRNT PRESENT THROAT AND BODY ITCH |
| 60 | 2021-01-17 | itchy skin | itching all over |
| 60 | 2021-01-17 | itchy skin | itching all over, restlessness, patient allergic to benadryl. |
| 60 | 2021-01-17 | itchy skin |
patient states that she had a reaction with the first vaccine but not until after she left the clini...
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patient states that she had a reaction with the first vaccine but not until after she left the clinic here. She states she had tingling in her lips and throat, she states she has already taken Benadryl 25mg prior to coming here today. Within 10 minutes of receiving vaccine she began with tingling of throat and lips, feeling woozy and ears itching. After speaking with healthcare worker the patient was given Benadryl 25mg IM. A medical alert was then called due to patient c/o chest pain. She was taken to the ER as a precaution.
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| 60 | 2021-01-18 | itchy skin |
6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN...
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6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN. TOOK TWO BENEDRYL AND SYMPTOMS RESOLVED BY AM. 1/16 HAD SYMPTOMS OF AN ON-COMING COLD, SLIGHT SORE THROUGH, SINUS PRESSURE AND FELT WARM. NO TREATMENT OTHER THAN FLUIDS AND REST AND RESOLVED BY MORNING. 1/17 AND 1/18 ONLY SYMPTOM MILD FATIGUE
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| 60 | 2021-01-18 | itchy skin | Pt presented with itchy hands, itchy face |
| 60 | 2021-01-18 | rash |
began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and ras...
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began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and rash to face
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| 60 | 2021-01-19 | itchy skin |
Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. To...
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Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching
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| 60 | 2021-01-20 | hives, itchy skin |
1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later....
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1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later. Fever ran about 102 degrees most of the time. 2. Chills 3. Loss of appetite and body aches lasting approximately 3 days 4. Hives in armpits, worse on the side of the injection. I noticed it 48 hours after the injection, and I still have them 1 week later. They are much better, but still visible and itchy. 5. Sensitive and painful gums
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| 60 | 2021-01-20 | injection site redness, injection site swelling, injection site pruritus, injection site pain |
Injection site got really red started about a quarter in diameter and swelled to about 9 inches in ...
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Injection site got really red started about a quarter in diameter and swelled to about 9 inches in diameter. Itched and was painful. Lasted about 1 weeks time. Ibuprofen and diphenhydramine.
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| 60 | 2021-01-20 | rash macular |
taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the co...
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taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
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| 60 | 2021-01-21 | rash |
INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of...
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INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of both legs- no fever
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| 60 | 2021-01-24 | injection site bruising, injection site pain |
12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours l...
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12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.
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| 60 | 2021-01-24 | hives, itchy skin |
7 hours after the injection, I broke out in hives in my torso. Over the next 2 days, it has spread ...
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7 hours after the injection, I broke out in hives in my torso. Over the next 2 days, it has spread to my whole body. I am taking Benadryl to try to relieve the itching.
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| 60 | 2021-01-24 | bruising |
BRUISING, IT STARTED ON LEFT THIGH AND WENT TO LOWER LFT ABDOMEN WITH FIRST INJECTION. AFTER 2ND IN...
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BRUISING, IT STARTED ON LEFT THIGH AND WENT TO LOWER LFT ABDOMEN WITH FIRST INJECTION. AFTER 2ND INJECTION IT WENT TO THE RIGHT THIGH AND HAD SMALL BRUISES.
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| 60 | 2021-01-24 | injection site pain, injection site swelling |
Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at s...
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Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days
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| 60 | 2021-01-24 | itchy skin, hives, rash |
I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the ...
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I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the male nurse that was present and he said that had Epinephrine, I had benadryl and he said that I could take one. Half an hour later my rash got worse and I took 20 mg prednisone that I had for my asthma. During the next two days I have had palpitations, fatigue and tiredness. Today my blood pressure was high and I have never had it like that before.
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| 60 | 2021-01-24 | injection site bruising |
Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; T...
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Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-01-24 | hives |
Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate...
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Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 60 | 2021-01-25 | injection site rash, injection site pruritus, rash |
1 hour after vaccine -itchy injection site and small rash starting on top of left arm, took 50mg of ...
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1 hour after vaccine -itchy injection site and small rash starting on top of left arm, took 50mg of Benadryl 1 hour after Benadryl- rash was spreading to the whole arm , neck and intermittent labored breathing started patient was taken to hospital and received 2 doses of epinephrine and nebulizer treatment
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| 60 | 2021-01-25 | itchy skin, rash, redness |
25 minutes status post the vaccine patient experienced head itchiness. Patient was brought to the tr...
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25 minutes status post the vaccine patient experienced head itchiness. Patient was brought to the triage room and had fine rash on chest. BP noted to be 190/90, HR 60, RR 16, sat 100%, and no SOB/difficulty breathing. Allergy on call was paged and patient was given zyrtec. After given zyrtec patient was monitored for two hours. There was a redness on patient's neck which was continually lessened, HR, RR, and sat remained stable throughout. Sat remained between 150-170 for the next hour. After 2 hours the redness on neck has completely resolved and BP 153/79. Allergist on call notified. Plan was to have patient go to ER if she experienced SOB, chest pain, or headache.
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| 60 | 2021-01-25 | rash with redness |
Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestio...
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Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering. Information about lot/batch number has been requested.
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| 60 | 2021-01-25 | redness, vaccination site rash |
Received Pfizer vaccine on January 7 at approximately 5:20PM. This morning on January 13 at 5:20 AM...
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Received Pfizer vaccine on January 7 at approximately 5:20PM. This morning on January 13 at 5:20 AM, I noticed a rash on my left upper arm/deltoid at the vaccine site. Rash is flat and red, approximately 8 cm x 8 cm, but not circular.
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| 60 | 2021-01-25 | injection site pain |
Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took...
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Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took a Tylenol went back to bed. No fever upon waking. Minor muscle aches and mild soreness at injection site.
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| 60 | 2021-01-25 | redness |
Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myal...
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Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myalgias; This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (Lot number: Ek5730), via an unspecified route of administration in left arm on 22Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing (COVID prior vaccination: Yes). There were no concomitant medications. The patient experienced very swollen and erythematous arm, chills, severe neck pain, myalgias, all on 22Dec2020 14:00. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment given. The outcome of events was resolved. Facility type vaccine: Hospital. No other vaccine in four weeks. No other medications in two weeks. No COVID tested post vaccination. Not known allergies or other medical history.
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| 60 | 2021-01-26 | bruising |
First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and ...
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First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.
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| 60 | 2021-01-26 | itchy skin, rash, redness, hives |
RASH STARTED 2 DAYS AFTER VACCINE ON MY WRISTS, AND SLOWLY WENT UP MY ARMS BY SUNDAY MORNING. BY MO...
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RASH STARTED 2 DAYS AFTER VACCINE ON MY WRISTS, AND SLOWLY WENT UP MY ARMS BY SUNDAY MORNING. BY MONDAY MORNING RASH WAS ON MY LEGS, CHEST, BACK AND ARMS. ITCHY, RED AND RAISED WELTS IN PLACES. JUST UNCOMFORTABLE. IT'S NOW WEDNESDAY AND IT'S SLOWLY GOING AWAY, STILL RED AND ITCHY. I DID NOT GO TO MY PCP. I DID SHOW MY RASH TO MY INFECTIOUS DISEASE PHYSICIAN AT OUR HOSPITAL. I HAVE BEEN TAKING AN ANTIHISTAMINE THAT HAS HELPED.
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| 60 | 2021-01-26 | redness, skin tightness, rash, dry skin |
There are two events I am reporting, one each from the first dose on 12/19/20, and the second dose o...
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There are two events I am reporting, one each from the first dose on 12/19/20, and the second dose on 1/9/21: Approximately 53 hours after Dose #1: Redness on hands and wrist, rash-like small dot appearance on hands and wrists, skin dryness and tightness of hands. I experienced no itching of hands or wrists. Approximately 53 hours after Dose #2: Small, painful red pustule-like occurrence on base of right thumb, with the appearance of a few small dots in it. I experienced no itching of thumb or hand. These events both occurred within the same timeframe following the vaccine doses. Following the first event I was seen in the ER. I checked out fine and they could not say exactly what this was. They said it did not appear to be an allergic reaction to the vaccine because it was not systemic and I had no other symptoms such as trouble breathing. They thought perhaps it was coincidental...I work in the hospital as a radiologic technologist where I hand-wash and hand-sanitize all day. Perhaps I just over-washed that day? However I've worked there for 17 years and never had this happen. The redness and rash dissipated by end of day. Following the second event I did not follow up with any medical provider. This pustule I got happened while I was at home, and otherwise I felt fine so I left it at that. It took several days for the pustule to go away. I hope you don't mind but I am writing to report this information in the event it may be helpful to you and I am also reporting it because I want to know if what I experienced could be considered an immune response to the vaccine? Another words, not an allergic response but an immune response ? I can find absolutely nothing about this on-line and no one knows what to make of it. Thank you.
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| 60 | 2021-01-26 | hives, rash vesicular, rash, itchy rash, itchy skin, rash papular, skin peeling |
like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes ...
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like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes were swollen and itchy; itching and inflammation, in eyes as well; swelling on her eyes and itching on her eye lids; swelling on her eyes and itching on her eye lids; welts; whelps on her hip, inflamed and itchy/general arthritis symptoms; Headache dull; shingle like rash on tailbone, genital area / raised itchy rash on the tailbone like shingles; itching on her face that she couldn't see / raised itchy area on her left cheek and eyes; rash / rash down her thighs/rash that was across her body; rash vulva; swelling / vulva was swollen; itching / itching around the genital area, vulva; itching / itching around the genital area, vulva; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) worked in outpatient mental health reported that a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021) via an unspecified route of administration on 04Jan2021 at 16:20 in the left arm at single dose for COVID-19 vaccination. Vaccine administered at hospital and not military facility. No additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Graves' disease (the patient had her thyroid irradiated away for Grave's disease 25 years ago). Family Medical History was none. Concomitant medication included ongoing levothyroxine 1.25 mcg once daily by mouth Graves' disease taking for 25 years. Prior vaccination within 4 weeks was none. The patient received her Pfizer COVID 19 vaccine on 04Jan2021. Since then she started to experience a genital itch immediately; a rash that was across her body; eyes were swollen and itchy; new itchy rash 13Jan2021. She felt okay going home then she started to have itching around the genital area. She thought she might have a yeast infection but she didn't have any other symptoms for a yeast infection. Her vulva became swollen from 05Jan2021 and itchy from 04Jan2021 and she noticed rash around her body. It all started in the genital area. The next day the rash spread down her thighs and she noticed an itchy place on her face, but you couldn't see it. Her thighs were inflamed and she noticed patches of angry whelps on her hips as well as a itchy rash area on her tailbone that seemed more like shingles; size of a quarter; raised, itchy, rash, that felt like it was radiating out. Then she noticed the rash on her face on her cheek, general swelling on her eyes and itching on her eye lids. Now the genital itching was less and most of her symptoms were improved but her eye was driving her crazy and it was more swollen on the outside. She tried to treat her eyes with eye drops Dry Eye Relief (manufacturer Similasan; no UPC seen, lot number: 15942; expiration date: Sep2022, ingredients include Belladonna) but it didn't help. They were still itchy and weepy. The eye drops were not working. She also treated the rash and itching with Benadryl at night and it improved the symptoms overall. She took Tylenol (UPC 300043760; lot number: PMA003; expiration date: Aug2022) and Bayer Aspirin (81mg; lot number: NAA93E1; expiration date: Feb2023. No UPC code on bottle) every day for general arthritis symptoms, but they didn't touch her dull headache she has had on and off since the vaccine. Before she got the vaccine, she had a little tag on her vulva, it was tiny. Now after experiencing the itching, swelling, rash on her vulva, the tag was gone. It just took a layer of skin right off. It was not uncomfortable but the whole layer of the skin was gone. It was very uncomfortable while it was happening but now it was okay. When she noticed these symptoms, she tried to call occupational health and a institute but didn't get anyone. She also contacted her HCP but had not heard back. It seemed to her like a lot of side effects and a lot of itching. She didn't have it in her throat, but all that itching seems a lot like an anaphylactic reaction. She was curious whether we would recommend her to take the second dose since they say the reaction to the second dose was worse. She had multiple COVID tests that have all come back negative. A friend tested positive so she had a test; and she had a test when she traveled. The events did not require a visit to physician or emergency room. The patient had reactions: itching, rash, swelling, welts, shingle like rash on tailbone, genital area, hips moving to her face, itching and inflammation, in eyes as well. She wanted to know if the 2nd dose was recommended. It was "like an anaphylactic reaction but not in her throat." itching around the genital area, vulva started from 04Jan2021, vulva was swollen started from 05Jan2021; Rash vulva started from 06Jan2021 to 10Jan2021; rash down her thighs started from 07Jan2021; Raised itchy rash on the tailbone like shingles started from 06Jan2021, whelps on her hip, inflamed and itchy from 07Jan2021; itching on her face that she couldn't see started from 06Jan2021; raised itchy area on her left cheek and eyes started from 07Jan2021; Headache dull started from 06Jan2021. The events Headache dull, itching on her face that she couldn't see; whelps on her hip, inflamed and itchy and raised itchy rash on the tailbone like shingles were reported as non-serious by the reporter and other events were considered as medical significant by the reporter. Investigation assessment for the events was reported as No. The outcome of the event anaphylactic reaction, inflammation in eye, welts was unknown, outcome of the event Rash vulva was recovered on 10Jan2021; of Headache dull, swelling eye was not recovered, of other events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-01-27 | injection site pain |
Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection howeve...
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Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection however the fever has continued x7 days, getting as high as 101.9. I began noticing soreness in the lymph nodes in my neck and underarms on the evening of 1/25 and that lasted until midmorning of 1/27.
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| 60 | 2021-01-27 | rash |
Rash across face, part of her cheeks over her nose; Arm sore; Received two vaccine within 10 minutes...
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Rash across face, part of her cheeks over her nose; Arm sore; Received two vaccine within 10 minutes of each other and now to be re-vaccinated again the second dose; not enough research can guarantee if that's safe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140, expiry:Mar2021), intramuscular on 12Jan2021 at a SINGLE DOSE then intramuscular on 12Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol increased, fistula, surgery on 18Dec2020. It was stated, "Sure, I am hoping you can help me. I am one of the legal guardians for our younger sister who has special needs. She is residing in a group home, group home in the city area she is currently been out of it because she has surgery. They have made arrangements for them to still ask for them to receive the first Pfizer Covid 19 Vaccination just this past Tuesday so I go from up there from my home in city and we had a problem in there they screwed up and ended up vaccinating her twice within 10 minutes. I asked the pharmacist, there I asked the RN what does that mean for her I mean I didn't know what that meant but normally we would sat for 15 minutes, they made her sat for 30 minutes. The nurse was there from the group home monitored her blood pressure and temperature and then we got in the car proceeded to drive 3 and half hour. They said just watch for temperature, labored breathing, take her to the emergency room call 911, the only thing she did have about an hour after she broke out that was "malar" (not clarified) rash across her face part of her cheeks over her nose that lasted for about 30 minutes. The next day her arm was sore which was going to happen but here is my question though she received two vaccine within 10 minutes of each other and now they are wanting her to be re-vaccinated again which would have been the second dose, supposedly on 02Feb2021. Nobody can tell me if that's safe or if that's okay, they can't guarantee, they all kept telling me, the nurse says, I called the pharmacist kept saying there's not been enough research to know if it's safe for her to get that next vaccine, so I don't know what to do." The reporter also stated, "IM, Both went for IM, first one went into her left arm and second shot was given in her right arm." The patient underwent lab tests and procedures which included blood pressure measurement: unknown result on an unspecified date, blood test: unknown result on 05Jan2021, body temperature: unknown result on an unspecified date, sars-cov-2 test: unknown results pre-surgery and post-surgery. The outcome of the event rash across face, part of her cheeks over her nose was recovered and arm sore was unknown.
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| 60 | 2021-01-27 | injection site warmth, injection site redness, injection site rash | Red, warm rash around injection site cold sweat, chills, and swelling to Left arm |
| 60 | 2021-01-27 | vaccination site pain |
tongue on the side is bruised; it was a big black spot that she noticed this morning while brushing ...
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tongue on the side is bruised; it was a big black spot that she noticed this morning while brushing her tooth; right arm being sore started after 1.5 hours after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose in the right arm for covid-19 (immunization). There were no medical history and concomitant medications. Patient had got her Pfizer Covid vaccine on 13Jan2021 and thought she had a reaction and wanted to know if anyone had this reaction. On 14Jan2021, patient stated on right side where got shot on that her tongue on the side was bruised. She stated that her arm hurt last night. She stated this was her first dose. She later clarified that it was her right arm. Patient stated that it was a big black spot that she noticed this morning while brushing her tooth (14Jan2021). Her right arm being sore started after 1.5 hours after the shot (13Jan2021). No treatments received in response to the events reported. The events "tongue on the side was bruised" and "it was a big black spot that she noticed this morning while brushing her tooth" were not recovered. The outcome of the event "right arm being sore started after 1.5 hours after the shot" was recovered on 14Jan2021.
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| 60 | 2021-01-28 | rash, redness, injection site reaction |
I received the vaccine at approximately 8:10 a.m. Approximately 12 hours post-injection, I began to ...
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I received the vaccine at approximately 8:10 a.m. Approximately 12 hours post-injection, I began to feel malaise and fatigue. Upon waking around midnight, I had developed a 102.4 degree (F) fever, total body ache, headache, chills, and cough. Most symptoms lasted approximately 24 hours. The headache, although now mild, persists into the third day. On the third morning following the injection, I woke to find a slightly painful triangular-shaped red, raised patch on the same arm as the injection (left). The "rash" measures approximately 4.5 cm x 7 cm.
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| 60 | 2021-01-28 | redness |
Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain ...
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Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain Headache
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| 60 | 2021-01-28 | rash, rash with redness | Swelling of lips and tongue Intense itching Bright red rash on neck, face |
| 60 | 2021-01-28 | itchy skin |
itchy, swollen soft pallet, need to cough started approx. 15 mins after vaccine given and continued ...
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itchy, swollen soft pallet, need to cough started approx. 15 mins after vaccine given and continued and plateaued for hour and half. Benadryl and prednisone given in ED. Monitored and D/C with no further progression of sx.
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| 60 | 2021-01-29 | itchy skin, redness | 2? diameter redness/swelling, soreness, some itching, resolved after 2 days |
| 60 | 2021-01-31 | injection site swelling, injection site pain |
6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days...
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6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.
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| 60 | 2021-01-31 | itchy rash, rash, rash macular |
Patient received their first dose of Pfizer vaccine on 1.27.2021. Patient reports little red spots t...
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Patient received their first dose of Pfizer vaccine on 1.27.2021. Patient reports little red spots that are itchy on their legs, thighs, and chest that started the day after receiving the vaccine. The patient states that they are NOT experiencing any facial swelling, scratchy/itchy throat/ShOB. Patient states the rash has improved with over the counter medications. Encouraged the patient to reach out to provider with any more worrisome or bothersome conditions, including worsening of rash. Reviewed when the patient should seek emergency care.
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| 60 | 2021-02-01 | injection site nodule | 6 days after injection, I noticed a 5x5 cm sized lump under my left arm. |
| 60 | 2021-02-01 | injection site pain | Arm sore at site. |
| 60 | 2021-02-01 | rash, shingles, itchy rash |
Developed chills, a low grade fever and headache on same day of her vaccination. The next day, she ...
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Developed chills, a low grade fever and headache on same day of her vaccination. The next day, she developed an itchy rash on her left arm which became panful. She saw her PCP who diagnosed shingles.
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| 60 | 2021-02-01 | sensitive skin |
Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, s...
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Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.
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| 60 | 2021-02-01 | skin warm, redness |
FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR 36 HOU...
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FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR 36 HOURS
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| 60 | 2021-02-01 | injection site pain |
Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On ...
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Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.
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| 60 | 2021-02-01 | itchy rash, injection site rash, rash with redness, rash papular |
Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This starte...
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Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This started on Feb. 2. Also had fever of 100 degrees, body aches, headache for about 36 hours, it started 12 hours after I received the vaccine.
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| 60 | 2021-02-01 | injection site redness, injection site pain, injection site warmth, injection site mass |
headache, joint & bone pain, red lump at injection site, injection site warm to the touch, soreness ...
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headache, joint & bone pain, red lump at injection site, injection site warm to the touch, soreness at injection site, some wheezing 40 x 40 mm
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| 60 | 2021-02-01 | redness, itchy skin |
noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the ...
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noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; This is a spontaneous report from a contactable consumer reported for self. This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK9231) at single dose on left arm on 03Jan2021 at 0830AM for COVID-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Medical history was none. Family medical history was none. Relevant test was none. Prior Vaccinations (within 4 weeks) was none. There was no concomitant medication. Patient received 1st dose on 03Jan2021. Yesterday (18Jan2021), she noticed 3 lumps the size of finder tip on her shoulder that were red and itchy. Across her cleavage, she noticed another 3-4 lumps. She noticed last night, 18Jan2021, three lumps on her shoulder that were really itchy and red and three or four across her cleavage area but not as large. She was just checking, she knew it said could have swollen lymph glands. Patient mentioned she tried to set the phone thing set up where they call you but she could not do it. The shoulder lumps were on her left side and about the size of tip of her little finger. She tried Witch Hazel; she rubbed it on and that soothed it a little at that time. she was scheduled for the second dose of the vaccine on the 25Jan2021. Patient asked if this was normal and what could the end result possibly be. The adverse events did not require a visit to physician or ER. The outcome of events was not resolved.
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| 60 | 2021-02-01 | vaccination site warmth, vaccination site redness, vaccination site pain |
slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; ...
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slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; at the site of vaccination was redness, soreness, and heat; possible cellulitis; This is a spontaneous report from a contactable other HCP. A 60-years-old female patient receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 16:45 at single dose (lot number: EK4176) for covid-19 immunisation. Medical history included hypertension (HTN), anxiety, arthritis, seasonal allergy, known allergies: Penicillin, Sulfa, Bactrim. No covid prior vaccination. Concomitant medication included losartan, citalopram, cetirizine. The patient experienced vaccine resulted in slight redness and soreness at the site. This gradually dissipated over a few days, but not completely. On 15Jan2021 a couple hours after exercising (elliptical use and hand weights) at the site of vaccination was redness, soreness, and heat. Upon waking up 16Jan2021, the redness, soreness and heat had increased - area was 6cm x 7cm - contacted pcp and was advised to go to (urgent care withheld) which she did and was prescribed Doxycycline for possible cellulitis. Today 18Jan2021, redness, soreness, and heat have much improved. Treatment received for the events. Events resulted in physician office/clinic visit. Outcome of events was recovering.
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| 60 | 2021-02-02 | itchy skin |
Developed Itching and feeling of tightness in back of nose/throat. Advised employee to go to ED. Was...
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Developed Itching and feeling of tightness in back of nose/throat. Advised employee to go to ED. Was given 1L fluid, Solu-Medrol and Benadryl. No swelling of airways was observed and no respiratory distress noted. ED discharged patient to home.
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| 60 | 2021-02-02 | rash, itchy skin, hives | Itching, rash, hives |
| 60 | 2021-02-03 | injection site pain |
minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reporte...
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minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reported to job 1/15. She had hard time to ambulate wearing a facemask. 1/17 sx fully resolved.
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| 60 | 2021-02-04 | rash |
At 2:30 pm after being in observation for 30 minutes, patient became concerned about a rash to her l...
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At 2:30 pm after being in observation for 30 minutes, patient became concerned about a rash to her left arm. There was a small area that had a lace modeling appearance. Patient denied any pain or itchiness to this area and there were no hives. Patient very anxious and concerned and asked if she could take her own liquid Benadryl which she had on hand. She was offered Benadryl from the clinic but refused and really wanted to take her own. Approval from supervisor obtained and Benadryl was verified. VS BP 110/60, HR 76 and pulse ox 98% at 2:35 pm. Patient denied any other signs and symptoms of allergic reaction except anxiety. VS repeated at 2:55pm and were; BP 110/60, HR 68, Pulse ox 100%. No change in condition and patient felt good enough to leave. Patients sister accompanied her to the clinic today and will stay with her tonight.
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| 60 | 2021-02-04 | skin spots |
admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a co...
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admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a contactable physician. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) via Intramuscular on 18Jan2021 into left arm at a single dose for covid-19 immunization. Medical history included hypothyroidism and neomycin allergies. The patient did not get covid prior vaccination. Concomitant medications included calcium, levothyroxine sodium (SYNTHROID), trazodone, tocopherol (VIT E) and no other vaccine in four weeks. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via Intramuscular on 28Dec2020 into left arm at a single dose for covid-19 immunization. 24 hours after injection she developed petechiae and was admitted to hospital with platelet count of 8,000 on 20Jan2021 22:00, the patient has ITP with baseline platelet count of 60,000. All events lead to hospitalization for 5 days (PENDING CLARIFICATION) and received IgG and oral Dexamethas as treatment. On 20Jan2021, the patient did Sars Co V 2 RNA test via Nasal Swab and result negative. The outcome of the events was recovering.; Sender's Comments: Based on a close chronological association, a causal relationship between events petechiae and thrombocytopenia and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-02-05 | rash |
Client complaining of rash on upper chest and feeling flush . evaluated by EMS. BP 140/94, P 90, O2 ...
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Client complaining of rash on upper chest and feeling flush . evaluated by EMS. BP 140/94, P 90, O2 97% Lungs clear.Client called family to pick her up and take to her PCP.
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| 60 | 2021-02-05 | hives, injection site reaction |
Nothing major. A weeping painful welt to the right of injection site started overnight on the day o...
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Nothing major. A weeping painful welt to the right of injection site started overnight on the day of injection. Did not report Subsided several days later
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| 60 | 2021-02-06 | rash |
Developed rash at back. Resolved spontaneously at one week post vaccination. Vaccine #2 given 3 week...
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Developed rash at back. Resolved spontaneously at one week post vaccination. Vaccine #2 given 3 weeks later @ 2/7/21. Rash reported when patient came in for Pfizer vaccine #2 (after resolved). Did not report to healthcare system or present to medical care for evaluation.
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| 60 | 2021-02-07 | itchy skin |
Pt had vaccine at about 1pm, did well, went back to work. At 2pm, pt came back to say she was itchin...
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Pt had vaccine at about 1pm, did well, went back to work. At 2pm, pt came back to say she was itching all over arms, back hands, scalp. BP 138/62, gave one diphenhydramine 25mg po. At 2:15-- same symptoms, no worsening. At 2:30pm, per pt less itchy; NO n/v; NO thickening feel of tongue/throat; pt will take Allegra at 6pm; will notify Dr/ER if any worsening of symptoms
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| 60 | 2021-02-07 | rash, vaccination site pain |
injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous repor...
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injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous report from a non-contactable other hcp (patient). A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 14:30 at single dose in Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history was none. Concomitant drug received within 2 weeks of vaccination included Multivitamin. The patient previously received first dose of BNT162B2 on 29Dec2020 03:15 PM at single dose in Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 6 hrs on 19Jan2021 21:00 PM, the patient experienced injection site pain. After 12 hrs the patient experienced chills, muscle aches, fatigue in Jan2021. The patient experienced Rash on torso, arms 36 hours after in Jan2021. The outcome was Recovering. No treatment received for events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.
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| 60 | 2021-02-08 | hives | HIVES ALL OVER |
| 60 | 2021-02-08 | hives |
The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and g...
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The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and globus sensation pale and tremulous. Nurse noted that she had a 4mm hive above her lip. The treatment of the reaction was: o Epinephrine: x1 Transferred to ED
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| 60 | 2021-02-08 | injection site mass |
her face got swollen; lymph node right there it was extremely swollen and very tender and very painf...
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her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.
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| 60 | 2021-02-08 | skin warm, injection site swelling, injection site redness |
left upper arm redness and swelling. She reports she got the second Pfizer COVID-19 vaccine on Mond...
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left upper arm redness and swelling. She reports she got the second Pfizer COVID-19 vaccine on Monday 2/1. She reports the area is red right after the vaccine. She reports she has had increased swelling, redness, warmth. She reports she did have reaction to her first vaccine with redness and swelling, but that occurred 10 days after. She reports she has had some fever and body aches that she associates with having the second vaccine. Constitutional: Negative for chills and fever. HENT: Negative for sore throat. Eyes: Negative for visual disturbance. Respiratory: Negative for cough and shortness of breath. Cardiovascular: Negative for chest pain. Gastrointestinal: Negative for abdominal pain, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for joint swelling and arthralgias. Negative for back pain. Skin: Positive for color change. Negative for rash. Neurological: Negative for weakness and numbness.
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| 60 | 2021-02-09 | rash |
fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22De...
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fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22Dec2020, second dose 15Jan2021; first dose 22Dec2020, second dose 15Jan2021; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) on 15Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient previously received first dose of BNT162B2 (lot number: EL0140) on 22Dec2020 at single dose for COVID-19 immunization, and experienced fatigue, low grade fever and rash. The patient received the vaccine and had minor side effects that were explained like fatigue, low grade fever, everything responded to the ibuprofen (ADVIL) a NSAID. The booster received on time on 15Jan2021 and she had a quite a challenge with it for about a week, she had the increased fatigue, really incredible body ache, the fever went away in about 2 days but fatigue lasted definitely a full week. About the 3rd day a rash started and that was not going away, she was not sure what to so about it, it became worst if she exercise, very prominent if she exercise. It's been a little over a week with symptoms of fatigue and body ache went away. The rash that she can not get rid of; It was very disturbing the rash; looks like measles on her face. Treatment included the body ache was responding to ibuprofen but fatigue she just trying to take more rest. Lab data included CBC (Full blood count) on unspecified date, that was normal. The outcome of fatigue, low grade fever, incredible body ache was recovered on unspecified date, outcome of other events was not recovered. Causality assessment from the reporter between the vaccine and events was related.
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| 60 | 2021-02-09 | vaccination site swelling |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3249, exp.date May2021 on 15Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm. The patient had get earlier in January a DPT (diphtheria, pertussis, and tetanus) vaccine in the left arm. The patient had have a Pneumonia and Shingles vaccines in the last 2 years and she had no problems in past with vaccines, but stated she did get a little bit of swelling and had to put heat to the area with vaccines, but never had a fever afterwards. The patient had not medical history. Concomitant medications were not reported. No other vaccines given the same day. Since 16Jan2021, he started having symptoms, fever, cough and Diarrhea. On 17Jan2021 the patient was positive to SARS-CoV-2 test. On 19Jan2021 she received monoclonal antibody therapy. The outcome of the event was not recovered.
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| 60 | 2021-02-10 | injection site swelling, skin warm, injection site warmth, injection site pain, injection site redness |
Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the ne...
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Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the neck. Then my arm pit was swollen, hot and the swelling went down my arm. I also had diarrhea, Nausea, slight head ache, chills, body ache with a temp of 101.5. Went to the doctor yesterday because of my armpit swelling, hot to touch and it had a red band. She said where they gave it was not in a muscle. It was given sub Q & that it went into my lymph gland and leaked down my arm to swell. Right now I just have on and off nausea , pain in my lymph glands in my arm pit. The swelling and pain has gone down and the other symptoms have faded away.
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| 60 | 2021-02-10 | itchy skin |
Evening of vaccine. Slight itching. Day after vaccine - Headache, mild "fever /chills" No Rigor, All...
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Evening of vaccine. Slight itching. Day after vaccine - Headache, mild "fever /chills" No Rigor, All over body aches worse than flu, fatigue.
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| 60 | 2021-02-10 | injection site pain |
For about 24 hours soreness in left arm near injection site, more swelling and a lump under left arm...
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For about 24 hours soreness in left arm near injection site, more swelling and a lump under left arm and burning sensation under left arm and chest area where I typically have swelling and numbness due to lymphedema post mastectomy. Resolved within 24 hours with no treatment.
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| 60 | 2021-02-10 | hives |
On Tuesday she woke up with a headache that gradually worsened. The headache was behind the right ey...
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On Tuesday she woke up with a headache that gradually worsened. The headache was behind the right eye, the right ear, and the teeth on the right side also hurt. Nothing helped taking Acetaminophen; Ibuprofen. She went to sleep around 4:00 am finally, and then woke up 6 hours and the headache was gone. Then you had hives located behind the right ear and down the neck, into the right shoulder. They are also in her scalp. They have now down to the tops of her legs, hips, and back and are spreading. She called her doctor who called her in some prescriptions.
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| 60 | 2021-02-10 | injection site pain, redness, rash macular |
The skin on my arms and legs (mostly noticed arms) looked marbled red immediately after vaccine. It...
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The skin on my arms and legs (mostly noticed arms) looked marbled red immediately after vaccine. It is still there but not as bad as it was initially. I googled skin conditions and it looks like Livedo reticularis. I went to my Cardiologist on 2/5/21 and he took bloodword CBC, Prothrombin Time and bloodwork was normal. Cardiologist told me to go to a dermatologist. My arm was sore also where the injection was and it was hard to lift my arm. That lasted one day. I also had aches and pains and was fatigued on 2/3/21 for 24 hours.
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| 60 | 2021-02-10 | injection site pruritus |
on 2/6/2021 woke up in am with headache, chills, temperature . Symptoms continued with chills, sweat...
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on 2/6/2021 woke up in am with headache, chills, temperature . Symptoms continued with chills, sweating, lethargic with muscle aches and pains along with temp. Temperature returned to normal in pm on 2/7/2021. Muscle aches and pains, itchy at injection site and being tired lasted another couple of days. Feeling back to normal by 2/10/2021
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| 60 | 2021-02-10 | skin warm |
pt reported mild dull headache and warm head.given water and saltines with improvement. BP slightl...
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pt reported mild dull headache and warm head.given water and saltines with improvement. BP slightly elevated. Pt admitted to stress. Monitored for additional 30 min. Pt felt ok to go.
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| 60 | 2021-02-14 | itchy skin |
2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYE...
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2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.
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| 60 | 2021-02-14 | itchy rash, rash papular, rash |
About 30 hours after vaccine I had bumps on my shoulder blade on left side where I received the vacc...
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About 30 hours after vaccine I had bumps on my shoulder blade on left side where I received the vaccine - a rash that itched. It lasted about 4 or 5 hours - I put Calamine lotion on it and that soothed it. I also experienced a little itching of eyes and a slight itching in mouth. About 9:30 pm I had a rapid heartbeat for about 30 or 40 minutes. The itching sensation continued off and on the next day but bumps weren't visible any longer. The itchy eyes continued off and on for the next day as well.
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| 60 | 2021-02-14 | injection site pain | Injection site pain, body aches, lightheadedness, chills |
| 60 | 2021-02-14 | injection site pain, itchy skin, redness |
Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbea...
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Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbeat with severe pressure and chest pain. Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.
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| 60 | 2021-02-14 | vaccination site pain |
Soreness at site of injection; loose bowels; This is a spontaneous report from a contactable consume...
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Soreness at site of injection; loose bowels; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via unspecified route of administration on 26Jan2021 at 02:30 PM in left arm at single dose for COVID-19 immunization in the workplace clinic. There was no other vaccine administered in four weeks. Medical history included gluten intolerant. No Known allergies. Concomitant medication included calcium, ergocalciferol (VIT D), ibuprofen (ADVIL), multivitamin. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient experienced soreness at site of injection and loose bowels on 27Jan2021 at 07:15 AM. No treatment was received for adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was not recovered. No follow-up attempts possible. No further information expected.
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| 60 | 2021-02-15 | injection site pain |
8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; sev...
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8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; severe body aches; injection site throbbing; upset stomach and a feeling of nausea. Temperature 100.2 at 8:45. Took temp every hour. By midnight temp reached 102.7. Head ache started. Couldn?t sleep on my left side because of the extreme pain around the injection site and down my left arm. Finally fell asleep around 2:30 and woke at 5:30. Fever was gone. Temp read 98.9. Body aches still present but not as severe. Arm pain had eased but head ache remained most of the day. Felt much better but just very tired.
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| 60 | 2021-02-15 | itchy skin, redness |
Patient was premedicated with Zyrtec 10 mg at 2:15 prior coming to her second appointment. She repo...
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Patient was premedicated with Zyrtec 10 mg at 2:15 prior coming to her second appointment. She reported similar symptoms from pfizer Vaccine first dose after 25 minutes of observation for the second vaccine. Reported slight itchiness and facial redness. sightly less than previous dose. The allergist on call was notified, ordered Zyrtec 10mg. Zyrtec 10 mg a/o. Initial BP 176/76 HR 64-sat 100% RA. . BP186/80 - HR 54. HR 60 BP 168/78, Observation 1:1 by RN maintained. BP prior dc 152/79 Hr 58.
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| 60 | 2021-02-15 | injection site bruising, injection site mass, injection site discolouration, injection site redness, hives |
The day of the vaccine there was no reaction. Day 2 I woke up with red angry lump at the injection s...
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The day of the vaccine there was no reaction. Day 2 I woke up with red angry lump at the injection site, about the size of a 0.50 cent piece. Later that day I had a fever of 102.5 and chills. Day 3 the redness had spread and still had the lump. Day 4 or 5 the color changed to purple and the lump had decreased. It took about a week for the lump to go away. I still have a discoloration on my arm where the vaccine was given. It looks a bruise but no pain. The whole time the area blanched well. The first dose I had on my left arm and the next day I had a small welt with redness. I am on my second round of steroids to try and get my asthma under control and had to increase my Advair to the highest dose. My doctor put me on a antibiotic as well with the second round of steroids. My asthma is a little better but not at my baseline.
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| 60 | 2021-02-16 | rash |
2nd dose pizer 2/11; 2/12 fatigue, body aches, 2/16 rash noticed 5PM (bra line, breast, back, legs,...
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2nd dose pizer 2/11; 2/12 fatigue, body aches, 2/16 rash noticed 5PM (bra line, breast, back, legs, down thighs at bedtime, under arms), rash was spreading, pt put calamine lotion on rash, woke up 2/17/21 and rash is gone.
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| 60 | 2021-02-17 | vaccination site redness, vaccination site mass, vaccination site itchiness, vaccination site warmth, redness, skin discolouration |
This is a spontaneous report from a contactable consumer. A 60-year-old female patient received sec...
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This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, subcutaneous on 20Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included diabetes, anaemia, blood pressure, cholesterol. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EU9899, in the left arm on 30Dec2020 15:00 at SINGLE DOSE for COVID-19 immunization and experienced swelling and redness at the site. Concomitant medications included liraglutide (VICTOZA), labetalol (LABETALOL), diltiazem (DILTIAZEM), valsartan (DIOVAN), rosuvastatin, metformin, aspirin and iron. The patient thinks that it wasn't given to her intramuscularly. This is a potential inadvertent subcutaneous administration of the BNT162B2. This patient received her second dose on 20Jan2021 on the side of her arm and reported that it was swollen, red, and hot, but has gotten 100 times better' over the last 6 days since administration. She was asking for efficacy of the incorrectly administered dose. It was further stated that in the middle of the night, her arm was red almost like a little bullseye and she said that she was getting burning, and pins and needles down her arm, and a fullness in her hand like her hand was swollen. She said that she still kind of feels it. As the days progressed on day 2, 3, and 4, the swelling got more intense, the circular red swollen area got worse to the size of like a small baseball. She was feeling okay other than that. Today was day 6 and it was not as red and was more black and blue, swelling went down 80 percent, she still feels a little bit of the pins and needles and the fullness in her hand. She said that there was like a big knot that was very hot. It was a hard like knot at the injection site. The injection site was really big, round, hot, red, and had a knot that lasted; adds it is still there but 99% better; and she had tingling down her arm with pins and needles in her hand. She noticed it was little red a couple of hours, like 8 hours later; but by the next day it was circular, more red, swollen, itchy, and burning down her arm. By the third day, the site had a big, red, hard knot; still burning down her arm and with pins and needles down her arm. She added that her hand felt like a fullness in her hand filled with fluid. By Friday the swelling at the site was gigantic. The site swelling is improved but the redness was more of a black and blue now. Her arm has been very dark red, discolored, swollen, painful and has nerve pain described as "hot tingling down the arm like pins and needles" to her hand. She states that she has a very large knot at the injection site. This was in her non-dominant arm. She spoke with two of the pharmacists that she works with and they looked at her arm and both felt like she may have received the injection subcutaneously instead of intramuscularly. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
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| 60 | 2021-02-18 | injection site pain | Fever, pain in the arm where I got the shot. nauseated |
| 60 | 2021-02-18 | hives | Hives on the neck, breast and torso . |
| 60 | 2021-02-21 | vaccination site swelling | Large red bump 2 inches below vaccination site. Seems to be getting bigger. |
| 60 | 2021-02-22 | rash with redness, itchy rash, rash | Round rash the size of a 50 cents coin. Itchy and red. The area turns white when I lift my arm. |
| 60 | 2021-02-23 | skin discolouration, hives, injection site pain |
2/9: redness and blue color and pain around the shot site 2/13: fever 101F, body ache, headache, tir...
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2/9: redness and blue color and pain around the shot site 2/13: fever 101F, body ache, headache, tiredness, - Tylenol every 5 hours 2/14: fever 99 F, body ache, headache, tiredness, hives on chest, stomach, back, arms, - Tylenol every 6 hours 2/15: no fever, hives fading out 2/16: tiredness, hives cleared up
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| 60 | 2021-02-23 | skin burning sensation |
Felt burning towards the ears and cheeks and some numbness, reported not having any difficulty brea...
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Felt burning towards the ears and cheeks and some numbness, reported not having any difficulty breathing but felt like she had to take off her mask to get "air", slight numbness in the arms and felt flushed.
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| 60 | 2021-02-23 | rash, itchy rash |
I had the shingle injection in between the two covid injections. I've had a itchy rash for 6 weeks ...
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I had the shingle injection in between the two covid injections. I've had a itchy rash for 6 weeks on my legs and torso. Some raised welts and some regular rash. Nothing over the counter seems to help much.
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| 60 | 2021-02-23 | injection site pain |
Other than mild soreness at the injection site she experienced no adverse reactions during the first...
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Other than mild soreness at the injection site she experienced no adverse reactions during the first 24 hours post-vaccine. On the second day after vaccination she developed chills without fever followed by the appearance of rhinorrhea and sinus headache that persisted for about one week. As she has a past history of genital herpes and this resembled her prodrome for recurrence she self-administered valacyclovir for several days. On the eighth day after vaccination she noted mild hand tingling. The following morning she awoke with numbness and hyperesthesia of the left shin that is still present.There was no persistent tingling and no pins and needles sensation
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| 60 | 2021-02-23 | redness, rash with redness, itchy skin |
Pt reported slight tongue "tingling" and also has a small patch of flat erythematous area on her ski...
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Pt reported slight tongue "tingling" and also has a small patch of flat erythematous area on her skin about 8 minutes after the vaccine was administered. She does report the reddened area is itchy. She denies SOB, denies airway tightness, denies chest pain. Her vitals at 1356 hours are a HR of 66, BP of 139/74, RR of 18, Sats 100%, RR 16. Pt took a PO benadryl at 1347 hours per her request as she had already declined further EMS care (ALS and ambulance declined). Her Sxs resolved by 1356 hours. She stayed a few more minutes to be sure her symptoms were completely resolved and left POV at 1407 hours. She will follow up with her physician as soon as she leaves. She has been notified that her symptoms could return.
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| 60 | 2021-02-23 | injection site pain, injection site swelling, redness |
The vaccine was not injected into the muscle as prescribed. The nurse pinched up the fat on my arm w...
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The vaccine was not injected into the muscle as prescribed. The nurse pinched up the fat on my arm with a short needle. My upper arm swelled almost to the size of a baseball and was red and painful for over one week. I think it was administered SQ although intended to be IM. I am a nurse and thought to myself at the time of injection that the proper technique for administering the shot was not followed, but thought perhaps I could be wrong and the extra swelling might be normal with the second injection. My first injection was in left arm and did not swell and was only sore for a few days. If administered SQ, will the vaccine dose be effective?
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| 60 | 2021-02-24 | rash | 10 min. After shot developed rash to chest, torso. On 4th day developed SOB, chest pain and fatigue. |
| 60 | 2021-02-24 | redness |
1010 pt c/o eyes draining clear fluid, generalized tingling, redness Dr notified and assessed order ...
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1010 pt c/o eyes draining clear fluid, generalized tingling, redness Dr notified and assessed order received to administer po benadryl 25 mg po 1030 symptoms resolving continued to monitor for additional 30 min. 1100 pt stable and symptoms resolved left premises this time.
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| 60 | 2021-02-24 | rash, itchy skin, rash macular | itchy, chickenpox type rash on armpit, back, and trunk |
| 60 | 2021-02-25 | itchy skin |
Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some...
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Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.
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| 60 | 2021-02-25 | itchy skin, injection site redness, rash, injection site pruritus |
Itchiness and Rash: Multiple body areas: between and under breasts, lower back area, under arms. ...
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Itchiness and Rash: Multiple body areas: between and under breasts, lower back area, under arms. It was also on my left arm around the injection site but that has gone away. Date of 1st dose: 1/8/2021 - ELO140 Date of 2nd dose: 1/29/2021 - EJ1686
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| 60 | 2021-02-26 | rash, hives | Pfizer-BioNTech COVID-19 Vaccine EUA Rash/hives, 2 Benadryl at 7:30P |
| 60 | 2021-02-26 | rash, itchy rash |
While in observation area, patient reported to EMT a rash and itchiness in abdominal area. EMT notif...
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While in observation area, patient reported to EMT a rash and itchiness in abdominal area. EMT notified lead nurse on site. EMT assessed patient and reported blood pressure 142/90 mmHg, regular pulse 60 bpm, and respirations 16 breaths per minute. Patient denied difficulty breathing, difficulty swallowing, and chest pain. Patient revealed history of allergies to unspecified medications. Patient offered diphendyramine. Patient refused diphenhydramine. Patient advised to wait 15 minutes for further observation. Lead nurse assessed patient. Patient reported decreased itchiness and denied difficulty breathing, difficulty swallowing, and chest pain. Patient advised to seek emergency care if symptoms progress. Patient left observation area with steady gait.
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| 60 | 2021-02-27 | rash, rash papular |
Rash on neck last for one week. After one week, small bumps still remain 10 days later. Bumps are fo...
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Rash on neck last for one week. After one week, small bumps still remain 10 days later. Bumps are focused vertically from chin
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| 60 | 2021-02-28 | itchy skin | itching to head, face, neck, arms, chest, back 20 minutes after administration |
| 60 | 2021-02-28 | vaccination site redness, vaccination site swelling |
swelling at the site; redness at the site; This is a spontaneous report from a contactable consumer ...
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swelling at the site; redness at the site; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: EU9899), via an unspecified route of administration in the left arm on 30Dec2020 at 15:00 as a single dose for COVID-19 immunisation. Medical history included anemia, diabetes mellitus, blood cholesterol abnormal, blood pressure abnormal, and low FE. The patient had no additional vaccine/s administered on the same date as BNT162B2, had no prior vaccinations within four weeks, and had no family medical history. Concomitant medications included liraglutide (VICTOZA; taking for 8 years), labetalol (taking for 20 years), diltiazem (CD taking 20 years), valsartan (DIOVAN; taking for 20 years), rosuvastatin (taking for 10 years), metformin (taking for 20 years), aspirin [acetylsalicylic acid] (taking for 10 years), and iron; all are ongoing. On 30Dec2020, the patient experienced swelling at the site and redness at the site. The patient stated that after the first dose, she noticed a little bit of swelling and redness at the site that went away in 48 hours. She had no relevant tests done. The events did not require any visit to a physician or to the ER. Outcome of the events was recovered.
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| 60 | 2021-03-01 | redness |
I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I ...
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I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge. During the night I woke up because the phlegm was much worse and abundant I wanted to sleep so at first was swallowing it, then it was so much that I got up and went to the bathroom. That is when I noticed that the palms of my hands were scarlet red. on both hands and not on the wrists or any where else. by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach. Yesterday , 3 days later, still had diarrhea and nausea and was tired,,symptoms are not severe, but since these are not typical symptoms for me. I figured they will go away, but also I figured that I should communicate the reaction . I am scheduled for my 2nd shot in 3 weeks,
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| 60 | 2021-03-01 | redness, skin warm |
Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By ...
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Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By 2/10/21 in the morning both elbows, knees and wrists were sore. Elbows and right knee felt warm to the touch. Nodules or red spots developed around the joints. I could barely walk or climb in and out of the car, the bed, and had a very difficult time standing up from the toilet or a low chair or couch. No fever, but did have a few chills with teeth chattering at least twice.
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| 60 | 2021-03-02 | itchy rash, rash with redness | 8 days later got Covid arm, itchy red rash on arm |
| 60 | 2021-03-02 | injection site pruritus, injection site redness, injection site swelling |
Metallic taste in mouth that dissipated after about an hour, redness/swelling at injection site and ...
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Metallic taste in mouth that dissipated after about an hour, redness/swelling at injection site and itching that persisted for 3-4 days.
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| 60 | 2021-03-03 | shingles | Shingles erupted on right hip/buttock |
| 60 | 2021-03-04 | rash macular |
COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient dev...
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COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD
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| 60 | 2021-03-04 | bruising | Pfizer COVID vaccine. Bruise on LEFT HAND of the left arm where I received the shot within 1 hour. |
| 60 | 2021-03-04 | injection site pain |
Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on m...
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Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.
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| 60 | 2021-03-04 | itchy rash, rash with redness |
Red, itchy, bumpy, swollen rash on right shoulder extending to right breast. Swelling of left hand...
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Red, itchy, bumpy, swollen rash on right shoulder extending to right breast. Swelling of left hand, stiffness, hard to move fingers, same rash as above between fingers.
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| 60 | 2021-03-06 | rash, itchy rash, rash with redness |
Four days after vaccination my trunk was covered with a red rash that was slightly itchy. The next d...
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Four days after vaccination my trunk was covered with a red rash that was slightly itchy. The next day it spread partly down my arms and legs. On day 6 I had malaise and fatigue and lessening of rash.
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| 60 | 2021-03-07 | injection site discomfort |
Almost immediate discomfort at injection site, followed by sore shoulder (left) and neck pain as wel...
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Almost immediate discomfort at injection site, followed by sore shoulder (left) and neck pain as well as headache for 24 hours. One week later, severe joint pain for 48 hours.
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| 60 | 2021-03-07 | redness, skin warm |
On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My thr...
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On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My throat and left cheek started to swell and turn slightly red. I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment. At the hospital, they gave me steriods, benadryl and Pepcid in an IV. After allowing this to work, they sent me home with a steriod prescription for 60Mg for the next 5 days. They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine. Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned. I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days. They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body. It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees. In the morning, it is usually in my face and then it moves around during the day. I can feel this fluid moving around in my body because the redness brings swelling/fluid. This last saturday 3/6/2021 was horrible, it was in my right ear and right foot. It was very painful and made me very dizzy. I struggled to walk. Then on Sunday morning, I felt fine all day. Today Monday, it feels like it is in my right foot again, but I feel like It is getting better.
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| 60 | 2021-03-07 | redness |
left arm became red and tender 2 days after the shot- and has continued for a total of 3 days withou...
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left arm became red and tender 2 days after the shot- and has continued for a total of 3 days without change
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| 60 | 2021-03-07 | rash, itchy rash |
swelling, itchy spots: , itchy knot on hip, itchy spots: under breasts, ears, and palms-- swollen li...
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swelling, itchy spots: , itchy knot on hip, itchy spots: under breasts, ears, and palms-- swollen lips
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| 60 | 2021-03-08 | itchy skin | Facial swelling and total body itching |
| 60 | 2021-03-08 | injection site pain |
Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hur...
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Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hurt, weak, mild consistent headache, nausea, skin sensitivity, feeling like a bad case of the flu for 30 hours. Getting better by Sunday evening. Still not 100% as of Tuesday. Slight headache comes and goes like a sinus infection would feel like.
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| 60 | 2021-03-08 | vaccination site pain |
Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 60...
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Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9265, via an unspecified route of administration, in the right arm, on01Feb2021 11:30 at SINGLE DOSE for covid-19 immunization. Medical history included diabetes, high cholesterol, high blood pressure and penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced soreness at injection site on 01Feb2021 11:30. The outcome of event was recovered. No follow-up attempts possible. No further information expected.
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| 60 | 2021-03-08 | injection site reaction |
This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier t...
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This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.
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| 60 | 2021-03-09 | rash |
FLARE OF A RASH ON MY LOWER LEGS, HIGHLY INFLAMED AND SWOLLEN, DR. PRESCRIBED TRIAMCINOLONE ON 02/12...
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FLARE OF A RASH ON MY LOWER LEGS, HIGHLY INFLAMED AND SWOLLEN, DR. PRESCRIBED TRIAMCINOLONE ON 02/12/21. IT IS BETTER BUT NOT GONE AT THIS TIME.
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| 60 | 2021-03-09 | vaccination site pain |
Fever ranging from 100 to 100.9; Chills; Headache; Soreness at site of injection; This is a spontane...
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Fever ranging from 100 to 100.9; Chills; Headache; Soreness at site of injection; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration in left arm, on 05Feb2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231) on 13Jan2021 at 01:45 PM for COVID-19 immunization (in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 06Feb2021 at 02:00 AM, the patient experienced fever ranging from 100 to 100.9 accompanied by chills and moderate headache as well. Fever subsided by the morning of 07Feb2021 and headache was mild by then. The patient also experienced soreness at site of injection on 06Feb2021 at 02:00 AM only if she touches it. No treatment was administered for the adverse events. The patient has not been tested for COVID-19 post vaccination. The patient was recovering from the events.
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| 60 | 2021-03-09 | injection site swelling, injection site pain |
On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3...
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On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.
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| 60 | 2021-03-09 | itchy rash, rash with redness |
Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction....
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Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction. Itchy red spots all over head, ears and neck, some on lower part of body. Swollen lip. Took two benadryl at 1:45 am Wednesday . This helped to ease the itching. Had a headache so on Wednesday morning I took two Tylenol and made a Dr. appt. Also was weak and faintish on Wednesday when I got up. Dr's said to keep taking anti-histamines and report to ER if tongue or throat starts to swell.
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| 60 | 2021-03-09 | redness, itchy skin |
Within 15 minutes after 2nd COVID-19 mRNA vaccination (Pfizer) today, patient reported itching of le...
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Within 15 minutes after 2nd COVID-19 mRNA vaccination (Pfizer) today, patient reported itching of left forearm (vaccine administered in left deltoid), which then also started in right arm and upper back. Slight redness noted on left forearm where patient had been scratching but no visible hives or rash. Patient denied any difficulty breathing, shortness of breath, throat tightness or itching. Diphenhydramine 25mg PO x1 dose administered. A few minutes after diphenhydramine administration, patient reported that her eyes had become itchy. 20 minutes after diphenhydramine dose, patient denied any worsening of symptoms, reported lessened itching and opted to leave clinic.
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| 60 | 2021-03-09 | rash, rash with redness, itchy rash, rash papular, skin peeling |
burning itchy red bumpy rash started on left elbow, then spread to right elbow. Went to dermatologi...
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burning itchy red bumpy rash started on left elbow, then spread to right elbow. Went to dermatologist on 2/24 for biopsy (gluten rash, psoriasis) and was prescribed Clobetasol 2x day. Rash dried up with skin flaking and peeling in about 5 days. Second vaccine received 3/4, no rash as of 3/10
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| 60 | 2021-03-09 | injection site pain |
mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after in...
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mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after injection lasting 2 days. Headache, nausea and weakness day after vaccination lasting 24 hours.
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| 60 | 2021-03-09 | rash papular, rash, rash with redness |
raised, red rash bilateral hands from inside of thumbs to mid-forarm. provided 50mg of diphenhydram...
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raised, red rash bilateral hands from inside of thumbs to mid-forarm. provided 50mg of diphenhydramine. observed patient for additional 30 minutes. rash decreased in severity and there were no other symptoms (difficulty breathing, increased heart rate, etc)
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| 60 | 2021-03-09 | itchy skin |
sever headache itching over entire torso both began about an hour after injection. Lasted through th...
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sever headache itching over entire torso both began about an hour after injection. Lasted through the evening and night Took Tylenol
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| 60 | 2021-03-10 | itchy rash, injection site pain |
Itchy rash looks like mosquito bites on legs, stomach and arms; soreness at injection site, tirednes...
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Itchy rash looks like mosquito bites on legs, stomach and arms; soreness at injection site, tiredness
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| 60 | 2021-03-10 | hives, rash | On March 6, I experienced swelling of the face, hands, throat accompanied by hives/rash over body. |
| 60 | 2021-03-10 | rash | Rash around neck area |
| 60 | 2021-03-11 | itchy skin | Itching, coughing, wheezing, |
| 60 | 2021-03-11 | injection site pain |
Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started aro...
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Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9
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| 60 | 2021-03-11 | itchy skin, hives |
Patient was receiving an IVIG infusion at the time of reaction. Patient has had infusion many times...
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Patient was receiving an IVIG infusion at the time of reaction. Patient has had infusion many times in the past with no reaction, so we are possibly attributing the reaction to her recent COVID vaccine. Severe hives/boils from neck to knees Itching IV methylprednisolone was administered in the home to control reaction. Her MD prescribed famotidine and loratadine to assist with relieving her symptoms.
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| 60 | 2021-03-12 | hives, itchy skin |
whole body sever itching. Scratched shin raw, back had hives, abdomen continues to sporadically itc...
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whole body sever itching. Scratched shin raw, back had hives, abdomen continues to sporadically itch. Never experienced itching of this nature this before. MUCH BETTER, but not fully resolved. (My Mother had same response to her second Moderna COVID19)
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| 60 | 2021-03-13 | injection site rash, skin peeling, injection site pain |
2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:...
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2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache
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| 60 | 2021-03-13 | injection site pain, itchy skin |
Burning sensation at injection site, felt itching in ears when administered. Felt sore since vaccine...
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Burning sensation at injection site, felt itching in ears when administered. Felt sore since vaccine was administered. Today, 03/14, woke up feeling very sore and around 11:45am I began to feel chills, body aches, headache and fever.
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| 60 | 2021-03-13 | injection site pain |
Extreme energy within 30 minutes of injection Followed about 2 hours later by extreme fatigue (slep...
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Extreme energy within 30 minutes of injection Followed about 2 hours later by extreme fatigue (slept over 3 hours between 11am and 3pm) Severe pain at the injection site and muscles surrounding it (approx. 8pm) continuous as of this report (3/14/21 12:45am) Pain in the lower left jaw (approx 9pm) continuous as of this report (3/14/21 12:45am)
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| 60 | 2021-03-13 | redness |
I have a swollen uvula with blood red spot on the side. It is hard to swallow and it burns. I will ...
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I have a swollen uvula with blood red spot on the side. It is hard to swallow and it burns. I will call my doctor tomorrow morning.
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| 60 | 2021-03-13 | injection site pain |
INJ. PAIN 3/11/2021 TIREDNESS 3/12 &13/2021 HEADACHE 3/11 & 12/ 2021 MUSCLE PAIN 3/11 & 12/2021 C...
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INJ. PAIN 3/11/2021 TIREDNESS 3/12 &13/2021 HEADACHE 3/11 & 12/ 2021 MUSCLE PAIN 3/11 & 12/2021 CHILLS 3/12 & 13/2021 JOINT PAIN 3/11/12/13/2021 FEVER 3/12/13/2021 102.5 & 100.2 FEELING UNWELL 3/12/13/2021 I JUST KEPT TAKING TYLENOL TILL I FELT BETTER. I AM FINE TODAY. 3/14/2021
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| 60 | 2021-03-13 | injection site redness, injection site rash, injection site pain |
red rash around injection site soreness at injection site had bump on injection site body aches head...
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red rash around injection site soreness at injection site had bump on injection site body aches headache
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| 60 | 2021-03-14 | vaccination site redness, vaccination site warmth |
Injection site warm, raised, and red; Injection site warm, raised, and red; Left arm felt bruised af...
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Injection site warm, raised, and red; Injection site warm, raised, and red; Left arm felt bruised after she got the injection; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL9262, first dose) solution for injection intramuscular in the left arm on 08Feb2021 at 12:00 (at the age of 60-years-old) at single dose for COVID-19 vaccination. Medical history included obesity, arrhythmia (that was fairly under control, and was not life threatening) and palpitations (palpitations from time to time, but this medication did not cause that). Concomitant medications included escitalopram oxalate (LEXAPRO) and lisinopril. Historical vaccine included flu vaccine in Oct2020 and experienced bruised after the injection. After the vaccination, the patient experienced injection site warm, raised, and red on 08Feb2021. The patient experienced left arm felt bruised after she got the injection in Feb2021. The patient has had no treatment for her arm yet. The outcome of the events injection site warm, raised, and red and left arm felt bruised after injection was unknown.
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| 60 | 2021-03-14 | itchy skin | Left eye began watering, itching, swelling. Itching under left breast. |
| 60 | 2021-03-14 | rash with redness, rash papular |
Within 30-40 mins, I had a raised red mark starting at the base of my throat running up to my left ...
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Within 30-40 mins, I had a raised red mark starting at the base of my throat running up to my left nostril. There was a lighter red mark on the right side that stopped just above my chin. There was no burning, itching or soreness associated just the raised red marking. It started to dissipate within 2 hours
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| 60 | 2021-03-15 | itchy skin |
3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat ...
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3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat and upper chest. It got a bit worse and then improved over the next few hours. I also experienced a scratchy/itchy sensation in my throat and a slightly itchy feeling on the skin of my neck and upper chest. No wheezing or swelling. Took 25 mg Benadryl at bedtime. 3/13 ? Sensations continued, still fairly mild, but with occasional tingling on lips in addition to other symptoms. Took 25 mg Benadryl at bedtime. 3/14 ? Feeling about the same; still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime. 3/15? Symptoms continue to improve, but I?m still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime.
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| 60 | 2021-03-15 | injection site pain |
About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hou...
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About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hours having bouts of diarrhea every 5 to 10 minutes along with chills and feeling hot and abdominal pain. This morning on the 16 of March I feel okay with some fatigue and sore right shoulder at injection site.
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| 60 | 2021-03-15 | rash |
Allergic reaction to COVID-19 vaccine (rash on stomach - left side) Began 03/08/2021 cleared up and ...
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Allergic reaction to COVID-19 vaccine (rash on stomach - left side) Began 03/08/2021 cleared up and then reoccurred 03/11/2021 still evident 03/16/2021
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| 60 | 2021-03-15 | redness |
This patient was vaccinated approximately 1 hour prior to presentation here with her first dose of t...
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This patient was vaccinated approximately 1 hour prior to presentation here with her first dose of the Pfizer COVID-19 vaccine. She felt fine right after her vaccination but as she drove to her destination where she was going to take a walk, she started to develop left-sided facial burning and swelling. That prompted her to call her PCP in that office recommended she come back to the vaccination clinic to be evaluated. I evaluated her at approximately 2 PM.. She was feeling well for the most part with the exception of left-sided facial burning and swelling and a little bit of redness over her left cheek. She denied fevers, chills, itching, other areas of rash, difficulty speaking, difficulty swallowing, tongue swelling, lip swelling, wheezing, chest pain, or difficulty breathing. She recalls a penicillin allergy at age 5 or 6 but cannot remember the reaction. She has never reacted to a vaccine before. Initial vital signs included a blood pressure of 134/73, a pulse that was 70 and regular, and an oxygen saturation of 100% on room air. She had normal mental status and her lungs were clear. The left side of her face was slightly swollen over her left cheek as compared to the right with some slight increased flushing on the left side. There was no stridor, she was speaking comfortably, and her lungs were clear with good airflow. Her heart demonstrated S1 and S2 with regular rate and rhythm. I administered 2 doses of Benadryl, 25 mg with each dose about 15 minutes apart with her last dose at approximately 2:25 PM. I rechecked her vital signs at 2:50 PM and her blood pressure was 138/79 with a pulse of 70 and regular and an oxygen saturation of 99% on room air. Her lungs were clear and she was moving good air. I did take a relook at her face which was improved with decreased swelling. At 3 PM, because she was doing much better, I discharged her to home with instructions to use Benadryl 50 mg when she got home and then 25 to 50 mg every 4 hours today. If she develops any respiratory symptoms such as difficulty swallowing, cough, breathing difficulty, swollen tongue or swollen lips, as well as increased facial swelling, she will call 911 to be evaluated. She should not get the second Pfizer COVID-19 vaccine.
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| 60 | 2021-03-16 | rash, itchy skin, shingles |
40 hours after COVID-19 mRNA vaccination patient awoke in the middle of the night with itch, swellin...
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40 hours after COVID-19 mRNA vaccination patient awoke in the middle of the night with itch, swelling, rash on left eyebrow. Subsequent 6 days rash developed into typical herpes zoster (shingles) rash localized over left eyebrow.
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| 60 | 2021-03-16 | itchy skin, redness |
60 yo woman who 3-5 minutes post vaccination developed facial itching and erythema, initially in her...
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60 yo woman who 3-5 minutes post vaccination developed facial itching and erythema, initially in her eyes and nose. Administered 50 mg diphenhydramine PO. In the minutes thereafter, the pruritis spread to the upper lip, then face and scalp, and became more generalized (but mild) on limbs. She also reported a "dry throat" sensation, but denies throat tightness or itching and did not have any respiratory compromise for the hour that she remained under observation. Symptoms subsided and patient left the facility. Followed up with her later by phone to inform her that her immediate allergic reaction was a contraindication to her receiving the second Pfizer COVID-19 vaccine and that she should not return for a second appointment. Advised that she seek allergist consultation given her history of multiple allergies, and to determine whether there was a common substrate for any of them. Said that she could possibly consider the Johnson&Johnson vaccine thereafter, if she did not have any known allergies to components of it.
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| 60 | 2021-03-16 | injection site pain | Dizzyness, nausea, severe headache, painful arm, sore throat, fatigue. |
| 60 | 2021-03-16 | itchy rash | Slightly itchy rash on neck, face, shoulders and chest. |
| 60 | 2021-03-16 | redness, rash macular, itchy rash |
generalized pruritic rash and redness, patient describes symptoms as "red and blotchy" Patient takin...
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generalized pruritic rash and redness, patient describes symptoms as "red and blotchy" Patient taking Benadryl to relieve symptoms. Recommended to see primary provider if symptoms worsen.
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| 60 | 2021-03-17 | vaccination site pain |
Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness ...
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Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-03-17 | hives, itchy skin, redness |
Face begin to itch, then neck. About 20 minutes later started to notice large hives on face and nec...
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Face begin to itch, then neck. About 20 minutes later started to notice large hives on face and neck. Very red and itchy. Went to pharmacy to get Benedryl and pharmacist suggested to go to ER immediately. Went to ER and was evaluated and kept for observation. No swelling of tongue or difficulty breathing. Stayed for observation and given prednisone (deltasone) . Given an epi pen and instructed to take benedryl. Hives subsided. No reactions since that night. Arm a bit sore but nothing severe. Seeing an allergist next week as followup.
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| 60 | 2021-03-17 | rash, itchy skin |
I already alerted you to the rash and itching. I got a headache starting about 30 minutes after the ...
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I already alerted you to the rash and itching. I got a headache starting about 30 minutes after the shot. I started having what looked like bruising all along the veins in my arms and hands. Still have that. I went to the doctor and also found that I had high blood pressure and an elevated heart rate. BP 140/90 and Heart rate 85. My normal heart rate is between 55-60 and my usual blood pressure is 108/70. The doctor gave me a steroid shot. This morning, my blood pressure and heart rate were still high and I still had a headache. Then the headache stopped and I took my blood pressure and it was down to around my usual 108/70 and the heart rate was 60. So hopefully I'm starting to recover from this shot.
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| 60 | 2021-03-17 | itchy skin |
Patient presented to ER around 5pm on 3/13 complaining of skin itching - this involved the forearms,...
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Patient presented to ER around 5pm on 3/13 complaining of skin itching - this involved the forearms, chest, under her breast, lower back and trunk. She took Claritin and used hydrocortisone cream before coming into the ER. She received diphenhydramine 50mg PO and prednisone 60mg PO in the ER. she was discharged home with prescriptions for Zyrtec 10mg, Diphenhydramine 50mg a Prednisone taper.
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| 60 | 2021-03-17 | rash | swollen lymph nodes (felt like a lump) in neck and rash on lower lip and chin |
| 60 | 2021-03-18 | injection site bruising, injection site hardening, injection site bleeding |
Date and time adverse event started: 3/18/21 1520 immediately 1707 Caller states about 2 hours ag...
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Date and time adverse event started: 3/18/21 1520 immediately 1707 Caller states about 2 hours ago called was given Pfizer in the Left deltoid. Felt slight pain then when needle withdrawn started bleeding. Pressure was applied for about 45 minutes dressing changed two times. now has a band aid over the area. Area is starting to bruise and the patient is getting a headache. Patient has a grape sized hard knot at the injections site. Patient using ice indirectly for 10 minutes on 10 minutes off. Caller questions if vaccine went into the blood stream will it be effective, or does the vaccine need to be placed in the muscle to have time to replicate to be effective. . Does caller need another first shot.
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| 60 | 2021-03-18 | injection site pruritus, itchy skin, injection site swelling, redness, injection site redness |
Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fat...
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Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone
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| 60 | 2021-03-18 | injection site swelling, injection site pain, injection site inflammation |
Had vaccine on Tuesday, 3/9 and on Thrusday night and Friday evening , my right elbow area was very ...
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Had vaccine on Tuesday, 3/9 and on Thrusday night and Friday evening , my right elbow area was very sore. The pain is very localized and responded to a couple of days of ibuprophen. Started again this week and the arm is swollen/inflammed. Uncomfortable for daily activities like typing or eating. Does respond to ibuprophen. Trying to rest it and have it in sling to rest it.
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| 60 | 2021-03-18 | itchy skin |
Itching mostly on upper body, chest back, arms &neck w/o rash started on 3/11/2021 & stopped on 3/1...
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Itching mostly on upper body, chest back, arms &neck w/o rash started on 3/11/2021 & stopped on 3/15/2021
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| 60 | 2021-03-19 | hives, itchy skin, rash |
3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went t...
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3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went to bed about 10:30. Got up about 4:30 am to use bathroom, felt lightheaded and blacked out and apparently hit my head on something. Realized ears were closing up and had soreness in chest that made deep breath's difficult. Called 911 and nursing line and decided to go to Emergency Dept. Did CT scan for bumps on head and IV and gave me epinephrine and Pepcid. Was discharged with prescription for Epi Pen, Zyrtec, and Pepcid. Still have rash and hives but not as extensive, comes and goes.
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| 60 | 2021-03-19 | redness, skin warm, itchy skin, pain of skin |
Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, ...
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Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache
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| 60 | 2021-03-19 | injection site pain | Headache, injection site pain, nausea, tiredness, joint pain |
| 60 | 2021-03-19 | redness, injection site nodule |
The patient's arm was slightly red in color and swollen. When felt, there seemed to be a lump where ...
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The patient's arm was slightly red in color and swollen. When felt, there seemed to be a lump where the vaccine was given after 5 days.
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| 60 | 2021-03-19 | injection site swelling |
swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really ...
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swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really tired.
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| 60 | 2021-03-20 | itchy skin | Chills, itching, swelling of lips, itchy eyes, sore joints, |
| 60 | 2021-03-21 | injection site pain |
8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscl...
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8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.
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| 60 | 2021-03-21 | hives |
About 45 minutes after the injection two large spots on the face had hives, moderate swelling beneat...
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About 45 minutes after the injection two large spots on the face had hives, moderate swelling beneath right side of lip, minor swelling beneath left side of lip. Took Zyrtec and symptoms went away.
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| 60 | 2021-03-21 | injection site swelling, injection site pain | Headache, site of injection hurt, swollen injection site, slight fever and chills |
| 60 | 2021-03-21 | injection site warmth, injection site swelling, injection site pruritus, injection site pain | Injection site hot red swollen itchy burning |
| 60 | 2021-03-21 | hives, itchy skin, rash |
Rash and hives, itchy and swollen lymph node on right neck - appeared approximately 24 hours after s...
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Rash and hives, itchy and swollen lymph node on right neck - appeared approximately 24 hours after second dose of vaccine. Received one shot of steroid and prescribed a 6 day dose of oral steroid.
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| 60 | 2021-03-21 | injection site swelling, injection site redness, injection site warmth, injection site pruritus, injection site bruising, injection site pain |
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injecti...
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Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient stated started next day, reddness, used coritsone and the spot began to grow, now is red and hot to touch, but no longer painful. Thinks it may be celluilitis and is going to check with primary MD as follow up.
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| 60 | 2021-03-21 | injection site pain |
Swollen lymph nodes under arms and in groin, headache, pain at injection site, tiredness, fever, chi...
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Swollen lymph nodes under arms and in groin, headache, pain at injection site, tiredness, fever, chills, felt unwell
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| 60 | 2021-03-21 | injection site pain | pain from vaccine site up back of neck, tingling lips and glassy eyes |
| 60 | 2021-03-22 | injection site tingling |
At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fing...
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At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.
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| 60 | 2021-03-22 | injection site pain, injection site swelling, injection site pruritus |
Extreme arm pain, swelling at injection site as well as intense itching. Used extra strength Tylen...
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Extreme arm pain, swelling at injection site as well as intense itching. Used extra strength Tylenol, store brand antihistamine and extra strength Benadryl cream.
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| 60 | 2021-03-22 | itchy rash, rash |
Pfizer-BioNTech COVID-19 Vaccine EUA: nine and thirteen days after vaccination patient evaluated for...
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Pfizer-BioNTech COVID-19 Vaccine EUA: nine and thirteen days after vaccination patient evaluated for persistent, raised, pruritic rash on chest. Patient reports reaction is similar to previous allergic reactions to shrimp. Did not take any medications to treat rash prior to first evaluation. Patient denies wheezing, dyspnea, fever, chills, myalgias, arthralgias, bleeding, nausea, mouth sores, and angioedema. Vital signs within normal ranges. Patient advised to use diphenhydramine.
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| 60 | 2021-03-22 | itchy skin | Pt developed dyspnea, significant voice changes and pruritus. Symptoms almost completely resolved.0 |
| 60 | 2021-03-22 | redness |
Red swollen eyes, runny nose, congestion, fatigue, and small amount of shortness of breath. Lasted a...
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Red swollen eyes, runny nose, congestion, fatigue, and small amount of shortness of breath. Lasted about two days
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| 60 | 2021-03-22 | injection site pain | Severe headache 101 temp Nausea Intense pain at injection site Intense body pains |
| 60 | 2021-03-22 | injection site redness, injection site swelling |
She started noticing about an hour and a half after she got her vaccination that the injection site ...
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She started noticing about an hour and a half after she got her vaccination that the injection site started turning red and her arm started swelling from her shoulder down to her hand. She has started taking Advil and icing her arm. It has improved since the evening after she received her vaccination.
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| 60 | 2021-03-22 | itchy rash |
Swollen face; Swollen puffy eyelids and below eye; itchy rash on face,neck, and chest; This is a spo...
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Swollen face; Swollen puffy eyelids and below eye; itchy rash on face,neck, and chest; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 14Feb2021 at 12:30 at single dose for COVID-19 immunization. Medical history included allergies to dust mites, dogs, and corn; Hashimoto's thyroid; and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. She was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluvoxamine maleate (LUVOX), thyroid (ARMOUR THYROID), and amlodipine. The facility where the most recent COVID-19 vaccine was administered was reported as other. The patient experienced swollen face, swollen puffy eyelids and below the eye, and itchy rash on face, neck, and chest on 14Feb2021 at 17:30. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was told to take ALLEGRA and PEPCID in the morning and CLARITIN AND PEPCID in the evening by the allergist. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were assessed as non-serious. Information on the lot/batch number has been requested.
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| 60 | 2021-03-23 | itchy skin, rash with redness |
At approximately 11:05, patient, reported to her vaccinator that she had a reaction of rashes and it...
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At approximately 11:05, patient, reported to her vaccinator that she had a reaction of rashes and itchiness after she received the first dose of Pfizer BioNTech Covid-19 Vaccine (LOT# EN6198; exp. 06/30/2021) on 02/27/21 at 10:59 AM. Vaccinator immediately reported to lead nurse at vaccination site. Lead nurse assessed patient history. Patient reported reported itchiness on torso, scalp and left breast approximately 5 minutes after first dose. Patient offered oral diphenhydramine in observation area. Patient declined diphenhydramine. Patient went home and stated she noticed redness and rashes before going to bed. Patient reported redness and rashes extending from deltoid to elbows on both left and right arms. Patient took bendadryl to alleviate symptoms. Symptoms lasted for approximately 3 weeks. Patient also reported no reaction to prior vaccinations. Patient reported talking to her doctor after first dose. Patient advised to apply hydrocortisone cream before 2nd dose of Pfizer and to take benadryl after 2nd dose was given. At approximately 11:11 lead nurse elevated situation. Lead nurse advised to not give patient her 2nd dose of Pfizer, offer Janssen as her 2nd dose, and recommend patient to see an allergist. Patient agreed to take Janssen as her 2nd dose. Lead nurse recommended patient to see an allergist and took patient contact information to set up her appointment for Janssen as her second dose.
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| 60 | 2021-03-23 | itchy skin |
Pruritis, shortness of breath Patient to the hospital via EMS. Vitals remained stable and lungs cle...
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Pruritis, shortness of breath Patient to the hospital via EMS. Vitals remained stable and lungs clear. Vitals upon discharge 164/99, HR 86, oxygen saturation 98%. Patient was observed until 12:15pm and was wheeled out to her transportation service.
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| 60 | 2021-03-23 | injection site pain |
She has shoulder injury related to vaccine administration with decreased range of motion of shoulder...
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She has shoulder injury related to vaccine administration with decreased range of motion of shoulder, pain at deltoid and pain with overhead activities that persists, albeit some improved, for 2.5 months post vaccination
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| 60 | 2021-03-23 | injection site pain |
Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and...
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Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and minor headache and fatigue on the day after injection through the following day (2 days after injection).
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| 60 | 2021-03-24 | itchy skin |
After coming into the observation post vaccination, the patient told the nurse that she was itchy. T...
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After coming into the observation post vaccination, the patient told the nurse that she was itchy. The nurse assessed her and did not note any hives but did see scratch marks. Soon after, the patient stated she felt hot and had a headache. She quickly noted that her throat had begun to also hurt at that time. EMT's came over to assess her, per the nurses request the EMT's at that time suggested to the patient that she be further evaluated at the hospital. She accepted the transport to the ER.
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| 60 | 2021-03-24 | rash, itchy skin |
Body aches and chills at first. On Sunday 3/21, my fever spiked to 103.7. called doctors office. Was...
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Body aches and chills at first. On Sunday 3/21, my fever spiked to 103.7. called doctors office. Was told to take Tylenol for fever and if it didn't drop to the walk in or ER. It finally dropped later that evening. Then the next day 3/22 i have a rash on my arm i received the vaccine in. On 3/24 it was worst. put a call back into the doctors. Said if it continues to get worst to go to the ER. I put ice and cortisone cream on it which helped take the itching away.
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| 60 | 2021-03-24 | itchy skin, hives | Suddenly broke out with itchy hives inside arms and legs. |
| 60 | 2021-03-24 | injection site pain |
this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400m...
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this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.
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| 60 | 2021-03-25 | itchy skin |
Itching from my head that progressed to my knees by early afternoon. No hives or anything else. Res...
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Itching from my head that progressed to my knees by early afternoon. No hives or anything else. Resolved after two doses of benadryl about 4 hours apart. Woke up next morning feeling fine.
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| 60 | 2021-03-25 | injection site swelling | Right arm biset swollen. Body aches |
| 60 | 2021-03-26 | skin warm |
1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12mi...
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1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12midnight My arm was sore and in pain and very warm to the touch 2- on Tuesday morning I was very cold and very tired . 3- Around none or so I notice my self cleaning my mouth the left side , it feel like you just where out of the Dentist , like went you anesthesia from the dentist is running out. I have feeling but it almost feel like my drooling like my saliva is out of my mouth and also my left eye felt heavy and at first very watery and the dry . My left side of my mouse feel different and I?m connately cleaning my mouth.
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| 60 | 2021-03-26 | redness, itchy skin |
2nd dose of Pfizer COVID vaccination at 1pm. Had sudden onset itchiness, erythema, difficulty breath...
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2nd dose of Pfizer COVID vaccination at 1pm. Had sudden onset itchiness, erythema, difficulty breathing and lip swelling at 7pm. Brought to ED, given epipen and methylprednisolone. Monitored closely overnight, symptoms resolved by AM.
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| 60 | 2021-03-26 | itchy skin | Itchy on upper body |
| 60 | 2021-03-26 | rash | Left leg rash. Right leg rash |
| 60 | 2021-03-26 | skin discolouration |
Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip complete...
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Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.
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| 60 | 2021-03-26 | injection site reaction, injection site redness, injection site nodule | Red circle around injection site, knot at injection site |
| 60 | 2021-03-26 | injection site pain |
Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., s...
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Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021
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| 60 | 2021-03-27 | injection site swelling, injection site redness |
1. Some Swelling and redness at injection site 2. Some lymph node swelling and discomfort under righ...
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1. Some Swelling and redness at injection site 2. Some lymph node swelling and discomfort under right arm Outcome not known yet, swelling and redness seem to be lessoning.
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| 60 | 2021-03-27 | itchy skin, rash macular |
Patient walked to medical tent complaining of itchy, blotchy skin chest and hand; voice breaking; t...
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Patient walked to medical tent complaining of itchy, blotchy skin chest and hand; voice breaking; throat uncomfortable, shaking BP 164/74 P 111 02 97%. Epi 0.3mg IM administered transferred to EMS for hospital transfer.
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| 60 | 2021-03-27 | injection site pain |
Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness...
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Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
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| 60 | 2021-03-28 | injection site pain | Extreme headache for 3 days weak and tired very sore arm at injection site |
| 60 | 2021-03-28 | itchy skin, injection site mass | Very large lump that itches. |
| 60 | 2021-03-29 | redness, hives |
Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from ...
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Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot EN5318) via an unspecified route of administration in left arm on 09Mar2021 at 10:00 AM (at the age of 60-years-old) at single dose for COVID -19 immunisation. Medical history included systemic lupus, asthma, rheumatoid arthritis, thyroid cancer. She had allergies for antibiotics, pneumovax and morphine. She had taken other medications in two weeks. No other vaccine in four weeks was received. She experienced urticaria, bronchospasms, itchiness, shortness of breath, flushing/redness on 09Mar2021 at 10:15 AM. The adverse event was resulted in emergency room/department or urgent care. She was treated with IV fluids, benadryl, decadron and solumedrol. She did not have COVID prior vaccination and COVID tested post vaccination. Outcome of events was ecovering. No follow-up attempts are possible. No further information was expected.
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| 60 | 2021-03-29 | rash, itchy skin |
rash; itchiness; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregn...
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rash; itchiness; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration, in the right arm on 26Feb2021 at 15:45 (at the age of 60-years-old) as single dose for COVID-19 immunisation. Medical history included cardiac murmur, allergy to walnuts, and shellfish, allergy to penicillin, bilateral stenosis of ureters, and obesity; all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received unspecified concomitant drugs within 2 weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took morphine and experienced drug hypersensitivity. On 26Feb2021 at 17:00, the patient experienced rash and itchiness. The patient was given diphenhydramine (BENADRYL) as treatment for the events, rash and itchiness. The patient recovered from the events, rash and itchiness on an unknown date.
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| 60 | 2021-04-02 | vaccination site pain |
Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a...
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Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a spontaneous report from a contactable Pharmacist. A 60-years-old female patient received BNT162B2 ( BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) first dose via an unspecified route of administration, administered in left arm on 18Feb2021 9:15 as single dose for COVID-19 immunization. Vaccination administered facility Workplace clinic. The patient medical history included Osteoporosis; irritable bowl syndrome. The patient concomitant medications included : Citracal; Centrum; Vit D (ergocalciferol); Colace; Evening Primrose (oenothera biennis), ascorbic acid, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, chromium picolinate, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium borate, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, panax ginseng root, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium metavanadate, sodium molybdate, sodium selenate, stannous chloride, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM ENERGY). On 18Feb2021 10:00 patient experienced with sore left arm at injection site (vaccination site pain), tingling feeling on forehead, slight headache, and sore neck on left side. The outcome of the event was recovering. Follow-up information was received on (25-MAR-2021): No new medically significant information was received on this case.
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| 60 | 2021-04-05 | hives, rash |
Received first shot on 3/15/21. On 3/25/21, I developed a rash (hives) around 6:30-7pm. After dinner...
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Received first shot on 3/15/21. On 3/25/21, I developed a rash (hives) around 6:30-7pm. After dinner, around 7:30pm I noticed that my lips were swollen and the rash was spreading. Took one Benadryl and waited 1 hour. Condition worsened so left for ER around 8:45pm. Once there, I was diagnosed with an anaphylatic reaction. I was given Prednisone, Pepcid and Benadryl intervaneously. The Benadryl injection caused my throat to close for a few seconds. Things calmed down so we waited an hour to see if I was responding. There was not a lot of improvement so ER doctor decided to use Epinephrine (EP pen injection). After 2 hours of observation, I was set home to follow up with primary care physcian.
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| 60 | 2021-04-06 | hives, itchy skin, redness |
Hives including 1 that was blister like; Redness on arm; itching; arm soreness; This is a spontaneou...
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Hives including 1 that was blister like; Redness on arm; itching; arm soreness; This is a spontaneous report received from a contactable consumer. A 60-year-old (age at vaccination) female consumer reporter for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; ER8727) via an unspecified route of administration on 23Mar2021 at 11:45 am at single dose on left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Vaccine was administered at hospital facility. Patient's medical history included COPD mild (Chronic obstructive pulmonary disease) and allergies to medications, food, or other products (unspecified). Concomitant medications included (received within two weeks of vaccination) inhaler and vitamins (drug name unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Hives including 1 that was blister like, redness or arm, itching and arm soreness on 23Mar2021 at 01: 15 pm. Self- warm compression initially then iced was the treatment given. It was unknown if the patient was diagnosed with covid-19 prior to vaccination. Patient was not tested for covid-19 since the vaccination. The outcome of events was unknown. information on lot expiry has been requested.
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| 60 | 2021-04-06 | bruising, skin spots |
Lower right leg vein popped out about 1/2-3/4" - didn't feel anything; Lots of petechiae from back t...
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Lower right leg vein popped out about 1/2-3/4" - didn't feel anything; Lots of petechiae from back to feet; Blood blisters; Turned into bruise; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 07Mar2021 21:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included allergies: anesthesia and thrombocytopenia that developed during childbirth (went away after a few weeks). The doctors said that it may have been a drug reaction. Concomitant medication included omeprazole (PRILOSEC). The patient previously took codeine and experienced allergies -severe nausea. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 08Mar2021 18:00, patient's lower right leg vein popped out about 1/2-3/4" but did not feel anything. It later turned into a bruise. Lots of petechiae from back to feet and blood blisters noticed; large on torso. AE resulted in: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for AE. It was also reported that the events caused hospitalization. Platelets were tested last week (unspecified date in 2021) and are on low end of normal range. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-04-06 | rash, pain of skin |
On 3/31/21 woke with severe skin pain on entire left thigh. On 4/4/21 the pain continued and then th...
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On 3/31/21 woke with severe skin pain on entire left thigh. On 4/4/21 the pain continued and then there was a rash all around my thigh. The pain is still present and the rash has gotten worse. I went to my doctor on 4/6/21 and he says the event is caused by the vaccine. He said the symptoms resemble shingles but also varies from shingles.
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| 60 | 2021-04-09 | rash, itchy skin |
Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor; ...
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Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor; Anaphylaxis; chest hurt to breathe; Itching in my arms and chest in the evening.; rash; This is a spontaneous report from a contactable healthcare professional (patient). A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left arm on 15Mar2021 at 17:00 (Batch/Lot Number: EP8534) as SINGLE DOSE for covid-19 immunisation. Medical history included Only occasional migraines. Never anything like this and known allergies: Some grasses. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES) taken for an unspecified indication, start and stop date were not reported. On 18Mar2021, at 8pm, the patient reported that "3 days after 2nd shot I started itching in my arms and chest in the evening. Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor. My rash was worse and spreading and chest hurt to breathe and I had bumps on head so we called # and nurse and my husband drove me to (Name). They gave me an IV and epinephrine shot and Pepcid and did CT scan of head and blood work. Diagnosed Anaphylaxis. They sent me home a couple hours later with prescription for Epi pens Zyrtec and Famotidine. Over the course of Friday my rash/hives got worse and spread over my body and my lips /mouth started to swell. I called the nurse who suggested I come back in and they checked by throat to ensure it wasn't closing up and gave me ibuprofen and Benadryl and sent me home. Rash/hives worse and spread all over body and face when I woke up Saturday morning (today). Plan to see specialist Sunday or Monday." The outcome of the events was not recovered. The patient was not tested for COVID-19 after vaccination.
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| 60 | 2021-04-11 | skin mass, hives |
Within 30 minutes I had a headache, fatigue that lasted 2 days. I had small hives on my face startin...
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Within 30 minutes I had a headache, fatigue that lasted 2 days. I had small hives on my face starting day 2 lasting 2 days. I had a lump behind left ear that lasted 5 days. I have had ringing in my ears, louder in the left ear, since the injection, for 2 weeks now. It is quite loud and annoying. I have recovered from all side effects except the ear ringing.
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| 60 | 2021-04-21 | skin discolouration, rash |
1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of...
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1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of both legs. 2) Sharp breast pain, on the left breast,
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| 60 | 2021-04-21 | shingles | Reactivation of shingles. |
| 60 | 2021-04-21 | injection site redness, injection site hives, injection site pain, injection site swelling |
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient reported significant swelling and a 4 inch raised hive at injection site. Patient took Benadryl and it went down and resolved after a few days. Reaction started on day 8 after injection.
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| 60 | 2021-04-26 | vaccination site pain |
I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swoll...
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I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at age of 60 years) at single dose for COVID-19 immunization. Patient relevant medical history included chronic obstructive pulmonary disease (COPD). Patient concomitant medications were not reported. After receiving covid-19 vaccine patient started running really high temperature and pain at the vaccination side, really tired, headache, chill, throat pain, fever, nausea, Patient said swollen lymph nodes, throat has been sore on unspecified date. Patient stated that run temperature but took Tylenol and it took it down it was high, but I still have the soreness. Patient also mentioned having COVID 19 infection months ago. Treatment received for events was unknown. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 60 | 2021-04-26 | rash |
Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccinat...
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Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccination site.
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| 60 | 2021-04-27 | shingles, rash, itchy skin |
Had prior pain from shoulder blade up to neck and ear. Lasted 3-4 days. Had been increasingly Itchy...
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Had prior pain from shoulder blade up to neck and ear. Lasted 3-4 days. Had been increasingly Itchy. On 4/23/2021, rash on shoulder neck. Went to dr rash not there. Treated for shingles. Rash reappeared later that evening. Husband received vaccine same date/time. Being Treated for shingles. He reported his event
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| 60 | 2021-04-30 | vaccination site pain |
Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Diz...
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Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-04-30 | itchy skin |
Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency ...
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Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency room; couldn't swallow; right side of the patient's face swelled up and her lips were numb; right side of the patient's face swelled up and her lips were numb; face numb; hands itching; tongue had swelled up; voice was scratchy; This is a spontaneous report from a contactable consumer, Reporter's sister via Pfizer-sponsored. A 60-year-old female patient received the second dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Ex-piry Date: Unknown) via an unspecified route of administration on 01Mar2021 on an unknown ana-tomical location as a single dose for COVID-19 immunization. Caller provided that her sister got the vaccine for COVID Prevention and because the patient has a handicapped, bedridden husband who has MS and is immune compromised, and it was to help prevent him from getting sick. Caller reported that the patient received the product during the daytime, all the women at the patient's job, which was home health payroll, everyone left to get the vaccine during work hours, like in the AM at around lunch time. Patient's medical history and concomitant medications were unknown. Patient has not received any prior vaccinations within 4 weeks. Patient had no other vaccines on the same day as the suspect product. Patient received first dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Expiry Date: Unknown) on 08Feb2021 with no reaction. She worked for a health agency and the whole office went and got it. Caller provided that her sister had a reaction the first time, on 03Apr2021, where her sister woke up with itching started in her hands and ended up migrating to her whole body. By morning patient's tongue had swelled up, couldn't swallow and her voice was scratchy, like the caller couldn't understand her sister's speech well. Caller provided that her sister went to the ER and said there was a whole team giving her urgent care, medication, and such. Caller reported that her sister said the ER didn't find anything in her bloodwork, and the caller did not think the patient was being treated for any other medical conditions, and caller did not think her sister is on any medications, but caller said to not quote her on that. Caller knew her sister had a weight problem, but she did not know if her sister needed blood pressure medication or anything. Caller reported her sister said that the bloodwork from the ER did not find any-thing, and the patient was not admitted to the hospital. Caller reported that at this time, her sister's adverse events were no longer ongoing as her sister was given Steroids, like Prednisone, Benadryl and Famotidine, and she took those products as recommended by the doctor. Caller did not know the end date of her sister's events; all she knew was that the reaction initially started on 03Apr2021. Caller stated that her sister was allergic to nothing, and she has never had incidences of itching like that, where the itching was so bad that she was stripping down and the patient's daughter was patting the patient down with witch hazel. Caller stated that ER released the patient and gave her some medications and such. Caller stated that a day or so later, there was a second round of reaction: the right side of the patient's face swelled up and numb and her lips were numb, like when people have a dental procedure. Lips were numb for a while. Upon completion of the medications she was given, the reactions stopped. Patient regularly saw the family doctor. She would go back to see her Doctor on Thursday. HCP Information was unknown to the caller, but caller stated that her sister had been recommended to go to her PCP and get an Epi Pen. Caller stated that knock on wood, so far, her sister was holding her own, and it had not happened again. Caller stated that she was reporting the data that her sister gave to her after having the Pfizer vaccination. Caller stated the patient had an anaphylactic reaction twice that caused her to go to the emergency room. No relevant tests were done. Caller stated that she had the dates that she had her shots and where she had her shot at. Caller stated somebody called and reported it already. Caller stated she was trying to press three but never could figure out which prompts was. Caller stated they said if she called this number, they would tell her at the medical information department if this occurrence has happened to other people, like statistics. Caller stated they tried to call this number, but it was too long of a wait. Caller stated that she did not have the vaccination card, she never asked for them. Caller does not have card with her at time of call for LOT, NDC, Expiry date. Caller stated that she knew that all the COVID vaccines are just in the Emergency Use Authorization stage and in clinical trials, but caller really thought that all manufacturers should be advertising that they would like feedback from patients. Caller has not heard anything from any of the manufacturers saying that people are welcome to reach out and report side effects. Caller states that she only knew to call because she used to be a Home Health Worker, and she thought this is an important data. Caller has never seen on any of her 19 TV channels about calling to report. Caller stated that the girl who first answered her call, read a clinical data sheet about joint pain being seen in 23% of patient's and not knowing a percentage for anaphylactic reactions, caller was wondering if this was true. Caller verified that she just wanted to ask basically that patient was not alone, if other people might have had that happen too. Caller stated that she tried to call, and it would ask another question and it would say press 1 or 2, then it would ask other questions and it would say press 1 or 2, she never got an option 3. Caller asked: how much percentage, has anyone reported this side effects weeks after the second dose. Caller was wondering if this reaction could have been from the vaccine. Investigation Assessment: No. The outcome of the events were unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-05-04 | rash | Rash and hives on and around neck and chest and under chin. |
| 60 | 2021-05-06 | itchy skin, vaccination site redness, vaccination site pain |
Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eye...
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Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.
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| 60 | 2021-05-07 | rash vesicular, blister |
started scratching and now the holes are open on areas to her chest; stated that the left side of he...
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started scratching and now the holes are open on areas to her chest; stated that the left side of her face is hard as a rock; Has rash on left side of face down to chest with blistery spots; could not breathe/cannot catch her breath every now and then; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 60-year-old, dose 1 via an unspecified route of administration, administered in right arm on 17Apr2021 (Lot Number: EW0171) as single dose for COVID-19 immunisation. Medical history included high blood pressure; and bad feet since 2004. The patient's concomitant medications were not reported. The patient had first vaccine on 17Apr2021. On 18Apr2021, she had a reaction, could not breathe. She cannot catch her breath every now and then and had to use the Epipen. Has been using nebulizer. Has more Epipens in case something else happened. Stated that she has a rash on the left side of her face down to her chest with blistery spots and that the left side of face was hard as a rock on 19Apr2021. Stated that the rash was worst on her chest. Has put some cream on the rash but it burns. Had a pain cream called Volten that she put on it because the rash was painful but that made it worst. Stated that she started scratching and now the holes are open on areas to her chest on 21Apr2021. Stated that she had to wear low shirts because her shirts were rubbing her chest. Stated that she was told by her doctor not to take the second shot that was scheduled for 17May2021. Stated that she has scheduled doctor's appointments that were fine. The patient wanted to know if she could get something in writing to submit with her passport stating the she could not have the second shot. The outcome of the event could not breathe/cannot catch her breath every now and then was recovered with sequel, and for the rest of the events was not recovered.
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| 60 | 2021-05-09 | injection site pain |
April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark ...
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April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark urine Jaundice went to urgent care, they advised i go to ER as they felt i needed an abdominal scan to see why i had so much bilirubin in my urine. Went to Hospital. CBC showed my hemoglobin was 5.9. Went down to 4.9 before first transfusionhad CT SCan and sonogram.. Was admitted and disagnosed with hemolytic Anemia brought on by Covid Vaccine. had 5 blood transfusions over the course of my 8 day hospital stay. As of 5/06/21 My hemogloblin is 10.3 and has been at this level for past three weeks, I am currently under the care of a hemotologist
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| 61 | 2020-12-31 | shingles, blister |
12/28 developed shingles for the first time. Started antivirals 12/31when vesicles appeared and I re...
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12/28 developed shingles for the first time. Started antivirals 12/31when vesicles appeared and I realized it was shingles.
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| 61 | 2021-01-03 | itchy skin, rash, hives | Rash/Hives day after vaccine continual and increasing itching. Takjng Zurtec and Benedryl |
| 61 | 2021-01-03 | pain of skin, itchy skin |
Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, ...
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Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.
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| 61 | 2021-01-04 | hives, itchy skin |
Developed itching on right side of face between temple and earlobe while driving home. Once home wa...
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Developed itching on right side of face between temple and earlobe while driving home. Once home was noted to have 3 dime sized hives in that area which lasted approximately 2 hours and then resolved without intervention or further adverse event.
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| 61 | 2021-01-04 | injection site pain, rash with redness |
Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees a...
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Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees and elbows and arm pain at injection sites. This is the 2nd dose, patient reports no adverse reactions on the first dose.
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| 61 | 2021-01-04 | injection site redness, injection site pruritus, injection site swelling, injection site pain |
VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADA...
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VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADACHE,PAIN IN LEFT ARM AT INJECTION SITE. TEMP SEEMED TO BREAK THAT EVENING 98.0 . MONDAY INJECTION SITE VERY RED AND RAISED, ITCHY, ABOUT 1 TO 1 1/2 INCHES IN SIZE. TODAY TUESDAY SAME SIZE ITCHY NOT RAISED .
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| 61 | 2021-01-04 | itchy skin, rash |
development of rash on arms, itchy feeling on arms and torso; feeling of increased warmth all ove...
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development of rash on arms, itchy feeling on arms and torso; feeling of increased warmth all over body--temp 96.8 temporal but felt very, very warm took Benadryl rash faded, decreased itchiness
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| 61 | 2021-01-04 | rash, itchy skin |
rash/legs are all rash/checked her back and told her there was a rash; itchy in back; This is a spon...
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rash/legs are all rash/checked her back and told her there was a rash; itchy in back; This is a spontaneous report from a contactable healthcare professional. A 61-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 22Dec2020 at left arm at single dose for COVID-19 immunisation. Medical history included ongoing diabetes from about 3-4 years before, and an allergic reaction to the dye when testing heart - couldn't remember the dye put in. She was allergic to that and sent to the ER because her throat was starting to close up about 3 years before. Concomitant medications were none. Patient received the Covid vaccine and developed rash on 24Dec2020 that was worsening and she asked if there was any recommendation on whether this was it going to get worse. Patient received the vaccine and was very worried because she was really itchy in back and her legs were all rash and in her back. She was starting to itch really bad. This was after 2 days of the vaccine (on 24Dec2020). She didn't take note until it came to her back and her friend checked her back and told her there was a rash. She asked if this could be related to the vaccine. She asked was this a severe reaction and should she receive the next dose. Her second dose was scheduled for 08Jan2021. She did not know at this time if she would get the second dose as scheduled or not. Onset of rashes started on her legs; she thought it would go away; but the rashes had worsened; they were now on her back and were getting really itchy; she had a friend look at it who told her she had patches of rashes on her back. She reported that she was going to contact her doctor about this information because she was scared about the rashes. Outcome of the events was not resolved. Lot/Batch and Expiration date has been requested.
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| 61 | 2021-01-05 | itchy skin |
Ee stated upon observation entrance, that she would be observed until 10:15am r/t "anaphylaxis" to M...
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Ee stated upon observation entrance, that she would be observed until 10:15am r/t "anaphylaxis" to Morphine. Informed us that she became "itchy" for "3" days prior to the 1st dose on 12-16-20. Ee c/o "itching" to this nurse @ 1005. Benadryl 25mg given @ 1005. Remains to c/o "itching" @ 1015. Ice pack applied to chest to relive itching @ 1015. Around 1025 Ee stated she felt "relief of itching". This nurse also gave Ee (1) Benadryl 25mg to take w. Her. Ee stated she was feeling better @ 1034. Left observation @ 1035.
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| 61 | 2021-01-05 | injection site redness, injection site irritation |
Pfizer-BioNTech COVID-19 Vaccine EUA Beginning one week after receiving the injection, the site has ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Beginning one week after receiving the injection, the site has a red spot about the size of a quarter and feels slightly irritated. It has been this way for approximately 24 hours.
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| 61 | 2021-01-05 | shingles |
Shingles; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old...
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Shingles; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number PAA156571) via an unspecified route of administration, on 20Dec2020, single dose for COVID-19 immunization. Relevant medical history included hypercholesterolemia. Concomitant medications were not reported. The patient took unspecified medication for hypercholesterolemia however the patient stopped taking it for a month or two already. The patient got the first Pfizer vaccine shot on work (clinic) on 20Dec2020. On 28Dec2020, the patient developed shingles which is now being treated. The patient does not know if this is because of that or a part of it. The patient never had Shingles before. Outcome of the event was unknown.
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| 61 | 2021-01-05 | vaccination site pain |
couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my a...
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couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my arm; This is a spontaneous report from a contactable nurse, the patient. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 (at the age of 61 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced soreness in her arm that was gone by the next day. On 23Dec2020, while driving home, she felt severe pain in neck. She almost felt like something went up in her neck and started squeezing on a nerve. It proceeded to get bad so she took muscle relaxants. Christmas day was horrible, she couldn't lift her head off her pillow. The pain came from up head, under her clavicle and down her back. Her pain started getting better, but then next morning it up started again. The only way she's able to get some sleep is to take Flexeril, 800mg of Motrin and applying moist heat. The clinical outcome of severe pain in neck, squeezing on a nerve, couldn't lift her head off her pillow was unknown, and for event had soreness in her arm was recovered on 19Dec2020. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 61 | 2021-01-05 | vaccination site pain |
pain in arm at injection site; This is a spontaneous report from a contactable other healthcare prof...
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pain in arm at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp). A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284, expiry date not given), intramuscular on 29Dec2020 18:00 at a single dose in the left arm as Covid Vaccine. Medical history included hypothyroid, low adrenal cortex and allergies to sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of the vaccination. Concomitant medication included fluoxetine. The patient had no vaccine in four weeks. The patient previously took amoxycillin and experienced allergies. On 29Dec2020 (reported as at 5:30 AM and 5:00 AM; pending clarification), the patient experienced pain in arm at injection site. Since the vaccination, the patient has not been tested for COVID-19. The event reported was not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The outcome of the event pain in arm at injection site was recovering.
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| 61 | 2021-01-06 | itchy skin, hives |
2 days after receiving 1st vaccine, began with hives and itching to arms face and torso. Also after ...
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2 days after receiving 1st vaccine, began with hives and itching to arms face and torso. Also after 24 of receiving 2nd dose began with hives and itching to face hands and arms.
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| 61 | 2021-01-06 | injection site pain |
Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction last...
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Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction lasted 3 days, employee did not report to work on day 3 after vaccine.
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| 61 | 2021-01-06 | vaccination site pain |
Mild- moderate tenderness in left deltoid; This is a spontaneous report from a contactable physician...
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Mild- moderate tenderness in left deltoid; This is a spontaneous report from a contactable physician. A 61-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number=EK 9231, via an unspecified route of administration, in left arm, on 30Dec2020 at 13:45 (at the age of 61 years-old for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included allergic rhinitis, a distant history of thyroid cancer and an allergy to iodine. Concomitant medication included biotin (BIOTIN), cetirizine (CETIRIZINE), fish oil (FISH OIL), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levothyroxine sodium (SYNTHROID). . The patient has not had any vaccinations in 4 weeks. The patient has taken other medications (concomitant medications) within 2 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 31Dec2020 at 0700 the patient experienced mild- moderate tenderness in left deltoid. The patient was not hospitalized for the event nor received any treatment. The clinical outcome of the mild- moderate tenderness in left deltoid was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 61 | 2021-01-06 | itchy skin |
Pt stated that she was feeling a tickle in her throat 10 minutes after administration of the vaccine...
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Pt stated that she was feeling a tickle in her throat 10 minutes after administration of the vaccine. Pt stated that her throat is dry and feels a sensation to cough. Pt stated that started feeling swelling of the tongue 30 minutes after administration of the vaccine. Pt was given water and says that it helped relieve itching. Pt was given benadryl 25mg IM and is being monitored. Charge nurse is taking over monitoring and care of patient.
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| 61 | 2021-01-07 | injection site pain, itchy skin, itchy rash, hives |
1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after...
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1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM
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| 61 | 2021-01-07 | vaccination site pain |
Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; tem...
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Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; temperature 102; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer-BioNTech ;lot number: EK9231) intramuscularly at right arm on 02Jan2021 at 07:45 A.M. at a single dose (dose number: 1) for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19 on 07Dec2020. No known allergies (no allergies to medications, food, or other products) and no other medical history. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination were none. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included chills, temperature 102, general aches, fatigue, pain at injection site, dry cough, general malaise, no appetite. Temperature elevated till 03Jan2021, 6pm. Symptoms similar to what she experienced when diagnosed with covid-19 on 07Dec2020. All events with start date on 02Jan2021 at 06:00 P.M. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Since the vaccination, the patient had not been tested for COVID-19.
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| 61 | 2021-01-07 | injection site pain |
Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had ...
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Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.
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| 61 | 2021-01-07 | vaccination site swelling |
Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Naus...
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Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Nausea; Diarrhea; shivering; Sweating; Body ache; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: PFL72TRA9899), intramuscular in left arm, on 31Dec2020 at 07:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (diagnosed prior to vaccination). There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 31Dec2020 at 8 PM (also reported as after exactly 12 hours; possibly discrepant), the patient experienced swollen stiff arm at the site of the injection, severe episode of nausea, diarrhea, shivering, sweating, and severe body ache. Treatment received for the adverse events included paracetamol (TYLENOL). The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
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| 61 | 2021-01-08 | injection site numbness |
About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left d...
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About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.
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| 61 | 2021-01-08 | sensitive skin |
Extreme skin sensitivity to torso (chest & back) on left side parallel to the injection site, shingl...
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Extreme skin sensitivity to torso (chest & back) on left side parallel to the injection site, shingles type sensitivity without a rash or redness
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| 61 | 2021-01-08 | rash, redness |
muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blis...
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muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blistering; redness on left should blade and over left breast
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| 61 | 2021-01-10 | injection site pain, injection site redness |
24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 h...
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24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 hours- more chills, more wheezing, LA still sore Took Tylenol twice, using inhaler 72 hours- LA still sore, skin red over deltoid and biceps with tenderness, still wheezing, using inhaler throughout day Symptoms somewhat controlled with repeated doses of Tylenol and Proair
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| 61 | 2021-01-10 | sensitive skin | Headache (moderate to severe), chills, fatigue, muscle aches, skin sensitivity |
| 61 | 2021-01-10 | itchy rash, rash with redness, shingles, rash |
Raised red itchy rash on left palm of hand, evaluated by pharmacy, diagnosed as Shingles onset same ...
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Raised red itchy rash on left palm of hand, evaluated by pharmacy, diagnosed as Shingles onset same day as Covid-19 vaccine obtained.
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| 61 | 2021-01-10 | hives, itchy rash, rash |
Received her 2nd dose of the covid vaccine on 1/8/2021. No side effects all weekend. Woke up on 1/11...
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Received her 2nd dose of the covid vaccine on 1/8/2021. No side effects all weekend. Woke up on 1/11/2021with systemic hives, rashes that itch. Denies prior reaction to previous variance dose #1 on 12/18/2020. Denied any difficulty breathing or SOB. Took 25 mg of Benadryl this am and then called PCP who is a OB who said to take 50 mg of Bendery and if symptoms do not improve go to Urgent Care. Follow-up call made by provider 1816: Employee reported going to Urgent Care where she recieved Soulmedrol IM and an AB test. Hives covering entire body and scalp.
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| 61 | 2021-01-10 | injection site redness |
Slight headache the night I received the dose, shot site redness and muscle pain for 2 days after r...
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Slight headache the night I received the dose, shot site redness and muscle pain for 2 days after receiving dose
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| 61 | 2021-01-10 | injection site pain |
injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13...
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injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13 hours after injection lasted 72 hours. headache started 12 hours after injection lasted 60 hours tiredness started 4 hours after injection lasted 48 hours I only took tylenol
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| 61 | 2021-01-11 | injection site pain | Injection site pain |
| 61 | 2021-01-11 | itchy rash, redness, itchy skin, rash |
Patient reported rash on left wrist approximately 10 minutes after receiving vaccine. Also reported ...
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Patient reported rash on left wrist approximately 10 minutes after receiving vaccine. Also reported pruritus at site of redness. Patient was monitored by provider and throughout duration of monitoring developed rash on wrist, neck, and left forearm with pruritus at all sites. Patient given 50mg of Benadryl PO approximately 25 mins after reaction. Within 30 mins of administering medication redness and pruritus had resolved and patient left clinic in stable condition.
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| 61 | 2021-01-11 | redness |
Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hour...
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Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hours later cheeks still red not as red. Am home. Don?t feel normal. Very dry mouth and throat.
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| 61 | 2021-01-11 | vaccination site swelling, vaccination site pain |
Soreness and swelling at injection site; Soreness and swelling at injection site; Malaise; feels tir...
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Soreness and swelling at injection site; Soreness and swelling at injection site; Malaise; feels tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP (Patient) reported for a 61-year-old female patient received the first dose of BNT162b2 (lot: EK92331), intramuscular at left arm on 04Jan2021 (approximately between 18:15-18:30) at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications included supplements. The patient experienced soreness and swelling at injection site, malaise and feels tired on 05Jan2021 08:00. She was scheduled for second dose a day later for COVID vaccine so after the 21 days to get her second dose. Patient is a Dental Hygienist. She received the first dose on 04Jan2021 and is scheduled to receive second dose on 26Jan2021. She should have it scheduled for 25Jan2021. There is no prescriber. She received it at a local hospital through her employer. They did not offer her the 25Jan2020, and said next day is 26 days. They told her there would not be any problem being a day late. She called back with a concern and had evening appointment with the intention of being 3 weeks later. She did it while she had 2 days off work in case she had a reaction. She was told it was not a big deal to get it 1 days later. She asked if she could go to a different location and they told her no, it had to come from the same batch and lot to receive second dose. She is just concerned about doing it a day before she has to go back to work because there are worse side effects with second dose. There is a 4 day grace period from what she read of of 17-21 days and not over 21 days. She is not sure if that is true though. The outcome of the events was not recovered.
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| 61 | 2021-01-11 | vaccination site pain, redness |
fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen aft...
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fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen after the injection; This is a spontaneous report from a contactable other HCP (patient, Respiratory Therapist) reported that a 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , Batch/lot number: EJ1685) via an unspecified route of administration on 21Dec2020 around 6:00 PM in left upper arm at 0.3mL single dose for COVID Prevention. The patient's medical history was covid at the end of Apr/May2020 with shortness of breath, seasonal allergies and allergies to "some anitbiotics." The concomitant medications was reported as none, received no other vaccines on the same day as the COVID vaccine. The patient experienced soreness at site, redness and swelling, fever, nausea, general feeling of unwell 3 days. Patient stated, "I had covid at the end of April/May with shortness of breath. I thought I would have less reaction from the vaccine. I know someone who was out of work for a while week after the vaccine." States that she read that the 2nd dose is supposed to have worse side effects than the first. If she had bad side effects from the 1st dose, will the 2nd be worse? Also asking if the side effects are the immune system reacting or just an allergic reaction. Patient was anxious about getting her second COVID shot on 11Jan2021. Patient stated that she had all the side effects listed, for three days. Patient stated that she didn't mind the side effects at the time, she had fever, soreness at the injection site, nausea, and a general feeling of unwell, but Patient stated that she could not work like that. Patient stated that her question was, statistically she has read that the side effects from the second shot are supposed to be worse than the first shot, but she was wondering, if she had bad side effects from the first shot, will her side effects be worse after the second, or will they maybe be lessened because she already had bad side effects. Patient reported that she did fill out the VSafe significant because she had to work on the third day after her shot, which was Christmas Eve, and work, was so busy and she did not feel well. Patient stated that she does have two days scheduled off work after her next injection, but it is the third day that she was worried about because she does not want to work feeling like that. Patient stated that the arm soreness started that same day (21Dec2020). At first, Patient reported that the arm soreness resolved, but then she states that it is still a little sore to the touch. So Patient confirmed that it is ongoing but improved. Patient reportsed that the fever started the day after the injection, 22Dec2020 and it has resolved. Patient reported that the last day she recorded a fever was on 24Dec2020. Patient stated that she woke up on 24Dec2020 and her temperature was normal, so she went to work and she did not feel so well at work, but they were so busy that she barely noticed, and then when the Patient went home that night, she took her temperature and it was 100 degrees Fahrenheit. Patient reported that the nausea started on 22Dec2020, which was mild at times, but then she got to where she did not want to eat. Patient reported that the nausea has resolved but she was not entirely sure when it resolved because she had been so busy at work on 24Dec2020, and it was hard to tell what she was feeling because she was non-stop busy that day. Patient stated that she was nauseous for a full three days, and she remembered that she did not eat much on the 24th either. So Patient stated that her nausea may have resolved on the third day after her injection, but it is unknown to her what day exactly that it resolved. Patient was also experiencing the general feeling of unwell from 22Dec2020 for a few days, but stated that by 25Dec2020 she felt okay. Patient also included that her left arm was also swollen, like her whole upper arm was swollen after the injection in Dec2020. Patient stated that she also experienced redness, there was a like a red mark that was further down her arm than the injection site in Dec2020. The outcome of soreness at site was recovering. Patient confirmed that both the swelling and redness had resolved in Dec2020.The outcome of fever was recovered on 24Dec2020. The outcome of general feeling of unwell and nausea was recovered on 25Dec2020.
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| 61 | 2021-01-11 | rash |
notice a rash on her left hand; This is a spontaneous report from a contactable consumer (patient). ...
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notice a rash on her left hand; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via unspecified route of administration on left arm on 05Jan2021 at single dose for Covid. The relevant medical history and concomitant medications were reported as none. The patient stated that she just got the first shot of COVID vaccine and noticed a rash on her left hand. She stated that it was the same arm that she got the shot. She wanted to know if there was anything that she needed to do. She stated that she got it through the state as a healthcare worker. She stated that she noticed the rash 20 minutes prior to the report. The patient had no treatment for the event. The patient was tested for COVID the week prior the report in Dec2020 and it was negative. She was going in at the time of the report to get another COVID test. The outcome of the event was not recovered.
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| 61 | 2021-01-11 | rash |
rash started 15 mins post administration on left arm, and spread to chest, and other arm treated wit...
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rash started 15 mins post administration on left arm, and spread to chest, and other arm treated with Benadryl
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| 61 | 2021-01-11 | injection site swelling, injection site redness, injection site swelling, injection site redness | swelling redness at injection site |
| 61 | 2021-01-12 | injection site pruritus, injection site hardening, injection site redness |
Itching at site. Removed bandaid. Reddened area in triangular pattern along bandaid and below banda...
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Itching at site. Removed bandaid. Reddened area in triangular pattern along bandaid and below bandaid approx 3 inches. Site not hot, site firm. By 10:00 pm itching and redness resolved. Site remains slightly firm.
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| 61 | 2021-01-13 | injection site rash, rash with redness |
Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at ...
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Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at injection site. Swelling at injection site. Diarrhea for 2 Days
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| 61 | 2021-01-13 | injection site hives | Hives on the injected arm 10 days after the vaccination. |
| 61 | 2021-01-13 | cellulitis | Systemic: reported she developed cellulitis; symptoms lasted 0 days |
| 61 | 2021-01-13 | vaccination site pain |
chills; body aches; cold; fever; pain at injection site; This is a spontaneous report from a Pfizer-...
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chills; body aches; cold; fever; pain at injection site; This is a spontaneous report from a Pfizer-sponsored Program Pfizer First Connect. A contactable consumer (patient herself) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunization. Patient had a history of COVID in Nov2020. Concomitant medication included levothyroxine sodium (SYNTHROID) (for twenty some years), bupropion hydrochloride (WELLBUTRIN) (for about a year), naltrexone (for about a year), all from an unspecified date and ongoing. The patient got the vaccine yesterday (06Jan2021). Patient experienced chills, body aches, cold, fever, and pain at the injection site started at 10 am on 07Jan2021. The fever has went up a little since this morning, but everything else has stayed the same. Her fever was 100.6 degrees Fahrenheit now. Earlier this morning it was 99.3 degrees Fahrenheit. Outcome of events were not recovered.
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| 61 | 2021-01-14 | bruising |
As stated I fainted about 3 hours after injection. I thought it was because I had worked all night. ...
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As stated I fainted about 3 hours after injection. I thought it was because I had worked all night. I fell forward and sustained bruising to my right cheek and temple. I will be reporting another report regarding the second dose with adverse reaction that is the same but required EMS and Emergency Room visit. Approximately 3 hours after injection I was getting ready for bed (as I work nights). I was talking with my daughter and I stood up and remember waking up on the floor. Bruising to the right cheek and temple. I did not seek medical attention and went to bed. I had no further episode but remained dizzy for several days.
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| 61 | 2021-01-14 | bruising |
Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on...
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Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on the floor. EMS was called and I was sent to the emergency room. Bruising to my left eye with a short LOC.
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| 61 | 2021-01-14 | injection site pain |
Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at inje...
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Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.
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| 61 | 2021-01-14 | shingles |
Shingles type reaction without a rash or redness; Extreme skin sensitivity on torso (chest and back)...
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Shingles type reaction without a rash or redness; Extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site.; This is a spontaneous report from a contactable pharmacist (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the left arm on 22Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included diabetes and hypertension (HTN). It was also reported that the patient had allergies with quinolones. Concomitant medications included metformin (METFORMIN), cetirizine hydrochloride (ZYRTEC), semaglutide (OZEMPIC), simvastatin (ZOCOR), levothyroxine sodium (SYNTHROID) and "elav". On 01Jan2021 19:00, the patient had extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site. The patient also had shingles type reaction without a rash or redness. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. Outcome of the events were not recovered.
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| 61 | 2021-01-14 | vaccination site pain |
trouble lifting things like my tea kettle; lot of pain in right elbow; bad neck and shoulder pain; b...
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trouble lifting things like my tea kettle; lot of pain in right elbow; bad neck and shoulder pain; bad neck and shoulder pain; sore right arm similar to after a tetanus shot; This is a spontaneous report from a non-contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: EL1284, intramuscular on right arm from 05Jan2021 09:45 to 05Jan2021 09:45 as single dose (first dose) for COVID-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 05Jan2021 at 03:00pm, the patient experienced sore right arm similar to after a tetanus shot. On 06Jan2021, the pain in upper arm gone but by afternoon but the patient got bad neck and shoulder pain on right side that she treated with heat and Advil. On 07Jan201, neck pain still present and by late afternoon, the patient got a lot of pain in right elbow. On 08Jan2021, the patient still have the neck to shoulder pain in addition to the right elbow pain. It feels like she sprained her elbow and was having trouble lifting things like my tea kettle. The outcome of the event sore right arm/pain in upper arm was recovered on 06Jan2021; having trouble lifting things like my tea kettle was unknown; while the other events were not recovered. Treatment has been given for the event bad neck and shoulder pain. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.
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| 61 | 2021-01-15 | rash, skin peeling |
Total body rash with severe ankle and feet swelling and peeling that continues even after getting v...
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Total body rash with severe ankle and feet swelling and peeling that continues even after getting vaccine more than 3 weeks ago
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| 61 | 2021-01-15 | itchy skin |
minor itchy spots torso and neck. started 24 hours after shot. first 7 days just 2 to 3 spots dail...
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minor itchy spots torso and neck. started 24 hours after shot. first 7 days just 2 to 3 spots daily. days 9 thru 11 spots increased to about 8 to 10 daily. These spots only lasted about a day. They did not break open, merely disappeared with no lasting marks. There has been no new spots after day 14. No medications was take, it was mild and I wanted to watch what would happen without treatment.
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| 61 | 2021-01-16 | injection site pain |
"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle...
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"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle pain, fever, loss of appetite, HR in lower 90's, pulse OX in low 90's.
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| 61 | 2021-01-17 | rash, itchy skin |
Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a ...
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Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a circular redden skin rash on her arms, legs, and torso. Temperature: 99 degrees. Employee took Tylenol and Claritin for rash, complained of diarrhea, vomiting, and weakness of both knees within 24 hours all symptoms were gone.
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| 61 | 2021-01-17 | injection site pain |
i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 ...
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i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 woke up feeling a little tired, went to work. went home early at 1:30 pm, feeling a little chilly. no fever. 1/15/21 in the morning noted pain on Left armpit ( injection site is left arm), pain from left shoulder blade to right shoulder blade. took advil. In the afternoon, about 4:00 pm, noted some swelling and soreness on left armpit. took Advil.. 1/16/21, Called employee health to report this. Advised to take advil and monitor and call pcp if symptoms persists.
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| 61 | 2021-01-18 | injection site pruritus, skin warm, injection site redness | Chills, swelling, warm to touch , redness on the right arm inject site area and very itching |
| 61 | 2021-01-18 | injection site redness, injection site pain, injection site pruritus, injection site swelling |
Redness, sore, large bump and itching - no change since original symptoms. 3 days later still have ...
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Redness, sore, large bump and itching - no change since original symptoms. 3 days later still have a large bump under site given, itching and soreness.
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| 61 | 2021-01-18 | injection site mass |
Though I had pain and soreness in the arm after both the shots I am left with a residual weakness an...
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Though I had pain and soreness in the arm after both the shots I am left with a residual weakness and ache in the arm almost a month later. I find I am not able to lift items that I was able to lift last month and there is a lump in my left upper arm that is new as well.
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| 61 | 2021-01-18 | vaccination site pain, itchy skin, hives, rash |
itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swellin...
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itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swelling back of neck; inj site very sore; fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK923) , via an unspecified route of administration on 29Dec2020 09:45 at the first single dose at arm left for covid-19 immunisation. Medical history included known allergies: Sulfa. The concomitant drug was unspecified. The patient previously took cipro and experienced drug hypersensitivity. On 29Dec2020, the patient expected side effect of inj site very sore and fatigue for 24 hours. On 06Jan2021 14:00, the patient started with itching of scalp, arms, legs ,rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck, took 50 mg Benadryl w some relief. 630 PM symptoms reoccurred, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of the back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER. The patient received Prednisone 50 mg orally and for the 4 days. The outcome of event inj site very sore and fatigue was recovered on 30Dec2020; the outcome of events was recovered.
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| 61 | 2021-01-18 | itchy rash | itchy rash on bilateral elbows, headache |
| 61 | 2021-01-18 | rash |
she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had...
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she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; rash on the neck; which was burning /burning on skin where the rash is; had difficulty in breathing due to congestion in throat; had difficulty in breathing due to congestion in throat; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 07Jan2021 15:45 at single dose for covid-19 immunisation. The patient's medical history ongoing Asthma, ongoing Psoriasis, ongoing Eczema, and ongoing Osteoporosis. There were no concomitant medications. The patient stated yesterday she got the vaccine, about a half hour later her neck started to get red like a rash, and as the evening went on it felt like burning on her skin at the rash. She had a hard time breathing last night and had to sit up to sleep. Then this morning she had a blister on her tongue.The patient clarified the first dose of vaccine was on 07Jan2021 at 15:45 PM in the right arm. She noticed about 30 minutes later, a rash on the neck and then burning on the skin where the rash was that evening; then that night she had a hard time breathing and had to sit up to sleep due to congestion in her throat. She had to keep clearing her throat. This morning (08Jan2021) she noticed she has blisters on her tongue or maybe ulcers, just on the right side. Asking should she take some Benadryl? Was this expected side effects?. The patient wanted to know find out if she should get the next dose? The patient relevant tests include COVID 19 test on 07Dec2020 and it was negative. The outcome of the event Neck rash was recovering and not recovered for the remaining events.
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| 61 | 2021-01-19 | injection site warmth |
I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a wa...
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I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.
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| 61 | 2021-01-19 | injection site pain |
Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic...
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Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic sensation of tilting while sitting on a couch. Had I been driving, this would likely have caused an accident. This is the first time I have ever experienced this feeling. There were 2 or 3 other episodes of feeling like I was falling. 2 of this happened while lying down. They were sudden sensations that made me gasp. Spent most of 1 week in bed with fatigue, vertigo, and 2 times vomiting. Vomiting occurred day 2 post vaccine. Fatigue was continuous for about a week. At day 16 now, certain movements still illicit vertigo. All vertigo symptoms have lasted under 1 minute. However, some have been back to back, such as after repositioning multiple times in bed. Ears have felt very full for almost 2 weeks. Certain head positions or movements, still illicit sensations of the room moving. There was no specific headache, but my head did not feel good for about 2 weeks. There was no fever, but there was chilling one night, a couple of days after the vaccine. I don't know if getting 2nd vaccine is wise.
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| 61 | 2021-01-19 | shingles, itchy skin, rash |
adverse affect was on 1/12 and was diagnosed by her PCP with Shingles. Today, 1/20, remains with Shi...
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adverse affect was on 1/12 and was diagnosed by her PCP with Shingles. Today, 1/20, remains with Shingles, with rash, itchy and pain.
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| 61 | 2021-01-20 | injection site pain |
Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6...
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Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6 to touch and on abduction. About 11 hours after vaccination, I became increasingly uncomfortable, feeling warm, chills, muscle aches. I could not sleep. 22 hours after vaccination, my temperature was 101 F (did not take it before this time). Temperature waxed on waned from that point (day #2). About 36 hours after the vaccine, my temperature stabilized to normal. 48 hours after the vaccine, I felt better and better with each hour.
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| 61 | 2021-01-20 | itchy skin |
I developed mild itching of my right forearm and abdomen at 2100 but about 2300 I awoke with severe ...
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I developed mild itching of my right forearm and abdomen at 2100 but about 2300 I awoke with severe itching from my head to my hips--no rash. 1 Benadryl did not help, so about another 1.5 hrs later I took another Benadryl and that made the itching tolerable. Having taken 50mg Benadryl I was not able to work at 0430 the next morning as scheduled. The itching continued even with Benadryl every 8 hrs until mid-morning of 12/30. I got the 2nd dose 1/20 & --per the advise of my GP premedicated with 50mg Benadryl, 20mg Pepcid, and 1000mg Tylenol 45 min before the 2nd dose; then I repeated 25 mg Benadryl at bedtime. I developed itching again about 8 hrs later but it resolved by the next morning and was not as intense as with the first dose.
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| 61 | 2021-01-20 | hives, rash, itchy rash |
Patient was vaccinated at work on 1/16/21 and developed rash the morning of 1/18/21. It started on t...
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Patient was vaccinated at work on 1/16/21 and developed rash the morning of 1/18/21. It started on the neck / chest and gradually spread to abdomen, back, and extremities. She took Benadryl on 1/20/21 with mild improvement. Rash is described as pruritic. Patient reported to clinic on 1/21/21. At that time rash was present on the neck, back, chest, and lower extremities. Appearance was pink, 1 cm discrete wheals with areas of coalescence especially on neck where it was more excoriated. Patient was treated with prednisone, topical steroid cream, and hydroxyzine. Treatment response is unknown at this time.
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| 61 | 2021-01-20 | rash papular | bumpy rash on different parts on my body |
| 61 | 2021-01-21 | injection site pain |
I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs fe...
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I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.
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| 61 | 2021-01-21 | itchy skin | Itching, headache, chills |
| 61 | 2021-01-23 | itchy skin, rash |
Rash in my chest, under my breast and some in the side. Experience some tingling, itching in my legs...
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Rash in my chest, under my breast and some in the side. Experience some tingling, itching in my legs.
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| 61 | 2021-01-24 | injection site swelling, vaccination site pain |
Extremely lethargic Swelling in vaccinated arm Pain in vaccinated arm Body aches Headache Congesti...
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Extremely lethargic Swelling in vaccinated arm Pain in vaccinated arm Body aches Headache Congestion
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| 61 | 2021-01-25 | injection site pain |
Extreme soreness at injection site. Impacts ROM. Painful to lift left arm above head. Pain starts...
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Extreme soreness at injection site. Impacts ROM. Painful to lift left arm above head. Pain starts below the left AC and extends up to the acromion process. Intermittent relief when taking OTC pain medications.
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| 61 | 2021-01-25 | itchy skin, redness | Itchy really red, got worse the 2nd day, 01.22.21. Getting redder with bigger circle each day. |
| 61 | 2021-01-26 | injection site redness, injection site pain, injection site swelling |
AT VACCINE SITE R ARM - REDNESS, SLIGHTLY SWOLLEN, TENDER. ALSO C/O H/A SINCE 1500 1/26/21. NOTED CH...
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AT VACCINE SITE R ARM - REDNESS, SLIGHTLY SWOLLEN, TENDER. ALSO C/O H/A SINCE 1500 1/26/21. NOTED CHILLS 1/26/21 PM ALSO
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| 61 | 2021-01-26 | vaccination site pain |
felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; Th...
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felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; This is a spontaneous report from a contactable consumer report self. This 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL4176), via an unspecified route of administration at left arm on 12Jan2021 14:30 at single dose for covid-19 immunization. Medical history included COVID in Nov2020 (Patient was tested for Covid on 23Nov2020 and found out the 25Nov2020 the result was positive), she just quarantined herself at a hotel (They gave her Benzonatate, but she was also taking Tylenol 500mg and Robitussin DM). Concomitant medications not reported. Patient did not get any other shots or 4 weeks prior. No problems with vaccines in past that she can remember. No additional vaccines administered on same date of the Pfizer suspect. Patient received the Pfizer BioNtech vaccine on 12Jan2021 and after that on 12Jan2021 night she didn't feel anything but mild pain in arm, it was so painful, but not as bad on 13Jan2021 even though she still has it. She can't move her arm up and down. On 13Jan2021 morning at dawn she had a fever and it is now 101.2. Has taken Tylenol 500mg (Lot number: SLA071, UPC number: 30047112, Expiry Date: Aug2024). Patient had body aches started 12Jan2021 at midnight (12:00) that is start date of 13Jan2021. She felt cold and chilly and not sure if it was the weather or her. No Emergency Room or Physician Office visit. The outcome of "felt cold and chilly" was unknown, of else events was not recovered.
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| 61 | 2021-01-27 | skin mass |
My eye is swollen, I have knots on my forehead over my right eye. I thought it was a spider bite bu...
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My eye is swollen, I have knots on my forehead over my right eye. I thought it was a spider bite but now I am not sure
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| 61 | 2021-01-27 | rash | Rash lasting 72 hours |
| 61 | 2021-01-27 | rash | Rash lasting 72 hours after vaccination |
| 61 | 2021-01-27 | injection site pain | Sore arm at injection site |
| 61 | 2021-01-28 | redness |
day after shot. Woke up at 3:00 Am with severe pain in my right arm with redness and swelling around...
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day after shot. Woke up at 3:00 Am with severe pain in my right arm with redness and swelling around the shot area.
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| 61 | 2021-01-29 | skin warm |
in first half hour, heat/flush came up the left side of neck and face up to eye. inside of ears felt...
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in first half hour, heat/flush came up the left side of neck and face up to eye. inside of ears felt warm. extreme tinnitus. took Benadryl and slept. after 5 hours, symptoms came back. feels like lower jaw is pulling to right. took more benadryl.
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| 61 | 2021-01-30 | skin discolouration, injection site warmth |
Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and b...
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Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting
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| 61 | 2021-01-31 | itchy skin |
(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she ...
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(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she in fact received the Pfizer.) I got the 2nd dose of the Pfizer vaccine late last Wednesday afternoon (1/20). Before the 2nd dose, I premedicated (as instructed by my medical office) with Benadryl 50mg and Pepcid 20mg (for the histamine blocking effect) since I had terrible itching for about 36 hrs after the 1st dose; but the itching didn't begin-after the 1st dose-until about 8hrs after the shot & became intense 2 more hrs later. I had itching the night of the 2nd dose that kept me awake part of the night but was FAR less intense than after the 1st dose. I came to work Thurs not feeling ill--just cold and tired all day (I attributed to the cold weather and not sleeping well). Thurs about noon I began feeling ill--like I was coming down with the flu; I went home after my shift and found my temp to be 100.4. Shortly thereafter it was 100.9. I thought it would pass by morning so I just showered, drank fluids, took Tylenol and slept. By 0200ish Fri 1/22 I still had a fever of 100.9 (even with Tylenol on board), a bad headache, sinus congestion, and significant neck and back pain so I called out for work. I continued to treat the fever and by noon Fri the fever finally had resolved-along with the head, neck and back pain. I've been fine since.
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| 61 | 2021-01-31 | injection site redness, injection site pain |
Began with pain to injection the same evening of injection on Sat 1/23/21, then 2 days later on Mon ...
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Began with pain to injection the same evening of injection on Sat 1/23/21, then 2 days later on Mon 1/25/21 with some redness around injection, no drainage or fevers.
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| 61 | 2021-01-31 | redness | Face swelling and redness. for 3 hours. |
| 61 | 2021-01-31 | injection site pain, injection site rash | Injection site rash and pain |
| 61 | 2021-01-31 | vaccination site pain |
exhaustion; Chills; feeling feverish; aching left arm at injection site; This is a spontaneous repor...
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exhaustion; Chills; feeling feverish; aching left arm at injection site; This is a spontaneous report from a contactable other health professional (HCP). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 10Jan2021 at 15:30 on her left arm at a single dose for COVID-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing and known penicillin (PCN) allergy. There were no concomitant medications. The patient previously took erythromycin and clindamycin and experienced allergies. The patient received the first dose of BNT162B2 (lot number: EH9899), intramuscularly on left arm on 20Dec2020 at 03:30 PM. The patient experienced chills, feeling feverish, aching left arm at injection site and exhaustion on 15Jan2021 at 16:45. On 16Jan2021, consumer stated, "I recently had the COVID vaccine and it was last Sunday. Is that possible to have a reaction 5 days out?" There was no treatment received for the events. The outcome of the events was not recovered.
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| 61 | 2021-02-01 | itchy skin, hives |
I'm not sure if this is related; Was at work in out patient hospital facility and placed a mask on f...
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I'm not sure if this is related; Was at work in out patient hospital facility and placed a mask on from a new box. I noticed my nose was itching a bit (I'm very sensitive to certain masks and usually air them out) A little while later I had an intense itching / prickly, sensation in my nose and started itching on my face under the mask. I took it off and found a different brand and took some benedryl. Seemed to get some relief and later that evening, I started to itch again including my head and inside ears, face had flushed with hive like rash. This continued throughout the weekend on and off eventually my whole body was randomly itching/tingly. No problems breathing. Took allergy meds and felt good but noticeably annoying. Called our covid info line on Monday and they gave me a few numbers for allergists. Mine retired. Had an appointment Tuesday morning. Dr felt it probably was reaction to mask not vaccine. Did a patch test with a piece of mask and did itch some but had a reaction to the tape that held the piece of mask in place so results not good. Took medrol dose pack and increased allergy meds. Still itching on and off randomly all over body, not as severe Delaying second vaccine by a week or two until this resolves per DR
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| 61 | 2021-02-01 | injection site pain, injection site swelling | Injection site pain and swelling X 48 hours |
| 61 | 2021-02-01 | redness, itchy skin | Redness and itchy hands a few days after vaccination. |
| 61 | 2021-02-01 | vaccination site pain |
Sore at injection site (felt like bruise); Sore at injection site (felt like bruise); This is a spon...
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Sore at injection site (felt like bruise); Sore at injection site (felt like bruise); This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in the right arm on 16Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included asthma/allergies and eggplant/zucchini sensitivity. The patient's concomitant medications were not reported. The patient experienced sore at injection site (felt like bruise) on 17Jan2021 that lasted approximately 36 hrs. The patient was okay by 18Jan2021 afternoon. Outcome of the events was reported as recovered on 18Jan2021. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior vaccination and has not tested for COVID-19 post vaccination.
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| 61 | 2021-02-01 | vaccination site pain |
very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; hea...
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very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; headache; felt nauseous; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 18Jan2021 10:00 at first single dose for COVID-19 immunization. Medical history included high blood pressure (BP) on medication, known allergies: Penicillin (PCN), levaquin, covid-19 on 18Nov2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient had a very sore painful arm at injection site, no redness, started chilling and ran a fever between 102- 103 degrees during the night and into the next day. Had headache felt nauseous. Events start date/time: 19Jan2021 02:00 AM. By 6 pm the next day the patient started to feel a little better. The patient tested positive for covid 19 in 18Nov2020. Covid was not tested post vaccination. No treatment was received for the events. Outcome of the events was recovering.
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| 61 | 2021-02-02 | itchy skin |
C/O "TINGLING PIN PRICKS" WITH SLIGHT ITCHING SENSATION, NO SOB, NO HEADACHES B/P 136/100 SYMPTOMS S...
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C/O "TINGLING PIN PRICKS" WITH SLIGHT ITCHING SENSATION, NO SOB, NO HEADACHES B/P 136/100 SYMPTOMS SUBSIDED 10 MIN. LATER
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| 61 | 2021-02-02 | injection site pain |
FATIGUE, SORENESS AT INJECTION SITE, MUSCLE ACHES, DIZZINESS, LIGHT HEADEDNESS, MUSCLE AND BODY ACHE...
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FATIGUE, SORENESS AT INJECTION SITE, MUSCLE ACHES, DIZZINESS, LIGHT HEADEDNESS, MUSCLE AND BODY ACHES
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| 61 | 2021-02-03 | rash with redness |
Day 1 After - overall body aches Day 2 After- no ill effects until evening - noticed red rash on up...
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Day 1 After - overall body aches Day 2 After- no ill effects until evening - noticed red rash on upper torso (front and some on back) Not itchy. No medical attention sought Day 3 After - rash persists and has spread to entire torso - front (Today is day 3)
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| 61 | 2021-02-03 | itchy rash |
Itchy rash on bilateral elbow; This is a spontaneous report from a contactable pharmacist. A 61-year...
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Itchy rash on bilateral elbow; This is a spontaneous report from a contactable pharmacist. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via intramuscular route of administration on 08Jan2021 at a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Jan2021, the patient experienced itchy rash on bilateral elbow. The patient did not receive any treatment for the reported event. The patient was not pregnant at the time of vaccination. The outcome of the event was recovering.
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| 61 | 2021-02-03 | itchy rash, rash with redness, rash |
Rash was reported as worsened.; she has developed a rash all over her face, arm, chest, and belly; T...
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Rash was reported as worsened.; she has developed a rash all over her face, arm, chest, and belly; The rash is just red, raised, and itchy; The rash is just red, raised, and itchy; This is a spontaneous report from a contactable Nurse (patient). The 61-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL3248, Expiry Date: 01Apr2021), unknown in right deltoid on 13Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Patient History: No. No allergies. There were no concomitant medications. The Caller, an LPN, reporting on the COVID 19 Vaccine and who explains she had it on 13Jan2021. Starting Friday into the weekend and through today she has developed a rash all over her face, arm, chest, and belly on 18Jan2021. The only thing that she can figure is the injection. She was told to call and report this. There has been no treatment, due to the holiday everything is closed. The rash is just red, raised, and itchy and driving her crazy. It is not anything too terrible, just uncomfortable. Rash was reported as worsened. No visit to emergency room or physician office. The outcome of the event condition aggravated was unknown and was not recovered or the rest events. No follow-up attempts possible. No further information expected.
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| 61 | 2021-02-03 | redness |
Redness numbness and tingling in both hands Increases when hands are pointed down improves when lif...
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Redness numbness and tingling in both hands Increases when hands are pointed down improves when lifted above the heart Is lessening but is clearly not listed as a side effect It is improving however is concerning more information and direction needs to be addressed several other coworkers have experienced or went to the ED with the same adverse effect. It is clearly not life threatening but I hope it will not increase with the second dose or continue in the future
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| 61 | 2021-02-03 | itchy skin |
woke up at 3 am with itching to her chest and arms; This is a spontaneous report from a contactable ...
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woke up at 3 am with itching to her chest and arms; This is a spontaneous report from a contactable other health professional. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231), via an unspecified route of administration in the left arm on 18Jan2021 17:45 at SINGLE DOSE for COVID-19 immunization. Medical history included "hypothyroid", HTN (hypertension) and allergy to contrast dyes. The patient has been diagnosed with COVID-19 on an unspecified date prior vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included thyroid (ARMOUR THYROID), silybum marianum (MILK THISTLE), magnesium chloride and unspecified BP medications. The patient previously took tetanus toxoid and experienced allergies. On 19Jan2021, the patient woke up at 3 am with itching to her chest and arms. Patient took generic Zyrtec as treatment to the event. Outcome of event was recovering. The events were considered as non-serious. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 61 | 2021-02-04 | injection site pain | Site: Pain at Injection Site-Medium |
| 61 | 2021-02-05 | injection site pain |
Dizziness started about 5 minutes after shot. Nurse had me lay down. Better after 20 minutes. Bad he...
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Dizziness started about 5 minutes after shot. Nurse had me lay down. Better after 20 minutes. Bad headache started while driving home. Took Tylenol but 24 hours later still have headache. Arm hurts at injection site. Very tired. slept 14 hours and still tired. Temp has been around 99.5 when I've been awake enough to take it.
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| 61 | 2021-02-06 | injection site pain |
I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty ba...
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I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day
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| 61 | 2021-02-07 | redness |
facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no it...
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facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.
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| 61 | 2021-02-08 | rash |
Thyroid levels change meds changed to 50 mcg, red dots all over on torso, both back sides left , rig...
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Thyroid levels change meds changed to 50 mcg, red dots all over on torso, both back sides left , right. front breast right one , lower stomach area right, left. Emergency room doctor took photographs.
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| 61 | 2021-02-08 | rash, itchy skin | patient complain of itchiness and rash. Treatment was Benadryl 50mg IM to Left arm |
| 61 | 2021-02-10 | injection site pain |
Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, fee...
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Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, feeling unwell, cough
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| 61 | 2021-02-10 | injection site redness, injection site rash, itchy skin, injection site swelling |
Slight redness, slight swelling, and rash around the shot site. Applied benadryl cream for the itch...
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Slight redness, slight swelling, and rash around the shot site. Applied benadryl cream for the itching. Resolved within 24 hrs.
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| 61 | 2021-02-11 | rash, itchy skin | Rash on the left side of face, neck, and chest; intermittently itchy. |
| 61 | 2021-02-14 | rash papular, rash, itchy rash, itchy skin |
On February 4, 2021, I started to itch and feel like pins were sticking me on the front of my neck u...
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On February 4, 2021, I started to itch and feel like pins were sticking me on the front of my neck under my chin. On February 5, 2021 I started taking benedryl 25mg to combat the itching. By February 8, I had a fine rash, small raised all around my neck and very itchy and again I took benadryl without improvement. Benadryl would have a short term effect and just made me sleepy. This continued for 3 more days until February 15 when I was able to see my doctor who has now listed me as having a reaction and allergic to the Covid 19 Vaccine. I am prescribed topical steroid cream and hopefully it will improve.
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| 61 | 2021-02-15 | rash |
Developed generalized rash over body, more pronounced on knees and lower legs. Rash remains now but...
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Developed generalized rash over body, more pronounced on knees and lower legs. Rash remains now but is lighter. Significant L knee pain.
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| 61 | 2021-02-16 | rash with redness, skin discolouration |
Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101...
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Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have
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| 61 | 2021-02-18 | injection site pain, skin burning sensation |
Having pain and burning sensation to skin at injection site of left shoulder. It radiates to the bas...
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Having pain and burning sensation to skin at injection site of left shoulder. It radiates to the base of the head, posterior left shoulder and upper arm. Took one dose of Excedrin with temporary relief.
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| 61 | 2021-02-19 | rash, itchy skin |
Numerous tiny white bumps on both legs only that were somewhat itchy & disappeared completely after ...
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Numerous tiny white bumps on both legs only that were somewhat itchy & disappeared completely after 4 days; no treatment given
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| 61 | 2021-02-21 | injection site redness, injection site pruritus, injection site mass, injection site warmth |
2/10/21: Woke up with chills, no fever @5:15am, back to sleep, Temp 99.3F at 10:05am, Tylenol at 10...
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2/10/21: Woke up with chills, no fever @5:15am, back to sleep, Temp 99.3F at 10:05am, Tylenol at 10:50am, Temp 100.3F at 5:15pm Temp 101.3F at 9:10pm and took tylenol and regular medications, Temp 100.6F at 10:55pm and went to sleep. 2/11/21: woke up with temp 98.7 at 10:00am, had body aches, red and feverish area where vaccine was given in upper left arm. The red, itchy and feverish area about 3 inches x 2 inches on upper left arm lasted about 5 days, also got a lump under left arm that lasted about 6 days and all of these went away by 2/17/21. But I've had more fatigue, and shortness of breath since this 2nd vaccine. Misses my doctor appointment on 2.17/21 due to the winter storm, not going anywhere , we were having all last week.
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| 61 | 2021-02-21 | rash | Vomiting, rash, dizziness, weakness |
| 61 | 2021-02-22 | pain of skin |
Right side upper arm ache spread to right side of neck and into headache at back and top of skull. ...
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Right side upper arm ache spread to right side of neck and into headache at back and top of skull. Persisted through night and spread down into right side of neck to left arm ache. Throat became red and right, then left side of tonsil became pus filled. Chills but no fever. Fatigue every day. Took 2-3 hour naps every couple of days and slept 8-10 hours through the nights. Headache off and on for 10 days. Throat remained red, becoming most sore late afternoons, voice hoarse. On and off drippy nose. On the 13th day I felt normal energy level in the morning but today, my 15th day at nearly 3pm, my normal energy is waning and throat becoming sore again.
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| 61 | 2021-02-22 | injection site pain | nausea, vomiting, headache, tired, chills, pain in injection site |
| 61 | 2021-02-23 | shingles |
I don't want to file two reports. I had an episode of feeling very dizzy and when I laid down for an...
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I don't want to file two reports. I had an episode of feeling very dizzy and when I laid down for an hour and I got up I couldn't remember names of anyone, went to hospital to rule out stroke. EEG and double echo both normal. MRA and MRI, no evidence of stroke, transient global amnesia, it took a couple hours for me to get back to normal. I also had a shingles outbreak 10 days post both vaccines.
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| 61 | 2021-02-23 | itchy skin, redness, injection site swelling | Red circular swelling at injection site; forearm and wrist swollen, wrist itchy. |
| 61 | 2021-02-24 | rash, itchy skin, redness |
Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My ...
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Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My lymph nodes right neck is swollen, also painful mass around 2x3cm below right clavicle near the sternum. I also have flu-like symptoms, body weakness especially lower extremities. Rashes and itchiness upper chest still present. 2/9/21 : Lymph node swelling of right neck & below right scapula still present. Rashes & itchiness upper chest still present but controlled with hydroxyzine tablet. Flu-like symptoms still present. 2/11/21: Rashes & itchiness minimal, less medication needed. Lymph node swelling less, still gets tired easily. 2/19/21: lymph node below right clavicle bigger for 1 day. No more lymph node swelling right neck. Still gets tired easily. 2/24/2021: Lymph node below right clavicle 1x1 in size, not painful.
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| 61 | 2021-02-24 | shingles, blister |
Pain on right-side of back all the way to front of chest and under breast and part of right shoulder...
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Pain on right-side of back all the way to front of chest and under breast and part of right shoulder. Week prior felt sensation of "pins and needles" on back. Patient reports 1 blister spot on chest. Patient went to urgent care and was diagnosed with shingles. Doctor prescribed Valtrex and Ibuprofen.
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| 61 | 2021-02-25 | injection site pain, hives, itchy skin |
chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helpe...
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chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.
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| 61 | 2021-02-26 | injection site pain, injection site swelling | Extreme chills, fever, body aches, headace, extreme fitigue, swelling and pain at injection site |
| 61 | 2021-02-27 | injection site pain |
Pain at the injection site was typical for vaccination and was essentially gone by the next day. Hea...
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Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.
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| 61 | 2021-02-28 | itchy skin |
About 10 minutes after receiving the vaccine, patient reported feeling somewhat short of breath and ...
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About 10 minutes after receiving the vaccine, patient reported feeling somewhat short of breath and itchy. She presented to the clinic somewhat short of breath because of her asthma, but the itching was completely new. Gave the patient an age appropriate dose of Benadryl and symptoms resided within 15-20 additional minutes of observation time.
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| 61 | 2021-02-28 | rash |
Eyes bloodshot; Rash over entire body...arms, legs, abdomen, back, neck; dose number= 1, administrat...
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Eyes bloodshot; Rash over entire body...arms, legs, abdomen, back, neck; dose number= 1, administration date= 06Jan2021/dose number= 2, administration date=20Jan2021; dose number= 1, administration date= 06Jan2021/dose number= 2, administration date=20Jan2021; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at the left arm on 20Jan2021 07:45 at single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (WP THYROID), methocarbamol, and paracetamol (TYLENOL). The patient has known allergies to cefalexin (KEFLEX) and statins. The patient was previously vaccinated with the first dose of BNT162B2 on 06Jan2021 07:45 at the age of 61-year-old intramuscular at the right arm for COVID-19 immunization. The patient experiences rash over entire body, arms, legs, abdomen, back, neck, not on the face yet and eyes bloodshot; symptoms appeared over 8-hour period beginning at 7 am on 26Jan2021. The patient did not receive any treatment for the events. The outcome of the events rash over entire body and eye bloodshot were not recovered.
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| 61 | 2021-02-28 | rash, vaccination site pain |
Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if...
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Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if she pressed where the injection was it is still a little sore; She called in sick last week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiration date not provided), via an unspecified route of administration in the right arm on 19Jan2021 13:30 at a single dose for COVID-19 vaccination. Medical history included Blood pressure high diagnosed a couple years ago. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) for COVID-19 immunization on 29Dec2020 and unspecified flu shot last fall, she thinks in Sep or Oct2020, but she has never had problems with those. Concomitant medications included unspecified medications. The patient called and said she had reaction to the Pfizer COVID-19 vaccine 12 hours after her second dose and wanted to report it. She said also this past weekend, on Sunday, on 24Jan2021, she started to develop a localized rash that has like a border to it. She added that she got her second dose of the COVID-19 vaccine on 19Jan2021 at about 01:30 PM in her right arm. She said that she woke up the next morning, 20Jan2021 at 03:00 AM with a high fever, nausea, vomiting, dizziness, and rapid heart rate. She said that the high fever that started the temperature she took was 103 initially, she says she took paracetamol (TYLENOL) and it came down to 101, and the next day it was probably 100 most of the day, then it broke that evening. She said the Tylenol, the dose was the extra strength, unknown if it was 500 mg, they were capsules. She says she normally doesn't keep it around, the in-house nurse suggested it so she went and got a sample thing and took a couple doses, she doesn't have it with her as she is at work and is not at home. She said that the nausea and vomiting subsided after the first day or second day, she had the on and off fever and slept most of the day both days. She said that she doesn't have a fever now. She said that she doesn't have her exact heart rate from when she was having the rapid heart rate, she just felt it in her chest. She added that the only reason she said anything was because she called in sick last week on an unspecified date in Jan2021. She said that the rash started developing after that and it is now probably the size of a 16 oz or 60 oz cup, unable to clarify number with caller, she said that it is definitely big but it doesn't bother her, though she is concerned it is there. She clarified that it is a couple inches in diameter and kind of looks like the state of (State Name), on her injection arm which was her right arm. She said her arm is not sore now, it was after the shot on an unspecified date in Jan2021, if she pressed where the injection was it is still a little sore. She said that the hospital said to report it. She said she also has a concern if she should she get another shot if they decide this is needed for more than two vaccinations. She said that she knows they are still gathering information at this point, so she thought she should better turn in, hopefully there will be solution later on. The outcome of the events localized rash, dizziness, heart rate increased and sickness was unknown. The outcome of the events fever, nausea and vomiting was recovered on an unspecified date in Jan2021 while the outcome of the event vaccination site pain is recovering.
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| 61 | 2021-02-28 | itchy rash | Rash, itchy around neck, hot, weak, drowsy, evaluated by EMS-transported to nearest ER |
| 61 | 2021-03-01 | injection site pain, rash, shingles |
Fever, chills, body aches, nausea, pain at injection site, extreme fatigue, headache. Also on 2/8 ha...
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Fever, chills, body aches, nausea, pain at injection site, extreme fatigue, headache. Also on 2/8 had a Shingles rash for which I consulted a dr and was treated
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| 61 | 2021-03-01 | injection site rash, injection site pruritus |
Severe neck soreness and tenderness 2/27 & 28, took Tylenol Rash& Itching at injection area. 2/27 4:...
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Severe neck soreness and tenderness 2/27 & 28, took Tylenol Rash& Itching at injection area. 2/27 4:00pm. Itching stopped 2/28 however the rash is still present on 3/2. Took Benadryl.
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| 61 | 2021-03-02 | hives, itchy skin, rash |
rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't go...
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rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL; developed a bad rash, hives, all over her body; developed a bad rash, hives, all over her body; itching; a few bumps kept increasing up to 3 days later; her feet were incredibly hot over the next 3 days; arm soreness; She was unable to sleep from being so itchy; Allergic reaction; This is a spontaneous report from a contactable consumer herself. A 61-year-old female patient received bnt162b2 (, Solution for injection, Batch/lot no: EN5318), via an unspecified route of administration on 04Feb2021 15:00 in the left arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously did get a flu shot in Nov or Dec2020. The patient developed a bad rash, hives, all over her body and itching on 10Feb2021. She reports, her feet were incredibly hot over the next 3 days on 07Feb2021. What started off as a few bumps kept increasing up to 3 days later. She was unable to sleep from being so itchy. Her doctor said it was an allergic reaction and prescribed an antihistamine after which it left in Feb2021. She was due for the 2nd dose of the vaccine on 25Feb2021. The patient did not had any investigation assessment. The patient states that there was little information out there to compare the experience she had. Wanted to call to make Pfizer aware of that and maybe get some more information out there. Has printed out the fact sheet and assumes she should not get the second vaccine because of what happened the first time. Wants to clarify what happened and share with Pfizer this information since she can't find much information for people who have had a delayed reaction. Went to get the vaccine on 04Feb and doesn't consider herself an allergic type person. Has no allergy to foods, medicines, only gets poison ivy and bug bites like most people. By Monday, the 4th day (08Feb2021) after getting the vaccine, noticed a couple of bumps on the wrist and does not know where else and didn't think of it as anything else. Thought it was a bite or she touched a plant and then it went away. It was not much. In the evening of Tuesday she had a bad reaction and on the 10th (10Feb2021) she had rash, hives, and itching that just moved to different places over the body. Her feet were so hot on the 3rd day and had to plunged them into cold water and used Epsom salt off and on and it helped some. This happened only for 2 nights and the reason she didn't go to the doctor, it went away. Again, mentions the first night she had a couple bumps and didn't think much about it. The second night, it was all over her body, the rash, and she took Epsom baths that helped, but she didn't get much more than an hour of sleep. She tried to take pictures of her thighs and backside, but unable to take good pictures, not a selfie person. The next morning she had her husband take pictures in case it went away and she went to the doctor they would have pictures to show. Her husband thought it may be shingles. Called the doctor on Thursday and had pictures to show her since the rash went away. Again, mentions the reaction was so bad on Wednesday. The doctor didn't believe areas on pictures of her back were shingles since shingles does not come and go away like that and that she must have had an allergic reaction to something. Provider didn't believe it was from the vaccine. Was given a prescription for Hydroxyzine HCL 25mg and was informed if areas didn't improve or returned she may need to see an allergist or immunologist. After the appointment she didn't get much sleep and woke up at 4pm in the afternoon and felt a little off, it could have been in her head or maybe she was paranoid, but she wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL and went to bed at 7:30pm and didn't do anything since. Got up and the reaction/rash, hives, itching was all gone after taking only one. It's like an antihistamine or Zyrtec. No further details provided. Later mentions after getting the first vaccine on the 4th, the next day she had arm soreness up until that Monday when the rash started. No further details provided. Says as far as recommendations were concerned for the paper she printed, the fact sheet. It says pretty much listed, she shouldn't have the second dose if difficulty breathing, swelling in the face and throat. The only thing she had was the rash on the neck, not the face. Paperwork also lists heart beating fast, or severe allergic reaction. The patient had no emergency room visit. The patient visited the physician office. The outcome of the event hot feeling in feet was recovered on feb2021 and rest of the events was recovering.
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| 61 | 2021-03-03 | hives, itchy skin |
numbness in her lips; swelling in her face; her tongue was feeling funny; her throat was feeling str...
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numbness in her lips; swelling in her face; her tongue was feeling funny; her throat was feeling strange; she had itchiness to her right hand; started to develop hives; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 01Feb2021 at 09:00 (at the age of 61-years-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives on 01Feb2021. The clinical course was reported as follows: Approximately 3 hours after receiving the vaccine, the patient started to experience numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, and she had itchiness to her right hand and started to develop hives. The patient stated that she cannot take diphenhydramine hydrochloride (BENADRYL), but she did take cetirizine hydrochloride (ZYRTEC) to help with the symptoms. The patient was still having symptoms at the time of reporting. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 61 | 2021-03-04 | itchy skin, hives | Severe systemic itching and hives |
| 61 | 2021-03-05 | injection site swelling, injection site pain |
Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD d...
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Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD did not see visible swelling). And roof of mouth was numb, throat felt like it was closing up, Started getting hoarse, chest tightening. MD gave me 25mg Benadryl and after 30 minutes starting relaxing, Coughing up phlegm. My left arm was very sore and swollen like a lemon... Today. My lip feels kind of burning (like pre herpes outbreak). and roof of my my mouth is still numb. I noticed that I lost sense of taste completely!
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| 61 | 2021-03-05 | itchy skin, redness, hives | Redness, itching, and large hives (welts?) on anterior neck within 4 hours of receiving vaccine. |
| 61 | 2021-03-06 | itchy skin |
At 0900 this morning my face next to the right side of my mouth started itching. I immediately felt ...
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At 0900 this morning my face next to the right side of my mouth started itching. I immediately felt it swell. I looked in the mirror and could see the left lower part of my face (lower cheek by the edge of my mouth) swell and my right upper lip started to swell. I took a Benadryl (25mg oral tablet) and my roommate drove me to the Emergency Room. That area of my face continued to swell and impacted my lower lip as well. My lips were numb and tingling and I could feel my cheek swell more inside my mouth as it was touching my teeth. I was monitored (vital signs and pulse ox) for 90 minutes and received 20 mg of pepcid oral tablet and 10 mg dexamethasone oral tablet- both 1x only.
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| 61 | 2021-03-07 | vaccination site pain |
arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days;...
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arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days; enlarged left breast lymph nodes; This is a spontaneous report from a contactable health care professional (patient) reported for herself. A 61-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL0140, expiry date: unknown) via an Intramuscular on 28Dec2020 at 12:00 PM (at the age of 61-years-old) on Left arm at single dose and second dose (lot number; EL0142, expiry date: unknown) via an intramuscular route on 19Jan2021, at 08:30 AM on left arm at single dose; both for COVID-19 immunization. Medical history included hypothyroidism and hyperlipidemia. Patient received unspecified concomitant medications (Other medications the patient received within 2 weeks of vaccination (unspecified)). Patient had no Allergies to medications, food, or other products. On an unknown date, the patient had arm soreness at injection site (both vaccines); on 20Jan2021, at 05:00 am, patient had fever less than 100.6 F x 24 hours, delayed headache x 3 days for 3 days, enlarged left breast lymph nodes (routine mammogram/sonogram was 2 days post injecting on left arm). No treatment was received for the adverse events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, patient underwent nasal swab (SARS-COV-2-BY-NAAT) test and resulted as negative. Seriousness of the events was reported as non-serious. Outcome of the events was recovered on an unknown date in Jan2021.
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| 61 | 2021-03-08 | hives, itchy skin |
Hives on back of neck. Slightly itchy. Noticed a couple hours after vaccine. Noticed a bit more th...
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Hives on back of neck. Slightly itchy. Noticed a couple hours after vaccine. Noticed a bit more the next morning. Took Benadryl 3/7 night. No increase or decrease in hives noticed so far.
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| 61 | 2021-03-08 | rash, itchy skin |
I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had ...
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I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had a slight rash on chest area. When checked to be released, upon mentioning the rash, they checked my blood pressure, which is normally in the 90-100/68-70 range (low!) and it was 138/80. Sounds normal, but I?ve never had a blood pressure reading that high! I felt ok enough to leave with my husband, but later got dizzy, nauseous and throughout the day my joints (neck, shoulders, arms and legs) got increasingly painful, to the point where I could barely climb the stairs that night without assistance. Note: I run 5K every other day and bike or walk on off days, so I?m pretty active. I took Tylenol and went to bed early and was stiff, but better the next morning. Made myself get outside for a light run and was basically fine (albeit very tired) the next day. First day was a little scary though.
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| 61 | 2021-03-08 | rash | rash on the body |
| 61 | 2021-03-09 | hives | Hives swollen lips |
| 61 | 2021-03-10 | skin warm |
After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6...
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After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6 for 3 days. Hips achy. I have a total knee replacement of my R knee. That became warm to touch, painful and very stiff. The knee surgery was 3 years ago. I was prescribed MOBIC for the knee by my surgeon when I reported the issue.
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| 61 | 2021-03-10 | itchy skin, hardening |
I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was...
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I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.
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| 61 | 2021-03-11 | itchy skin |
He received his 1st COVID-19 vaccine around January 24th and 30 minutes later developed mild lip ede...
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He received his 1st COVID-19 vaccine around January 24th and 30 minutes later developed mild lip edema, itching of the skin Nose and ears. A day after injection patient had Benign fasciculations
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| 61 | 2021-03-11 | rash | diffuse rash after Pfizer Covid-19 vaccine. Treated with H2 and H1 blockers |
| 61 | 2021-03-12 | rash, itchy skin, hives |
Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. O...
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Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. One hour later my ears and scalp began to itch. I had chills and severe nausea. Severe stomach cramping. Rash covering arms, legs, scalp, back and shoulders, Hives across chest and down both arms. Swelling and hives on palms of hands. Difficulty breathing. Symptoms began one hour after vaccine and continued to worsen. Was treated at Center for allergic reaction. Was given Benedryl and Famotadine, then released.
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| 61 | 2021-03-12 | injection site pain | Sore arm at site injection. no treatment, lasted 2 days |
| 61 | 2021-03-13 | vaccination site pain |
Around 12;00pm on 3/13 , I felt muscle aches through back, shoulders, neck. Sore at site of vaccin...
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Around 12;00pm on 3/13 , I felt muscle aches through back, shoulders, neck. Sore at site of vaccine and Headache. I felt tired and rested around 1:00p.m. Took 1 extra Strength Tylenol. Then started getting chills. Felt like I had swollen lymph node on ride side of throat when swallowing and had some pain going up into my ride ear. These symptoms lasted all evening. I didn't feel like eating dinner so rested and took 2 extra strength Tylenol at 9:00 p.m. and went to bed. Woke up early in morning with bad headache so I took another 2 extra strength Tylenol around 6:00am. I finally started feeling better around 9:00am.
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| 61 | 2021-03-13 | pain of skin | Low grade fever, chills, body aches, intense headache , excruciating eye pain and my hair hurt |
| 61 | 2021-03-13 | injection site warmth, injection site redness, injection site swelling |
One week after receiving the vaccine, my arm began to swell at the injection site. Today it?s larger...
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One week after receiving the vaccine, my arm began to swell at the injection site. Today it?s larger, about the size of a tennis ball and it?s warm to the touch. It?s also a little red. It does not hurt.
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| 61 | 2021-03-13 | redness | Redness, flushing, swelling |
| 61 | 2021-03-13 | injection site pruritus, itchy skin |
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-M...
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Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: itchiness at site of injection, mild
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| 61 | 2021-03-13 | rash | mild headache mild rash on the chest |
| 61 | 2021-03-14 | skin burning sensation |
8 days after vaccine, developed burning sensation of skin which has changed locations in upper and l...
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8 days after vaccine, developed burning sensation of skin which has changed locations in upper and lower extremities. Lasts hours at a time and changes location. Also developed diarrhea, vomiting, body aches, chills 8 days after the vaccine.
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| 61 | 2021-03-14 | rash |
Developed a rash near my eye after a couple of days rash moved to my face and neck. After the second...
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Developed a rash near my eye after a couple of days rash moved to my face and neck. After the second shot rash covered face, neck and face and eyes would be swollen
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| 61 | 2021-03-14 | injection site pain |
Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and ...
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Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and neck and in my shoulders. I was not hungry and I had a fever(101.2). I slept until 1pm and I started getting nauseous. I never got up off the couch saturday. Pain in left arm/shoulder blade went away around 5pm Saturday. I still had a slight fever and headache saturday evening. Sunday I felt better but I still had a slight fever and headache but felt generally much better. Monday I had no fever no headache, and a little aching in my right arm at the injection site.
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| 61 | 2021-03-14 | injection site mass, injection site hardening, injection site warmth |
Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and ho...
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Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and hot at injection site. All this started the day after injection .so severe that it felt like I had covid AGAIN! Couldnt eat or hardly get out of bed the day after shot and the second day after the shot I still felt the same but was able to eat . The third day after shot, my fever went away and most of the body aches except I still have the headache and my arm is still hot, and swollen. Just have been taking tylenol this whole time and cold wash cloth for fever and swelling.
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| 61 | 2021-03-14 | injection site pain |
Pfizer-BioNTech COVID-19 Vaccine EUA. injection site pain, tiredness, headache, muscle pain, chills...
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Pfizer-BioNTech COVID-19 Vaccine EUA. injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell
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| 61 | 2021-03-15 | itchy skin | Itching/burning of eyes, body, feet (~7 pm) |
| 61 | 2021-03-15 | hives, redness |
Patient was sitting in monitoring area status post covid vaccine injection (Pfizer 0.3mL). Patient c...
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Patient was sitting in monitoring area status post covid vaccine injection (Pfizer 0.3mL). Patient complained of flushing, erythema noted on anterior neck and chest, and hive was observed. Patient denied shortness of breath. BP 132/92, HR 90, Pulse ox 98% room air. Benadryl (Lot #080012, exp. 08/2022) was administered 50 mg/IM per order into left deltoid @ 1337. EMS was called per protocol. 1340- Vital signs were 156/110, HR 84, pulse ox 98%. 1342- EMS arrived- VS 162/110, HR 85, pulse ox 98%. Patient then complained of feeling lightheaded. Patient was transported to ED without further incident
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| 61 | 2021-03-15 | injection site pain | Swelling around eye Face is slightly swollen Soreness at infection site |
| 61 | 2021-03-15 | vaccination site pain, vaccination site swelling |
Swelling/pain in Left deltoid at injection site; Mild frontal headache; Fatigue 4 hours after vaccin...
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Swelling/pain in Left deltoid at injection site; Mild frontal headache; Fatigue 4 hours after vaccine Mild frontal headache; Swelling/pain in Left deltoid at injection site; This is a spontaneous report from a contactable nurse (patient). A 61-year-old non-pregnant female patient received BNT162B2 (solution for injection; lot number: EL9264) in left arm, via an unspecified route of administration on 09Feb2021 09:30 am at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included osteopenia, mild depression. The patient had no known drug allergies. The patient concomitant medications included citalopram, ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+). The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient experienced Swelling/ pain Left deltoid at injection site, fatigue 4 hours after vaccine, mild frontal headache on 09Feb2021 13:00. The patient did not receive treatment for the events. Outcome of vaccination site swelling and pain was recovered on an unspecified date of 2021 and rest of the events was unknown.
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| 61 | 2021-03-15 | injection site pain |
Within minutes of getting the shot in my left arm I started to feel the left side of my neck getting...
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Within minutes of getting the shot in my left arm I started to feel the left side of my neck getting stiff. It felt like the stiffness was creeping up my neck. After about a hour I felt my ear lobes tingling and the left side of my face in the jaw area seemed a bit swollen and felt a little numb. It resolved and I had only a sore injection site the next day and no other symptoms. I'm wondering if I should be concerned about getting the second shot
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| 61 | 2021-03-15 | vaccination site pain |
nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; ...
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nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.
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| 61 | 2021-03-16 | rash |
Developed skin rash within hours of receiving vaccine, started on the forehead and spread down the ...
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Developed skin rash within hours of receiving vaccine, started on the forehead and spread down the face including the ears and eyelids, a more mild rash on the arms, legs and stomach. took some Benadryl which help with the rash. rash lasted about 4 to 5 days.
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| 61 | 2021-03-17 | injection site pain | Headache, chills, muscle soreness, pain at injection site, tired - still lingering |
| 61 | 2021-03-17 | injection site pruritus, injection site warmth, injection site swelling, injection site redness |
Large raised red area at injection site started the day after injection and it has now been 8 days a...
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Large raised red area at injection site started the day after injection and it has now been 8 days and it is still there and itching and warm to touch
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| 61 | 2021-03-17 | bruising, rash, itchy skin, redness |
bruise to her back; rash on back of neck/rash all over her body; redness; swollen area back of neck/...
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bruise to her back; rash on back of neck/rash all over her body; redness; swollen area back of neck/ swollen area to her back; a lot itchier; This is a spontaneous report from a contactable Nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via intramuscular on left deltoid on 21Jan2021 at 14:00 at single dose to prevent Covid 19. The relevant medical history included obese from an unspecified date. Concomitant medications were reported as none. The patient experienced rash on back of neck/rash all over her body on 26Jan2021 at 19:30, swollen area back of neck/ swollen area to her back on 26Jan2021 at 10:00, redness on 26Jan2021 at 19:30, bruise to her back on 27Jan2021 at 10:00, a lot itchier in Jan2021. The nurse stated that she wanted to report that she had the Pfizer vaccine last Thursday. Stated that two days prior to the report that a rash started on the back of her neck and stated yesterday it was a lot itchier (as reported). Stated that she got undressed to put her PJs on and noticed that she had a fine raised rash everywhere and it was swollen. Stated that she went through her house to see if there was anything that could have caused it. Stated that she went to that doctor at the time of the report and was started on Prednisone taper. Stated that the doctor was concerned about the Prednisone reducing her ability to prevent antibodies. Stated that the doctor stated that he was unsure if she should get the second dose. Caller wanted to ask questions about these things. Had not started the Prednisone yet. Stated that there was redness to the back of her neck and back. Stated that the swelling was to the back of her neck and back. The events did not require a visit to Emergency Room but required a visit to Physician Office. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The event bruise to her back was reported as non-serious, while the events rash on back of neck/rash all over her body, swollen area back of neck/ swollen area to her back and redness were reported as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "rash on back of neck/rash all over her body", "swollen area back of neck/ swollen area to her back and redness" and the administration of the COVID-19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 61 | 2021-03-18 | rash with redness, injection site pain, itchy rash, rash |
Immeditely after my first shot on March 7 I felt fine (except some mild soreness at injection site)...
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Immeditely after my first shot on March 7 I felt fine (except some mild soreness at injection site). A full week later, on March 14, I had some mild chills, fatigue, headache, and a red itchy rash. The rash was located on my right inner forearm, my left inner thigh, my lower back and hip area, and my ears. No rash on injextion site arm. I took benadryl and used a topical 1% hydrocortisone cream, and the rash eventually subsided after 5 days.
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| 61 | 2021-03-19 | injection site pain, skin warm |
I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pai...
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I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pain in left arm from shoulder to elbow (injection was in left arm), and nausea. Got up to try to get Tylenol tablets, but returned to bed because I was unsteady on my feet & didn't feel like I should try to go downstairs to get the Tylenol or a thermometer to take my temperature. But my husband said I was warm to touch when he brought me extra blankets to help mitigate persistent chills I was having t/o the night. Symptoms continued until morning of March 20, 2021 and gradually lessened by evening. Stayed in bed all of March 19th and took Tylenol 650mg every 6 hours to lessen bad headache. Ate a few saltine crackers to lessen nausea symptoms & drank ice water. Had a small nosebleed evening of Mar 19th that resolved with pressure to the bridge of my nose. Today (Mar 20th), I have residual light headache that goes away with Tylenol, but no fever, chills, nosebleeds or arm pain.
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| 61 | 2021-03-20 | itchy rash, rash, hives |
A very itchy rash which looked like shingles about 5 inches in diameter appeared under my right arm ...
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A very itchy rash which looked like shingles about 5 inches in diameter appeared under my right arm close to my breast on Sat. About 30 mins. later it began to look like large welts. About 30 mins. after that it disappeared leaving raised skin. The raised skin went away in about 30 mins.
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| 61 | 2021-03-20 | injection site redness, injection site pruritus |
After taking a hot bath. Redness at vaccine site and down the left arm on both sides. Some itchine...
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After taking a hot bath. Redness at vaccine site and down the left arm on both sides. Some itchiness at the vaccine site. Took 1 benadryl and the redness and itchiness disappeared rather quickly. Some mild redness at the site.
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| 61 | 2021-03-20 | itchy skin |
Patient received the Covid-19 vaccine. She reports symptoms of sudden onset itching throughout entir...
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Patient received the Covid-19 vaccine. She reports symptoms of sudden onset itching throughout entire body 5 minutes post-injection along with sudden onset severe headache. Vaccine injection time 1715, symptom onset at 1720. Vitals: @1720: BP 148/94, HR 79, O2 98 @1725: BP 148/83, HR 80, O2 99 (PO benadryl 50mg given at this time) @1730: BP147/80, HR 70, O2 96 @1735: BP 148/82, HR 71, O2 99 @1745: 149/92, HR 74, O2 98 @1755: BP 148/71, HR 73, O2 97 @1805: patient ambulated to restroom. Patient stated that "symptoms aren't improving at all after benadryl -- I think I should go to the emergency room. Wait until I get back from the bathroom to call 911." @1814: Patient returned from restroom, 911 called @1820: EMS arrived, care handed off to EMS @1825: EMS transported patient to ER
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| 61 | 2021-03-20 | itchy skin |
Patient stated that approx. 5mins after getting the vaccine, she felt very nauseous and had full bod...
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Patient stated that approx. 5mins after getting the vaccine, she felt very nauseous and had full body itchiness. 50mg of PO Benadryl was given prior to coming to the hospital. Patient arrived at hospital & still complained of itchiness. Pt received solumedrol & Pepcid IV.
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| 61 | 2021-03-21 | rash |
On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with...
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On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with that during the night and on 3/20/2021 I still had the body aches and felt weak. On 3/21/2021 I noticed that I had a rash developing in places. On 3/22/2021 I woke at 5:00 a.m. covered with a rash over my entire body that itched. I took Benadryl and that is when I went to the ER.
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| 61 | 2021-03-21 | skin warm, redness, pain of skin | Painful half dollar size warm red lump. Lump is both below and on top of skin. |
| 61 | 2021-03-21 | rash, itchy rash, itchy skin |
Rash on my abdomen and arms started about 5 days after the vaccine. Rash is itchy and looks like ra...
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Rash on my abdomen and arms started about 5 days after the vaccine. Rash is itchy and looks like raised bug bites. Itching mostly at night. Will break out in different areas on arms from day to day. Abdominal rash remains constant. Started using OTC cortisone to minimize the itch and started taking Zyrtec for the itch. It still remains as of this report and hasn't gotten any better.
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| 61 | 2021-03-21 | injection site pain |
Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00...
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Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00 am started feeling dizzy. Approximately noon stated feeling chills and general body aches. 6:00 pm took ibuprofen and slept until 6:00 am next day . All symptoms then gone
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| 61 | 2021-03-21 | vaccination site rash |
very large red rash at the injection site; This is a spontaneous report from a contactable consumer ...
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very large red rash at the injection site; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL9265), via an unspecified route of administration in the left arm on 29Jan2021 1:00 PM a single dose for COVID-19 immunisation. The vaccine was administered at a hospital. The patient did not receive any other vaccines in four weeks prior to receiving BNT162B2. The patient was not pregnant. Medical history included seizure disorder. The patient did not have covid prior to vaccination. She had no known allergies. On 06Feb2021, the patient had a very large red rash at the injection site 8 days after vaccination. It was not particularly itchy or uncomfortable. It seemed notable only because it was over a week later. The patient did not receive any corrective treatment for the event. Outcome of the event was recovered on an unspecified date. The patient was not tested for covid post vaccination.
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| 61 | 2021-03-22 | injection site pain, injection site warmth |
Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump unde...
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Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump under my left arm pit (was very tender). I did not go to sleep like that. I did not have any symptoms by the time I went to bed. I also felt hot, and then cold, then hot, then cold, I would feel too hot and then too cold, freezing, I could not keep my temperature under control. I had to call in at work during the weekend I was feeling so bad. I had a lump under my armpit the size of a fist and I could not close my arm completely. It was huge and painful. I decided to go to a clinic over the weekend (unsure if Saturday or Sunday) to seek medical care and they ran some labs and a CBC to check for infection. All results came well no infection. They suggest to keep taking Tylenol. By Monday or Tuesday I started feeling well enough to return to work. The lump was still present and took about a week to go down. The injection site also was sore for a while, about a week also like the lump.
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| 61 | 2021-03-22 | injection site pain |
Low fever (100 F), pain at injection site, nausea and dizziness. It lasted about 12 hours. I took a...
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Low fever (100 F), pain at injection site, nausea and dizziness. It lasted about 12 hours. I took a Tylenol when nausea subsided (in the afternoon).
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| 61 | 2021-03-22 | hives, itchy skin |
Pfizer-BioNTech Covid 19 vaccine The night of the vaccine March 11th , I had fever of 100.8, chills,...
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Pfizer-BioNTech Covid 19 vaccine The night of the vaccine March 11th , I had fever of 100.8, chills, headache, muscle aches, sore throat, joint pain that lasted until Tuesday morning, March 16th. I had no symptoms on Tuesday & Wednesday, but developed hives on my ankles Thursday afternoon exactly one week after the Covid 19 vaccine. When I got up Friday morning I was covered in hives on my legs, arms and abdomen. The whelps were raised and itchy and appeared to be spreading. I went to my HCP and they administered an intramuscular steroid shot and advised me to take Benadryl as needed
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| 61 | 2021-03-22 | skin warm, redness | Red, hot, sore patch on arm that developed 6 days after shot |
| 61 | 2021-03-23 | bruising |
BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; ...
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BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.
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| 61 | 2021-03-23 | skin mass, shingles |
I started developing painful nodules upper neck(right), around outside ear(sright) lower jaw line. B...
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I started developing painful nodules upper neck(right), around outside ear(sright) lower jaw line. Being a nurse I thought I was breaking out as the days went by I noticed it was Shingles.
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| 61 | 2021-03-23 | blister, rash |
Patient received vaccine Saturday morning 3/20/21. She stated she woke up on Sunday morning 3/21/21 ...
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Patient received vaccine Saturday morning 3/20/21. She stated she woke up on Sunday morning 3/21/21 and had a "rash on her arms and chest, and some of the spots looked like blisters." She went to her dermatologist on Wednesday 3/24/21, but they did not give her medication for treatment. Patient states that the rash is improving.
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| 61 | 2021-03-24 | bruising, hardening, skin warm |
Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symp...
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Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symptoms started 3 days after injection on 03/24/2021. Headache, chills, fatigue, atypical chest pain.
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| 61 | 2021-03-24 | injection site pain | Injection site pain, tiredness, headache, chills, joint pain, fever |
| 61 | 2021-03-24 | redness | Red, swollen circle approximately 2 inches in diameter with rash |
| 61 | 2021-03-25 | injection site warmth |
Patient expressed anxiety. Had same symptoms with flue vaccine in 10/2020. Left arm injection site...
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Patient expressed anxiety. Had same symptoms with flue vaccine in 10/2020. Left arm injection site no redness, warmth. Patient expressed both parents recently passed away and expressed increased anxiety. Pt walked to the car, steady and stable. Pt will take tylenol as prescribed, rest, and hydrate. Recommend pt to follow-up with PCP on Monday for anxiety and elevated BPs. Pt denied HTN. Vitals: At 13:25, 160/82. 1 minute after 99 At 13:45, 160/82, 98HR, 99% spo2.
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| 61 | 2021-03-25 | vaccination site pain |
Rheumatoid arthritis/Rheumatoid arthritis attack; herpes outbreak- blisters in her mouth; wound on l...
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Rheumatoid arthritis/Rheumatoid arthritis attack; herpes outbreak- blisters in her mouth; wound on leg started to get worse, leaking a lot of fluid; back is hurting; felt like a tetanus shot in her arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9809), intramuscular in left arm on 10Feb2021 14:30 at single dose for covid-19 immunization. Medical history included high blood pressure, rheumatoid arthritis and kidney issues. Concomitant medication included insulin. The patient had the first COVID-19 vaccine. She had a lot of issues wrong with her, however she did not have them hit her at the same time. It was currently the 9th day since she had her first shot. About 4 or 5 days into it, the wound on her leg started to get worse. She had rheumatoid arthritis and she had an RA attack. She had herpes, but she did not had an outbreak in a couple of years. She got blisters in her mouth, and this also hit her. She explained everything hit her all at once. She was now on antibiotics for each one of the things. Her doctor figured out that her body just couldn't handle it. She clarified putting the vaccine into her body, she couldnt fight off everything. Like whatever in in the vaccine and how the vaccines works, her body was just not strong enough to fight off everything at the same time. The patient did not went to the emergency room. It was reported that the patient would receive her second dose on 03Mar2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 61 | 2021-03-26 | itchy skin, rash |
3/23 mild headache 3/24 mild headache 3/25 mild headache 3/26 rash started, in patches, right arm, t...
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3/23 mild headache 3/24 mild headache 3/25 mild headache 3/26 rash started, in patches, right arm, trunk, under hair on head, and partially down back of neck.Severe itchiness. Took OTC benadryl, two tablets, no relief. 3/27 rash continues, itches more in evening
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| 61 | 2021-03-26 | rash |
Beginning around 8:00 pm I felt prickly all over my body. Not severe, but uncomfortable. I believe...
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Beginning around 8:00 pm I felt prickly all over my body. Not severe, but uncomfortable. I believe I also developed a minor rash. I took benadryl that night and slept fine. I felt the same way on 3/23/21 and took benedryl again. It seemed better 3/24/21 but came back on 3/25/21 and has continued today 3/27/21. After a walk outside with no jacket it is feeling better, but I can tell it's still there. Called my doctor on 3/23/21 and she recommended benadryl at night and allegra or claritin during the day. And ibuprofen and pepcid. I only have taken the benadryl. She advised not getting the second shot.
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| 61 | 2021-03-26 | itchy skin, hives |
Complaint of itching beginning on face and all over body within 25 minutes of receiving vaccine. Hiv...
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Complaint of itching beginning on face and all over body within 25 minutes of receiving vaccine. Hive-like rash to back present. Patient was given Benadryl 50 mg IM per Nurse Practitioner order and symptoms began to resolve within 10 minute with complete resolution within 30 minutes. Patient left clinic with family member and was advised to contact emergency care or physician if symptoms return.
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| 61 | 2021-03-26 | rash |
Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p...
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Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p COVID - 19 vaccine # 2. Lowered to the floor by vaccine staff. Patient reports symptoms of weakness, other wise states she ""feels fine"". Two additional syncopal episodes witnessed by myself when patient attempts to change position. Past medical history is significant for mild persistent allergic asthma, pre-diabetes, OSA, obesity and BPPV. Patient reports history of same reaction s/p previous vaccine. At a approximately 0837 patient was noted to have a worsening rash present to her face. EpiPen administered via left lateral thigh at 0838. EMS called to transport patient the ED for further evaluation. Treatment administered: epipen (lot 0FM406, exp 02/22) left lateral thigh at 0838. Upon arrival to the ED, patient's temperature is 98.8° F, heart rate 92-103, respiratory rate 30, saturating 99% on room air with blood pressure 164/91. The patient's laboratory studies were largely unremarkable. While in the ED, the nurse was getting ready to get the patient up to the commode when the patient started to ""not feel right again."" She asked her to administer the medications for allergic reaction and reports wall the 2nd medication was being infused, she felt paralyzed and unable to talk, although she was able to hear everything and was aware, she was unable to move or speak for a short amount of time. CT head with completed at this time and showed no acute intracranial findings. Chest x-ray unremarkable. EKG showed normal sinus rhythm with sinus arrhythmia, heart rate 80 and prolonged QT at 470. The patient was administered Solu-Medrol 125 mg IV, Pepcid 20 mg IV, Benadryl 50 mg IV, normal saline 1 L IV. Pt was admitted to hospital for observation. The patient was seen on the unit laying in bed with her husband at the bedside. She reports that she is feeling slightly better and hungry and has never felt at paralyzed/unable to speak feeling before and is very nervous about this. She was wondering if she had a seizure, although she reports feeling aware the entire time and did not lose bowel or bladder function. We discussed that that is not typical for a seizure, but even if we did an EEG at this time, it would not be able to tell us what occurred in the past. We discussed continue the Benadryl, Pepcid, and IV steroids for today and likely decreasing them tomorrow. We discussed the workup of syncopal episodes as well. The patient and her husband were agreeable to this plan. Patient was discharged from the hospital on 03/24/2021 in a stable medical condition. Patient was instructed to follow-up with her PCP in 1 week.
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| 61 | 2021-03-26 | injection site pain |
Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later b...
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Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later became drowsy, had to leave work and go home, woke up around 5 p.m. body ached on left and right side, took Aleve for pain.. Overnight had chills, headache, next morning, took Aleve for pain. Whole body ached for about a week, headaches, lethargic, tiredness. About week and half later only ache in right arm, sore like I sprained it, still tender today.
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| 61 | 2021-03-26 | rash, hives, itchy rash | Rash/hives on neck, chest, arms and lower legs ........very itchy! |
| 61 | 2021-03-26 | itchy skin |
Severe itching all over, anaphylactic, took two allergy pills and medical test on music related to t...
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Severe itching all over, anaphylactic, took two allergy pills and medical test on music related to the nostril shot of Flonase
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| 61 | 2021-03-26 | itchy rash, rash | rash on face, scalp neck and chest. OTC Benadryl. Lessened the itch a little . |
| 61 | 2021-03-27 | hives, itchy skin |
Approximately 25 minutes after receiving the vaccine I noticed my eyes were beginning to itch and my...
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Approximately 25 minutes after receiving the vaccine I noticed my eyes were beginning to itch and my throat felt odd and was accompanied by a hoarse voice. I was driving home at that point and considered turning back for medical advice (should have but did not). Over the next few hours itching sensation on my tongue, face including eyes, head and back. Developed just one hive on my eyebrow approx 3 hours after vaccination, and one on my thigh at least six hours after vaccination. The symptoms were not severe but obviously I monitored them. Now 24 hours after the vaccination and still have some itching as described above. Throat is somewhat better. Eyes feel odd more than itchy at this point.
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| 61 | 2021-03-27 | injection site redness, injection site pain |
Injection site pain and redness, tiredness, splitting headache, muscle ache, chills, joint pain, in...
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Injection site pain and redness, tiredness, splitting headache, muscle ache, chills, joint pain, intermittent fever, loss of appetite
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| 61 | 2021-03-28 | rash papular, rash | Raised Rash on chest left side of neck and side of face |
| 61 | 2021-03-29 | hives |
Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt li...
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Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".
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| 61 | 2021-03-29 | injection site swelling, injection site pain |
pain / swollen area where injection given. joint pain in every joint in my body - never had this bef...
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pain / swollen area where injection given. joint pain in every joint in my body - never had this before vaccine. Facial muscel spasms; both eyes and left side of cheek area. Never had this before.
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| 61 | 2021-03-30 | injection site pain |
Body aches; Sore injection site; Nausea; This is a spontaneous report from a contactable consumer. A...
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Body aches; Sore injection site; Nausea; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Arm Right on 09Feb2021 15:30 as Single Dose for covid-19 immunisation. Medical history included drug hypersensitivity (Sulfa allergy), thyroid disorder and hypertension from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, liothyronine (NP THYROID) from unspecified date to unspecified date for unknown indication. On 09Feb2021 23:00, The patient experienced body aches, sore injection site and nausea. The action taken in response to the events for BNT162B2 was not applicable. Outcome of events was not recovered.
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| 61 | 2021-03-30 | itchy skin |
Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and ...
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Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
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| 61 | 2021-03-30 | vaccination site pain |
Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appet...
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Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available
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| 61 | 2021-03-30 | itchy skin |
Patient was given vaccine at 10:45am - Patient reported scratchy throat at 10:48am - at 10:50am we g...
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Patient was given vaccine at 10:45am - Patient reported scratchy throat at 10:48am - at 10:50am we gave 50mg of Diphenhydramine orally, patient condition worsened, she described her throat starting to swell up, and had noticeable difficulty breathing and shortness of breath. We administered Epinephrine at 10:55am and within 5 seconds patient reported improvement. Patient remained stable until EMS arrived about 5-10 minutes later. Patient was advised to be taken to the hospital for monitoring and agreed. She remained stable and reported an "itchy back" upon exit.
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| 61 | 2021-03-30 | vaccination site pain |
chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nod...
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chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nodes are impacted a little bit; nausea/feeling nauseous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206) via an unspecified route of administration, administered in Arm Left (left shoulder), at the age of 61-year-old, on 03Mar2021 19:00, as SINGLE DOSE for covid-19 immunisation. The patient medical history was overweight, diagnosed COVID last Apr2020 she had it for 17 days and had every symptoms. The patient tried to give antibodies for many months and she was told she had two different kinds of antibodies which prevented her from doing that. The patient has long hauler symptoms which are nerve pain in her thighs and mouth. The patient's concomitant included an unspecified medication (she takes something but not relevant). The patient did not receive any vaccine within 4 weeks prior. The patient previously received shingles vaccine on 14Feb2020 and tetanus shot on an unspecified date (years ago) both given for immunization and her arm hurt/ pain at the injection site (if she touches it, it hurts). On 03Mar2021 at 7PM, after receiving first dose, she felt blah described as she developed injection site pain which is dissipating but still there, headache, muscle pain, tiny fever, impacted lymph nodes, nausea/ feeling nauseous which she didn't have before. The patient can get up and walk around. On 04Mar2021, the patient had chills in the afternoon. It was just a little fever. The patient took Tylenol and Advil in the afternoon and it helped it go away. The patient took one of each. It was reported that the COVID headache is like none other and she had the headache again. For the COVID headache if you take things it doesn't make it go away. When the patient said she had the headache again she meant she had the same headache that she had in April. The events did not require ER or physician office visit. Outcome of injection site pain was not recovered while it was unknown for the other events. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
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| 61 | 2021-04-01 | rash with redness, rash macular, rash, rash vesicular |
The rash began as a faint red macular rash below the knee on the left leg before progressively sprea...
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The rash began as a faint red macular rash below the knee on the left leg before progressively spreading and involving the contralateral leg, lower abdomen, and bilateral upper extremities. The rash was mildly painful but not pruritic. She was otherwise asymptomatic. On examination, the patient was afebrile and well appearing. There was erythematous to violaceous palpable purpura scattered on the lower abdomen, lower legs extending to the feet, and forearms extending to the palmar hands. The lower extremities had several dusky violaceous vesicles, some with superficial erosions. Punch biopsy confirmed Leukocytoclastic vasculitis. She was treated with topical corticosteroids and rash is still resolving.
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| 61 | 2021-04-09 | vaccination site pain |
feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of...
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feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021. On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day. Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy. Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear. She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.
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| 61 | 2021-04-11 | injection site pain, itchy skin |
Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard...
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Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard work before she came to get her vaccine. After she received her vaccine she felt fine. On Tuesday night she started to feel some itchiness. She said the itchiness got worse over the next two days. She talked to her husband and he advised her to take Benadryl so she took two Benadryl. On Wednesday she had some soreness at her injection site. Very early Thursday morning she noticed a golf ball sized knot in her armpit. She said it was sore and if she rubbed it, it felt like it was pushing into her breast. She said it felt like pressure going all the way to her breast bone and along her esophagus. She ended up calling EMS and her blood pressure was up to 181/107 and had a high heart rate. She said she never had any hives but did have some throat, tongue, and lip swelling and said that her throat felt raw. The EMS gave her 2 nitroglycerin tablets and 5 aspirin. She spent Friday and Saturday in the hospital. She said the hospital did all kinds of cardiac tests on her and everything can back clear besides a leaky heart valve. She said she is feeling much better now and that the hospital was not sure if it was a reaction to the vaccine, something else, or a combination of things that caused it.
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| 61 | 2021-04-13 | bruising |
4/9/21-30 minutes to 1 hour after receiving 2nd dose of vaccine patient had bloody nose, clots, with...
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4/9/21-30 minutes to 1 hour after receiving 2nd dose of vaccine patient had bloody nose, clots, with bleeding sores on tongue and side of mouth. Began to have bruises on arms, feet and legs. Blood in urine and bruises on back. Presented to emergency department on 4/11/21. CT brain revealed a right sided posterior temporal hemorrhage. Patient was emergently treated with platelets, DDAVP, factor VII, Decadron, IVIG. 4/12/21, patient denies headache, changes in vision, double vision, change in sensation, including burning, pinprick, numbness, no focal or motor weakness. No change in bowel or bladder control. No sensory changes. Patient states she is now back to her normal state of health, save for the bruising described.
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| 61 | 2021-04-13 | injection site pain, skin discolouration, cellulitis |
Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills...
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Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.
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| 61 | 2021-04-17 | vaccination site itchiness, vaccination site pain, dry skin |
My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super water...
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My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
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| 61 | 2021-04-18 | redness |
anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely r...
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anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization/Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered. No follow up attempts are possible. No further information is expected.
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| 61 | 2021-04-18 | vaccination site pain |
having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, lef...
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having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.
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| 61 | 2021-04-21 | injection site swelling, injection site redness, injection site hardening, injection site pain, injection site pruritus |
After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the ...
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After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the arm. Throughout the day and into the night I had pain, redness, itching and swelling at injection site. The next day (21st) a hard lump developed under the skin where I had the injection. I also had a headache and muscle aches. I didn't take any medication for the pain and discomfort as I was told it was beneficial to let the reactions occur without drug interaction or interference.
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| 61 | 2021-04-21 | rash, injection site rash |
The patient had a localized rash near the injection site. The patient was told to monitor the rash a...
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The patient had a localized rash near the injection site. The patient was told to monitor the rash and report to the ED if symptoms continue or worsen.
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| 61 | 2021-04-24 | vaccination site swelling |
Anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizzi...
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Anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness; Anaphylaxis-swelling of eyes, tongue, and injection site.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration, administered in right arm on 05Apr2021 16:00 as single dose for COVID-19 immunization. Medical history included known allergies: yes and hypertension. The patient was not pregnant. Concomitant medications included metoprolol succinate (TOPROL XL), lisinopril dihydrate (LISINOPRIL), and cetirizine hydrochloride (ZYRTEC). The patient had no other vaccine in 4 weeks. On 05Apr2021 16:15, the patient experienced anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness. The events resulted in emergency room/ department or urgent care. Therapy for the events included prednisone, antihistamine, and intravenous (IV) fluid. The patient did not have covid prior vaccination and was not Covid tested post vaccination. Outcome of events was recovering. Information about lot/batch number has been requested.
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| 61 | 2021-04-24 | vaccination site pain |
Her platelets are 200, which is very low; Bell's palsy; Shot on the top of my shoulder; excruciating...
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Her platelets are 200, which is very low; Bell's palsy; Shot on the top of my shoulder; excruciating pain/shoulder pain/given high on the top of her shoulder. It hurt; sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 61-years old via an unspecified route of administration on 19Mar2021 10:10 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included systemic lupus erythematosus from 1985 and ongoing, arthritis and osteoarthritis from an unknown date and unknown if ongoing (She has osteoarthrosis throughout her body and her feet). Family history included stroke (husband died at the age of 59, he was having stroke upon stroke). The patient's concomitant medications were not reported. It was reported that when she received the shot, it was given high on the top of her shoulder and it hurt. She could not move her arm for 3 days. The pain was excruciating. On the 4th day, her arm was sore, but she could move it. She had no fevers, she didn't get sick, but she just couldn't move her arm. The shot was given at at 10:10 am, and by noon she could barely move her arm. Her left side of the mouth doesn't want to work properly. Her Bells Palsy started on 05Apr2021. She was in her car and driving to the store, when all of a sudden her left eye was watering. She got home and she didn't see anything wrong with her eye, except it was watering. She could tell a difference between the left and right side of face when she touched it. Something was wrong with her right side. Her eye was not opening all the way, it's been dropping, and her lip was down. She can't smile, and when she drinks water it's comes out. The patient clarified that it was her left side that is drooping. She went to the emergency room due to Bell's palsy. She could not move her arm within 2 hours of getting the shot. The patient mentioned her whole body aches from the Lupus and arthritis, but the shoulder pain was different after the vaccine. The shot itself hurt, and she thinks the one who administered the vaccine might have hit something. There's not a day that doesn't go by that she is not in pain. Her platelets are 200, which is very low. The patient underwent lab tests and procedures which included activated partial thromboplastin time: unknown result, blood glucose: unknown result, computerised tomogram: unknown result, full blood count: unknown result, glomerular filtration rate: unknown result; all on 06Apr2021, magnetic resonance imaging: showed a darkened area in her brain that looks like its connected with Bells Palsy on an unspecified date, basic metabolic panel: unknown result on 06Apr2021, platelet count: her platelets are 200, which is very low on an unspecified date, prothrombin time: unknown result, troponin i: unknown result (High sensitive ); both on 06Apr2021. The patient did not recover from Bell's palsy, recovered from vaccination site pain on 23Mar2021, from sore arm on 19Mar2021 and the outcome of the remaining event was unknown. Information about Lot/batch number is requested.
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| 61 | 2021-04-27 | itchy skin, skin peeling, rash |
I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pai...
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I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.
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| 61 | 2021-04-27 | vaccination site swelling, vaccination site redness |
the site was swollen and red, draining pus; the site was swollen and red, draining pus; the site was...
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the site was swollen and red, draining pus; the site was swollen and red, draining pus; the site was swollen and red, draining pus; This is a spontaneous report from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received the first does of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Mar2021 13:15 (Batch/Lot Number: EN6204) (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, spinal neuropathy and allergy to latex. Concomitant medication included atenolol taken for an unspecified indication, start and stop date were not reported. Past drug history included the patient had allergy to acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the site was swollen and red, draining pus and she cleansed the area and it was size of a walnut. The area opened on its own with a moderate amount pus. The patient had no fever. She had been cleansing and keeping the area clean and dry. She kept applying antibiotic and cove. It was red but no drainage. It had not spread. The patient had no other symptoms. The outcome of events, the site was swollen and red, draining pus was recovering. No follow-up attempts are needed. No further information is expected.
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| 61 | 2021-05-07 | itchy skin |
Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the bac...
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Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.
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| 61 | 2021-05-07 | shingles |
Very late diagnosing as shingles; Headache at work after vaccine; then got more severe along with le...
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Very late diagnosing as shingles; Headache at work after vaccine; then got more severe along with leg very sensitive and burning feeling; then got more severe along with leg very sensitive and burning feeling; severe stomach pain; This is a spontaneous report from a contactable other HCP (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 28Jan2021 09:00 (at 61 years old), single dose for covid-19 immunisation. Medical history included concussion, endometriosis, all from an unknown date. Concomitant medications included estradiol; progesterone. No other vaccine in four weeks. On 28Jan2021 09:00, patient experienced Headache at work after vaccine , then got more severe along with leg very sensitive and burning feeling, better then 5 nights very severe stomach pain-Dr appt and ER to get sonogram, CT-Very late diagnosing as shingles. The outcome of the events was not recovered. Treatment of adverse events was CT, Sonogram. No covid prior vaccination. Not covid tested post vaccination. No Known allergies. Information about lot/ batch number has been requested; Sender's Comments: Based on known disease pathophysiology, the event herpes zoster is assessed as not related to suspect vaccine BNT162B2.
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| 61 | 2021-05-13 | vaccination site pain, shingles |
1st and 2nd dose- swollen glands; injection site pain in right arm; 2nd dose- shingles/shingles blis...
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1st and 2nd dose- swollen glands; injection site pain in right arm; 2nd dose- shingles/shingles blisters; felt quite ill/not feeling well; second dose- extreme pain in left hand/sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 08Mar2021 (Batch/Lot Number: EN6208) (at the age of 61-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included breast cancer (2-time breast cancer survivor), had lymph nodes removed, and has low thyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for low thyroid from an unspecified start date and ongoing; ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) taken for an unspecified indication from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication from an unspecified start date and ongoing; famotidine (PEPCIDAC) taken for an unspecified indication from an unspecified start date and ongoing; esomeprazole sodium (NEXIUM) taken for an unspecified indication from an unspecified start date and ongoing. Patient previously took shingles vaccine on an unknown date (reported as number of years ago) for immunization, flu shots on an unknown date for immunization and also previously took the 1st dose of BNT162B2 (Batch/lot number: EN6200) (at the age of 61-years-old) on 15Feb2021, intramuscular administered in the right arm for COVID-19 immunisation, and experienced injection site pain in right arm, sore arm and swollen gland. Patient stated having what was considered typical, like a sore arm and did have some swollen glands with the first and second dose. It was also reported that after 1st and 2nd dose, there was injection site pain in right arm. After second dose she developed shingles, or what was later found out to be shingles, she had extreme pain in her hand. She thought it was injured or something, it was very painful. She got shingles blisters on her hand, and then also got some on her arm, the opposite arm as the injection. Her dermatologist and internist verified it was shingles. Her internist said it may have been triggered by the vaccine. She clarified it started in the palm of her hand and then traveled up her arm on the opposite side of the vaccine, she got the vaccine in the right arm and the shingles in the left arm. She felt quite ill as a result of the shingles. Her dermatologist put on Valtrex, three times a day. It helped with the spread; it stopped spreading. Her dermatologist was not associating it with the vaccine, and she was not sure she was either. After not feeling well for several days she told internist and he was confident that the vaccine was what caused the shingles. She doesn't remember for sure the event extreme pain in left hand, but it was within a few days after the 2nd dose. The swollen glands started within 24 hours, as well as, the sore arm. It wasn't anything she didn't expect. Like with the flu shot maybe a little worse, but it wasn't severe. Her sore arm was not ongoing. It recovered completely by the next day. Swollen glands came back when the shingles first happened, but they initially began within 24 to 48 hours, for both doses. After the second dose she took two extra strength Tylenol again on the first night again; she just took it once after the 2nd dose. Pain in the hand was 98 to 95 percent better. Her doctor did whole blood work up (unknown results) just to see her white count (unknown results) to rule out something else. The blisters were too small for the dermatologist to scrape and get a biopsy. She did not get the most current 2 dose vaccine for shingles, she only got one dose and that was a number of years ago, she was going to get it but then COVID happened. The outcome of event herpes zoster and pain in extremity was resolving while for other events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
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| 62 | 2021-01-03 | cellulitis |
Cellulitis: below left elbow; Soft tissue swelling; This is a spontaneous report from a contactable ...
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Cellulitis: below left elbow; Soft tissue swelling; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient (62 years old at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), intramuscular in left upper arm on 21Dec2020 13:00 at a single dose for COVID-19 immunization administered in the hospital. Medical history included ongoing hypertension and cervical cancer from 2015 and ongoing. The patient has been taking unspecified concomitant medication/s. The patient previously took amoxicillin and had allergies and nausea. On 24Dec2020 16:00, patient had cellulitis below left elbow and soft tissue swelling. On 25Dec2020, patient went to ER and X-ray was taken and patient was prescribed Keflex 500mg 3x day. Prior to vaccination, the patient was not diagnosed with COVID-19: Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of cellulitis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 62 | 2021-01-04 | itchy rash, rash, redness |
Had gotten a headache within 1/2 hour of getting the injection. Within 2 hours after receiving the i...
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Had gotten a headache within 1/2 hour of getting the injection. Within 2 hours after receiving the injection my arms started to itch and upper back areas. Within 4 hours I noticed rash like redness with tiny little spots/bumps all up and down both arms and the itching was getting worse with both arms and upper back areas. This went away by Friday evening. I had the headache until the following Monday evening.
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| 62 | 2021-01-04 | skin warm, rash, rash with redness |
Red rash on neck both sides below hyoid to scapula 6 inches from left to right and 3 inches top to b...
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Red rash on neck both sides below hyoid to scapula 6 inches from left to right and 3 inches top to bottom. Hot to touch, very red.
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| 62 | 2021-01-04 | itchy skin, hives |
starting developing hives on back of my neck and head 6 days after the covid vaccine was administer...
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starting developing hives on back of my neck and head 6 days after the covid vaccine was administered. The hives progressed to my ears, arms, abdomen, groin, and upper thighs. I started taking Benadryl the first evening the hives started and continued benadryl for 2 more days. The benadryl did not stop the progression or help much with the intense itching. Had a telehealth visit via the telephone with Dr on Monday Jan 4. He ordered Atarax prn. I also started taking Pepcid and Zyrtec. Today I still have hives that are developing but at a much slower pace. The itching is much improved. DO I TAKE THE 2ND VACCINE?
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| 62 | 2021-01-05 | vaccination site pain |
Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asle...
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Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asleep most of the whole day; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: Arp2021), via an unspecified route of administration on 30Dec2020 at single dose at right arm for Covid virus. Medical history included blood thinner treatment. Concomitant medication included ongoing apixaban (ELIQUIS) for blood thinner treatment. The patient previously took coumadin, warfarin. Patient received the Covid-19 vaccine yesterday. She had been asleep most of the whole day (Dec2020). She had injection site pain, headache, tiredness, muscle pain and chills. She thought she was going to work but that didn't work. She was currently taking Eliquis. She had been on coumadin and warfarin before. She looked at the different medications that needed to be reported. She would also call her physician and make her aware. The start date for "Injection site pain" was 30Dec2020. The start dates for headache, tiredness, muscle pain and chills all were 31Dec2020. The patient also experienced nausea, feeling unwell on 31Dec2020. Investigation assessment was no. The outcome of the event "Injection site pain" was not recovered. The outcome of the other events was unknown.
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| 62 | 2021-01-05 | injection site pain | Fever,body aches,chills,heada he body aches,light sensitivity,,sore throatpain at site |
| 62 | 2021-01-05 | injection site pain | Injection site soreness Narrative: |
| 62 | 2021-01-05 | vaccination site swelling, vaccination site warmth |
Swelling, and warmth at injection site, right arm; Swelling, and warmth at injection site, right arm...
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Swelling, and warmth at injection site, right arm; Swelling, and warmth at injection site, right arm; swollen and tender right axillary node under right arm; swollen and tender right axillary node under right arm; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140), intramuscular on 22Dec2020 10:30 at first single dose at arm right for covid-19 immunisation . Medical history included breast cancer, allergy to penicillin, levaquin, neosporin, cocoa butter. Concomitant medication included vitamin c [ascorbic acid]. The patient experienced swelling, and warmth at injection site, right arm, swollen and tender right axillary node under right arm on 28Dec2020 16:00. No treatment for events. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
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| 62 | 2021-01-05 | injection site pain |
after initial, expected, deltoid aching pain which lasted for a few days, very mild achiness has per...
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after initial, expected, deltoid aching pain which lasted for a few days, very mild achiness has persisted. at approximately 1.5 weeks (17d), I noticed actual weakness when I attempted to lift weights (5#) above my shoulders. isolated to the left arm, which was the injection site. Exercising now, daily, with very slow response and increased aching. despite history of intermittent radiculopathy, there had been no weakness prior to the vaccine. Is this a reported vaccine AE?
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| 62 | 2021-01-05 | injection site swelling, injection site bleeding, injection site bruising |
swelling and joint pain in the little finger on left arm; swelling and joint pain in the little fing...
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swelling and joint pain in the little finger on left arm; swelling and joint pain in the little finger on left arm; She got a bruise at the injection site; It bled a little bit when she put it in; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231), via an unspecified route of administration on the left arm, on 28Dec2020 at 14:15 at a single dose for Covid-19 immunization. Medical history included environmental allergies, she has allergies and can have an asthmatic attack from cat dander and perfume, blood pressure (abnormal) and sleep (disorder). Concomitant medications included ongoing lisinopril for blood pressure, colecalciferol (VITAMIN D), acetylsalicylic acid (BABY ASPIRIN), paracetamol (TYLENOL). The patient previously took novocaine but was allergic. She got all this information when she got the vaccine on Monday at (place name) in (state name). It tells all the side effects from the first injection. She wanted to report that it is the same arm that she got the vaccine in. She has swelling and joint pain in the little finger on left arm. It says you can have joint pain, but nothing about swelling. She thought she better report it. This was her first shot. She is supposed to get the second one on 18Jan2021. She wanted to make sure she can take it. She received the vaccine on 28Dec2020. She laid around that day. Today is the first day she doesn't have arm pain and swelling at the injection site. It was the first time she has had arm pain. She has never had that with flu shot. The arm pain started within the 15 minutes she was observed. It hurt like hell until that day. She got a bruise at the injection site. It bled a little bit when she put it in. Swelling and joint pain in the little finger on left arm: she doesn't know if it was later that day. She can't remember. She really noticed it yesterday. She has never had joint pain or swelling. She doesn't have any problems with arthritis. Now her little finger is bigger than the rest of her fingers. It hurts because of the swelling. She doesn't want to take anything. It might be fluid. She has a high pain tolerance. She keeps bending it thinking it will get better. It isn't as bad, but its still swelled up. At first she thought it was better, but it is still pretty swollen. To her this is a reaction. She was thinking if she took paracetamol before, it wouldn't hurt as bad, but she can't remember if she took it that morning. She takes 500mg before bed for the heck of it at night. It helps her sleep better. She has allergies and can have an asthmatic attack from cat dander and perfume. They think she was allergic to the preservative in the flu shot, but she has never had any trouble with the flu shot since. She has environmental allergies. They thought she was allergic to Novocaine once at the dentist office. Who knows, it only happened once. She's been to the dentist many times and who knows what they injected and why she reacted that way. She felt like she was going to pass out. They don't give it to her anymore. She doesn't know what was in it. She is worried since this vaccine is emergency authorization. She doesn't want to get the next one and have a worse reaction. She is not sure if she should be worried. The events of swelling and joint pain in the little finger on left arm were assessed as medically significant. Outcome of the event of 'swelling of fingers' was not recovered, the other events were unknown.; Sender's Comments: There is a reasonable possibility that the event joint pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the event swelling with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-01-07 | itchy skin, injection site pain, rash |
Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upp...
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Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upper back,upper chest and bend of both arms.Benadryl 25 mg OTC 1/6/21 and 1/7/21.Itching. Itching decreasing 1/8/21. Having copious side effects also of injection site pain,tiredness,headache,joint and muscle pain,nausea,lymphadenopathy and feeling unwell.1/6/21,1/7/21 but feeing better when tylenol 500mg ing system to relieve aches and pains
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| 62 | 2021-01-07 | itchy skin |
Itching; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-...
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Itching; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in the left upper arm on 02Jan2021 13:00 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced itching on 02Jan2021 with outcome of not recovered. The patient got the COVID vaccine on 02Jan2021 around 1 o'clock. That evening (5-6 hours after getting) the vaccine she started itching and has been itching since then. The itching is on her body, back, and stomach. She has been itching since, it comes and goes. Itching worsened. It also worsens in the evening, night, and morning. As treatment the patient took a baby loratadine (CLARITIN).
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| 62 | 2021-01-07 | itchy skin |
My body had started itching and I didn't know why. I had not eaten anything new or changed any sha...
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My body had started itching and I didn't know why. I had not eaten anything new or changed any shampoo or soap. Finally on Thursday night I realized maybe it is the shot that is giving me all the itching. My whole body was flushed I kept scratching my arms and legs, especially around my ankle, knee, under arm and goin area. I took an allergy pill and called Kaiser and spoke with an advice nurse. she mentioned that taking an allergy pill will relief some of the itching. I fell asleep around after midnight normally I go to bed around 9:30. I also called pfizer and explained and the person took all my information and symptoms.
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| 62 | 2021-01-07 | itchy skin |
Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She ha...
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Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She has not had history of reaction before. Starting from midnight that night she has fever between 100.6-101.2, body aches and stiff neck. She also has swollen left arm pit, head ache, Pruritus breathing. She has a history of afib and last night she had two runs of it and took metoprolol.
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| 62 | 2021-01-08 | pain of skin, skin swelling | Area still swollen and still hurts when touched |
| 62 | 2021-01-08 | injection site pain | Injection site soreness Narrative: |
| 62 | 2021-01-08 | itchy skin |
c/o mild itching. 132/78, 78, 18, 99% O2 sat. Narrative: After vaccine c/o mild itching. Cetirizine ...
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c/o mild itching. 132/78, 78, 18, 99% O2 sat. Narrative: After vaccine c/o mild itching. Cetirizine given PO. Observed 30 min. @ 1340: 132-78, 78, 18m 99% O2 sat. Feeling better. D/C'd stable
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| 62 | 2021-01-09 | skin warm, redness |
About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the...
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About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the chills subsided during the night and then had mild/moderate body aches for about another 12 hours. About 48 hours after the injection the top half of my arm is currently slightly swollen, red and hot to the touch.
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| 62 | 2021-01-09 | injection site pain |
Early morning Friday 01/08/21, moderate pain at injection site, PO Tylenol 1000mg, @ 0615, heading i...
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Early morning Friday 01/08/21, moderate pain at injection site, PO Tylenol 1000mg, @ 0615, heading into work. Then @ 1030 feeling tired, neck & shoulder pain, chills, headache, right ear pain, slight sore throat, PO Motrin, 400mg moderate relief. Total of 30 hrs of recurring symptoms, alternating Tylenol & Motrin throughout. Started to feel better Saturday afternoon 4-4:30p
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| 62 | 2021-01-10 | injection site pain |
Arm pain @ injection site, able to sleep on right side; relieved with Ibuprofen. Headache, mild, nex...
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Arm pain @ injection site, able to sleep on right side; relieved with Ibuprofen. Headache, mild, next afternoon, relieved with Ibuprofen.
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| 62 | 2021-01-10 | injection site pain |
ON 12/31/20 AT 1PM, DEVELOPED SORENESS AT INJECTION SIGHT, GREATER THAN NOTICED WITH OTHER VACCINATI...
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ON 12/31/20 AT 1PM, DEVELOPED SORENESS AT INJECTION SIGHT, GREATER THAN NOTICED WITH OTHER VACCINATIONS. LASTED 48-72 HOURS. ALSO HAD HEADACHE, WHICH WAS PRESUMED TO BE SINUS HEADACHE, BUT DID NOT RESPOND TO SINUS MEDICATION. HEADACHE CONTINUED THRU 1/1/21 WITH NAUSEA ALSO NOTED. SYMPTOMS SUBSIDED BY 1/2/21
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| 62 | 2021-01-10 | injection site swelling, injection site pain, injection site redness |
On 1/6/21, I received the initial COVID vaccination. Later that evening, I started to experience pai...
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On 1/6/21, I received the initial COVID vaccination. Later that evening, I started to experience pain, swelling and redness at the injection site (right arm). I also had a severe headache with nausea. I was directed to get a COVID test, at the hospital on 1/7/21. I continued to experience these side effects of the vaccine for the next 2 days.
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| 62 | 2021-01-10 | injection site pruritus, rash with redness, itchy skin |
Red rash and itching in 4 inch circumference around injection site that lasted 4 days. Sudden onset...
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Red rash and itching in 4 inch circumference around injection site that lasted 4 days. Sudden onset of runny nose and itching of eyes.
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| 62 | 2021-01-10 | injection site pain |
shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever...
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shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 62 | 2021-01-11 | injection site pain, injection site bruising |
2nd dose- Headache, bodyaches pain at injection site and bruising; symptoms lasted for 24hrs then re...
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2nd dose- Headache, bodyaches pain at injection site and bruising; symptoms lasted for 24hrs then resolved. Pain and tenderness persist at injection site. 1st dose - no reported adverse events
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| 62 | 2021-01-11 | vaccination site pain |
A chest x-ray showed some inflammation on the lungs; Slight pain in her arms after taking the vaccin...
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A chest x-ray showed some inflammation on the lungs; Slight pain in her arms after taking the vaccine; Bad headache; She started to develop a cough after the injection that did not improve and had worsened by the end of the second week; This is a spontaneous report from a contactable Nurse (reporting for herself). A 62-year-old female patient started received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on 18Dec2020 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. As reported, patient asked, "should I get the second injection of the COVID-19 vaccine since I have this cough that will not go away?." This female nurse, who was also the patient, reported receiving her first injection of the PFIZER COVID-19 VACCINE on 18Dec2020. She started to develop a cough after the injection that did not improve and had worsened by the end of the second week. Treatment has included cetirizine (ZYRTEC), dextromethorphan (ROBITUSSIN),Guaifenesin (MUCINEX) and albuterol inhaler. A chest x-ray showed some inflammation on the lungs and she was given a steroid inhaler, which has helped. She has received two COVID-19 tests at different time intervals, and both were negative. She was scheduled to receive the second COVID-19 vaccination on Friday but was uncertain if she should receive it given her cough was not improving. She had a bad cough, and other symptoms just before her injection (pending clarification). But her general practitioner (GP) put her in a steroid inhaler. She talked to her GP but can't give her complete advice as to whether she can still take the 2nd dose or not due to her situation. She said she had very slight pain in her arms after taking the vaccine, and felt a really bad headache on 18Dec2020. She would like to know if she still needs to continue the 2nd dose of vaccine or not since she still has a cough. Patient asked if there was any guidance on getting a second dose and what if test was a false positive and she really did have COVID-19?. Outcome of the event "She started to develop a cough after the injection that did not improve and had worsened by the end of the second week" was not recovered while "A chest x-ray showed some inflammation on the lungs", Slight pain in her arms and Bad headache were unknown. Information on the Batch/Lot number has been requested.
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| 62 | 2021-01-11 | rash, rash, itchy skin, itchy skin |
During administration of vaccine pt became dizzy and faint. Pt was able to go to the observation are...
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During administration of vaccine pt became dizzy and faint. Pt was able to go to the observation area, waited approximately 15 mins and then reported chest tightness, dizziness, rash and itching on her arms, fast heart rate, watery eyes, runny nose, and throat irritant. Vitals were obtained and pt was requested to wait another 15 mins for monitoring. During monitoring period, patient became to complain of increased throat irritation and new tongue swelling. Response team was contacted. During reassessment patient's symptoms decreased. Team decided patient was stable and did not require transport to the ED. Patient was monitored for another 15-20 minutes with symptoms resolving. Patient was advised to discuss reaction with her PCP prior to getting second dose of the vaccine.
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| 62 | 2021-01-11 | injection site numbness, injection site tingling |
Immediate numbness/tingling in left arm and left hand and both feet. Left arm/hand symptoms lasted...
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Immediate numbness/tingling in left arm and left hand and both feet. Left arm/hand symptoms lasted ~15 minutes. Symptoms in both feet lasted 5-6 hours and continue intermittently.
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| 62 | 2021-01-12 | itchy skin, hives, rash |
1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itch...
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1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itching, lymph swelling, chills
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| 62 | 2021-01-12 | itchy skin |
C/O ITCHINESS AROUND MOUTH. OBSERVED X15 MINS. STATES FEEL BETTER AND REFUSED ER EVAL. TOOK BENAD...
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C/O ITCHINESS AROUND MOUTH. OBSERVED X15 MINS. STATES FEEL BETTER AND REFUSED ER EVAL. TOOK BENADRYL AND WENT HOME WITH RELIEF. VITALS STABLE. O2 SAT 98%
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| 62 | 2021-01-12 | hives, rash |
Patient received the vaccine (dose 2) on Thursday, woke up early Saturday morning with hives all ove...
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Patient received the vaccine (dose 2) on Thursday, woke up early Saturday morning with hives all over body - no history of reaction to anything. Did not take anything. Went back to sleep. Reaction resolved within 4 hours. No other identifiable changes in diet or detergents.
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| 62 | 2021-01-13 | injection site pain |
Almost immediately after the injection, I noticed a metallic taste. It was mild enough that it did n...
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Almost immediately after the injection, I noticed a metallic taste. It was mild enough that it did not interfere with the taste of foods or drinks. It was noticeable whenever I had not had anything by mouth for a while. This lasted for 2 to 3, maybe 4, days. Soreness at the injection site, and stiffness of the arm, began the evening after the injection. Warming applications and moving the arm relieved these symptoms. They were gone the next day.
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| 62 | 2021-01-13 | injection site pain | Sore Throat , Fatigue, Chills, Pain at the injection site, headache |
| 62 | 2021-01-13 | injection site pain | Soreness at the injection site. Chills, sore throat. slight fever. headache |
| 62 | 2021-01-13 | injection site pain | Soreness in the arm , sore throat Mild fever, Pain at the injection site. Headache that |
| 62 | 2021-01-13 | injection site pain | Soreness of the site then was sick 6 days later positive for COVID -19. Fatage |
| 62 | 2021-01-13 | injection site pain | site pain |
| 62 | 2021-01-14 | injection site pain, injection site swelling |
2nd dose next day had nausea in am since subsided. chills muscle aches and swelling soreness at arm ...
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2nd dose next day had nausea in am since subsided. chills muscle aches and swelling soreness at arm site present @ this time.
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| 62 | 2021-01-14 | injection site swelling, injection site warmth, injection site pain | Soreness with swelling and heat at injections site. Chills, Body Aches & Fatigue lasting 48hrs. |
| 62 | 2021-01-14 | injection site swelling |
Swelling at the injection site. Looked like a bubble and swelling was slowly spreading. Pt did not r...
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Swelling at the injection site. Looked like a bubble and swelling was slowly spreading. Pt did not report dizziness or trouble breathing. Blood pressure machine was not accurate so bp not reported.
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| 62 | 2021-01-14 | injection site pain |
left arm pain at injection site, barely able to lift arm above shoulder without pain for first 2 day...
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left arm pain at injection site, barely able to lift arm above shoulder without pain for first 2 days. 2 weeks later, still painful at injection site and general left deltoid area. no pain to touch, just with movements. pain with certain range of motion
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| 62 | 2021-01-17 | injection site pain |
12/21/20 - SYMPTOMS STARTED ONE HOUR AFTER RECEIVING THE VACCINE. DIZZINESS, HEADACHES FOR 24 HRS. P...
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12/21/20 - SYMPTOMS STARTED ONE HOUR AFTER RECEIVING THE VACCINE. DIZZINESS, HEADACHES FOR 24 HRS. PAIN ON INJECTION SITE. TOOK TYLENOL.
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| 62 | 2021-01-17 | injection site pain |
EVENING OF 12/28/20, DEVELOPED HEADACHE, FEVER, CHILLS, BODY ACHES, FATIGUE, AND INJECTION SITE PAIN...
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EVENING OF 12/28/20, DEVELOPED HEADACHE, FEVER, CHILLS, BODY ACHES, FATIGUE, AND INJECTION SITE PAIN. RESOLVED BY 12/30/20.
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| 62 | 2021-01-17 | itchy skin, hives, rash |
Had second injection 10 am on 1/16/21 . Woke up at 1:30 am during night on 1/17 with rigors, took ...
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Had second injection 10 am on 1/16/21 . Woke up at 1:30 am during night on 1/17 with rigors, took tylenol, temp in am 99.6. Had headache next day, Ok with tylenol. Woke up in am of 1/18/21, itchy all over. Looked in mirror and had hives over right side of torso in back, and on chest and abdominal area in front. Very itchy. No shortness of breath. O2 sat 96%. Took 10 mg of Atarax I had at home for allergy itching. Called our Occupational Health office, instructed to call back if worsens or unresolves in next 24 hours.
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| 62 | 2021-01-17 | injection site pain, injection site swelling |
I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflam...
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I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflammed arm over deltoid muscle that resolved after 3 days. Second dose given 21 days later- some swelling and soreness, low grade fever. Then 3 days later, I awoke, turned in bed and experienced an intense shearing pain in my neck and arm. The pain was the worst ever felt, and was not improved with NSAIDS, Acetaminophen, Hydrocodone, or Tramadol. I went to an urgent care center on 1/16 where a tentative diagnosis of sprained neck was made. The sypmptoms continue with slight improvement with steroids, and a muscle relaxant. I am concerned because I understand that covid itself can impact the nervous system considerably. I am awaiting improvement in symptoms and if none seen then I will see my primary care MD
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| 62 | 2021-01-17 | shingles | development of shingles, confirmed by dermatologist |
| 62 | 2021-01-18 | injection site pain | Body aches, fatigue, left arm soreness |
| 62 | 2021-01-18 | injection site redness, injection site swelling, injection site rash |
Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going...
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Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going over the top half of arm around the injected area. chills , body aches, fever. stayed in bed the next 3 days. 4 day sweating, and low grade fever , fatigue very weak.
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| 62 | 2021-01-18 | rash | Rash on the upper thighs |
| 62 | 2021-01-20 | injection site pruritus, injection site redness |
30 minutes after being vaccinated with Pfizer vaccine (second dose) in her right arm, employee devel...
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30 minutes after being vaccinated with Pfizer vaccine (second dose) in her right arm, employee developed itching and red splotching (not elevated) on her left arm. She had no difficulty breathing, no swelling and said she "felt fine" except for the itching. She took Allegra about 1:30 pm. We recommended she call her husband to come and take her home and to go to ER if symptoms progressed. She declined. At about 3:00 pm redness was improving on upper arm but had spread down to the palm of her hand. Again she stated she felt fine. Patient drove home on her own about 4 pm but agreed to text Nursing Supervisor when she got home. She reported at about 7 pm that she was greatly improved. Follow up today (1/21) itching/redness is gone but does have body aches and headache. Her only known past allergy is to Sulfa drugs. No issues with first dose. Let employee know that if there is ever a reason for another covid vaccine that she would have to have it done in the care of a doctor's office.
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| 62 | 2021-01-20 | bruising |
Bruise in arm; I lost some weight; This is a spontaneous report from a contactable Consumer. This co...
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Bruise in arm; I lost some weight; This is a spontaneous report from a contactable Consumer. This consumer reported for herself that the 62-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on unknown date at a single dose for covid-19 immunisation. Medical history included "I went to the doctor because I wasn't feeling well just little congestion inside my lungs." Concomitant medications included "Yes, Antibiotics, I was worried I didn't think about it since I think about it yesterday, wow is this going to effect the vaccine (further not clarified)." Consumer stated, "I have a question I received the First shot (clarified as Covid 19 vaccine) here 20th of this month I get my second but 7th of this month I didn't even think about it I went to the doctors even though I was negative and they put me on antibiotics is that going to interfere with the vaccine. Consumer stated, "I guess no, I had no side effects, I got a bruise in my arm and that was all." Consumer stated, "120 pounds, I lost some weight." Consumer stated, "I just had my blood count checked that's all." The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 62 | 2021-01-20 | rash with redness, hives, itchy skin |
Felt itchy and shaky after vaccine. Left after 30 min. She later developed hives and was seen at E...
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Felt itchy and shaky after vaccine. Left after 30 min. She later developed hives and was seen at ED. Per ED notes, approx 1 hour after vaccine, she developed mild erythematous rash over upper chest/ collarbone region. Slightly itchy. She took benadryl PO x 1 with resolution of itching and rash within 1-2 hours. Patient has noted she is needing to clear her throat more often, feeling like it is "a little mucousy". She does not have a frank cough. She denies SOB, chest pain, difficulty breathing, stridor, wheezing or nasal congestion. She does not feel her mouth, lips, face or tongue are swollen. She has no difficulty swallowing. She denies abdominal pain, vomiting, and diarrhea. Denies myalgias, headaches, chills or fevers at this time. Discussed can use additional antihistamine as needed for further rash. Does not need epi IM at this time. Reviewed common side effects for 2nd vaccine to expect in next 24 hours. Reviewed elevated BP and asked to recheck at PCP or next medical visit to monitor for possible hypertension
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| 62 | 2021-01-20 | hives | Pressure on the chest, labored breathing, hives on neck, upper arms, back |
| 62 | 2021-01-20 | itchy skin, rash |
tongue itching; lips itching; face feels flushed; left hand is tingling or numb (the palm)/left hand...
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tongue itching; lips itching; face feels flushed; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; palm of left hand was itchy; inside of nose; it feels like someone is pinching nose/It's swelling; inside of nose; it feels like someone is pinching nose/It's swelling; face has a rashly feeling; This is a spontaneous report from a contactable consumer reported for self. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on an unspecified date at single dose in left arm for COVID-19 immunisation. The patient medical history and concomitant mediations not provided. The patient reported that she had the vaccine at her work, waited 15 minutes and left the clinic. About 20 minutes then, her tongue was itching, lips were itching; face felt flushed. Face had a rashly feeling. Her left hand was tingling or numb (the palm). Her palm of left hand was tingling and itchy. The inside of nose; it feels like someone is pinching nose. It was swelling. The patient stated "Whenever I get stung by bees, this is how I feel". The patient stated that it was mild. She stated she was having a reaction, but not severe enough maybe it will subside. Her left arm is where she got the injection and it was left hand that was puffy and tingling. The patient stated that she also had N95 mask on and she guess she get that reaction from it. The patient stated that she was just wondering what she should do, if she should just go by some diphenhydramine hydrochloride (BENADRYL). The outcome of events was not reported. Information about lot/batch number has been requested.
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| 62 | 2021-01-21 | itchy skin, hives |
Patient was given the Pfizer vaccine at 9:27 on 01/21/21. At about 5 minutes post vaccine she was n...
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Patient was given the Pfizer vaccine at 9:27 on 01/21/21. At about 5 minutes post vaccine she was noted to have some throat clearing but denied any concerning symptoms. At 9:40 she began experiencing fluttering in her chest and at 9:41 she was noted to have some chest tightness and wheezing. She was given Benadryl 50 mg oral at 9:42 but then symptoms began to progress and she started to have angioedema of her upper lip and her hands/arms started itching and she was noted to have some early hives. Epipen 0.3 mg was given at 9:45. She continued to have some swelling of her upper lip and chest tightness and soulmedrol 125 mg IM was given at 9:49 and then she was placed on O2 via NC at 2 L. At 9:50 she stated that her throat swelling was starting to improve and her chest tightness and wheezing was getting better. EMS arrived at about 9:51 and report was given and care turned over to them. They left the clinic at 10:00 without further incident.
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| 62 | 2021-01-24 | hives | Allergic Urticaria |
| 62 | 2021-01-24 | dry skin, skin warm |
Patient c/o shortness of breath and "throat closing up"after receiving Covid vaccine at 10:00am.. O...
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Patient c/o shortness of breath and "throat closing up"after receiving Covid vaccine at 10:00am.. O2 started at 4l/min via n/c at 10:10am. , BP taken and advised to administer her Epi pen that she had with her due to allergy to Gelatin, administered Left thigh by patient.at 10:15am. 911 called at 10:20am. BP 152/93 HR 80 at 10:25am, 154/105 HR 75 at 10:27am, 148/92 HR 75 at 10:30 when departed to Medical Center. 02 sat remained at 99%. Skin warm and dry and remained alert through out process.
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| 62 | 2021-01-24 | rash |
Systemic: Rash (other than injection site), Systemic: Chills, Systemic: Generalized Body Aches , Sys...
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Systemic: Rash (other than injection site), Systemic: Chills, Systemic: Generalized Body Aches , Systemic: Headache.
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| 62 | 2021-01-25 | redness, itchy skin |
Client approached a Public Health Nurse after 30 minutes of waiting and stated her hands felt itchy,...
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Client approached a Public Health Nurse after 30 minutes of waiting and stated her hands felt itchy, prickly, and were reddened. Denied SOB and denied chest pain. Benadryl was offered and taken, client felt better after that and was released, offered a ride home, but left with a friend.
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| 62 | 2021-01-25 | injection site swelling, injection site pruritus, injection site pain |
Patient self-reported to the hospital's electronic ADR reporting system. In her own word, "After 2...
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Patient self-reported to the hospital's electronic ADR reporting system. In her own word, "After 2nd dose of Pfizer COVID-19 Vaccine 1/15/21, the injection site became swollen , itchy, and painful. The following day, under my armpit was swollen and painful. This lasted for 5 days".
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| 62 | 2021-01-26 | redness |
The next day after the vaccine my arm was red and really painful. Each day the redness got larger a...
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The next day after the vaccine my arm was red and really painful. Each day the redness got larger and by friday it was near my elbow so I went to an Urgent Care. I was given a prescription for an antibiotic because they states infection had set in it and I also took tylenol and antihistimines to help with the pain.
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| 62 | 2021-01-27 | injection site pruritus | Itching at injection site Flushing Tachycardia Syncope Unable to control BUE?s. Felt very heavy |
| 62 | 2021-01-27 | injection site warmth, injection site rash, injection site redness | Red, warm rash extending from injection site down to elbow lasting 48 hours |
| 62 | 2021-01-27 | injection site pain |
Very sore arm at injection site, aching joints, 101 degree temperature with chills starting at hour ...
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Very sore arm at injection site, aching joints, 101 degree temperature with chills starting at hour 12 and ending at hour 23 post shot and fatigue the entire next day. 48 hours after vaccine all symptoms are gone.
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| 62 | 2021-01-27 | redness |
Within a minute -face,ears,neck turned bright red. Paramedics took EKG and BP was 211/110. That mor...
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Within a minute -face,ears,neck turned bright red. Paramedics took EKG and BP was 211/110. That morning ( I check it regularly due to salt sensitivity) it was 123/69 (Normally 120-140/ 60-76.
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| 62 | 2021-01-27 | hives |
hives on back of my head neck ,ears that progressed that day to bilateral arms, abdomen groin/hives ...
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hives on back of my head neck ,ears that progressed that day to bilateral arms, abdomen groin/hives also on my thighs; This is a spontaneous report from contactable nurse reporting for herself (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), via an unspecified route of administration on 26Dec2020 20:15 (reported as 08:15 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history was reported as none. No known allergies. There were no concomitant medications (reported as "I take no meds"). No other vaccine in four weeks. No COVID prior vaccination. On 01Jan2021 10:15 PM, 6 days after 1st vaccine, patient started having hives on back of her head, neck, ears that progressed that day to bilateral arms, abdomen groin. The next day hives were also on her thighs. The patient had hives for a week. Treatment for the event was reported as "Zyrtec Pepcid atarax prednisone". Event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the event was recovered in Jan2021. Patient was not tested for COVID post vaccination.
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| 62 | 2021-01-27 | vaccination site pain |
migraines; arm is sore where the injection; she could hear like blood going through her, and if she ...
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migraines; arm is sore where the injection; she could hear like blood going through her, and if she moved it got faster and faster; Chills; muscle aches; not feeling well; Headache; fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 21Dec2020 by injection once to right arm (Lot Number: EJ1685) at SINGLE DOSE, via an unspecified route of administration on 11Jan2021 (Lot Number: EL3302) at SINGLE DOSE for covid-19 immunization (reported as healthcare worker, medical receptionist). Medical history included Other Conditions No. There were no concomitant medications. The patient experienced fever on 11Jan2021, headache on 12Jan2021, chills on 12Jan2021 23:30 , muscle aches on 12Jan2021 06:00, not feeling well on 12Jan2021 , migraines and arm is sore where the injection on an unspecified date. The caller had her second vaccine (later clarified as COVID vaccine) on 11Jan2021, and had the same symptoms as on the first one. They were not as bad, and she thought the first one was pretty bad. She previously reported her symptoms with the first vaccine. Symptoms with the second were fever, headache, chills, of course, and muscle aches, her arm weighs a ton, and not feeling well. Fever was noted when she was sleeping, it is now 99.6, but it was was 103. Headache was noted in the early morning, it was not a normal headache, it was the worst thing, and she is prone to migraines, but this was not even like that, she could hear like blood going through her, and if she moved it got faster and faster, one time, she stood still and it was like ahhh! Chills started about 11:30 last night, they went away this morning, about 11AM. Muscle aches started at 6AM yesterday, and are finally gone, as of probably about 9AM, they are fine now, just her arm is sore where the injection was. Not feeling well started yesterday and is getting better. First dose was 21Dec2020, she previously provided lot EJ1685, confirms both were Pfizer vaccines. The outcome of the event fever, not feeling well was recovering, headache recovered on 13Jan2021, chills recovered on 13Jan2021 11:00, muscle aches recovered on 13Jan2021 09:00. No follow-up attempts possible. No further information expected.
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| 62 | 2021-01-28 | vaccination site pain |
some mild pain at the injection site; This is a spontaneous report from contactable nurses (one is p...
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some mild pain at the injection site; This is a spontaneous report from contactable nurses (one is patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced some mild pain at the injection site on 15Jan2021 shortly after injection. The outcome of event was unknown. Information on the Lot/Batch number has been requested.
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| 62 | 2021-01-29 | injection site pain | injection side pain, tiredness, headache, muscle pain, chills, joint pain, fever |
| 62 | 2021-01-30 | hives |
Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose...
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Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose Later in evening - hives Next morning - swollen lip on left side (had derm filler on 1/21/2021) Took Tylenol and Benadryl
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| 62 | 2021-01-31 | injection site pain |
I had to get cleared by a allergist prior to getting the vaccine due to my prior history allergy his...
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I had to get cleared by a allergist prior to getting the vaccine due to my prior history allergy history. I was advised by the allergist to take Allegra an hour before receiving the vaccine. About 10 minutes after receiving the vaccine, I started to throat my started to feel dry and tickling, it felt like it swelling starting from the left side to the center, I started having difficulties swallowing my salvia and any fluid. My blood pressure was checked and it was elevated. I started to have difficulty breathing. They transferred me over to the ER. They gave me IV medicines Benadryl, Prednisone, Pepcid (I think). After 6 hours I was able to go home. Everything went back to normal besides the pain in the left arm at injection site. I had a telemedicine visit today with my primary care physician to follow up.
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| 62 | 2021-01-31 | injection site swelling, injection site redness, injection site pain |
Pain swelling redness at injection site. Dizziness, Body Aches. headache stomach distress, tired...
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Pain swelling redness at injection site. Dizziness, Body Aches. headache stomach distress, tiredness
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| 62 | 2021-01-31 | injection site pain |
The vaccine was injected too high in left arm. I know this because I am a retired pharmacist and whe...
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The vaccine was injected too high in left arm. I know this because I am a retired pharmacist and when I removed the bandage noticed injection was near the shoulder and not in the mid deltoid area. The left arm/shoulder began to feel sore in the evening and was very sore the next day. Was unable to lift arm or move without pain. Over the next several days the severe pain decreased, but I continue to have pain in the arm, especially the bicep area. Range of motion is limited. Severe pain when trying to lift my arm from resting position while in bed. Severe pain when rotating arm inward. Pain occurs with certain movements.
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| 62 | 2021-02-01 | injection site swelling, injection site pain, injection site redness |
Caller states she received her 2nd dose of covid vaccine on Friday afternoon. Saturday morning she s...
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Caller states she received her 2nd dose of covid vaccine on Friday afternoon. Saturday morning she started with Left arm redness, swelling and soreness. Today the redness and swelling measures about 4x6. She also reports noticing a swollen lymph node to her left arm today. She denies fever. She has been taking tylenol and motrin, but has not tried compresses to injection site. She will call her PCP to schedule an appointment for tomorrow.
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| 62 | 2021-02-01 | rash, itchy skin |
Nausea, fever , aches and pains all over , flu like symptoms , Rash from chin to chest , itchy . st...
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Nausea, fever , aches and pains all over , flu like symptoms , Rash from chin to chest , itchy . still have itchy neck chin to chest.
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| 62 | 2021-02-01 | injection site pain |
Second vaccine given on 1/28/21. Got sick later that evening with pain & soreness at the injection s...
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Second vaccine given on 1/28/21. Got sick later that evening with pain & soreness at the injection site. Along with a severe headache, nausea, and chills. The symptoms lingered over the next couple of days. Contacted Employee Heath and manger the following day. Stayed out of work on 1/29/21.
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| 62 | 2021-02-01 | injection site pain | Severe site pain and muscle aches |
| 62 | 2021-02-01 | vaccination site pain |
pressure across chest; eyes were very swollen; flu symptoms; severe aches/ Pain radiated bilaterall...
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pressure across chest; eyes were very swollen; flu symptoms; severe aches/ Pain radiated bilaterally up neck, mandibular area, trigeminal and into head; abdominal pain; nausea; Injection site very painful, could not touch; This is a spontaneous report from a contactable nurse reported for herself. This 62 Years old patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 12Jan2021 13:15 on Arm left at single dose (Lot # EL0142) for covid-19 immunisation. Medical history included hashimoto disease, allergies to maxide. Prior to vaccination, was the patient did not diagnose with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), valsartan, Pravastatin, docusate sodium (COLACE), wool fat (EUCERIN) and Vitamin D Nos. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 22Dec2020 13:15 on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. The patient woke up 13Jan2021 at 2:00 AM with flu symptoms - severe aches, abdominal pain and nausea. By 13Jan2021 4:30 eyes were very swollen. Slept 14 hours. Next night 14Jan2021 at 1AM, severe arm pain radiating across chest to other armpit - pressure across chest. Pain radiated bilaterally up neck, mandibular area, trigeminal and into head. Injection site very painful - could not touch in Jan2021. As the pain at injection site subsided - so did the symptoms. Events were non serious. No treatments were received. On 15Jan2021, laboratory details included nasal swab which showed negative. Outcome of the events was recovered.
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| 62 | 2021-02-01 | dry skin, rash |
rash in the top of right hand/rash on the left hand; looks like dryness; This is a spontaneous repor...
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rash in the top of right hand/rash on the left hand; looks like dryness; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN9899), via an unspecified route of administration on 15Jan2021 at 13:30 on the left arm at a single dose for COVID-19 immunization. Medical history included partial seizures complex, asthma, beginning of heart disease and high cholesterol all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had no prior vaccination within four weeks. The patient stated she has a rash on the top of her hand right hand and rash on the left hand; it is real dry, it looks like dryness, on 18Jan2021. The patient stated that she doesn't know if it is allergic reaction. She needs help to figure it out. She is asking if she needs to see her doctor. The patient stated that otherwise, the vaccine was healing her and helping her. She stated that she knows you can have a rash all over your body and she wants to know if that is going to happen. She clarified she noticed the rash on the top of her right hand - not the palm. She isn't sure if it came from taking out the trash or cleaning stuff or some other reason. She stated that it is now trying to get on the other left hand too. She said you can't really tell it on her left hand but she noticed it on the night of 18Jan2021. She is unsure if when she washes her hands it is getting from the right hand onto the left hand. She just needs to know if it is from the vaccine or if she needs to stop taking out the trash or maybe wearing gloves. She is scheduled to receive the next dose on 5Feb2021. She lives in a senior facility building. One of the staff members got COVID so they had to get the vaccine. The adverse event did not require a visit to the physician or emergency department (ER). The outcome of the events was not recovered.
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| 62 | 2021-02-02 | itchy skin |
Patient had some flushing, sweating and headache. Patient also had generalized itching over entire b...
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Patient had some flushing, sweating and headache. Patient also had generalized itching over entire body. no rash noted.
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| 62 | 2021-02-02 | rash | Rash on trunk of body with nausea and vomiting x48 hours |
| 62 | 2021-02-03 | itchy skin, hives |
Pt came in for 2nd dose of Pfizer vaccine, pt reported itchiness on right arm. Provider informed, as...
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Pt came in for 2nd dose of Pfizer vaccine, pt reported itchiness on right arm. Provider informed, assessed pt's arm and torso and determined that the patient had hives that begin on her neck, and spread throughout her torso. Provider recommended she follow up with urgent care to manage the hives, and reschedule second dose of Pfizer vaccine to a later date.
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| 62 | 2021-02-03 | itchy skin |
headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consume...
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headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: unknown), via an unspecified route of administration on the right arm on 10Jan2021 at 09:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730 on 20Dec2020 at 09:00 AM on the right arm for COVID-19 immunization, and Benadryl. The patient took Benadryl before the second dose and throughout the day, and it somewhat helped with the constant skin irritation. On 10Jan2021, the patient experienced headache, itchy and prickly skin all over her body. No admission to hospital involved and no treatment was received. The events resolved on an unspecified date in 2021.
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| 62 | 2021-02-04 | injection site swelling, injection site warmth, injection site redness, injection site hardening |
Got injection Friday at 12 noon, Saturday morning woke up with fever 101.2, diarrhea x 12 hours, hea...
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Got injection Friday at 12 noon, Saturday morning woke up with fever 101.2, diarrhea x 12 hours, headache x 3 days (frontal) on Sunday developed a baseball size red, hard and warm to touch raised area around injection site. This lasted for 3 days
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| 62 | 2021-02-04 | redness |
My blood pressure shoots up really high; My upper body got red like tomato; I was really like confus...
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My blood pressure shoots up really high; My upper body got red like tomato; I was really like confused for several hours; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at left shoulder on an unspecified date at single dose for COVID-19 immunization. The patient medical history included food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient reported that: "my reaction was my blood pressure shoots up really high and my upper body got red like tomato and I was really like confused and 'spacing' for several hours". The patient did not receive any treatment. The patient outcome of the events was unknown.
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| 62 | 2021-02-04 | vaccination site pain, rash |
lower left side back pain; received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12...
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lower left side back pain; received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm/ she noticed a sore arm right afterward; rash; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: not reported), via an unspecified route of administration, on 15Jan2021 12:53PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was not administered at a military facility. The patient did not receive other vaccines within 4 weeks prior to receiving the Pfizer vaccine. Medical history included allergies/allergy from childhood 4 years old, back problem from 2001, back surgery in 2015, vaginal dryness, high cholesterol, depression, acid reflux, surgery in 2015, physical therapy, and allergy to mold, dogs, roaches. She has multiple allergies from childhood including allergy to mold, dogs, and roaches. She also mentioned she has had back problems since her first surgery in 2015. All of these predate treatment with Pfizer COVID 19 vaccine and Lipitor. She got to where she couldn't stand up straight, but she went to physical therapy. She had surgery in 2015. She had a problem in 2018 and they gave her shots and that helped. Family history was none. Concomitant medications included estradiol (ESTRING) (for three years) for vaginal dryness, fish oil (taking for three to four years) for high cholesterol, paroxetine hydrochloride (PAXIL) (taking for 20 years) for depression, cyamopsis tetragonoloba gum (BENEFIBER FIBER SUPPLEMENT) (using for a year), vitamin d3 (VITAMIN D3) (using for five years; she used to be on calcium but it can cause heart problems so her doctor told to take Vitamin D), dexlansoprazole (DEXILANT) (taking for five years) for acid reflux, (ALLEGRA) (taking for 5 years ) for allergy, (QNASL) (using for 3 years), allergy shots (used forever) for allergy and stool softener (taking for 5 years) to "keep things moving"; all were from unspecified dates and ongoing. The patient previously took atorvastatin (LIPITOR) for high cholesterol from 2017 to 2017 and experienced back pain from 2017 to 2017 (recovered). She also previously took calcium. The patient experienced "received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm/ she noticed a sore arm right afterward" on 15Jan2021, lower left side back pain on 20Jan2021, and rash on an unspecified date in Jan2021. The patient called to report a problem with her lower back after receiving the 1st dose of the vaccine. "I've had surgery and a couple of shots, the CAT scan kind. I have been fine for a while, just had a sore arm and yesterday I noticed a problem with my lower back and thought it may have been because I painted, but it is still bothering me. I remembered when I went on Lipitor I started having problems with my back about 3 weeks in, same deal. The doctor took me off and I went back on a month later and I started having problems again. Because I don't know if it was the vaccine, I am wondering if I should get the second dose." She clarified she received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm. She noticed a sore arm right afterward which lasted at least 48 hours. Then on 20Jan2021, she noticed lower left side back pain. Mentions she thinks it is at the L4 or L5 and this is the same place she had a shot there in 2018 for back pain and previously had surgery on that location in 2015. With regard to Lipitor, she is unsure of the exact year, but states it was probably back in 2017. After taking Lipitor she noticed her back pain coming back. Her doctor took her off of Lipitor for a month and it got better. Then he put her back on Lipitor and she had the same back pain problem. She stated that she is unsure if she will take the second dose and asked with regard to her back pain should she take the second dose. Outcome of "received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm/ she noticed a sore arm right afterward" was recovered on 18Jan2021, outcome of lower left side back pain was not recovered, while outcome of rash was unknown.
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| 62 | 2021-02-04 | itchy skin | soreness in arm, bad headache, nausea, itching on head, face and upper body. |
| 62 | 2021-02-05 | hives, itchy skin | TOTAL BODY ITCH AND HIVRD TX WITH BENADRYL |
| 62 | 2021-02-05 | injection site swelling, hives, injection site pain, injection site bleeding |
Wheal developed immediately upon injection. Bleeding from both site and internally as well. Pressur...
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Wheal developed immediately upon injection. Bleeding from both site and internally as well. Pressure was held to stop the bleeding. Ice applied to site to help with the swelling Area marked for size determination. Checked arm every 15 minutes during the evening. As of today, still have wheals in two spots and hematoma under the skin as well as tenderness.
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| 62 | 2021-02-07 | itchy skin, redness |
Patient developed headache within 24 hours of the vaccination. The headache has persisted. She the...
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Patient developed headache within 24 hours of the vaccination. The headache has persisted. She then developed a mild erythema, mild edema, and pruritus of the palms of both hands 3 days after the vaccination. Also has pruritus of both feet but no erythema. No vesicles, ulcerations, or papules have developed.
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| 62 | 2021-02-07 | itchy skin, injection site rash | lethargic underarm itchy 20 minutes after injection underarm on left side developed a rash |
| 62 | 2021-02-07 | itchy rash, rash with redness, rash |
slight itchy, tingly, red rash on R foot (plantar surface) and ankle. No blisters. Also some tendern...
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slight itchy, tingly, red rash on R foot (plantar surface) and ankle. No blisters. Also some tenderness in lower calf but no rash there. No treatment d/t it being mild reaction
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| 62 | 2021-02-08 | injection site pain |
Pain at injection site; mild headache, body aches, nausea, (flu like symptoms). 400mg ibuprofen twic...
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Pain at injection site; mild headache, body aches, nausea, (flu like symptoms). 400mg ibuprofen twice 6 hours apart. Symptoms last 24 hours
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| 62 | 2021-02-09 | skin discolouration, rash |
After receiving 1st vaccine dose (01/17/2021)- developed rash of the arms "covid arm" After receivi...
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After receiving 1st vaccine dose (01/17/2021)- developed rash of the arms "covid arm" After receiving 2nd vaccine dose on 2/7/2021- rash on both arms intensified in color
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| 62 | 2021-02-09 | hives, rash |
Six days after the shot I had a severe rash/hives all over my body; Six days after the shot I had a ...
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Six days after the shot I had a severe rash/hives all over my body; Six days after the shot I had a severe rash/hives all over my body; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1284), via an unspecified route of administration on 14Jan2021 03:15 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included Colitis, Arthritis, Allergies to Penicillin, Allergies to Mugwort. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included celecoxib (CELEBREX). The patient experienced ''six days after the shot i had a severe rash/hives all over my body'' (non-serious) on 20Jan2021 07:00. AEs resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. Therapeutic measures were taken as a result of events (treatment: benedryl, zyrtec, Pepcid). The outcome of events was not recovered.
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| 62 | 2021-02-10 | injection site pruritus | Severe itching at injection site 5 hours after vaccine |
| 62 | 2021-02-11 | injection site redness, injection site pain |
Injection site soreness and dark red circle for 3 weeks Severe chills 4 days Dizziness Headache Naus...
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Injection site soreness and dark red circle for 3 weeks Severe chills 4 days Dizziness Headache Nausea
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| 62 | 2021-02-11 | injection site pain |
Severe body aches, headache, pain under arms, pain at injection site and could not lift arm for 26 h...
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Severe body aches, headache, pain under arms, pain at injection site and could not lift arm for 26 hours
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| 62 | 2021-02-14 | injection site pain |
pain at site of injection at 24 hours post injection. Nausea, diarrhea, headache 24 through 48 hours...
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pain at site of injection at 24 hours post injection. Nausea, diarrhea, headache 24 through 48 hours post injection.
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| 62 | 2021-02-15 | itchy rash, rash |
I developed a rash that is very itchy. along the hairline of my entire face and on my shoulders and...
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I developed a rash that is very itchy. along the hairline of my entire face and on my shoulders and upper chest (not on my breasts)
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| 62 | 2021-02-16 | shingles, rash | Sore arm for one day. Rash started with pain left upper torso on day 7, diagnosed as shingles. |
| 62 | 2021-02-17 | vaccination site pain |
A lot of pain at the injection site; This is a spontaneous report from a contactable consumer (patie...
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A lot of pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247) via an unspecified route of administration on the left arm on 04Feb2021 09:15 at a single dose for COVID-19 immunization. Medical history included high blood pressure and coronary artery (disease). Concomitant medication included valsartan, rosuvastatin calcium (ROSUVASTIN) and acetylsalicylic acid (BABY ASPIRIN). On 04Feb2021 14:30 the patient experienced a lot of pain at the injection site. No treatment was received for the event. Event was reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Outcome of the event was recovering.
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| 62 | 2021-02-17 | vaccination site redness, vaccination site warmth |
The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperatu...
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The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperature; Difficulty remembering things; Vomiting; Headache 10/10; developed a red area below injection site/The site got worse through Thursday and was red, hot; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in right deltoid on 24Jan2021 at a single dose for prevention (COVID-19 immunization). Medical history included Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago, hereditary angioedema from 2010, asthma diagnosed in her 20's, Allergic to Thermarisol, diagnosed allergies, respiratory illness, and endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (LOT number: EJ1686) in right deltoid on 03Jan2021 for covid-19 immunization, and flu shot on Sep2020 without adverse event. She got second injection on 24Jan2021. On 25Jan2021, she woke up with 100.5 degrees temperature and could not stop vomiting. She had to go to the ER. They gave her Zofran, IV and also Toradol because she had a number 10 headache. She continued with low grade temperature throughout week from 99.5-100.5 degrees Fahrenheit, and by Tuesday morning, she developed a red area below injection site. By Thursday, there was a red area growth to 13 cm x 15.5 cm on the injection site. She could not remember her email address and said her brain was not thinking. This started after the vaccine that she began having difficulty remember things. She never had a headache that bad. It improved but she has a lingering headache still. She continued to have a temperature from Monday to Saturday. Currently, she does not have an elevated temperature. Difficulty remembering things was reported as just irritating, but significant. The site got worse through Thursday and was red, hot and ended up measuring 13 cm x 15.5 cm. Regarding weakness, she could walk but medics had to help support from her seat to the ambulance. The outcome of the events red and hot injection site was not recovered; the outcome of the events vomiting, headache, weakness was recovering. The outcome of difficulty remembering things was unknown. The outcome of high temperature was recovered on an unknown date. The events was assessed as medically significant.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
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| 62 | 2021-02-18 | hives, injection site pain |
Fever, headache, dizziness, muscle and join pain/aches - at time severe, hives, nauseous/stomach ach...
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Fever, headache, dizziness, muscle and join pain/aches - at time severe, hives, nauseous/stomach ache similar to indigestion, loss of appetite, injection site pain, fatigue
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| 62 | 2021-02-18 | hives, itchy skin |
Took 2 benedryl prior to vaccine. Vaccine rec'd at 4:30 pm woke up at 2 am with hives and severe itc...
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Took 2 benedryl prior to vaccine. Vaccine rec'd at 4:30 pm woke up at 2 am with hives and severe itching on arms, throat and upper torso along with scratchy throat. Hives reappeared for two days afterwards. Should I get the second dose?
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| 62 | 2021-02-19 | itchy skin, hives, redness |
Red elevated welt about 4 inches in diameter, like a bee sting. Remained elevated for about 3-4 da...
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Red elevated welt about 4 inches in diameter, like a bee sting. Remained elevated for about 3-4 days and red for 14 days. On day 10 became very itchy.
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| 62 | 2021-02-21 | hives |
01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Calle...
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01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.
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| 62 | 2021-02-22 | injection site pain |
Soreness at injection site and fatigue within several hours; headache next morning with slight dizzi...
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Soreness at injection site and fatigue within several hours; headache next morning with slight dizziness
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| 62 | 2021-02-24 | shingles |
Pain in left back/rib cage radiating to front of chest. No blistering rash yet. Patient also report...
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Pain in left back/rib cage radiating to front of chest. No blistering rash yet. Patient also reports itching and burning sensations in affected area. Patient went to urgent care (2/25/21) and was diagnosed with shingles. Patient was prescribed valtrex.
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| 62 | 2021-02-25 | rash |
Cos tongue tingling and possible rash. was taken to ED by RRT. She stated having flushing neck and ...
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Cos tongue tingling and possible rash. was taken to ED by RRT. She stated having flushing neck and cheeks, elevated blood pressure 138/115 to 140/73
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| 62 | 2021-02-25 | shingles | Developed shingles 10 days after 2nd Covid vaccine |
| 62 | 2021-02-25 | injection site swelling, injection site hardening, injection site redness |
Have a round red circular mark the size of a silver dollar where injection was given. It is raised a...
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Have a round red circular mark the size of a silver dollar where injection was given. It is raised and painful and hard to the touch. Started the evening after receiving the injection, still have it 2 days later
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| 62 | 2021-02-25 | itchy rash, rash |
Pruritic morbilliform rash upper chest and bilateral arms , shoulders to hands. Eventually spread...
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Pruritic morbilliform rash upper chest and bilateral arms , shoulders to hands. Eventually spreading to pretibial region. Treated with OTC Claritin, Pepcid, Benadryl and eventually 0.5 % Triamcinolone cream. Rash resolved in same pattern that it appeared -chest arms and legs over a two week periord.
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| 62 | 2021-02-26 | injection site pain |
Arm was sore at injection site for about 24 hours then the next day severe arm pain started. Within ...
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Arm was sore at injection site for about 24 hours then the next day severe arm pain started. Within a few days it was painful to move my arm backward, upward and forward. The pain lasted over a week; I contact Primary Physician and he recommended ice and acetaminophen. I did that for several days and by day 10 it was spreading to my shoulder area and radiating down my arm. On 2/25 I went to urgent care (primary is 50 miles) and then my Primary is preparing consult for Ortho.
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| 62 | 2021-02-26 | injection site warmth |
high heart rate, muscle aches and pains, left arm still hurts, still swollen in areas. My arm flet ...
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high heart rate, muscle aches and pains, left arm still hurts, still swollen in areas. My arm flet like it had a fever at injection sight. I was pale in face.
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| 62 | 2021-02-27 | rash, itchy skin |
patient reports mild facial itching and rash; limited to face only; no rash on trunk or extremities....
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patient reports mild facial itching and rash; limited to face only; no rash on trunk or extremities. no other complicaitons.
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| 62 | 2021-02-28 | skin warm |
10:16am Client c/o feeling warm. Alert, and oriented x 3, Denies SOB, dizziness, and dyspnea. Pulse=...
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10:16am Client c/o feeling warm. Alert, and oriented x 3, Denies SOB, dizziness, and dyspnea. Pulse= 80. B/P=128/76. No thermometer available to take temp. 10:17am Client left at end of 15mins stating that she feels it is the mask making her warm and will drink water once she gets out to car.
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| 62 | 2021-02-28 | injection site pruritus, itchy rash, rash, injection site warmth, injection site hardening, injection site redness |
4 inch area at injection site hard, red, hot. Extreme fatigue. Slight fever. Muscle and bone ache. R...
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4 inch area at injection site hard, red, hot. Extreme fatigue. Slight fever. Muscle and bone ache. Rash and itch on abdomen. Itch at injection site. Symptoms slowly decreasing over time, but not yet gone.
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| 62 | 2021-02-28 | itchy skin |
Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoar...
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Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.
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| 62 | 2021-03-02 | rash with redness, rash papular, rash | Face and neck skin rash. Raised bumpy inflamed red rash |
| 62 | 2021-03-02 | vaccination site pain |
minor injection site soreness; This is a spontaneous report from a contactable consumer (patient). A...
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minor injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El324? (as reported)), via an unspecified route of administration at the left arm on 08Jan2021 at 13:00 (01:00 PM) at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no medical history. The patient had no allergies to medications, food, or other products. Concomitant medication included levothyroxine sodium (UNITHROID) that was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced minor injection site soreness on Jan2021. The event was reported as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovered on Jan2021.
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| 62 | 2021-03-03 | rash, itchy skin |
On the right arm all through tattoo surface a ?rash? appeared that was very itchy. No where else on ...
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On the right arm all through tattoo surface a ?rash? appeared that was very itchy. No where else on my body did this occur. Treated with a steroid cream to calm the itching.
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| 62 | 2021-03-03 | itchy skin, hives |
WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, IT...
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WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, ITCHY/SCRATCHY THROAT, ITCHY SKIN, A COUPLE OF STRAY HIVES. ALL OF THESE SYMPTOMS WERE MILD, AND PASSED AFTER A COUPLE OF HOURS. THE NEXT DAY HAD A VERY BAD HEADACHE. ABOUT 18 HOURS AFTER THE SHOT BECAME ILL WITH FLU-LIKE SYMPTOMS. HEADACHE, CHILLS, MUSCLE ACHES, LOW GRADE FEVER, CHEST TIGHTNESS/PRESSURE, HEAD & CHEST CONGESTION. ALL RESOLVED JUST ABOUT 48 HOURS AFTER THE SHOT.
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| 62 | 2021-03-04 | itchy skin |
I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day...
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I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.
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| 62 | 2021-03-04 | injection site pain |
My husband also had the same vaccine at the same time but did not experience my symptoms as describe...
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My husband also had the same vaccine at the same time but did not experience my symptoms as described below: Vaccination was given very high on the should blade instead of upper arm of left arm. After the injection on 2/27/21 arm was mildly sore, but on the third day, there was more pain. On March 3, the pain was worse, very painful to lift or bend left arm, constant throbbing pain, there is no inflammation on the injection site but whole left arm especially the injection site is very very painful. To this day, March 5, 2021 the pain and throbbing persists, It is very painful to lift or bend the left arm. Will start take OTC CVS Ibuprofen 200 mg every 6 hours to ease the pain.
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| 62 | 2021-03-04 | rash, itchy skin | Rash, itching, swollen lymph nodes under right arm |
| 62 | 2021-03-06 | hives, rash | First day rash/ hives and headaches with fatigue Continue to aches, fever, headaches and nauseated |
| 62 | 2021-03-06 | hives |
Pt developed hives 19 mins. after receiving the vaccine. No resp distress noted, lungs clear, Benadr...
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Pt developed hives 19 mins. after receiving the vaccine. No resp distress noted, lungs clear, Benadryl 25 mg PO tab given. @ 4:12pm, Within 5 mins, hives began to subside. Pt stated she was feeing better. Observed for 30 mins more. Hives lessened significantly, and pt denied any other symptoms of acute reaction. and was released home. Husband drove pt home and she stated she would f/u with PCP. upon release. No distress noted.
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| 62 | 2021-03-07 | injection site redness, injection site warmth |
8:00 am 3/3/2021 had severe muscle and joint aches. Area of injection was red all around in large ar...
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8:00 am 3/3/2021 had severe muscle and joint aches. Area of injection was red all around in large area and warm to rich. Was lethargic.
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| 62 | 2021-03-07 | injection site pain |
Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chil...
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Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chills, muscle and joint pain, headache, tiredness
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| 62 | 2021-03-07 | itchy skin, rash | itchy all over body and throat rash on chest and arms |
| 62 | 2021-03-07 | rash | rash on neck. Evaluated by EMS-Cleared |
| 62 | 2021-03-08 | redness |
9 minutes after receiving Pfizer vaccination, while in the recovery area, c/o feeling of throat / to...
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9 minutes after receiving Pfizer vaccination, while in the recovery area, c/o feeling of throat / tongue swelling, with noted redness in the upper neck region just below the chin. Able to speak without difficulty, denied SOB/pain or dizziness. Vitals were taken, WNL, AA0 x3, received ongoing monitoring. 911 was called as patient continued to c/o throat swelling, called at 1648, arrived @ 1658, patient was assessed, recommended transport to ED to ensure no further progression, patient declined transport, Husband was on seen at all time, agreed not to transport, waiver signed by patient. DC from recovery area @ 1705 w/Husband, ambulating freely and with clear communication/speech.
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| 62 | 2021-03-08 | injection site warmth, injection site hardening, injection site rash | Large red circle around the injection site. Site is warm to touch and hard ???COVID arm |
| 62 | 2021-03-08 | shingles |
Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my ...
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Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my hand started to pain a lot; I couldn't even touch my own self it was so sensitive; may be I'm inflamed; nausea; severe pain/ my waist my back is so painful; My body feels so weak; my fingers and hand; It triggered the shingles pain in my back; It triggered the shingles pain in my back; had no appetite, I didn't eat; She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included shingles which she contracted in 2019, about one and a half years ago, it was a shingles on her back and lower back which she stated were the worst place for shingles has attacked, it left her with severe pain in both legs; diabetes; and high blood pressure. Concomitant medications included losartan, atenolol (a beta-blocker), and metformin for diabetes. The patient took the vaccine on 22Jan2021 and after about 2-4 days (Jan2021), she had a little chill and got very tired. She had to take care of herself. She was very tired not realizing it was the shot she took. She also felt like she has no energy. The patient was working from home but a lot of times, she was lying on the couch. Over the weekend (Jan2021), she had a slight pain on left arm. About a week or 8-10 days later (2021), she got very tired and couldn't even sit up. Her body was not itself. She started to feel like a bus rolling over her, like somebody took a baseball bat and beat her really bad. The patient uses her arm a lot and her hand started to feel a lot of pain. She couldn't even touch herself; it was so sensitive. She took paracetamol (TYLENOL) but it didn't work. She had celecoxib (CELEBREX) an anti-inflammatory, she thought she was maybe inflamed, but it didn't work. She had some diclofenac cream, she rubbed it, but it didn't work. The patient had shingles about a year and a half ago which was very bad. She just felt weak and didn't feel like herself anymore. She had a little bit of nausea and her whole body was really terrible. When she had the shingles, it left her with severe pain in both legs. She saw a neurologist and told her that she would have to take pregabalin (LYRICA) and it would go away. So, when she had severe pain last week, she took pregabalin but it didn't help. The patient took half of acetaminophen, oxycodone (PERCOCET) as she was not the person who takes pills, but it didn't work. Her body was so severe on Friday, it was not going away, the pain was there 24 hours. The patient has been experiencing this for 8-10 days now. She took one PERCOCET on Friday and had a slight relief and didn't took anything again. She kept rubbing the diclofenac cream, but it was not much of a relief. This morning, she has to work, she was sitting so she took PERCOCET. She is getting her second shot on Friday, 12Feb2021. She asked how she will feel after the second dose if she felt that way after the first dose, if the first shot was adequate, and if she should take the second dose. She stated that she didn't want to take the second dose. Her body felt so weak including her fingers and hand. It triggered the shingles pain in her back and felt like she was beaten up by someone. She has to lie down for the pain in her back. She also mentioned that she couldn't sit for so long as her waist and back were so painful. She was lying on a heating pad and ice and nothing was working. She even has a hard time getting up. She thought what happened was it triggered the shingles pain in her back and also left her with a problem under her feet. The shingles left her with some kind of damage when she took the shot. It was really bad. Her son was a physician and was concerned because last week, it got so bad, she didn't come out, she was in bed and bedridden from Friday to Sunday. She had no appetite, she didn't eat. The only thing that the patient had was diabetes and high blood pressure, but it was under control. She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit, but before my pressure was like 120 something, over 68 or 72 it was always around the 60s and 70s. Since she was having this, it was a little high. The outcome of the events was unknown.
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| 62 | 2021-03-08 | redness, itchy skin |
My left upper arm was red, swollen, knotted for 9 days after my 1sf shot. The knot and swelling has ...
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My left upper arm was red, swollen, knotted for 9 days after my 1sf shot. The knot and swelling has subsided but the area is still red and itching.
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| 62 | 2021-03-08 | injection site pain, injection site swelling, injection site redness, rash |
Pfizer-BioNTech COVID-19 Vaccine EUA - injection site pain & swelling & redness, tiredness, monster ...
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Pfizer-BioNTech COVID-19 Vaccine EUA - injection site pain & swelling & redness, tiredness, monster of a headache, chills but no fever, another red, itchy, blotchy, painful area, about the size of a man's wallet, just below injections site (but, not connected to injection site redness).
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| 62 | 2021-03-08 | injection site pain |
Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT...
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Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT came to my aid and took vitals all looked OK. I stayed in place until I felt better about 30 minutes. For the rest of that day and the next day I was extremely tired, a little nauseous, and kind of out of it. The third day I had very sore left arm at site and very sore and tender lymph notes on left side of Arm and trunk. Six days after the shot I came suddenly down with a massive headache and diarrhea. Al has since resolved and I am on day eight.
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| 62 | 2021-03-09 | injection site pain |
2nd dose of the COVID-vaccine administered on the morning of 2/18/21. Within the hour after adminis...
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2nd dose of the COVID-vaccine administered on the morning of 2/18/21. Within the hour after administration, severe pain on left shoulder (site of administration) was experienced. Swelling, consistent aching pain, and limited range of motion/inability to lift arm over her head. Motrin for 2 days was self administered with improvement in severity of pain but recurred when Motrin discontinued. Motrin was taken as needed thereafter and was the pain continued until 2/26. Employee was followed up on 3/10 and verbalized that the pain had fully resolved. No further interventions.
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| 62 | 2021-03-09 | rash, itchy skin, redness, itchy rash |
Rash on lower arms (right and left) as well as the back of both calves. The rash is more like red s...
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Rash on lower arms (right and left) as well as the back of both calves. The rash is more like red sores that itch. Also developed peeling splotches on both palms that are extremely itchy. There are also spots of thinning, red skin by the nail beds on numerous fingers on both hands. These areas on the hands are also sensitive to hot water. Began appearing on 3/3/21. I was prescribed a regimen of Methylprednisolone 4 mg DosePack on 3/10/21 to alleviate itching.
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| 62 | 2021-03-10 | vaccination site pain, redness |
After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stro...
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After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stronger pain at injection site than with yearly flu shot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient (who was not pregnant at time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 25Jan2021 13:15, as single dose for COVID-19 immunization, at hospital. Medical history included Allergy to All pain relievers and anti-inflammatory drugs and over the counter, allergies to penicillin and Allergies to sulfites all types. Patient was not allergic to Keflex injections, but allergic to the pull form. Concomitant medications included amlodipine, fluticasone propionate (FLONASE), famotidine (PEPCID AC), calcium, colecalciferol (CALCIUM/VIT D) and one a day multi vitamin (within 2 weeks of vaccination). Patient previously took cefalexin (KEFLEX), Bacitracin, Neomycin, Lidocaine, Prednisone; had allergies with these all medications. Historical vaccine included influenza vaccine (FLU SHOT) and had Pain at injection site. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. After 30 minutes of vaccine, face felt very hot. After 45 minutes cheeks red. After 1-hour facial swelling. Took 1 Benadryl tablet after noticing swelling. Heat and redness then faded. Facial swelling reduced over the next 24 hours without more Benadryl. Stronger pain at injection site than with yearly flu shot, for which patient was not received treatment. Seriousness of the events was reported as non serious. Outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.
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| 62 | 2021-03-10 | skin warm, redness, itchy skin |
Approximately 39 hours after immunization I woke with abdominal cramping. Upon standing I became li...
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Approximately 39 hours after immunization I woke with abdominal cramping. Upon standing I became light- headed and fell. My legs and arms turned red and warm and started itching. Itching subsided in an hour but redness remained for several hours. After itching stopped chills started and lasted several hours . By 7am symptoms were gone except for redness.
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| 62 | 2021-03-10 | redness, bruising, rash |
At time of injection, severe burning, bruising, and then a very large swelling/lump, redness/rash, a...
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At time of injection, severe burning, bruising, and then a very large swelling/lump, redness/rash, and pain. At three days post vaccine now and redness/rash almost gone, swelling some diminished but still very present, pain some diminished but still present, and bruising still present.
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| 62 | 2021-03-10 | rash with redness, rash macular, rash |
Bilateral medial forearms - transient, mild, NON- pruritic, macular (no raised lesions), pink, mottl...
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Bilateral medial forearms - transient, mild, NON- pruritic, macular (no raised lesions), pink, mottled /levido-like appearance between medial elbows and wrists. First noted at home, 3.5 hours after vaccine. No other new signs/ symptoms anywhere else in body following vaccine. (No respiratory symptoms, no swelling, itching or obvious other skin color changes.) Due to no associated itch or other discomfort associated with the BL medial forearm mottling, I would not have known the skin color changes had occurred if I had not removed my long-sleeved shirt upon arriving home 3.5 hours after vaccine. Therefore I do not know at what point during the 3 hours post-vaccine that the skin color changes occurred. The pink BL forearm mottling appeared to be more pronounced and visible after showering upon arrival home, but then it completely and rapidly faded within the next hour (and was completely resolved by 10:00 pm, 5 hours after vaccine). No treatment used for it that night or since (no topical or oral meds applied or taken). It has not reappeared since. (It is now 5 days post vaccine.) Just reported to PMD office next day and had followup call this week. No other action needed or taken.
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| 62 | 2021-03-10 | hives |
Developed hives 30 minutes after Vaccine, administered PO Benadryl observed an additional 30 min. an...
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Developed hives 30 minutes after Vaccine, administered PO Benadryl observed an additional 30 min. and hives resolved.
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| 62 | 2021-03-11 | injection site pain |
Injection site arm hurt from shoulder down to my elbow. Not sharp pain, achy. I took 1 naproxen 500...
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Injection site arm hurt from shoulder down to my elbow. Not sharp pain, achy. I took 1 naproxen 500 which I use occasionally for my arthritis and it helped alot. It was still slightly achy until March 11, 2021.
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| 62 | 2021-03-11 | redness |
Patient has allergies to several medications and keeps epipen on hand with her always. Was asked to ...
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Patient has allergies to several medications and keeps epipen on hand with her always. Was asked to sit for 30 minutes after vaccine. At minute 27 she started getting swelling and redness of her lips and face slightly. She normally takes Benadryl when this happens so gave her a Benadryl 50mg one dose. Her throat then became tight in a few minutes and she said that she needed an epipen because she was starting to have a little bit of trouble breathing. Gave epipen and her symptoms resolved within a few minutes. Kept her for 15 minutes. She stated that she knew she would be ok and asked if she could leave. I stated she needed to see the ER if she had any more trouble. I also consulted with her to check with her doctor about getting the 2nd dose because more than likely it's not recommended.
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| 62 | 2021-03-11 | rash |
Rash on her torso (no hives, no elevations) 48 hours after her 1st shot of Pfizer vaccine. She repo...
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Rash on her torso (no hives, no elevations) 48 hours after her 1st shot of Pfizer vaccine. She reported this to her Oncologist and he recommended her to take the second dose in 3 weeks.
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| 62 | 2021-03-11 | itchy skin |
Shortness of breath; joint pain in hands; Headache; coughing with extreme pain and described a feeli...
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Shortness of breath; joint pain in hands; Headache; coughing with extreme pain and described a feeling of bugs crawling in her lungs, bugs front and back/ painful cough; itching; This is a spontaneous report from a contactable nurse. This case was also received from Pfizer sponsored program. A 62-year-old female patient received the 2nd dose (at the age of 62-years-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration in Feb2021 at SINGLE DOSE for COVID-19 immunization. Medical history included lung and back problems (back pain). It was reported that the patient normally took an inhaler (not steroid inhaler because she didn't want to interfere with immune response), and other things. The patient previously took prednisone which started at 40mg for 2 days, 30 for 2 days, 20 for 2 days then goes down to zero for back pain (stopped taking 4 days before the second dose of the vaccine). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot# not provided) on 29Jan2021 (at the age of 62-years-old) for COVID-19 immunization. The patient's 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE was administered a week ago (Feb2021) Friday. It was reported that she got very ill initially which she said joint pain in hands and headache noted in Feb2021 (Saturday) which wasn't so bad. On Saturday afternoon, she reported shortness of breath, coughing with extreme pain (painful cough) and described a feeling of bugs crawling in her lungs, bugs front and back, and itching, and no one else reported it. The patient kept sleeping and waking up, thinking she was alright, but the coughing and lasted until Sunday evening, it was a very painful cough, and a creeping sensation in lungs front and back. She missed work on Monday. The events (joint pain in hands, headache, shortness of breath, coughing with extreme pain (painful cough) and itching) were medically significant as she was unable to go to work. It was also mentioned that since the patient stopped taking the Prednisone 4 days before the second dose of the vaccine. The patient had an exacerbation of pain (it came back). The patient was also wondering when can she start the inhaler and steroid for the back as she has lung and back problems. Outcome of the events were unknown. Information on lot number/batch number has been requested.; Sender's Comments: Based on data provided, the reported events are assessed as possibly related to BNT162B2. This case will be reviewed upon receipt of further information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-03-12 | redness, injection site tingling, injection site reaction |
Patient received the vaccine and about 3 minutes after she described a warm flushing feeling when it...
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Patient received the vaccine and about 3 minutes after she described a warm flushing feeling when it was injected, and tingling. No shortness or breath or chest pain, patient was removed from cell and taken to the observation area, her chest was red and flush. her blood pressure at 1145 was 178/122 and heart rate 89 and pulse ox 95% in her let wrist, patient was placed on litter and laid down, she was observed . Follow up blood pressure at 1208 on her left wrist was, 167/112, HR 87, pulse ox was 99 on room air. Blood pressure check in her right wrist was 175/99 . Patient stated that her symptoms were resolving with additional observation. Patient was then placed on the edge of the bed for additional time and patient was released from observation at 1215.
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| 62 | 2021-03-12 | injection site pain, injection site swelling |
Soreness at injection site, and also swelling....both occurring on the second day after the injectio...
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Soreness at injection site, and also swelling....both occurring on the second day after the injection.
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| 62 | 2021-03-13 | vaccination site pain |
After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well. I woke the next morni...
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After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well. I woke the next morning 2/25/21, and felt fatigue, arm was tender but not sore. Earlier that morning, I had an aura, but no migraine materialized. Around 10 a.m., I began to have chills, more fatigued, and sore muscles. Left work at 3 p.m. Arrived home, went to bed with temperature of 101.2. Took Tylenol. Friday, Fever was gone, felt fatigued, arm still tender, and had a headache. Took Tylenol. Did not go to work on 2/26/21. Saturday, 2/27/21, woke at 4 a.m., right arm where vaccinated was very sore, armpit very sore, and right breast very sore. Placed cool compresses on my breast, arm pit and arm where vaccine was given. Took Tylenol. Still fatigues, achy, with sore shoulder muscles. Sunday, 2/28/21, Vaccine arm still sore, with some soreness still in right breast area. Took Tylenol. 3/1/21, called Dr. Still a bit achy and arm still tender
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| 62 | 2021-03-13 | skin spots, rash |
Same day mouth and throat swelling, rash appeared several days later, not getting betting with stero...
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Same day mouth and throat swelling, rash appeared several days later, not getting betting with steroids, Benadryl. Petechial rash diarrhea several days later.
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| 62 | 2021-03-14 | injection site pain, injection site bruising |
A. 2-4 hours post dose: tiredness (may have been unrelated and due to lack of sleep and activity tha...
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A. 2-4 hours post dose: tiredness (may have been unrelated and due to lack of sleep and activity that day) B. Some buzzing in ears, and increased tinnitus (pre-existing) off and on up to ~ 24 hours post C. 4 hours post dose to current (24 hours post): Soreness in arm, at/around injection site, typical of other vaccinations (minimized bruising and soreness by rubbing arm during 15 min wait time to disperse serum and reduce bruising/ soreness); soreness increasing overnight ? feels much like exercise muscle soreness, still tender to touch at site at 30 hours post inoculation.
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| 62 | 2021-03-14 | itchy skin, redness |
Approximately 15 minutes after vaccination, patient began feeling bumps on lip and swelling under ja...
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Approximately 15 minutes after vaccination, patient began feeling bumps on lip and swelling under jaw. Soon after, she felt flushed with itching in feet and swelling of feet. I observed a mild redness to face and upper chest. I saw no swelling of neck, lips or oral cavity. I ordered 25 mg. benedryl po be administered at 3:10 PM. A few minutes later, she felt tightness in chest. At that point (3:15 PM) an EMT tried to inject an Epipen but only left the pen in for less than 1/4 second before she withdrew the pen. I then administered another Epipen directly after and the pen was in her thigh for over 3 seconds. The patient was transferred light and sirens to ER. She received no further Epi in the ER and received steroids, benedryl, and famotidine according to the ER Resident. She was doing well 90 minutes after vaccination per Dr.
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| 62 | 2021-03-14 | rash | Fever, 101.5, rash on legs arms, muscle aches |
| 62 | 2021-03-14 | itchy skin |
Itching starting at scalp progressed to lips, tongue, ears neck, chest , hands & legs. 2 Benadryl t...
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Itching starting at scalp progressed to lips, tongue, ears neck, chest , hands & legs. 2 Benadryl taken. Slightly itchy next day
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| 62 | 2021-03-14 | hives, itchy skin |
Patient developed typical viral type symptoms ( felt foggy and "off") Saturday evening and woke over...
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Patient developed typical viral type symptoms ( felt foggy and "off") Saturday evening and woke overnight into Sunday with severe itching which lasted all day Sunday despite Benadryl and Pepcid and lotion. I saw patient Monday morning and she had hives on back, abdomen, arms, and some starting on legs. Given extent of hives, we administered IM steroid and prescribed Medrol Dosepak. No airway involvement. No prior history of reactions to vaccines. Will not know how effective steroids are as this is an urgent care, but she was feeling some improvement after sitting for 10 minutes after the steroid injection.
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| 62 | 2021-03-15 | rash |
After 2nd dose (Pfizer EN6199, on 3/14/2021) I came to realize that the rash/outbreaks on my scalp s...
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After 2nd dose (Pfizer EN6199, on 3/14/2021) I came to realize that the rash/outbreaks on my scalp started after my first Covid-19 vaccine. I was thinking it might have been caused by my use of drinking a tablespoon of the Olive Oil I started about a month ago. After it became worse in the last days, 2 days after my second dose and 6 days after had stopped with the Olive Oil, I think it might have been caused by the vaccine. I didn't change anything else. Same cosmetics and shampoo/conditioner for months.
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| 62 | 2021-03-15 | rash, itchy skin, redness |
Allergic-Anaphylaxis Itching 17 min after administration, redness, rash, chest pressure under heart....
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Allergic-Anaphylaxis Itching 17 min after administration, redness, rash, chest pressure under heart. Facility called 911 administered Benadryl via IV transported to ER Once in ED given Epipen at 2:21 and Decadron @ 6:05, discharged at 6:60 pm
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| 62 | 2021-03-15 | injection site warmth, injection site swelling, injection site pruritus, injection site redness, redness, itchy skin, skin warm |
These started 31 hours after injection. Chills, Headache, low grade fever of 99.9 body aches, sore ...
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These started 31 hours after injection. Chills, Headache, low grade fever of 99.9 body aches, sore arm. On 3 rd day after vaccine, injection site became red, hot to the touch and swollen. A separate area from the injection site also became red, swollen and hot to the touch. 4 th day, injection site and random site became more swollen and began to grow together with intense itching. Still hot to the touch and red.
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| 62 | 2021-03-15 | injection site pain |
Whole body is sore like as if I just ran a mile and every muscle hurts. shoulder/injection site hurt...
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Whole body is sore like as if I just ran a mile and every muscle hurts. shoulder/injection site hurts. Legs especially hurt.
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| 62 | 2021-03-15 | redness | flushing, tongue tingling, redness chest, neck and cheeks. Evaluated by EMS-Cleared |
| 62 | 2021-03-15 | shingles | shingles outbreak on same area of vaccine given |
| 62 | 2021-03-15 | itchy skin, rash |
started with rash on chest then became itchy everywhere, had shot Friday started benadryl Monday ni...
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started with rash on chest then became itchy everywhere, had shot Friday started benadryl Monday night
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| 62 | 2021-03-16 | injection site pain | Injection site soreness Tiredness Chills |
| 62 | 2021-03-16 | itchy rash, rash |
Itchy rash, small red bumps on legs, arms. From 2 days after vaccination, for 6+ days. Less itching ...
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Itchy rash, small red bumps on legs, arms. From 2 days after vaccination, for 6+ days. Less itching after 4 days but rash still spread to hips , back and neck. Benedryl and Hydrocortizone cream. After seeing doctor, Zyrtec (OTC) and Triamcinolone Acetonide Ointment
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| 62 | 2021-03-16 | injection site bleeding, injection site bruising, injection site mass |
Person administering hit a vein and blood was dripping down. Sore arm, lump and dark bruise 1.5? ac...
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Person administering hit a vein and blood was dripping down. Sore arm, lump and dark bruise 1.5? across at injection site. Fatigue and body aches beginning 4 days after vaccination.
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| 62 | 2021-03-16 | rash, injection site rash |
Rashes over face, injection site 128/68, 100, 97, 100% H. Pt. alert and oriented X3. Rashes observe...
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Rashes over face, injection site 128/68, 100, 97, 100% H. Pt. alert and oriented X3. Rashes observed to injection site. Per EMS pt. will be transferred to Plantation for further evaluation.
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| 62 | 2021-03-16 | injection site pain | Tinnitus, hearing loss, joint pain, sore at injection |
| 62 | 2021-03-16 | skin warm | body warm, numbness left side of face,blood pressuure spick |
| 62 | 2021-03-17 | itchy skin |
About 4 hours after injection I started feeling pins and needles in my hands and then I started fee...
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About 4 hours after injection I started feeling pins and needles in my hands and then I started feeling it all over. It would come and go. A few days later it felt like burning, stinging and itchy. I?m still getting it but not as frequently. There?s no rash. I?m concerned about getting a 2nd vaccine. I know this could be related to the vaccine or anxiety. I saw blogs that this happened to others after the Covid vaccine.
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| 62 | 2021-03-17 | injection site swelling, rash with redness |
Injection site still swollen on day 11 with large rash/redness. Urgent care doctor said it is Covid...
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Injection site still swollen on day 11 with large rash/redness. Urgent care doctor said it is Covid arm.
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| 62 | 2021-03-17 | itchy skin, skin warm | It started 7 days after the injection. Swollen, itching, warm to the touch and sore |
| 62 | 2021-03-17 | itchy skin, rash | Mild throat swelling, itchy lower half of face, time of shot. Next day rash on chin |
| 62 | 2021-03-17 | injection site warmth, rash with redness, redness |
Pt experienced swelling immediately following injection. Pt was observed for 15 minutes following in...
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Pt experienced swelling immediately following injection. Pt was observed for 15 minutes following injection. After 15 minutes, pt left arm was red with a rash approximately 6 in in length. Site was warm to the touch. Pt denies pain or itching and denies any difficulty breathing.
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| 62 | 2021-03-17 | injection site pain |
Was sick for 1-1/2 days. Injection site sore for days. Had chills, just a general feeling of sick t...
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Was sick for 1-1/2 days. Injection site sore for days. Had chills, just a general feeling of sick to my stomach.
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| 62 | 2021-03-17 | pain of skin |
tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertip...
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tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertips and toes were very painful-burning sensation; fingertips and toes were very painful-burning sensation; Underarm pain-throbbing; skin hurt when applying lotion; Low grade fever 99.9; This is a spontaneous report from a contactable other healthcare professional (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262), intramuscularly at right arm on 29Jan2021 11:00 at single dose for COVID-19 immunization at workplace clinic. The patient's medical history included autoimmune disorder, kidney disease, angina, and high blood pressure. There were other medications that the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies: Simvastatin, Tramadol, Codeine. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), at the age of 62-year-old, intramuscularly at right arm on 09Jan2021 13:15 at single dose for COVID-19 immunization at workplace clinic. It was reported that on the 2nd day after the vaccine (30Jan2021 13:00) patient started having body aches, muscle pain, joint pain, nerve pain. Her fingertips and toes were very painful-burning sensation. Also reported underarm pain-throbbing. Her skin hurt when applying lotion. Had low grade fever 99.9. Treatment was received for the above mentioned events: Tylenol 500mg, 2 Caps Q6h. Patient was recovering from the above mentioned events. She do have an autoimmune disorder: her Rheumatologist is checking for Psoriatic arthritis. She had tested positive for Rheumatoid Arthritis (unknown outcome). No treatment for this condition at this time. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 or not prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 62 | 2021-03-18 | itchy skin |
About 6 hours after I got it, I felt tired. The next day, my arm was sore and my eyelids were swolle...
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About 6 hours after I got it, I felt tired. The next day, my arm was sore and my eyelids were swollen every day for about 5 days. I had aches and pain all over, itchiness, headache, joint pain over the next week. Around the 22nd, it stopped. It took almost 10 days for me to feel somewhat normal.
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| 62 | 2021-03-18 | injection site swelling, injection site pain |
Swelling of the arm at the injection site, including soreness, and headache, fatigue, muscle ache, j...
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Swelling of the arm at the injection site, including soreness, and headache, fatigue, muscle ache, joint pain, slight fever - felt like I had the flu. Started overnight after the shot and lasted the entire next day. Treated with rest, hydration and Tylenol. Symptoms were gone by the following morning.
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| 62 | 2021-03-18 | injection site pain | sore throat, dizziness, right eye pain, diarrhea, leg pain, fatigue, soreness at site area |
| 62 | 2021-03-20 | pain of skin | Malaise, fatigue, muscle aches, chills, sore skin, headache |
| 62 | 2021-03-20 | injection site pain | Slight fever. Headache,tiredness,diarrhea,injection site pain. |
| 62 | 2021-03-20 | injection site pain |
Triggered Trigeminal Neuralgia symptoms. 5 minutes after injection left shoulder sore. 25 minutes af...
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Triggered Trigeminal Neuralgia symptoms. 5 minutes after injection left shoulder sore. 25 minutes after injection left side of lips became numb. Medics responded, as we were talking, realized numbness had followed the trigeminal nerve back to the ear, and then from the ear, toward the nose. we determined it was not life threatening, and I was asked to contact my healthcare provider. Left lower quandrant of cheek/face was swollen for between 24 - 36 hours. Developed diarrhea 24 hours after injection.
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| 62 | 2021-03-21 | rash |
After 24-48 hours my cheeks looked flush, after 72 hours it was darker and had prickly bumps, after ...
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After 24-48 hours my cheeks looked flush, after 72 hours it was darker and had prickly bumps, after 96 hours bumps more pronounced with some small pimple sized and covering a larger portion of the cheeks . It was also warm to the touch and beginning to feel like a mild sunburn. It stayed this way until Monday morning , 6 days later when I contacted my doctor. Doctor instructed me to take benedryl and see if this relieves it. Also informed me to take benedryl before I get my next injection. It is still ongoing at this level at the middle of day 6 as I am submitting this report.
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| 62 | 2021-03-21 | redness |
Facial swelling, red hot cheeks. I took one Benedryl tablet and heat & redness subsided. 24 hours ...
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Facial swelling, red hot cheeks. I took one Benedryl tablet and heat & redness subsided. 24 hours later swelling was gone.
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| 62 | 2021-03-21 | itchy skin, injection site redness, injection site pruritus |
Slight itching the day of the shot. As the days went on, the injection site got redder, itched more ...
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Slight itching the day of the shot. As the days went on, the injection site got redder, itched more and felt hard. It reached the size of 3 inches across and about 2.5 inches tall. In addition, I'm feeling slight itching at different times at random places on my body. I refer to them as twitch itching. They itch briefly, and then another one starts somewhere on my body. The redness is still visible on my arm, but not to the degree it was. I am unclear if I should get another shot.
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| 62 | 2021-03-21 | cellulitis |
cellulitis; lymphadenitis; Fever 103; Still swollen from groin area down to knee; This is a spontane...
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cellulitis; lymphadenitis; Fever 103; Still swollen from groin area down to knee; This is a spontaneous report from a contactable other HCP (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: not reported), via an unspecified route of administration in the left arm on 26Feb2021 at 12:00 PM at a single dose for COVID-19 immunization. Medical history was unknown. Concomitant medications were none. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient experienced fever 103 white posture on knee that turned into cellulitis and lymphadenitis. The patient had IV antibiotics twice within 5 days of vaccine as treatment for events. The patient still had swollen from groin area down to knee. AE resulted in emergency room/department or urgent care. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was not recovered. Information on the batch/lot number has been requested.; Sender's Comments: The event cellulitis is assessed as unrelated to BNT162B2 based on the information provided. The event onset date is not reported, therefore the drug-event temporal relationship is not clear. In addition, the BNT162B2 vaccine was administered in the arm but the reported cellulitis was at knee area. It is very unlikely that the cellulitis was related to BNT162B2.
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| 62 | 2021-03-21 | injection site swelling, injection site redness |
high fever x 2 days, low grade fever x 1 day, fatigue, body aches, severe chills, shaking, brain fog...
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high fever x 2 days, low grade fever x 1 day, fatigue, body aches, severe chills, shaking, brain fog x 4 days , injection site reaction - swelling and redness in entire L arm x 3 days, hot flashes with intense sweating.
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| 62 | 2021-03-22 | injection site pain, injection site redness |
Underarm swelling, redness, and pain - in armpit and down inside of left arm. Starting Saturday - s...
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Underarm swelling, redness, and pain - in armpit and down inside of left arm. Starting Saturday - started 1 day after injection and has gotten worse each day.
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| 62 | 2021-03-23 | itchy skin |
Felt dizzy, had metallic taste in mouth. Numbness & tingling of lips, tip of tongue. Dizzyness got...
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Felt dizzy, had metallic taste in mouth. Numbness & tingling of lips, tip of tongue. Dizzyness got better after 15 minutes. Tingling of lips & tongue better after 1 hour, but still present. Face felt hot & flushed 40 minutes after shot. Also had some "burning" of veins in wrist . Metallic taste continues.. Some itching of face.
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| 62 | 2021-03-23 | injection site swelling, injection site pain |
No serious side effects after first dose. no fever, no tiredness. minimal site pain, very slight b...
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No serious side effects after first dose. no fever, no tiredness. minimal site pain, very slight bump at injection site. gone within 24 hours. Second dose small side effects; very slight bump at injection site, pain upon firm pressure on 3 inch area surrounding lasting for 38-45 hours . about 21 hours after waking the next morning, had eye pain, dryness, gritty feeling, used eye drops with minimum success on relief. after 25 hours eyes feel hot, apply cool compress to closed eyelids, tried eye drops again, some relief. 27 hours started a small temperature of 99.7 - 100.1 for 2.5-3 hours, laid down to rest, improved although eyes were still a little irritated, dry, gritty, not hot. went to sleep, no further symptoms.
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| 62 | 2021-03-23 | rash |
PT HAD RASH FROM PAST POSITIVE COVID TESTING. RASH INCREASED DRASTICALLY AFTER FIRST DOSE. RASH IS ...
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PT HAD RASH FROM PAST POSITIVE COVID TESTING. RASH INCREASED DRASTICALLY AFTER FIRST DOSE. RASH IS NOTED FROM NECK TO FINGERTIPS AND DOWN LEGS.
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| 62 | 2021-03-23 | rash |
Pt states that she went this morning to get the Pfizer vaccine, 1st dose. a few hours later she dev...
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Pt states that she went this morning to get the Pfizer vaccine, 1st dose. a few hours later she developed rash, approx 17:00, two tiny little dots on her back and one larger one, abdomen. adv that for this very minor "reaction" she may take antihistmine like benadryl, topical hydrocortisone and analgesics as needed. if it gets worse call back for further recommendations. if serious effects appear call 911.
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| 62 | 2021-03-23 | injection site redness | Slight swelling and redness around vaccine site |
| 62 | 2021-03-23 | hives | hives and difficulty breathing |
| 62 | 2021-03-24 | rash with redness |
2nd vaccine rec'd on 03/20/21. On 03/21/21 still a lot of soreness in left upper arm. On 03/22 PM, n...
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2nd vaccine rec'd on 03/20/21. On 03/21/21 still a lot of soreness in left upper arm. On 03/22 PM, noticed the armpit lymph nodes swollen and slightly sore to the touch. Symptoms same on 03/23. On 03/24/21, noticed a red rash on outer part of upper arm to the elbow. Sweats and chills in PM and 2 fever blisters appearing on moth on left side. Morning of 03/25/21, rash worsens, sweats and chills continue. Toward afternoon, lightheadedness and trembling in hands. Felt better after lunch, some lightheadedness, still.
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| 62 | 2021-03-24 | injection site swelling |
Client c/o swelling on site vaccine given, LD and some pressure when swallowing. Client reports hav...
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Client c/o swelling on site vaccine given, LD and some pressure when swallowing. Client reports having a headache on first COVID-19 dose. Site assessed and no swelling noted on LD, nor pain reported. No swelling observed near throat area. Upon client departure at 10:30 am, client was able to move arm and speak/swallow with no difficulties. Client advised to contact PCP if any other issues occur at home. Client verbalized understanding. Client assessed by EMT and nursing onsite. All vitals within normal limits.
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| 62 | 2021-03-24 | skin burning sensation |
Initially light headed and sever headache. The next day, developed severe skin burning sensation al...
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Initially light headed and sever headache. The next day, developed severe skin burning sensation all over body, including inside of mouth. This pain has increased as the days went on. This pain is severe, and continues into now 10 days. Dizziness and stomach upset has increased. Ringing in the ears and increased sensitivity to sound. Also experiencing weak and shakiness.
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| 62 | 2021-03-24 | rash, hives |
rash; hives; swollen face; congestion; This is a spontaneous report from a contactable consumer (pat...
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rash; hives; swollen face; congestion; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an specified route administered in Arm Left on 14Feb2021 10:30 AM at single dose, second dose via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Batch/Lot Number: ENG199) as SINGLE DOSE for covid-19 immunisation. Medical history included avn (left hip and both knees replaced), Known allergies: Bee stings, Cats. No covid prior vaccination. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT). No other vaccine in four weeks. The patient experienced Slight reaction from first shot: Rash, hives, swollen face, congestion. 10Mar2021 10:00 PM, the patient experienced same events after the second dose, resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient hospitalized for 1 day. The patient tested Covid post vaccination on 11Mar2021: Nasal Swab with Negative result. The outcome was recovering.
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| 62 | 2021-03-25 | injection site swelling, injection site rash, injection site redness, skin warm | An hour after vaccine arm very hot. Now red rash and swollen at injection site |
| 62 | 2021-03-25 | skin irritation, redness |
At 20 minutes from vacination my face became in flamed below the ear on both sides. Face became bri...
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At 20 minutes from vacination my face became in flamed below the ear on both sides. Face became bright red. Heart rate was taken. Blood pressure was taken (said to be 182 over 95 - nomal runs 82). Was given one benydrl. which makes me drozy. After approximately 30 minutes heart rate lowered. I wasn't given the full information. Representatives identified themselves as CDC documented information. PCP was notified. I need to get a second vaccine, I need to be advised on how to proceed.
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| 62 | 2021-03-25 | rash |
FELT FLUSH, DEVELOPES RASH ON CHEST. GIVEN IV DIPHENHYDRAMINE AND NORMAL SALINE BOLUS. DECLINED EMS ...
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FELT FLUSH, DEVELOPES RASH ON CHEST. GIVEN IV DIPHENHYDRAMINE AND NORMAL SALINE BOLUS. DECLINED EMS AFTER RECEIVING ADVICE FROM ER DR, NP AND EMS
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| 62 | 2021-03-25 | injection site swelling, injection site swelling |
HPI: The Pt is a 62 year old female who presents with localized injection site swelling immediately ...
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HPI: The Pt is a 62 year old female who presents with localized injection site swelling immediately after receiving her vaccination. Pt had 1st dose Pfizer to the right deltoid. She denies any pain at the injection site. Pt denies any Hx of allergic reactions or incidence of injection site inflammation in the past. She has a Hx of DDD, carpal tunnel syndrome, and nerve pain for which she takes Cymbalta and Celebrex. Pt also takes oral Prolia for osteoporosis. Pt denies any swelling of the face/lips/eye, difficulty swallowing, tightness of the throat, or itching of the skin. She also denies numbness or tingling in the bilateral UEs.
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| 62 | 2021-03-25 | rash with redness, itchy rash, injection site rash |
One week after injection, appearance of a mildly itchy red rash on arm near the injection site, appr...
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One week after injection, appearance of a mildly itchy red rash on arm near the injection site, approximately 2.5 inches.
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| 62 | 2021-03-25 | itchy skin |
Pt experienced lip numbness and tongue "thickness" between 5 and 10 minutes post-vaccine administrat...
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Pt experienced lip numbness and tongue "thickness" between 5 and 10 minutes post-vaccine administration. She was brought to Observation are, vital signs checked and symptoms monitored. 1 dose antihistamine given at 1205pm. She then felt itchiness in throat and ears. 2nd dose po antihistamine given with complete relief of sx's at 1235pm.
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| 62 | 2021-03-25 | vaccination site swelling, vaccination site pain |
Rheumatoid arthritis; little stiffness in her arm; she was not feeling very"/just felt little off; l...
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Rheumatoid arthritis; little stiffness in her arm; she was not feeling very"/just felt little off; little pain in her left arm where the vaccination was given; pain in her elbow; seems like her left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (lot number: EN6202 and expiration date: 30Jun2021) as 0.3 mL, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Vaccine last Friday (05Mar2021) and on an unknown date, she had little stiffness in her arm and she was "not feeling very" (incomplete sentence), you know she was just felt little off but other than that, not too bad. The patient also had a little pain in her left arm where the vaccination was given and some stiffness on unknown date. Since then, she had pain in her elbow on left arm and today (10Mar2021), the pain was pretty persistent and seems like her left arm was swollen. The patient also stated "I guess I should say, I have rheumatoid arthritis" (pending clarification)". The patient received treatment for the events, stated "The only thing I took in this morning is Tylenol." Outcome of the events was unknown.
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| 62 | 2021-03-25 | itchy skin, injection site pruritus |
c/o severe itching at injection site that then extended to legs and both arms. Vitals: at 1040 BP 1...
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c/o severe itching at injection site that then extended to legs and both arms. Vitals: at 1040 BP 199/110, HR 68, RR 14, O2 SAT 100%, Alert/oriented. Pt given Benadryl 25mg@1042a, pt initially declined Benadryl 50mg po as recommended; A 2nd dose of Benadryl 25mg po was given at 1054a for worsening itching. Care transfered to on-site EMS, remaining Vitals per EMS. At 1100a INT placed to Lt AC area. At 1108a Solumedrol 125mg IV given per EMS for worsening itching. Paramedics arrived @ 1128 to transport patient; they departed to the hospital at 1129a in route to NSH Duluth.
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| 62 | 2021-03-25 | shingles | shingles |
| 62 | 2021-03-26 | injection site pain |
Heart palpitations for 3 hours (11:30-2:30), dizziness, slight headache that morning, soreness at in...
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Heart palpitations for 3 hours (11:30-2:30), dizziness, slight headache that morning, soreness at injection site. I left work early and went home to lay down. I took 2 aspirin. I slept for 20 minutes and woke up feeling better. My doctors office was closed since this happened on a Friday. I consulted with a friend that is a RN and she advised going to emergency room. I have horrible health insurance so I didn?t want to pay 650.00 to go to emergency room. I?m not sure I want to get the second shot since I have heard that adverse reactions increase with the second shot.
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| 62 | 2021-03-26 | blister |
I developed Mononucleosis six weeks after my second dose of the Pfizer vaccine. Fever, severe night ...
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I developed Mononucleosis six weeks after my second dose of the Pfizer vaccine. Fever, severe night sweats, severe fatigue, loss of appetite, head aches, and blisters on my skin. I have not been exposed to Mononucleosis that I know of and have been isolated from the public because my husband had not been vaccinated yet. Mononucleosis has a 4-6 week incubation period which is when I took my second vaccine shot
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| 62 | 2021-03-26 | injection site pain |
Pfizer-BioNTech COVID-19 Vaccine EUA. Dizziness starting approx. 1 hour after shot; extreme fatigue ...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Dizziness starting approx. 1 hour after shot; extreme fatigue and sleepiness occurred approx. 5 hours after shot. It is now 14-1/2 hours after the shot and I am still dizzy. I fell asleep for 3 hours. I'm still tired but not falling asleep at the wheel. Pain at injection site started approx. 7 hours after shot and still hurts.
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| 62 | 2021-03-26 | rash |
Prickly rashes on ankle and back of thigh, started ~9 hrs after injection. I tried to describe rash...
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Prickly rashes on ankle and back of thigh, started ~9 hrs after injection. I tried to describe rashes in detail, but was kicked out of site after spending time to describe them carefully. Plese call if you need more info
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| 62 | 2021-03-27 | rash |
Outbreak of cold sores on chin, otc medicine - abreva or left alone, still ongoing - but usually las...
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Outbreak of cold sores on chin, otc medicine - abreva or left alone, still ongoing - but usually lasts a week or less.
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| 62 | 2021-03-27 | injection site pain |
pain at injection site. nausea, chills, headache, joint aches, general unwell feeling. This starte...
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pain at injection site. nausea, chills, headache, joint aches, general unwell feeling. This started during the afternoon after receiving injection in the morning-Friday. This continued all the next day-Saturday. All was resolved by the following morning-Sunday.
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| 62 | 2021-03-28 | itchy skin, rash |
Patient received 2nd vaccine. About 10 mins after administration she reported nausea, light headed, ...
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Patient received 2nd vaccine. About 10 mins after administration she reported nausea, light headed, itching, rash, numbness. Patient requested to only have 25mg of Benadryl administered. Per Dr. ok to administer that amount. Benadryl 25mg IM in the left deltoid at 11:30 AM by RN
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| 62 | 2021-03-28 | injection site warmth, injection site swelling, injection site redness |
Red, swollen and soreness. Receive the shot on a Thursday and today Monday injection site if very re...
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Red, swollen and soreness. Receive the shot on a Thursday and today Monday injection site if very red swollen and warm to the touch. Put ice on my are yesterday but it doesn't seem to have helped much
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| 62 | 2021-04-03 | hives |
Hives on torso, both upper arms, right upper thigh, both wrists and hands; This is a spontaneous rep...
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Hives on torso, both upper arms, right upper thigh, both wrists and hands; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 11Feb2021 15:45 (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included Diabetic, control cholesterol and allergies: Latex from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin, atorvastatin, glipizide; ciclosporin (RESTASIS) taken for an unspecified indication, start and stop date were not reported. The patient experienced hives on torso, both upper arms, right upper thigh, both wrists and hands on 11Feb2021 18:15. Therapeutic measures were taken as a result of hives on torso, both upper arms, right upper thigh, both wrists and hands and included treatment with Benadryl, cortisone cream. The outcome of the event was reported as recovering.
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| 62 | 2021-04-11 | itchy skin |
Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19...
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Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19, then found obtunded due to pulmonary embolus resulting in death within 24 hours of receiving 2nd dose
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| 62 | 2021-04-15 | redness |
fluid like blister on roof of mouth, red dots on skin, extreme fatigue and worsening of arthritis sy...
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fluid like blister on roof of mouth, red dots on skin, extreme fatigue and worsening of arthritis symptoms and GERD
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| 62 | 2021-04-17 | rash |
developed a severe body rash over my entire body; This is a spontaneous report from a contactable co...
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developed a severe body rash over my entire body; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that the 62-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included thyroid disorder from an unknown date and unknown if ongoing Other medical conditions: consumer stated, "No just thyroid." ( Further clarification unknown). Concomitant medication(s) included lurasidone hydrochloride (LATUDA) at 80 mg, once a day, oral for an unspecified indication, start and stop date were not reported; zolpidem tartrate (AMBIEN) at 6.25mg, once a day, oral for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) at 20mg, once a day, oral for an unspecified indication, start and stop date were not reported. The patient experienced developed a severe body rash over my entire body (hospitalization) on 16Mar2021 with outcome of unknown. Therapeutic measures were taken as a result of developed a severe body rash over my entire body. Reporter seriousness for have to go to the emergency room to get steroids to slow it down was Hospitalization. Consumer stated, "I had a reaction to the vaccine took vaccine ,I had it 6 days and I developed a severe body rash over my entire body." On paraphrasing concern: consumer stated, "This was the first shot, I had rash all over my body everywhere and I have to go to the emergency room to get steroids to slow it down, right, I am on Prednisone from 16March, I got shot on 10Mar and I got the reaction on 16Mar." Consumer stated, "That's what I want to report and do you know if have would have anything from having one shot my doctor won't let me take the second shot?" Consumer stated, "I have been on Prednisone since the 16th." ( Treatment in response to event), the Covid red rash, that's why they called me in hospital, when I went to hospital, I only I have this rash all over my body and it is slowly going away, I don't have thyroid I have rash all over my body."
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| 62 | 2021-04-17 | rash |
passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs...
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passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs and muscles (some short and some long duration); rash; cold; night sweat; no energy; intense dreams first night; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 30Mar2021 13:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included zolpidem tartrate (AMBIEN). The patient was healthy. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received the first dose of BNT162B2 (Lot number: EN6199) in the left arm on 11Mar2021 11:00 AM at the age of 62-year-old for COVID-19 immunisation. The patient experienced passed out twice, intense, rapid and irregular heartbeat (prolonged), intense pain in various organs and muscles (some short and some long duration), rash, cold, night sweat, no energy, intense dreams first night; all on 30Mar2021 with outcome of not recovered. Doctor appointment was scheduled. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment received for the events.
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| 62 | 2021-04-21 | shingles | Shingles |
| 62 | 2021-04-26 | shingles |
Suspected vaccination failure; Mild Shingles symptoms / after my first Covid vaccine on 4/16/21; Thi...
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Suspected vaccination failure; Mild Shingles symptoms / after my first Covid vaccine on 4/16/21; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, TOZINAMERAN (COVID-19 VACCINE PFIZER) (batch number ER2613, expiry date unknown) for prophylaxis, estradiol vaginal for drug use for unknown indication and estradiol + norethisterone acetate (Combipatch) for drug use for unapproved indication. The patient's past medical history included esophageal acid reflux and shingles (experienced one severe case and one mild case of shingles 10 years ago before the date of reporting, when patient was at her mid 50's). Previously administered products included Zostavax (received on 9th January 2015). Concurrent medical conditions included food allergy (Raw shrimp allergy), allergy to antibiotic (Sulfamethoxazole TMP DS 800-160 mg Tablet), drug allergy (vioxx) and fruit allergy (fresh pineapple). On 1st December 2018, the patient received the 2nd dose of Shingrix. On 2nd July 2018, the patient received the 1st dose of Shingrix. On 16th April 2021, the patient received the 1st dose of COVID-19 VACCINE PFIZER. On an unknown date, the patient started estradiol vaginal at an unknown dose and frequency and Combipatch .05 mg at an unknown frequency. On 16th April 2021, 867 days after receiving Shingrix and 1019 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with estradiol vaginal was unknown. The action taken with Combipatch was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional details were provided as follows: The ethnicity information and race information was available but not provide. The patient received the two doses of Shingrix,one dose of Covid-19 vaccine on left arm and within 2 weeks of Vaccination patient received estradiol (Vaginal Tabs 10 mcg,) and combipatch (0.05-0.14mg) and later patient experienced mild Shingles symptoms on left side of abdomen and left side of back. The patient had no Shingles side effects until 8 hours after her first Covid vaccine The patient did not received any treatment. The patient was not tested or diagnosed with COVID-19. It was unknown if the reporter considered the shingles to be related to Cocid-19 vaccine, estradiol vaginal tablet and combipatch. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
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| 62 | 2021-04-27 | redness |
Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee...
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Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee; Leg was swelling/right shoe was tight; Lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; It was tender on her right leg on the left side of the tibia/It is very tender to the touch; Red mark on her leg with a little nodule; Red mark on her leg with a little nodule; Calf pain; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533; Expiration date was not reported) on the right arm on 30Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic. Medical history included pain and headache. Concomitant medications included paracetamol (TYLENOL ARTHRITIS) for pain; hydrocodone for pain; amitriptyline for headache; and ongoing paracetamol (TYLENOL EXTRA-STRENGTH) for pain. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208; Expiration date was not reported) on the right arm on 11Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 07Apr2021, the patient's doppler showed a blood clot. On 30Mar2021, the patient had a really bad case of diarrhea; swelling in her knee; and leg was swelling/right shoe was tight. On 02Apr2021, the patient had pain behind her cast. On an unspecified date in 2021, the patient's lower extremity venous ultrasound showed right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; was tender on the right leg on the left side of the tibia that was very tender to the touch; had a red mark on her leg with a little nodule; and had calf pain. The events had resulted into an emergency room visit and physician's office visit. The patient had received treatment for the events, 'blood clot', 'lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein', 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'tender on her right leg on the left side of the tibia that was very tender to the touch'. The outcome of the events was recovered on 30Mar2021 for 'really bad case of diarrhea'; was recovering for 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'red mark on her leg with a little nodule'; and was unknown for all the other events.
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| 62 | 2021-04-30 | bruising |
felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell h...
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felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself). This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events. Information on the lot/batch number has been requested.
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| 62 | 2021-04-30 | hives |
hives on face; facial flushing; swelling of lips, tongue and throat; swelling of lips, tongue and th...
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hives on face; facial flushing; swelling of lips, tongue and throat; swelling of lips, tongue and throat; swelling of lips, tongue and throat; known allergy clearly the Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer. A 62-year-old female consumer reported that she received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318) intramuscular into the left arm on 01Apr2021 at 09:00 am (at the age of 62-year-old) at single dose for COVID-19 immunization. Concomitant drugs included vitamins only. Known allergies included all shellfish, Percocet, adhesives on bandages. On 01Apr2021 at 09:15 am the patient experienced facial flushing, hives on face, swelling of lips, tongue and throat. As per reporter the AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient was treated with IV with epi, solu-medrol, prednisone and Benadryl. The patient reported as known allergy 'clearly the Pfizer Covid vaccine'. The patient recovered from the events on an unknown date.
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| 62 | 2021-04-30 | vaccination site rash, vaccination site pain, vaccination site itchiness |
injection site soreness, red rash, itching; injection site soreness, red rash, itching; Injection si...
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injection site soreness, red rash, itching; injection site soreness, red rash, itching; Injection site soreness; This is a spontaneous report from a contactable Healthcare professional (Patient herself). A 62-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9263, Expiration date: Not reported), via an unspecified route of administration on 16Feb2021 03:15 PM at a single dose at her left arm for COVID-19 immunisation. Medical history included high blood pressure. No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included losartan, tocopherol (VITAMIN E), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12), estradiol (YUVAFEM) and replens iron, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced injection site soreness, red rash, itching on 18Feb2021. No treatment received for the adverse event. The patient had not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. Information about batch number has been requested.
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| 62 | 2021-05-06 | rash, rash with redness |
I first felt dizzy and tingling around my lips and mouth about 5-10 minutes after the injection, wai...
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I first felt dizzy and tingling around my lips and mouth about 5-10 minutes after the injection, waited a bit hoping it would go away and when it didn?t we alerted the EMT on site. My lungs sounded ok so I was instructed to go home and take Benadryl. On the way home my tongue began to swell and get a tingling sensation. My cheeks became extremely hot and had a red rash. I ended up having to take two Benadryl to get the symptoms to go away.
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| 63 | 2021-01-01 | itchy skin, rash |
Pt woke up day after vaccine with itchiness on her chest, throughtout the day the itching did not go...
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Pt woke up day after vaccine with itchiness on her chest, throughtout the day the itching did not go away. Woke up Wednesday with rash all over chest area. No rash elsewhere on body. Reported to employee health and was told to take benadryl and if rash continued to contact my primary care provider.
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| 63 | 2021-01-02 | injection site redness, injection site swelling, injection site pruritus |
Two days after vaccinated, injection site became red, swollen, and slightly itchy. Looked like a l...
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Two days after vaccinated, injection site became red, swollen, and slightly itchy. Looked like a large welt. It is getting better today, 1/3/2021.
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| 63 | 2021-01-03 | itchy skin |
Tightness on the chest Blood Pressure was high 185 or 198 Dry Mouth Hard time to breath After 1 ho...
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Tightness on the chest Blood Pressure was high 185 or 198 Dry Mouth Hard time to breath After 1 hour I started itching
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| 63 | 2021-01-04 | rash | Rash in antecubital and hand of same arm the vaccine was given in. |
| 63 | 2021-01-04 | vaccination site redness, vaccination site pain |
significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized i...
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significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized injection site pain and redness; localized injection site pain and redness; This is a spontaneous report from a contactable nurse (patient). This 63-year-old female Nurse reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular at right arm on 17Dec2020 08:30 PM at single dose for COVID-19 immunization. Facility type of vaccine was hospital. Medical history included shingles in Jun2020 after illness that mimicked COVID-19 but all tests came back negative - was sick for 3 weeks; no other chronic health conditions; severe beef/pork allergy - anaphylaxis. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications were not reported. No other vaccine in four weeks. On 18Dec2020 02:00 PM, patient experienced significant fatigue; she slept for 1 hour and temperature was taken when waking up - 101F orally; she slept more; she had localized injection site pain and redness for 3-5 days. No treatment was received for events. It was reported as non-serious. Outcome of events was recovered in Dec2020.
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| 63 | 2021-01-05 | injection site rash, rash |
Pt has a mild rash that covers the injection site and large parts of the chest. Pt advised to take a...
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Pt has a mild rash that covers the injection site and large parts of the chest. Pt advised to take allergy medications
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| 63 | 2021-01-05 | injection site rash, rash | Rash to the site on injection and large parts of the chest |
| 63 | 2021-01-05 | injection site pain | SORE ON RIGHT ARM |
| 63 | 2021-01-05 | injection site reaction |
right mouth drop; right face numbness from eyebrow to below chin with right mouth drop; pins and nee...
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right mouth drop; right face numbness from eyebrow to below chin with right mouth drop; pins and needles feeling at injection site; then ears itching; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK9231), via an unspecified route of administration, on 30Dec2020 at 03:45 AM (at the age of 63-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a workplace clinic and anatomically located on the right arm. Medical history included: History of Guillain Barre in 1970's with Swine Flu Vaccine. Concomitant medications included: clonidine (MANUFACTURER UNKNOWN), hydralazine ((MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took unspecified medications (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced sensitivity to some medications, and unknown if ongoing. On 31Dec2020 04:15 PM, the patient reported "Within 30 minutes of vaccine, I had pins & needle feeling at injection site. Then ears itching followed by right face numbness from eyebrow to below chin with right mouth drop." The patient did not receive any treatment for the events. The clinical outcome of the events pins & needle feeling at injection site, ears itching followed by right face numbness from eyebrow to below chin with right mouth drop, was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the temporal association.
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| 63 | 2021-01-06 | hives, itchy skin, rash |
My trunk area starting itching. I developed a fine rash on chest/ abdominal area. A few hive like we...
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My trunk area starting itching. I developed a fine rash on chest/ abdominal area. A few hive like weals appeared on abdominal area. No other symptoms. I took Benadryl 50 mg . After a while itching subsided. No further issues.
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| 63 | 2021-01-06 | redness, skin irritation |
Temp of 102 with chills and body aches and pains, incision site of left ORIF became red and inflamed...
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Temp of 102 with chills and body aches and pains, incision site of left ORIF became red and inflamed and I had to go to the emergency room where I was given doxycycline b.i.d. for seven days.
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| 63 | 2021-01-06 | hives |
This is a self report: two days after the vaccine I developed severe heart burn ( something I have ...
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This is a self report: two days after the vaccine I developed severe heart burn ( something I have never experienced). Several over the counter medication were used without relief. . The heart burn was followed by a horrible gastric disturbance. I experienced abdominal pain, cramping and rectal pain. During this time my temperature remand between 100.0 - 101.0 with fatigue and malaise. I have also noticed several welts on my body. I?m typically a very health person and have never experienced any of these experiences before.
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| 63 | 2021-01-06 | injection site mass, injection site redness, injection site warmth, injection site pruritus | Vaccine area warm to touch, red and itchy. lump is size of width of orange. |
| 63 | 2021-01-06 | injection site pain, injection site reaction |
Within 8 hours of vaccine receipt, I began to experience left-sided tinnitus. During the first vacci...
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Within 8 hours of vaccine receipt, I began to experience left-sided tinnitus. During the first vaccination; I experienced muscle soreness at the site of injection; mild fatigue the next day (12/14/2020). After the second vaccine, I experienced increased muscle pain, with decreased ROM of the left shoulder due to pain. Within 12 hours, I experienced diffuse myalgias. After 16 hours, I experienced a fever (101F) with chills (resolved within 24 hours). There was significant fatigue the first 36 hours after the second vaccine administration. I took two doses of Tylenol on the first day. No rash.
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| 63 | 2021-01-07 | hives, itchy skin |
Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her...
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Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; This is a spontaneous report from a contactable Health Care Professional (patient). A 63-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK572) in the left arm, on 21Dec2020 at 11:30 AM, at single dose, for COVID-19 immunisation. COVID-19 vaccine was administered at hospital. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks and 2 weeks prior to the BNT162B2 vaccine. The patient experienced in the past an allergy due to amoxicillin. On an unspecified date, the patient experienced hives from her head to her toes, intense itching, painful, swollen ears, swollen lip. Emergency room/department or urgent care required. Treatment was received: prednisone 60 mg for 5 days. The patient recovered from the events on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid test post vaccination (nasal swab) was performed on 25Dec2020 and the result was negative. The case was assessed as non-serious.
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| 63 | 2021-01-07 | vaccination site pain |
Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the i...
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Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the injection arm; Her arm was stiff feeling; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL0140), intramuscular on 18Dec2020 15:00 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The transferring agent stated that she has a caller on the line that received the first dose of the Covid-19 vaccine on 18Dec2020. She is supposed to get the second dose tomorrow 06Jan2021. She developed a urinary tract infection over new years and was put on antibiotics. She wanted to know if she could get the second dose while on antibiotics. The transferring agent stated that the caller reported that she started feeling achy and had a headache, but did not think it was related to the shot. She stated that she had injection site pain and was sore on the injection arm. She had the shot late in the afternoon around 15:00 on 18Dec2020. She said that she was sore later on that evening at the injection site and her arm was stiff feeling the next day, but it was resolved by the day after. She said that the headache came and went. She treated it with Tylenol. She said that she did not feel real good most of the day on Saturday 19Dec2020, but by Sunday she was back to normal again. The outcome of the event Urinary tract infection was unknown while the outcome of the other events was resolved on 20Dec2020.
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| 63 | 2021-01-08 | injection site pain |
Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taki...
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Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. I am awaiting an appointment with my primary care physician and will know then if more treatment will be recommended. Incident Report filed at the hospital.
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| 63 | 2021-01-09 | injection site pain |
Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine...
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Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine was administered. The tachycardia resolved without medical intervention within 2 minutes. The remainder of the symptoms remained the rest of the day, along with profound fatigue and intermittent self limited tachycardia. The headache was managed with Tylenol. I slept most of the day and through the night. The following day, I had a headache, which was mild. Fatigue remained. I also noted intermittent tachycardia with mild exertion, self limited, less than 1 minute. Mild soreness at injection site.
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| 63 | 2021-01-09 | redness |
Patient woke up Saturday am and right foot felt like it was sprained, painful at ankle joint, slight...
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Patient woke up Saturday am and right foot felt like it was sprained, painful at ankle joint, slightly red. Sunday morning, she could not put any weight on right foot, more red/all toes red (except one), redness is traveling down right big toe, right foot appears slightly swollen.
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| 63 | 2021-01-10 | hives |
On 1/9 /21, after walking 5 miles and taking a hot shower I had large welts that were red on the in...
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On 1/9 /21, after walking 5 miles and taking a hot shower I had large welts that were red on the inside of both thighs. Within 1 hour they were gone and did not return.
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| 63 | 2021-01-10 | injection site swelling, injection site redness | Redness and swelling at site |
| 63 | 2021-01-10 | itchy skin |
complained of vague complete LEFT arm Itching with NO others symptoms ; vitals stable; refused furth...
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complained of vague complete LEFT arm Itching with NO others symptoms ; vitals stable; refused further treatment; itching completely resolved on it's own in the next ten minutes and pt. left to go home.
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| 63 | 2021-01-10 | rash macular | large dark spot under lash line of lower eye, then 48 hours after small white bumps in dark spot. |
| 63 | 2021-01-11 | injection site redness |
After receiving second covid vaccine, injection site is red with a circle larger than 2 inches (4 by...
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After receiving second covid vaccine, injection site is red with a circle larger than 2 inches (4 by 6 inches). Symptoms include runny nose, headache, fever and are ongoing since vaccine. Have not visited healthcare professional yet.
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| 63 | 2021-01-11 | hives | Hives on neck and shoulder |
| 63 | 2021-01-11 | itchy skin, cellulitis | I asked patient to send me information when she finds it. |
| 63 | 2021-01-11 | redness |
I received my second vaccine uneventfully and approx. 2 1/2 days later I developed a painfully and s...
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I received my second vaccine uneventfully and approx. 2 1/2 days later I developed a painfully and swollen lower lip , and then it had severe erythema , pain and ulceration . I have never had a cold sore in my life, or shingles . I did receive the chicken pox vaccine in my 30's
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| 63 | 2021-01-11 | injection site redness, injection site bruising, injection site pain |
Large Erythematous area at injection site. Tender and bruising noted Low grade fever. General not fe...
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Large Erythematous area at injection site. Tender and bruising noted Low grade fever. General not feeling well
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| 63 | 2021-01-11 | vaccination site pain |
Soreness injection site; The initial case was missing the following minimum criteria: unspecified pr...
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Soreness injection site; The initial case was missing the following minimum criteria: unspecified product and adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the arm on 23Dec2020 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy and anaphylaxis to a penicillin type drug. The patient's concomitant medications were not reported. The patient previously took ampicillin (MANUFACTURER UNKNOWN) from an unknown date to an unknown date for an unknown indication and experienced drug allergy. On 23Dec2020, the patient experienced soreness at injection site. The patient did not receive any treatment for the event. The clinical outcome of the soreness at injection site was recovered in Dec2020 after about 48 hours. The reporter considered that there was a reasonable possibility that the soreness at the injection site was related to the vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 63 | 2021-01-12 | redness | Facial, ear, and neck redness and swelling, Throat tightened, tongue started to swell |
| 63 | 2021-01-12 | injection site swelling |
I developed a swelling in the right axilla, not a discrete node, but what felt like an accumulation ...
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I developed a swelling in the right axilla, not a discrete node, but what felt like an accumulation of fluid - lymph perhaps - about the size of a large lemon.
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| 63 | 2021-01-12 | injection site pain, injection site swelling |
Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors ...
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Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors to all extremities (for about 10 mins) and chills the night after getting the vaccine. tongue numbness happens to her at baseline at times, this has subsided The tremors started after stretching her arms, they stopped shaking after about 10 mins after she laid in bed. Temp was about 100-101.2 through the night Has not taken any medications for this.
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| 63 | 2021-01-12 | injection site pain |
temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both leg...
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temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both legs; aching all over and headache and body aches ; fatigue and extreme muscle tenderness in left arm (site of injection) Temp remained at above 100.0 even with Tylenol and headache and body aches until 9:00pm. Woke up on 1/13/2021 with only symptoms being sore arm; slight headache and muscle tightness in neck.
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| 63 | 2021-01-13 | redness | Developed DVT in left leg around January 9. Developed pain, redness and swelling in left calf |
| 63 | 2021-01-13 | hives, bruising, itchy skin |
Developed fever and headache then later developed hives, itching, and bruising. Already taking Zyrte...
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Developed fever and headache then later developed hives, itching, and bruising. Already taking Zyrtec daily. Began taking famotidine daily. Required Benadryl on 1/11/21 but still has hives as of 1/11/21.
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| 63 | 2021-01-13 | injection site pain |
Initially muscle soreness at injection site. At 12 hours headache began. During the night body aches...
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Initially muscle soreness at injection site. At 12 hours headache began. During the night body aches and restless sleep, bad dreams. Next day headache, significant fatigue and body aches. Emotional feelings like I wanted to fry ( I am not a crier). 2 Nd night restless sleep, bad dreams, headache. Next day brain fog and significant dizziness and vertigo.
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| 63 | 2021-01-14 | redness, skin warm | Left arm severe pain, swelling, redness, and hot to touch |
| 63 | 2021-01-15 | redness, itchy skin, hives |
On Friday, January 15 at approximately 6 PM while seated in a reclining chair watching television I ...
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On Friday, January 15 at approximately 6 PM while seated in a reclining chair watching television I started to develop hives below my right gluteal fold. Over the next six hours approximately 300 hives appeared on my skin. They were very itchy. At approximately midnight my lip began to swell and being a certified registered nurse anesthetist, who lives alone, I knew it was time to head to the ER. Prior to going to the ER I cleaned the lesions With alcohol, took prednisone 10 mg PO, and applied hydrocortisone cream. In the ER, I was given Benadryl 50 mg PO and Pepcid 20 mg and observed for one hour. The hives remained but there was no respiratory compromise. Approximately six hours later the hives were still increasing in size and number, were unbearably itchy and my swollen lips had not subsided. I took Claritin 10 mg PO and returned to the same ER and was given Epinephrine 0.3 mg IM, prednisone 20 mg po and observed for three hours. The hives did not decrease and again there was no respiratory compromise so I was sent home on prednisone And a H-1 blocker. Of note, both my palms and lips have been bright cherry red. I finished a five day course of Macrobid on January 13 at 10 AM. Final diagnosis: Alergic reaction
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| 63 | 2021-01-16 | injection site rash, itchy rash, hives |
One and a half days after inoculation, itchy rash appeared on abdomen around naval area and at inje...
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One and a half days after inoculation, itchy rash appeared on abdomen around naval area and at injection site . This lasted a couple days. Then on day 4 after vaccine, hives appeared on upper legs , then migratory hives and urticaria all over most of my body. Improvement but not completely resolved after 7 days.
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| 63 | 2021-01-16 | rash, redness |
Swollen lips started on 1/16 Redness, rash. on face noticed on 1/17 in am upon waking up. Swollen l...
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Swollen lips started on 1/16 Redness, rash. on face noticed on 1/17 in am upon waking up. Swollen lips continues.
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| 63 | 2021-01-17 | injection site pain, injection site swelling | 1/12 vaccination 1/13 swelling and pain at injection site. Admitted for 4 days. |
| 63 | 2021-01-17 | redness, vaccination site swelling, vaccination site pain |
Fatigue; low grade fever; reddening on her face on the nasal labial area or smile line area; a very ...
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Fatigue; low grade fever; reddening on her face on the nasal labial area or smile line area; a very sore left arm for a day; a very sore left arm for a day and swelled up a little; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the left arm on 19Dec2020 16:15 at SINGLE DOSE for COVID-19 immunization at the hospital. It was reported that the patient was menopausal. Ongoing medical histories included gastrooesophageal reflux disease (GERD), iron deficiency (reported as iron supplementation), sinus disorder, hypersensitivity; and hair disorder, nail disorder and immune system disorder (reported as help with hair and nail and immune system). Ongoing concomitant medications included fexofenadine hydrochloride (ALLEGRA) since unknown date (reported as taking for a year) for sinus and allergies, calcium (CALCIUM) since unknown date (reported as taking for a year) for menopause, famotidine (FAMOTIDINE) since unknown date (reported as taking for a year) for GERD, cyanocobalamin (VITAMIN B12) since unknown date (reported as taking for a year) to help with hair and nail and immune system, colecalciferol (VITAMIN D 3) since unknown date (reported as taking for a year or two) for menopause and multivitamin since unknown date (taking for 5 years at least). The patient received the first dose of the Pfizer COVID 19 vaccine on 19Dec2020 at 1615PM in the left arm. She then reported of a very sore left arm for a day and it swelled up a little on that same day. She then felt some fatigue a little the next day (20Dec2020) on Sunday but it didn't prevent her from going to work. On 20Dec2020 to 21Dec2020 (Sunday to Monday), she noticed a low-grade fever for a maybe 12 hours but she couldn't find a thermometer and doesn't know her temperature. She also developed a reddening on her face on the nasal labial area or smile line area but not very pronounced on 20Dec2020 (noticed it for about 8 to 12 hours). All of her symptoms resolved by the 21Dec2020. The events does require a visit to physician office or emergency room (ER).
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| 63 | 2021-01-19 | itchy skin | Itchy skin, throat swelling. Resolved with benadryl. |
| 63 | 2021-01-19 | injection site warmth, injection site pruritus, injection site swelling, injection site redness |
redness, itching swelling, warmth at site, muscle aches, fatigue evaluated by MD, tx with pepcid, Ty...
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redness, itching swelling, warmth at site, muscle aches, fatigue evaluated by MD, tx with pepcid, Tylenol, Claritin,Zyrtec began 01/19/2021 with mild relief
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| 63 | 2021-01-20 | injection site pain | Pain at injection site, headache, chills muscle aches, joint pain, restless |
| 63 | 2021-01-20 | injection site pain, injection site warmth, injection site redness, injection site hardening |
The following day after patient received 2nd dose of Pfizer vaccine, the area around the injection w...
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The following day after patient received 2nd dose of Pfizer vaccine, the area around the injection was light red, warm to touch and painful. The area was approximately 2.5 inches around. On Sunday 1/10 it was bright red, indurated, hot to the touch and much more painful. It was also painful to move his arm. On 1/13, the injection site was still tender to the touch and his shoulder area was sore with movement. Over the next couple of days his shoulder into his bicep had a dull ache and was very painful to any pushing, pulling or weight bearing. Ibuprofen did help but did not relieve it. On 1/17 patient went to a local urgent care because at that point it was even difficult to sleep due to pain. They diagnosed him with bursitis of the left shoulder due to SIRVA. He was started on a steroid pack and today, day 2 of steroids it feels slightly less painful.
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| 63 | 2021-01-20 | itchy skin |
itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight ...
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itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight band around chest.; sense the she couldn't get a good breath; pulse of 101-129; she had tinnitus, and she noticed that both injections made that worse; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176/expiration date) dose number 2 intramuscularly on 08Jan2021 11:45 at a single dose on the left arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included severe allergic reaction to pecans and tinnitus. Historical vaccine included BNT162B2 on 18Dec2020 (dose number 1, intramuscularly on the left arm) for COVID-19 immunization. The patient experienced tinnitus, sinus infection, and stuffy head after the first dose. No other vaccines were administered within 4 weeks and no other medications were taken within 2 weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post-vaccination. On 08Jan2021, after the 2nd dose, the patient experienced itching across shoulders/back of neck and sl nausea. She took Benadryl which relieved the itching. She went to bed and had onset of body aches, chills, and sense the she couldn't get a good breath. She felt like there was a tight band around chest. Her O2 Sat was 95% - 98%, with pulse of 101-129, T max was 101.8. The symptoms were lasting about 6 hours. In the morning, the patient took Aleve and Benadryl. Most symptoms were alleviated. She took those meds scheduled for 48 hrs. She noticed that if she tried to push past scheduled time, the itching started to return, so she just kept the meds scheduled for 48 hours. No other symptoms after that. She added that she had tinnitus, and she noticed that both injections made that worse. It was not yet subsiding since last injection. The patient also received Tylenol for the events. The outcome of the events was recovered in Jan2021.
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| 63 | 2021-01-21 | injection site pain, injection site redness, injection site warmth |
Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, cou...
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Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, couldn?t get warm. Got worse during the night. Couldn?t go to work the next day due to body aches, arm soreness, extreme tiredness. Slept almost all day 1-19-21. Spiked low grade fever during the night. Worked 1-20-21, but extremely sleepy. Injection site got hot and red. Slept 12 hours that night. Went to work 1-21-21 feeling good, just still a little arm soreness.
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| 63 | 2021-01-21 | rash | Developed rash |
| 63 | 2021-01-21 | injection site pain |
Diarrhea, nausea, abdominal discomfort, injection sight was very sore. Anti- diarrhea over the coun...
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Diarrhea, nausea, abdominal discomfort, injection sight was very sore. Anti- diarrhea over the count medication taken. Bed rest for 2 days.
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| 63 | 2021-01-21 | injection site pruritus, itchy skin, injection site warmth, skin warm, injection site redness |
Itching on the left arm near the site of the injection. area covered over 3-4 inches in length to 2 ...
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Itching on the left arm near the site of the injection. area covered over 3-4 inches in length to 2 inches in width. red and hot. Notice on 1-21-21 around 10pm, could not find my anti itch cream to apply to site. Next day on 1-22-21 notice it again around 11 am it was red and hot to touch. Itching again. but I would not scratch it . Finally found the anti itch cream and applied this to the area. An hour later it was still hot but seemed to look better. Still trying to get to the hospital Clinic to have it checked out.....
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| 63 | 2021-01-21 | hives |
hives covering entire body including soft palate, headache, body aches, stiff joints, fatigue Depo ...
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hives covering entire body including soft palate, headache, body aches, stiff joints, fatigue Depo medrol injection, Prednisone 20 mg/day X 4 days; Zyrtec X 12 days, Benadryl X 12 days
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| 63 | 2021-01-24 | itchy rash, rash, rash papular |
Caller states she received her vaccines 9 days ago. 2 days ago she developed a rash under her right ...
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Caller states she received her vaccines 9 days ago. 2 days ago she developed a rash under her right arm that is described as fine bumps that are itchy. The rash has now spread to both thighs. She denies other symptoms. She is going to call her PCP for appointment or instructions.
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| 63 | 2021-01-24 | pain of skin |
Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extr...
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Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extreme pain lasted from 0140- 0500, but continued with the skin tenderness, chills, headache and joint pain. Took Tylenol. Got up once and thought I would pass out. Started resting some around 7am. Drank plenty of fluids. Drained all day. Saturday morning headache, nasal congestion, joint pain, hard to get out of bed. Drained all day. Sunday feeling better, but lethargic. Monday back to work.
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| 63 | 2021-01-24 | injection site pain, rash |
Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, s...
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Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, swollen lymph nodes, difficulty breathing, swelling of face, fast hearbeat, bad rash , dizziness and weakness, intestinal pain. All symptoms lasted 18 days. Was given prescription medication for symptoms by primary care doctor.
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| 63 | 2021-01-24 | rash |
Nausea 2 days, headache 3 days, aches 5 days, fever one day (100.2), sniffles with clear drainage, r...
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Nausea 2 days, headache 3 days, aches 5 days, fever one day (100.2), sniffles with clear drainage, rash over right eye across inter canthus to lower lid, redness inner right eye, and slight rash right nose.
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| 63 | 2021-01-24 | rash, itchy skin |
right arm sore, 3 days later right arm and hand starting swelling and developed rash with itching, ...
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right arm sore, 3 days later right arm and hand starting swelling and developed rash with itching, also left hand swelled, with rash and itching. Next day woke up with sore throat and headache, and fatigue. went to primary care doctor was put on prednisone, symptoms lasted for 10 days.
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| 63 | 2021-01-25 | vaccination site pain |
Arm pain at site; Fatigue; Nausea; Body aches; This is a spontaneous report from a contactable nurse...
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Arm pain at site; Fatigue; Nausea; Body aches; This is a spontaneous report from a contactable nurse reported for herself. This 63-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Et1685) intramuscular on 11Jan2021 13:15 at single dose for an COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included atenolol Atenolol, Losartan, Calcium, plantago ovata (METAMUCIL), bifidobacterium lactis (PROBIOTIC). Patient received the first dose of BNT162B2 intramuscular in left arm on 21Dec2020 03:30 PM. No other vaccine in four weeks. On 12Jan2021, the patient experienced Arm pain at site, Fatigue, Nausea, Body aches. No treatment received. The outcome of events was not recovered.
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| 63 | 2021-01-25 | vaccination site pain |
Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days...
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Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days; Migraine headache on day 6.; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 30Dec2020 at 11:00 A.M., at a single dose, for COVID-19 immunization. Relevant medical history included high blood pressure (BP), seasonal allergies, migraine, asthma, right sided hearing loss. The patient was taking unspecified concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 01Jan2021, at 8:00 A.M., the patient experienced soreness at injection site for 72 hours. On day 3, the patient had low grade fever 99.6. On an unspecified date in Jan2021, the patient had gastrointestinal (GI) upset for 3 days. On day 6, the patient experienced migraine headache. The patient did not receive therapy for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
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| 63 | 2021-01-26 | rash |
I began breaking out in a rash on the right side of my face. Thinking it was the mask I had worn. ...
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I began breaking out in a rash on the right side of my face. Thinking it was the mask I had worn. Now the rash all over my face and chest
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| 63 | 2021-01-27 | injection site swelling, injection site pain, injection site vesicles, injection site redness |
2 days after 2nd dose, when bandaid removed, skin was broken on approx quarter-sized blister at inje...
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2 days after 2nd dose, when bandaid removed, skin was broken on approx quarter-sized blister at injection site. Large amt (sleeve wet & serous fluid dripped down arm) serous fluid drained. Add'l pea-sized, intact, fluid filled blister present beneath 1st blister. Non-intact blister continues to weep am. amt. Serous fluid 12 hrs later. Injection site mildly reddened and swollen. Arm sore, but no excessive pain.
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| 63 | 2021-01-27 | injection site rash, itchy rash |
2 days after the injection she developed an itchy rash around the injection site. Symptoms are impro...
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2 days after the injection she developed an itchy rash around the injection site. Symptoms are improving.
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| 63 | 2021-01-28 | shingles, rash |
1. Patient had sudden bilateral thigh rash ( vasculitic like, bright red, softball sized) that she n...
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1. Patient had sudden bilateral thigh rash ( vasculitic like, bright red, softball sized) that she noticed 2 hours after vaccination, and lasted for another 3 hours then went away without intervention. 2. Patient had shingles flare on Left Maxillary branch, starting 2 days after (1/10/2021). She took acyclovir for one week (800mg five times daily). After four days of completing this antiviral course, she had a left mandibular distribution of shingles sensation, was placed on a week of valacyclovir 1 gm TID.
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| 63 | 2021-01-28 | skin tightness |
8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest...
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8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-01-28 | redness, hives, skin warm |
My face got red and warm. A single hive developed on my left jaw. After a few minutes later my thr...
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My face got red and warm. A single hive developed on my left jaw. After a few minutes later my throat and tongue started to feel numb like I had gone to the dentist and gotten a novacaine shot. We went to a pharmacy immediately and got some Bennedryl which took the symptoms away within the hour.
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| 63 | 2021-01-28 | rash, redness |
Redness, rash on face and neck; Redness, rash on face and neck; Redness, rash on face and neck; Redn...
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Redness, rash on face and neck; Redness, rash on face and neck; Redness, rash on face and neck; Redness, rash on face and neck; Swelling of lips; This is a spontaneous report from a contactable pharmacist (patient) reported for herself. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) intramuscularly at right arm on 12Jan2021 at 11:45 AM for COVID-19 immunization. Medical history included known allergies included amoxicillin, cephalosporins, sulfa, griseofulvin, unknown excipient in a generic ibuprofen. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) intramuscularly at left arm on 21Dec2020, at 11:00 AM for COVID-19 immunization. No other medical history. No other vaccine in four weeks. Other medications in two weeks included multivitamin, fish oil (OMEGA FISH OIL), and collagen tablets. Facility type vaccine was at hospital. The patient was not pregnant. The patient received adverse events included swelling of lips started on 16Jan2021 at 02:00 AM (4 days post vaccine), redness, rash on face and neck started on 17Jan2021, with continued swelling of lips. AE resulted in doctor or other healthcare professional office/clinic visit. Treatment received for events included instructed to take cetirizine hydrochloride (ZYRTEC) 10 mg 2 times a day plus diphenhydramine hydrochloride (BENADRYL) at night. The outcome of event swelling of lips was not resolved, and of other events was unknown. No covid prior vaccination. No covid tested post vaccination.
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| 63 | 2021-01-28 | vaccination site pain, sensitive skin |
heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing h...
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heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing heaviness in chest/Shortness of breath; difficulty breathing heaviness in chest/ heaviness in chest with right flank pain; Chills; Sensitive skin; Super Thirsty; Fever 100.7/Low grade fever 99.9/ Low grade fever 99.0; Joint Pain; Congestion; Right arm injection site severe pain; This is a spontaneous report from a contactable other healthcare professional (Patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 06Jan2021 10:30 at single dose in Right arm for COVID-19 immunization. Medical history included hypertension. Concomitant medication included benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ, 10-12.5 MG Tablet), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER). The patient previously took codeine and experienced allergy. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient did not have covid-19 tested post vaccination. On 06Jan2021 20:00, the patient experienced Fever 100.7, Joint Pain, Congestion, Right arm injection site severe pain. On 07Jan2021, the patient experienced Chills, Fever 100.7, Sensitive skin, Super Thirsty. On 08Jan2021, the patient had Temperature 98.8, No Chills, Thirsty. On 09Jan2021, the patient was Some relief, no fever, no chills, no joint pain. On 10Jan2021, the patient experienced low grade fever 99.9, Pulse oximeter 89%, difficulty breathing heaviness in chest. On 11Jan2021, oxygen was 92%, Low grade fever 99.0. On 12Jan2021, vital signs stable no fever 97.7, oxygen 96%. On 13Jan2021, Vital Signs stable. On 14Jan2021, the patient experienced Shortness of breath, heaviness in chest with right flank pain, lots of phlegm, Temperature 98.0, Oximeter 96%. Coricidin HBP taken to relieve Congestion. Therapeutic measures were taken as a result of all reported events. The outcome of event chills was recovered on 08Jan2021, outcome of event Fever (event onset date: 06Jan2021 20:00) was recovered on 09Jan2021, outcome of event Low grade fever (event onset date: 10Jan2021) was recovered on 12Jan2021, outcome of event Joint Pain was recovered in Jan2021. The outcome of the other events was recovering.
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| 63 | 2021-01-29 | skin warm |
10 hours after my vaccine I got a rush of heat to my feet...felt like they were swelling. Tingling &...
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10 hours after my vaccine I got a rush of heat to my feet...felt like they were swelling. Tingling & numbness followed & also went to my hands. 9 days later I still have some residual tingling, mostly in my feet.
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| 63 | 2021-01-29 | itchy skin |
Itchiness in arms and shins, 50mg of Benadryl given orally. Symptoms improved, no new symptoms devel...
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Itchiness in arms and shins, 50mg of Benadryl given orally. Symptoms improved, no new symptoms developed.
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| 63 | 2021-01-29 | itchy skin, hives |
The employee received 1st dose of Pfizer Covid-19 vaccine at 14:00 pm 1/28/2021. About 5 minutes af...
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The employee received 1st dose of Pfizer Covid-19 vaccine at 14:00 pm 1/28/2021. About 5 minutes after receiving the injection, she felt itchiness of the ears, facial flushing and developed neck hives. She was taken to the MSB emergency room, where she was closely monitored. There, she was given dexamethasone 6 mg IM once, diphenhydramine 50 mg orally and famotidine 20 mg orally once. After about 2 hours of observation, he was discharged home on the following: prednisone 40 mg orally daily and diphenhydramine 25 mg q8h PRN.
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| 63 | 2021-01-30 | pain of skin, itchy skin |
Adverse effects not common. Skin itchy, skin sore , raw feeling, all over body...No rash or red...
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Adverse effects not common. Skin itchy, skin sore , raw feeling, all over body...No rash or redness. Started eve of vaccine. For 2 days now / present
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| 63 | 2021-01-31 | injection site redness |
2:30 AM 1/30/21 chills, skin sensitive to touch, fever, extreme headaches, dizziness, nausea, redne...
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2:30 AM 1/30/21 chills, skin sensitive to touch, fever, extreme headaches, dizziness, nausea, redness at site of injection
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| 63 | 2021-01-31 | vaccination site pain |
Sore arm at injection site; Sore arm at injection site; This is a spontaneous report from a contacta...
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Sore arm at injection site; Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL1284), via an unspecified route of administration in the left arm on 13Jan2021 at 18:30 as a single dose for COVID-19 immunization. Medical history included Sjogren's Syndrome, connective tissue disorder, high blood pressure, was pre-diabetic, and had a known allergy to penicillin. The patient had other medications in two weeks (unspecified). The patient was not pregnant, had no other vaccines in four weeks, and did not have COVID prior to the vaccination. The patient experienced sore arm at injection site on 13Jan2021 at 21:00. The patient did not receive any treatment for the events. She was not COVID tested post-vaccination. Outcome of the event was recovered.
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| 63 | 2021-01-31 | injection site tingling |
The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions...
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The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions and some tingling at the injection site about 30 minutes after vaccine. Around 9:00 pm I started feeling weak and muscle aches all over, so went to bed. Around 2:00 am on 1/31/21 I woke up in pain all over my body muscle ache, headache, and difficulty walking. Took temperature 99 and my average temp is 97.9. I took one extra strength Tylenol. On 01/31/21 I just felt bad all day felt like COVID symptoms but no breathing difficulties just bad headache all day, weakness, entire left side my body left arm, left side chest, left leg hurt worse than right side. I?ve just treated with extra strength Tylenol and rest. Last night temperature was still 99, but sleep through the night. Today, February 1 still weak, ache all over, mild headache, and some pain on my left side body. I have not sought emergency treatment as if the date/time of report. I?m a healthcare worker taking today and tomorrow off work to recover.
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| 63 | 2021-01-31 | itchy skin | itching 3-4 days tremors, weakness |
| 63 | 2021-02-01 | injection site redness, injection site pruritus, injection site pain, injection site hardening |
Hard lump (golf ball size) to right of injection site, accompanied by circle red patch about 2" in d...
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Hard lump (golf ball size) to right of injection site, accompanied by circle red patch about 2" in diameter. Reporting this because I was the only one in our group that I know had this reaction. Pain is minimal, not more than expected but the readness and hard lump is what is unusual. I've travelled abroad and had a variety of vaccines. This is the first reaction of this type. Redness and hardness is subsiding by day 4 and now my arm just really itches in that spot. Reporting not because of concern but just to help with research.
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| 63 | 2021-02-01 | rash, itchy skin |
Pt began complaining of itching and tingling. Made contact with patient and within a few minutes she...
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Pt began complaining of itching and tingling. Made contact with patient and within a few minutes she developed a rash and difficulty breathing
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| 63 | 2021-02-03 | itchy skin, rash |
1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,...
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1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,nausea,chills 4th day - headache, chills and feeling hot, nausea,skin rash , itching, tired,aches 5th day - headache,chills and feeling hot, nausea,rash and uncontrollable itching, tired.
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| 63 | 2021-02-03 | injection site pain | Sore arm at injection site, no treatment, resolved in 24 hours |
| 63 | 2021-02-03 | rash, hives |
hives and rash on arm, patient was alarmed, went and hid in the kitchen, was concerned tablets would...
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hives and rash on arm, patient was alarmed, went and hid in the kitchen, was concerned tablets wouldn't work so gave Benadryl 50mg
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| 63 | 2021-02-03 | vaccination site pain |
muscle aches and discomfort; muscle aches and discomfort; pain was at the injection site; This is a ...
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muscle aches and discomfort; muscle aches and discomfort; pain was at the injection site; This is a spontaneous report via a Pfizer-sponsored program from a contactable nurse (reporting for herself). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), intramuscular in the left arm on 02Jan2021 at a single dose for COVID-19 immunization. Medical history was reported none. The patient's concomitant medications were not reported. The patient previously received the flu vaccine on unspecified date and experienced discomfort. On 02Jan2021, the patient experienced pain at injection site. On 03Jan2021, the patient experienced muscle aches and discomfort. The patient was scheduled for the second dose of the COVID-19 vaccine and reported that she took Aleve after she got the first vaccine and was wondering if she can take Aleve after the second one. She stated that it helped with the pain. She said that she was getting conflicting information and stated that she heard that there have been more symptoms associated with the second vaccine. She wanted to know if it was contraindicated for her to take the Aleve after getting the second dose. The patient described it as discomfort and stated that she gets it with the flu vaccine too. Aleve helped with the discomfort and the ache. She did not pre-medicate. She took it afterward. She stated that she took maybe 1-2 doses of the Aleve the next day and stated that by the end of the next day her pain was fine. The patient clarified pain was at the injection site and was achy. She said that she received the first vaccine on 02Jan2021 in the morning. She noticed the pain later in the day around midafternoon and said that it was gone by the next day. The outcome of the event pain at injection site was recovered on 03Jan2021 while outcome of muscle aches and discomfort was recovered on unspecified date in Jan2021.
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| 63 | 2021-02-04 | hives | Hives, angioedema, tongue swelling. |
| 63 | 2021-02-04 | rash papular, itchy rash, rash, injection site swelling, injection site redness, rash with redness |
Individual received the 1st dose of the Pfizer COVID vaccine on 12/ 22/20.On the first week of Janua...
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Individual received the 1st dose of the Pfizer COVID vaccine on 12/ 22/20.On the first week of January 2021 she developed left neck and supraclavicular lymphadenopathy. CT scan on 1/13/21revealed multiple lymphadenopathy over the left supraclavicular area. Excisional biopsy of deep neck supraclavicular lymph nodes on 1/20/21. Surgical pathology revealed overall finding most consistent with a reactive lymphoid hyperplasia, etiology unknown. She received her 2nd Pfizer COVID vaccine on 1/12/21. She had slight redness/swelling of her left arm two to three days after vaccine. She developed red, raised itching rash on her trunk on 1/30/21. Rash continues as of today 2/5/21.
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| 63 | 2021-02-04 | injection site pain, injection site swelling |
Soreness and swelling at site of injection 4 hrs after injection Chills one day after vaccine Jo...
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Soreness and swelling at site of injection 4 hrs after injection Chills one day after vaccine Joint pain one day after vaccine Fatigue one day after vaccine Foggy, light headed feeling one day after vaccine Headache and fatigue day 2 after vaccine
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| 63 | 2021-02-05 | itchy skin |
Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hour...
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Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hours I began to notice itching. My back, neck, legs, arms. Begins once my zyrtec wears off around 7:30 pm I always take and antihistamine to keep my nose clear for better sleep. All nighttime meds are take at 8- 8:30 pm. Must take ativan to control anxiety and help get to sleep
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| 63 | 2021-02-05 | injection site pain |
Injection site pain started 6 hours after shot. 18 hrs after shot total body aches, fever, headache ...
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Injection site pain started 6 hours after shot. 18 hrs after shot total body aches, fever, headache lasting 16 hrs.
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| 63 | 2021-02-05 | itchy skin |
its been 7 days now and am just getting sicker from then shot itching has increased and now have hem...
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its been 7 days now and am just getting sicker from then shot itching has increased and now have hematomas on my body. lungs fill heavy and headaches gotten more painful and i fell like my brain is not right. and diarrhea with pain in lower abdomen . I do not think i should be getting the second shot. I do not have a doctor and cant afford to go to er. I send you information of the first 5 days but do not have that report number.
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| 63 | 2021-02-06 | rash |
Patient started complaining of tongue swelling, same as when she had an anaphylatic reaction to stra...
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Patient started complaining of tongue swelling, same as when she had an anaphylatic reaction to strawberries. Patient was given 1 epi pen at 11:07am in the left thigh at the clinic. EMS transport Patient is a 63 y/o F with h/o environmental allergies and asthma who presents to the ED via EMS for evaluation of an allergic rxn that began at 1030 today. Pt was at hospital and had just received her first COVID vaccine when she developed a facial rash and swelling to her tongue and throat. She also c/o dizziness. She was given Epi, Solumedrol, and Benadryl via EMS with improvement. Pt currently receives an allergy shot monthly for tx of her environmental allergies. She has never used an Epi pen previously. Pt denies fever.
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| 63 | 2021-02-06 | itchy skin | Thick Tongue, itching face, head, arms legs, increased temperature, headache, muscle pain |
| 63 | 2021-02-07 | injection site pain, itchy skin, rash |
I had pain at the injection site initially and it increased on day 2. Also on day 2, I saw a small r...
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I had pain at the injection site initially and it increased on day 2. Also on day 2, I saw a small rash after showering. The muscle pain has de erased, but the injection site is very tender and the rash has spread down my arm about 2-3 inches. Today, day 5, the rash is slightly itchy. On day 2, I had chills, body aches, joint pain and a headache. All symptoms were gone within 48 hours with the exception of the headache. The headache lasted until day 5.
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| 63 | 2021-02-07 | hives, redness |
My face started feeling very hot / feeling warm; my arms were looking mottled; first got hives under...
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My face started feeling very hot / feeling warm; my arms were looking mottled; first got hives under my neck on the left side and then it traveled to the tight side of my neck/ had hives on my arms legs neck chest and back; within 5 more minutes my neck was red / my face started getting red; This is a spontaneous report from a contactable Health Professional, the patient. A 63-year-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3242), via intramuscular route in the left arm on 22Jan2021 17:00 (at the age of 63-years) as a single dose for COVID-19 immunization. Medical history included Thyroid -Hashimoto's thyroiditis, Penicillin allergy, Brussels sprouts and avocados allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine and ibuprofen (ADVIL). The patient previously took erythromycin and experienced allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 22Jan2021 at 17:15, after approximately 10 minutes of receiving vaccination, the patient started feeling warm, she noticed her arms were looking mottled and she went to the nurse. She first got hives under her neck on the left side and then it traveled to the tight side of my neck. Within 5 more minutes her neck was red, and her face had started feeling very hot. Her face started getting red. The patient was taken to the emergency room and she had hives on her arms, legs, neck, chest, and back. The patient was treated for feeling very hot, arms mottled, hives, and neck and face red with intravenous (IV) Benadryl 50mg with Famotidine IV and saline solution IV. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event for feeling very hot, arms mottled, hives, and neck and face red were recovered in Jan2021; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events is possible . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-02-07 | itchy skin, vaccination site swelling, redness | Red, swollen and itchy where I got the vaccine |
| 63 | 2021-02-08 | injection site redness, injection site rash, injection site pruritus | COVID-19 arm, rash, redness, itchiness at injection site. Fever x 3 days. |
| 63 | 2021-02-08 | redness | Redness around mouth/face |
| 63 | 2021-02-09 | hives |
I had a light presentation of hives. The locations of the hives were in the crease of my right arm (...
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I had a light presentation of hives. The locations of the hives were in the crease of my right arm (elbow area), torso (tummy area), top of foot and ankles.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number: ELI283), via an unspecified route of administration on the left arm on 23Jan2021 11:45 at SINGLE DOSE for COVID-19 immunization. It was reported that the patient was allergic to Amoxicillin. The patient was not pregnant (including at the time of vaccination). Medical history and concomitant medications were not reported. On 23Jan2021 22:00, the patient had a light presentation of hives. The locations of the hives were in the crease of the right arm (elbow area), torso (tummy area), top of foot and ankles. The patient did not receive treatment for the event. The patient was not diagnosed with COVID-19 prior and not tested since vaccination. Outcome of the event was recovering.
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| 63 | 2021-02-09 | rash papular, rash with redness, rash vesicular, skin irritation |
burning sensation; severe blistering raised rash on right leg, arm, buttcheek and back; severe blist...
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burning sensation; severe blistering raised rash on right leg, arm, buttcheek and back; severe blistering raised rash on right leg, arm, buttcheek and back; Dermatitis; the rash/it is red; This is a spontaneous report from a contactable Consumer (patient). A 63-year-old female patient received bnt162b2 (lot number: EL3249, Expiry Date: May2021), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. Medical history included Hiatal hernia, heartburn and stuff. The patient's concomitant medications was unspecified medication for heartburn and stuff. The patient previously took clindamycin and allergy. The patient received vaccine on 15Jan2021, started developing severe blistering raised rash on right leg, arm, buttcheek and back on Jan2021. The patient experienced rash, now raised and blistering. On 15Jan2021, legs butt cheeks on back right side of body (same side of body) burning sensation. Patient got a dermatitis on Jan2021. She don't know what dermatitis looks like but the rash she got, it like raised up and it is red and some of it is like blistered. Because she got like a blistering rash at first it was just a rash then it started kind of blistering. They have gotten worsened, they started Monday or Tuesday (Jan2021), the rash started but its got worse since then and spread. She just put some Calmoseptine on it. It is over the counter, it is almost like a diaper rash that she used on it. But she kind of got like the burning sensation too. Its an ointment. It is like a diaper rash ointment. She figured she would try that because she did an antibiotic ointment (Unspecified Ointment) and it didn't work at all. The outcome of the event burning sensation was unknown, other events was not recovered.
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| 63 | 2021-02-10 | injection site pain |
Arm a little sore below injection site. Mild start of a headache for two days but never kicked in. W...
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Arm a little sore below injection site. Mild start of a headache for two days but never kicked in. Weird taste in my mouth 2 hours after shot that only lasted 2 hours.
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| 63 | 2021-02-10 | vaccination site warmth |
The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a t...
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The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; improper technique; bruising after the first shot because of improper technique; felt hot at the injection site; swelling; tiredness/tired; arm pain; headache; chills; This is a spontaneous report from a contactable pharmacist (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686, expiry date not reported), intramuscular on 02Jan2021 17:00 at a single dose in the left arm for COVID-19 immunization. Medical history included hypertension, known allergies to latex and has covid-19, all from unknown dates and unknown if ongoing. The patient was not pregnant at the time of the vaccination. Concomitant medications included hydrochlorothiazide, potassium chloride, and calcium citrate (CITRACAL). The patient had no other vaccine in four weeks. Patient stated that a cooler used to transport the covid 19 vaccines had a temperature of 31 to 33 degrees F and she was concerned about the vaccines on the bottom of the shipper that were next to the dry ice in the shipper (date unspecified). Patient wanted temperature excursion data for the covid 19 vaccine and stated in Jan2021 she felt hot at the injection site, swelling, tired, arm pain and had bruising after the first shot because of improper technique (02Jan2021 17:00). Patient reported on the first dose having only arm pain, chills, and tiredness, and headache in Jan2021. Patient also stated that the first dose was much better tolerated. Patient stated some of her pharmacist friends have had the same effects from the vaccine. Patient wanted to verify that the vaccine in the syringe is good for 6 hours and that she read Moderna is effective for 1 year and Pfizer is good for 6 to 12 months. She does not think her vaccination of covid 19 was valid because she thinks the temperature that the pharmacist recorded was not correct. Patient wanted to know if she should get tested to see if the vaccine worked. Patient stated that Pfizer is too complex and has too many pieces and states they need to give more information about how to use the thermal shipper. The patient had Covid test post vaccination as nasal swab on (BioReference COVID-19 Nasopharynx) on 26Jan2021 with results as pending. No treatments received felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache. The patient did recover from the events felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache on an unspecified date in Jan2021.
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| 63 | 2021-02-10 | rash, itchy skin | generalized mild rash with mild-moderate puritis |
| 63 | 2021-02-11 | hives | Hives days 4-8 after dose, treated with benadryl |
| 63 | 2021-02-11 | injection site pain |
Pfizer BioNTech COVID-19 Vaccine EUA left armpit lymph node swelling injection site pain headache na...
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Pfizer BioNTech COVID-19 Vaccine EUA left armpit lymph node swelling injection site pain headache nausea joint pain
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| 63 | 2021-02-14 | itchy skin |
Symptoms: pruritic chest Intervention: VS stable. Monitored. Stayed an additional 15 minutes due to ...
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Symptoms: pruritic chest Intervention: VS stable. Monitored. Stayed an additional 15 minutes due to appointment at the hospital, total 30 min. Instructed patient to go to the nearest ED if s/sx worsens. No SOB noted. Denies pain. States may take Benadryl at home.
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| 63 | 2021-02-15 | hair loss |
I washed my hair on Saturday. Had significant hair loss - HUGE amount of hair. I've lost 30 percent ...
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I washed my hair on Saturday. Had significant hair loss - HUGE amount of hair. I've lost 30 percent of the hair on my head. It continued to fall out and to have hair loss for one week. Saw doctor - She said the immune system was stressed and hair fell out. Dr. e-visit - Tuesday, the 9th.
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| 63 | 2021-02-15 | itchy rash, injection site reaction | Itchy rash at site |
| 63 | 2021-02-15 | hives, itchy skin, redness |
Patient started with itching all over. Redness and hives on chest. "Itchy throat" with frequent clea...
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Patient started with itching all over. Redness and hives on chest. "Itchy throat" with frequent clearing of throat observed. Bilateral breath sounds were clear and equal. No angioedema noted. Vital sings were monitored. Pulse was 98-99% on room air. Later felt a headache and felt jittery. Benadryl 50 mg PO was administered. Within 20 minutes of Benadryl symptoms improved. Prior to discharge the patient was no longer clearing her throat. Patient states she felt better. Husband reports chest and hive are basically gone. Patient remained alert and oriented x4 the entire visit. Reviewed to continue with over the counter Benadryl and take per directions on bottle. Husband reported he would stop and get Pepcid to take with Benadryl. Patient ambulates out of clinic without problems. 4:28 pm 161/88 89 16 97% 4:36 pm 149/82 79 17 99%. 4:43 pm 142/66 71 17 99%. 5:00 pm 124/ 83 72 15 98%.
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| 63 | 2021-02-15 | injection site rash, injection site pain, injection site swelling, injection site redness |
Within in an hour of receiving the vaccine, under the injection about 2-3 inches below the site, the...
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Within in an hour of receiving the vaccine, under the injection about 2-3 inches below the site, the muscle group was sore. The next morning I was dizzy, lightheaded, mild headache, nausea, chills. It went all throughout the day. I just drank some clear liquids and ate some soup. When I woke up the next day about 36 hours after receiving the vaccine I had low energy, nauseous, and lightheaded . By that night my arm started feeling weird, it had a tinging feeling, I went to look at it the mirror and there was a red area and bumps but it was lower under the injection site. It seemed to get worse, swelling and more rash so I took Loratadine 10 MG (antihistamine). I went to bed and when I woke up this morning the rash was gone but the soreness is still there and the tinging feeling in my arm is still there. It feels like when your arm falls asleep. I tried to called my doctor but their phones are down and I will try reach back out this afternoon.
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| 63 | 2021-02-15 | injection site pain | site pain, next day body aches, joint pain, headache, chills, no fever. tiredness. for two days |
| 63 | 2021-02-17 | shingles, rash |
I had a shingles vaccine on November 30, 2020. On Dec 30, 2020 I had my first dose of Covid vaccine...
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I had a shingles vaccine on November 30, 2020. On Dec 30, 2020 I had my first dose of Covid vaccine. On Jan 6, 2021 I went to the ER for severe abdominal pain, 2 days later broke out with rash and diagnosed with Shingles. I took steroid, Valtrex and Gabapentin. Rash on abd and around to lower back, left side. The rash was not bad but the nerve pain was horrible. 2nd dose was due Jan 22, 2021, I was advised to wait due to still having shingle pain. I was getting better, pain was subsiding so I got my 2nd dose on Feb 5, 2021. I experienced an increase in my shingle pain, from a 2 up to a 5, for about another week. It is still some pain, I am still on Gabapentin and Tylenol to keep the pain at about a constant 1-2 (Feb 18, 2021).
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| 63 | 2021-02-18 | sensitive skin |
First vaccine shot - No adverse events. Second vaccine shot - on the next evening (02/18/21), I had...
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First vaccine shot - No adverse events. Second vaccine shot - on the next evening (02/18/21), I had a very slight fever lasting just a couple of hours. Later in the evening, I had swelling and pain under my left arm pit lymph node. The pain continues as of this writing. The pain is dull in nature and more sensitive to the touch.
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| 63 | 2021-02-18 | rash |
Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), ...
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Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), thumb pain, brief leg "heaviness" (both) and fatigue, brief RLQ pain, increased tinnitus. The next evening: low back and neck (bone?) pain while attempting to sleep, out of character to usual back pain. By day 3 post injection, left nose tingling similar to onset of cold sore, which included left side of mouth the next day. By 7 days post injection, entire mouth area felt tingly similar to Novocaine wearing off. This lasted 3 days. Now improved. (took B-12 p.o.) Other brief episodes of chest discomfort, gum irritation, and anxiety. Vaccine #2 scheduled for 2/19/2021
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| 63 | 2021-02-18 | shingles | developed Shingles 10 days after vaccine and was treated with Valcyclovir |
| 63 | 2021-02-19 | rash |
24 hours after vaccine, developed: Chills - unable to get warm Rash on left arm, middle, chest, stom...
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24 hours after vaccine, developed: Chills - unable to get warm Rash on left arm, middle, chest, stomach, and back One lymph node enlarged under left arm - size of a golf ball, lasted 2 days
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| 63 | 2021-02-21 | rash vesicular, rash, itchy skin | "Blistery sores on the small of my back side itch and burn"; no treatment sought |
| 63 | 2021-02-21 | injection site pain, injection site swelling |
Experienced Double Vision about 30 minutes after injection. Cleared within 20 minutes. After 36 hou...
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Experienced Double Vision about 30 minutes after injection. Cleared within 20 minutes. After 36 hours: injection site tenderness, swelling, (no redness)
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| 63 | 2021-02-21 | injection site redness, injection site warmth, injection site pruritus |
I developed a red area on my right arm to the front side of where the Pfizer vaccine was administere...
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I developed a red area on my right arm to the front side of where the Pfizer vaccine was administered. The red area is about 2 inches in circumference, warm to the touch and itches.
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| 63 | 2021-02-21 | shingles |
I developed chills on Friday, February 19, 2021 in the afternoon. Chills continued through Saturday,...
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I developed chills on Friday, February 19, 2021 in the afternoon. Chills continued through Saturday, February 20, 2021. Did not feel well on Sunday, February 22nd and today, February 22nd, I woke up with a nice dose of shingles on my face. Went to see the nurse practitioner at Dr office. Not sure if this is a coincidence or a result of the vaccine.
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| 63 | 2021-02-21 | rash papular | papular rash bilateral arms chest and back |
| 63 | 2021-02-23 | itchy skin, rash vesicular, blister, rash |
Developed a blister on upper left inner forearm after about 10 hours. It resolved over night. After ...
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Developed a blister on upper left inner forearm after about 10 hours. It resolved over night. After 24 hours, developed several small blisters (some that ran into each other) on inside of lower left forearm. They itch and hurt a little. Also have a few blisters on inside of lower right forearm, back of left leg, a couple on chest and trunk.
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| 63 | 2021-02-23 | blister, rash with redness, rash |
Patient received 2nd dose of Pfizer COVID vaccine. Blanching, erythematous, somewhat serpiginous ras...
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Patient received 2nd dose of Pfizer COVID vaccine. Blanching, erythematous, somewhat serpiginous rash to L arm and hand with blister present on medial aspect of proximal forearm. Not pruritic, not painful. Area with blister is tender to the touch. Rash is not present on the L shoulder, R arm, or back. Denies fevers. 2nd dose of COVID vaccine to L arm last Thursday. The rash seems to originate from the vaccination site and does not extend upwards. The rash was noticed only today during an office visit. Patient has an intellectual disability, and very independent. always wears a long sleeve and her caregivers had not noticed it until today when rash extended down to her hands below the long sleeve.
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| 63 | 2021-02-24 | injection site pain |
Chills, 102°, headache, body aches, extreme fatigue and injection site pain Symptoms began within...
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Chills, 102°, headache, body aches, extreme fatigue and injection site pain Symptoms began within 45 minutes lasted 48 hrs , treated with Tylenol. Unable to get out of bed.
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| 63 | 2021-02-24 | injection site pain |
I had a minimally sore injection sight the morning I had the vaccine. As the day went on I began to ...
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I had a minimally sore injection sight the morning I had the vaccine. As the day went on I began to feel joint pain in my back. Around 2:00pm I began to feel chills. Around 5:00pm I registered a temperature of 99.1. My usual temperature is 96.7. I then had trouble staying asleep, had intense joint pain in my back, hands, and feet, which I treated with Tylenol around 11:00pm. I experienced heavy night sweats where I woke up at 5:15 am being soaked. The symptoms I felt overnight felt just like what I had when I was sick with Covid 19 in December 2020. My temperature had returned to normal by 6:00 am.
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| 63 | 2021-02-24 | itchy skin | Lasting effects are increased heart rate, itching, hematomas, head pain, chest pain and heavy lungs |
| 63 | 2021-02-25 | redness, rash, skin warm, hives, itchy skin |
(2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST...
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(2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST AND IT IS NOTED THAT PATIENT HAS PREVIOUS ISSUES WITH FLU SHOT WITH A HISTORY OF TORUBLE BREATHING. TEACHING IS PROVIDED WITH PATIENT REGARDING POSSIBLE SIMILAR REACTIONS WITH COVID-19 VACCINE AND THAT SHE SHOULD STAY AT LEAST 30 MINUTES AFTER VACCINATION IF SHE WISHES TO PROCEED. PATIENT CONSENT TO PROCEED WITH COVID-19 VACCINATION. VACCINE IS GIVEN AT 1000 INTO RIGHT ARM AND PATIENT IS ASKED TO STAY FOR OBSERVATION. AT 1030 PATIENT REPORTS TO THIS NURSE ITCHING AND HIVES. PATIENT IS OBSERVED TO HAVE HIVES COVERING BILATERAL ARMS AND CHEST. PATIENT DENIES BREATHING TROUBLE AT THIS TIME. EMERGENCY REACTION KIT IS BROUGHT TO PATIENT?S TABLE. AT 1032 ON CALL PROVIDER IS NOTIFIED OF REACTION AND ORDERS ARE GIVEN FOR BENADRYL 50MG IM. THIS IS GIVEN AT 1034 RN INTO GUTEAL AND PATIENT IS OBSERVED AND VS OBTAINED. AT 1040 PATIENT STATES HER THROAT FEELS ?SCRATCHY? AND ?TIGHT.? IT IS RECOMMENDED TO PATIENT SHE SHOULD BE SEEN IN THE EMERGENCY ROOM. PATIENT AGREES TO THIS IF SHE IS ABLE TO DRIVE HERSELF. PATIENT IS FOLLOWED IN HER VEHICLE TO EMERGENCY ROOM FROM OFF-SITE CLINIC (APPROX. 8 BLOCKS). ON CALL PROVIDER IS NOTIFIED AND HOSPITAL EMERGENCY ROOM IS GIVEN REPORT FROM THIS NURSE. UPON ARRIVAL TO ER PATIENT IS SEEN PER MD. PATIENT REPORTS SYMPTOMS OF CHEST PRESSURE, DYSPNEA, LIGHT HEADEDNESS, ABDOMINAL PAIN, RASH, REDNESS, WARTHM AND ITCHING. PATIENT IS GIVEN 0.4 MG SUBCU ADRENALINE AND 40 MG PREDNISONE ORALLY. PATIENT IS OBSERVED IN EMERGENCY ROOM x 1 HOUR. PATIENT REPORTS SHE IS STARTING TO FEEL BETTER. PATIENT IS DISCHARGED TO AT 1206 FROM EMERGENCY ROOM.
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| 63 | 2021-02-25 | itchy skin | Small bump on left wrist, itching |
| 63 | 2021-02-25 | skin warm, redness |
general aching joint pain, headache, spine pain not muscle pain felt like back was broken started ar...
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general aching joint pain, headache, spine pain not muscle pain felt like back was broken started around midnight lasted untill late evening. left thigh pain like someone was doing a vein stripping. nausea no vomiting. Felt bad for 2 days. reddness on left arm not at shot site with left arm pain for 2 days. reddness in lt arm still there 02-26-2021.Red raised area warm no drainage.
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| 63 | 2021-02-25 | vaccination site pain |
got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomf...
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got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomfortable.; Got hot and sweaty about 3 1/2 hours after shot.; Got hot and sweaty about 3 1/2 hours after shot.; administration_date=26Jan2021; other vaccine date = 26Jan2021; administration_date=26Jan2021; other vaccine date = 26Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unknown route of administration on left arm (L shoulder/Arm) on 26Jan2021 at 09:00 AM at the age of 63 years old at a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included RA (Rheumatoid arthritis), Penicillin allergy and covid-19 (The patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications included leflunomide (ARAVA) at 20mg, once a day, daily vitamins and mesalamine 1/day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Also reported administration date 26Jan2021; other vaccine date 26Jan2021. On 26Jan2021 09:00, the patient experienced sore injection site (shot was given very high on L shoulder/Arm). Felt like a sharp pain when given. Got hot and sweaty about 3 and an half hours after shot. Could not sleep, very uncomfortable. Next morning (on 27Jan2021), the patient was getting ready to eat breakfast and got dizzy and felt queasy. Temp was lightly elevated. Taking Tylenol to help control soreness. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events administration_date=26Jan2021; other vaccine date = 26Jan2021 was unknown and patient was recovering from all other events. Information on the lot/batch number has been requested.
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| 63 | 2021-02-25 | rash |
tingling and numbness on left side of mouth and face, beginning immediately after injection, and con...
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tingling and numbness on left side of mouth and face, beginning immediately after injection, and continuing intermittently for two days so far. Exacerbation of rash on right hand that usually occurs when exposed to wheat, beginning 24 hours after injection. Muscular pain in back beginning 12 hours after injection and subsiding 40 hours after injection.
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| 63 | 2021-02-28 | rash |
Rash on lower left leg and foot and burning sensation on saying. Patient is affected by CRPS 2. Chi...
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Rash on lower left leg and foot and burning sensation on saying. Patient is affected by CRPS 2. Chills aches and pains and headache the latter lasted three days
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| 63 | 2021-02-28 | skin warm, injection site pain |
Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, E...
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Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Dose potentially administered too high but patient didnt bleed. Banaid placement described as one finger width below acrimion bone. Immediately \u2026 at the time of injection \u2026 shooting nerve pain radiating down the arm into fingers. Pain became a hot tingle over the next 15-30 minutes. Impaired right arm mobility and range of motion \u2026 shoulder pain with motion beyond a modest range. Three days later still experiencing some pain with certain arm motions \u2026 primarily raising arm above shoulder
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| 63 | 2021-02-28 | vaccination site pain |
tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report fro...
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tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: 31May2021), via intramuscular route of administration in the left arm on 15Jan2021 10:05 at a single dose for COVID-19 immunization. Medical history included open cholecystectomy in 1990, hypertension, and sleep apnoea (CPAP). The patient's concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22 Dec2020 and experienced fever, nausea, vomiting, diarrhea, metallic taste in mouth, Loss of taste/smell, minimal soreness at the site of injection, strange sensation of tingling in her skull, chills, dry mouth, feels like she has no saliva, tongue felt a little bit too dry, extremely tired, thirst, and altered taste. The patient experienced mild left arm soreness on 15Jan2021 and fever 101.8 on 16Jan2021 23:00. Patient took ibuprofen 400mg and ondansetron (ZOFRAN) 4mg. The patient also experienced tingling sensation left skull continues as described. The patient had no cough, sore throat, stuffy or runny nose. She had no shortness of breath, no nausea vomiting or diarrhea, and no loss of taste/smell or metallic taste in mouth. The patient underwent lab tests and procedures which included body temp: 99.7 on 15Jan2021 18:00, 101.8 on 16Jan2021 11 PM, 99.5 on 16Jan20213 PM, 99.8 on 16Jan2021 10 PM, 99.5 on 17Jan2021 9:00, 99.8 on 17Jan2021 8 PM, 100 on 17Jan2021 10 PM, 99.4 on 18Jan2021 07:00, 99.7 on 19Jan2021 16:00, 98.6 on 20Jan2021 11 AM. Outcome of tingling sensation left skull was not recovered, of remaining events was unknown.
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| 63 | 2021-03-02 | vaccination site pain |
A little bit of soreness in arm injection was administered; This is a spontaneous report from a cont...
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A little bit of soreness in arm injection was administered; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in eft arm on 14Jan2021 09:05 at a single dose for vaccination. There were no relevant medical history and concomitant medications. The patient previously received flu shot on Sep2020. The patient experienced a little soreness in arm injection was administered on 14Jan2021 and recovered completely from this event by the evening of 14Jan2021. She was feeling good. Described the event as very minor, minimal similar to what one might get with a flu or tetanus shot. Information on Lot/Batch has been requested.
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| 63 | 2021-03-02 | bruising | Bruising and pain at palm up to mid-arm. Swollen arm. 24 hours Fever and chills. 4 hours |
| 63 | 2021-03-02 | injection site discomfort, injection site bruising, injection site pain, injection site reaction, injection site swelling, injection site warmth |
Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at...
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Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at injection site. She reports feeling like a foreign body in injection site and reports feelings of tightness, pressure, and heat at site. Patient developed swelling of right arm over the next 3 weeks. Patient saw her PCP on 2/12/21 and an ultrasound was done to R arm. Results were negative. Five to six weeks post vaccine administration, patient is reporting weight loss over 10 pounds, possible hair loss, loose stools, and sweaty palms and feet. She also reports the right arm pressure and tightness is now radiating to her upper back.
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| 63 | 2021-03-03 | vaccination site warmth, vaccination site redness, vaccination site swelling |
Fever; joint & muscle pain; joint & muscle pain; Injection site - large red spot (about 4 inches in ...
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Fever; joint & muscle pain; joint & muscle pain; Injection site - large red spot (about 4 inches in diameter); swollen; hot to touch; other vaccine same date dose number 6; This is a spontaneous report from a contactable healthcare professional (patient). This 63-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; EL3247) via an unspecified route of administration in the left arm on 29Jan2021 at 14:15 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to shellfish and allergy to eggs, both from unknown dates and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EL0142) in the left arm on 11Jan2021; codeine from an unknown date for an unknown indication and experienced allergy; celecoxib (CELEBREX) from an unknown date for an unknown indication and experienced allergy; and alendronate sodium (FOSAMAX) from an unknown date for an unknown indication and experienced allergy. The patient reported fever, joint and muscle pain 24 hours after the vaccine and stated it lasted about 18 hours. She also reported about the injection site that it was a large red spot (about 4 inches in diameter), it was swollen and hot to touch starting about 24 hours after vaccination. She reported 3 days later it was still red, swollen and hot to touch. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of fever, joint and muscle pain were recovered on 31Jan2021. The clinical outcomes of large red spot (about 4 inches in diameter), swollen, hot to touch were not recovered. The clinical outcome of other vaccine same date dose number 6 was unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19.
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| 63 | 2021-03-03 | itchy skin, hives, redness |
Pt received 1st dose of Pfizer Biontech vaccine. Patient reported history of anaphylactic reactions....
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Pt received 1st dose of Pfizer Biontech vaccine. Patient reported history of anaphylactic reactions. Pt told to stay 30 minutes for observation. During observation patient reported feeling itchy. VS taken at clinic and were stable: HR 88, BP 135/66 Spo2 94%. Patient's face was slightly red without edema. She reported breathing okay but felt a little tight in her throat. Sent to ER for management. Per ER note "63 year old female with a complex medical history including lupus, scoliosis, Sjorgen's syndrome, and anaphylaxis requiring intubation presents complaining of itching and dizziness following COVID 19 vaccination with the Pfizer mRNA vaccine...patient's exam demonstrates itchy red welts consistent with urticaria and she endorses a foreign body sensation in her throat. Examination of the oropharynx demonstrates uvular edema without stridor. The patient endorses chest tightness but does not have wheeze on exam...endorses nausea. Diagnosed with anaphylactic reaction. Patient received epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, famotidine 20 mg IV, and methylprednisolone 125 mg IV along with albuterol MDI. Had improvement in symptoms within an hour, observed for 6 hours without recurrence of symptoms and was discharged home. Advised not to receive second dose of vaccine until discussion with allergist occurred.
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| 63 | 2021-03-04 | skin warm |
Approximately one hour after the shot, my face began feeling strange. My nose was red and warm as w...
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Approximately one hour after the shot, my face began feeling strange. My nose was red and warm as well as my cheeks. Then my lower lip began to swell. I would consider these symptoms somewhere between mild to moderate. The symptoms began around 4:30 in the afternoon and subsided as the evening progressed. The next morning (today), my face feels basically normal again. My only symptoms now are a sore arm and a slight headache. I have experienced allergic reactions before but never from a vaccine.
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| 63 | 2021-03-04 | injection site reaction, redness, itchy skin |
Pt is 9 days post-vaccination and has a raised, pruritic, erythematous lesion at site of injection m...
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Pt is 9 days post-vaccination and has a raised, pruritic, erythematous lesion at site of injection measuring 8 x 4.5cm. Mild adverse event.
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| 63 | 2021-03-07 | redness, skin warm, rash | 8 days after vaccine- red , hot, swollen, half dollar size patch |
| 63 | 2021-03-07 | itchy rash, skin hardening |
Arm aching took acetaminophen. Extremely tired, short of breath, headache, low fever, achy muscles ...
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Arm aching took acetaminophen. Extremely tired, short of breath, headache, low fever, achy muscles all lasting to 30 hours after vaccine. Itchy Rash on arm and hard sport for 4 days.
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| 63 | 2021-03-07 | skin burning sensation |
Intense burning of my skin all over my body. I have multiple food allergies that cause this type of ...
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Intense burning of my skin all over my body. I have multiple food allergies that cause this type of reaction so I dealt with the burning in the same way that I do got good allergies. It helped. After two days the burning stopped.
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| 63 | 2021-03-07 | injection site pain |
Severe pain at injection site, unable to raise arm above 90 degrees of shoulder flexion without the ...
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Severe pain at injection site, unable to raise arm above 90 degrees of shoulder flexion without the assistance of the opposite arm.
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| 63 | 2021-03-07 | itchy skin, rash, redness |
The vaccine is the only variable that could have caused this reaction. Started mid-morning with a d...
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The vaccine is the only variable that could have caused this reaction. Started mid-morning with a deep flushing in my face, and then spread to arms(bright red elbows) and chest and upper thighs. Raised bumps but not large lesions, very itchy. Onset was this morning, so I do not know how long this may last. Ongoing two hours later. No other reactions.
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| 63 | 2021-03-08 | itchy skin, hives |
Beginning a few hours after the vaccine the day of the vaccine and into the next AM, I had diarrhea...
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Beginning a few hours after the vaccine the day of the vaccine and into the next AM, I had diarrhea. 30 hours after receiving the vaccine, I woke up at 3 AM with itching all over my body. I had hives on both eyes. I called my Dr., who scheduled me to come in for an office visit. She examined me and recommended that I proceeded to the ER for further monitoring. There they examined me and prescribed Benadryl for 5 days and Zantac for its antihistamine properties, as well as prescribing an EpiPen. It turned out that Zantac has been removed from the market, so I have just taken Benadryl.
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| 63 | 2021-03-08 | injection site redness | redness at site of injection and down the arm for several days |
| 63 | 2021-03-09 | vaccination site pain |
Chills; achy; low grade fever; tired; Arm sore at injection site; all the patient did was sleep.; Th...
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Chills; achy; low grade fever; tired; Arm sore at injection site; all the patient did was sleep.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EM9809) via an unspecified route of administration on 04Feb2021 16:00 in the left arm at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, COVID (prior vaccination). There was no other vaccine in four weeks. The patient received other medications in two weeks (unspecified). The patient has no COVID tested post vaccination. The patient experienced chills, achy, low grade fever, tired, arm sore at injection site, and all the patient did was sleep. Event onset date reported as 05Feb2021 06:00. Following day, feel much better. Body temperature showed low grade fever on 05Feb2021 06:00. No treatment received for the events. The outcome of the events was recovered in Feb2021.
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| 63 | 2021-03-09 | redness |
Onset of chills, body aches, joint pain, headache, diareah During night face turned bright red and b...
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Onset of chills, body aches, joint pain, headache, diareah During night face turned bright red and body felt hot General tired and achy lasting 4 days
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| 63 | 2021-03-09 | itchy skin |
Thickening of tongue; itching arms,legs,face, head; headache; This is a spontaneous report from a co...
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Thickening of tongue; itching arms,legs,face, head; headache; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 06Feb2021 at 12:00 (at the age of 63-year-old) at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included asthma, fibromyalgia, COVID-19 and allergies, all from an unknown date and unknown if ongoing. Concomitant medication included fluticasone furoate/vilanterol trifenatate (BREO ELLIPTA), tiotropium bromide (SPIRIVA), spironolactone, simvastatin and omeprazole (PROTONIX). On 06Feb2021, the patient experienced thickening of tongue, itching (arms, legs, face, head) and headache. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 63 | 2021-03-09 | injection site pain | sore, painful, tender left arm (injection site) |
| 63 | 2021-03-10 | itchy skin |
(Note; after 1st dose on February 1st had some tongue and lip tingling within 30 minutes, took Bena...
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(Note; after 1st dose on February 1st had some tongue and lip tingling within 30 minutes, took Benadryl 25 mg with relief). Prior to second dose, took Benadryl 25 mg at 310pm.... at 350pm, received second dose of Pfizer vaccine.... tingling of lips and tongue within 10 minutes, took Benadryl 25 mg at 4pm...?. progression of tingling of tongue to some numbness of tongue, towards back of throat, some difficulty swallowing, throat hoarseness, chest discomfort, sporatic spot itching of eyeballs - shoulder-forehead-top of right arm. Went to Emergency room around 5pm.... given corticosteroid and Pepcid IV... with relief. Left Emergency room around 730 with minimal tingling of tongue....no other symptoms. Took Benadryl 25 mg by mouth before bed. 3/6/21- woke up with no symptoms.
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| 63 | 2021-03-10 | itchy rash, rash, itchy skin, hives |
10 hours after first dose of Pfizer Vaccination, I developed an itchy, raised bump that looked like ...
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10 hours after first dose of Pfizer Vaccination, I developed an itchy, raised bump that looked like a mosquito bite on the inside of my left elbow (same arm as vaccination). It resolved over the following couple of hours. 24 hours after vaccination (14 hours after the original presentation of the itchy bump on my elbow), I developed a couple of itchy bumps on my leg and trunk. Over the following 16 hours (24-40 hours after vaccination) I had what was diagnosed by health care professionals as an outbreak of hives affecting both forearms, both ankles, left knee and trunk. This episode resolved about 40 hours after vaccination. One week later, I have had mild, generalized, off and on itching and prickly skin sensation but no obvious outward signs of bumps or rash. I am seeking advice from an allergist on whether to proceed with second vaccination. Will be tested for PEG reaction before then. This is my second report. I requested a key to update my initial report (VAERS E-Report) but never received one.
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| 63 | 2021-03-10 | injection site pain |
HA and muscle pain at injection site within 1 hour, joint pain at shoulders/hips/ feet starting at...
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HA and muscle pain at injection site within 1 hour, joint pain at shoulders/hips/ feet starting at 14 hours post dose and lasting for 36 hours. all treated with tylenol and NSAID. Moderate fatigue requiring rest for 24 hours. palpitations for 30 minutes at 14 hours post dose - no treatment, self-resolved
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| 63 | 2021-03-10 | injection site pain | Heavy tongue, pain at injection site, tingling bilaterally in arms. Cleared by EMS |
| 63 | 2021-03-10 | injection site pain | Low grade fever, chills, body aches, headache, shot site pain - lasted 12 hours |
| 63 | 2021-03-10 | injection site numbness |
Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced c...
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Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced chest pain radiating down left arm, shortness of breath, and nausea. Patient also endorses numbness to left upper arm and left lower leg. Denies any wheezing, throat swelling, facial swelling, diarrhea, urticaria. Vitals: BP 104/65, Pulse 78, SpO2. On chart review, she had similar symptoms in the past with full stroke workup that was ultimately determined to be conversion disorder. Admitted for observation to rule out ACS. EKG and serial troponin unremarkable.
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| 63 | 2021-03-10 | hives, redness |
Pt presented with hives and redness on chin, neck and upper chest, tingling sensation present in li...
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Pt presented with hives and redness on chin, neck and upper chest, tingling sensation present in lips and tongue. BP: 190/110, HR: 82, O2 sat: 95%. Administered 25mg PO liquid Benedryl. Pt released from observation once hives dissipate.
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| 63 | 2021-03-10 | redness |
pt stated that she got really warm within a couple of minutes of getting the vax. Pt got tightness...
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pt stated that she got really warm within a couple of minutes of getting the vax. Pt got tightness under eyes, checks, and inside her mouth. She had some pinching feelings in her chest which she said this may be acid reflux. Her right leg was hurting near her ankle and foot. Nurse at vax site checked her stats and everything was normal. She was given Benadryl. These symptoms subsided. After getting home she had some tickling in her throat. Pt only has soreness and redness in her left arm today.
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| 63 | 2021-03-10 | hives | throat swelling, tongue swelling, throat itching, SOB, hives |
| 63 | 2021-03-11 | injection site pain |
ADVERSE EVENTS: INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, JOINT PAIN, FEVER (1...
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ADVERSE EVENTS: INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, JOINT PAIN, FEVER (101.9 DEGREE F @ 2 AM 3/11/21 & BETWEEN 100.6 - 99.6 THROUGH THE EVENING 3/11/21), NAUSEA, FEELING UNWELL, SWOLLEN LYMPH NODE. TREATMENT: TYLENOL EVERY 4 HOURS STARTING AT 8 AM 3/11/21. SYMPTOMS SUBSIDED THROUGH THE LATE NIGHT OF 3/11/21 EXCEPT SWOLLEN LYMPH NODE & INJECTION SITE PAIN STILL PERSISTS 3/12/21.
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| 63 | 2021-03-11 | sensitive skin |
All over body aches and soreness, headache, heaviness in lungs with shortness of breaths, cough, an...
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All over body aches and soreness, headache, heaviness in lungs with shortness of breaths, cough, and hypersensitivity on skin. Took tylenol and rested. Lasted about 4 days.
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| 63 | 2021-03-12 | rash, itchy skin |
On 01/09/2021 & 01/10/2021 I was feeling itchy on both sides of my neck. On 01/11/2021 I was feeling...
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On 01/09/2021 & 01/10/2021 I was feeling itchy on both sides of my neck. On 01/11/2021 I was feeling heat in the breast area. I saw OB/GYN and was prescribed an antifungal cream. On 01/15/2021 the rash had spread to the abdomen, lower back, on the sides of my abdomen, upper thigh and a few on my forarms, so I had a virtual visit and was told to take benedryl and over the counter cream. It took about 2 1/2 weeks to clear up.
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| 63 | 2021-03-12 | injection site reaction, rash, rash with redness, rash papular, rash macular, itchy rash, injection site swelling |
Started vomiting, feeling lethargic . Bumpy raised red itchy rash started on my arm at injection s...
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Started vomiting, feeling lethargic . Bumpy raised red itchy rash started on my arm at injection site, but then to underneath my arm on both sides of my body and proceeded to my neck, chest, over my back, torso, abdomen and rib cage. Even the bottoms of my feet look like they have red itchy blotches and the palms of my hands????? Also developed an On and off again painful left temple headache.... thought I was going to have a stroke or some thing! That comes and goes for one week now. , slight fever for two days, and then the pain and set in: GOUT LIKE I?VE NEVER EXPERIENCED!
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| 63 | 2021-03-13 | injection site pain, injection site bruising | Bruised injection site and very sore for 2 days; fatigue; headache; body aches; very weak |
| 63 | 2021-03-13 | pain of skin, shingles, injection site pain |
Minor soreness in arm 24 hours after injection. Sharp pain in right hip 72 hours after injection, fo...
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Minor soreness in arm 24 hours after injection. Sharp pain in right hip 72 hours after injection, followed by break out of shingles rash the following morning. Diagnosed at visit to doctor 3/2 and treated with Valtrex and Gabapentin. As of 3/14 rash is fading and pain is mostly gone.
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| 63 | 2021-03-13 | rash | Tiredness, muscle aches, stomachache. Rash on Neck |
| 63 | 2021-03-13 | vaccination site pain |
Within an hour after receiving the vaccine which stung going in, I started to experience severe and ...
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Within an hour after receiving the vaccine which stung going in, I started to experience severe and debilitating pain in my neck. It starts at the base of my skull and ends at the top of my back. This pain is incredibly severe and is not resolved with anything. I tried Tylenol, Advil, Aleve, CBD oil, meditation, hot shower, whiskey, heat, and ice. NOTHING works. It is now Sunday and the symptoms are still present. They are not as often, but still as severe when they occur. I am very hesitant to get the 2nd shot now because of this reaction. I typically have a high tolerance for pain, but if this was constant I would not be able to live with it. Talking and breathing were unbearable!
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| 63 | 2021-03-14 | itchy rash |
1st Vaccination on 3/4; Symptoms began 3/11 - itchy rash on upper back and left underarm; underarm r...
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1st Vaccination on 3/4; Symptoms began 3/11 - itchy rash on upper back and left underarm; underarm rash became tingley and burning; rash has spread to the rest of my left arm and onto my right arm; very little itching on arms, more on back; only left underarm tingles and burns
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| 63 | 2021-03-14 | itchy skin, rash with redness |
3-10-21PM RASH TO BOTH ARMS - RED/ITCHING. NO SOB/DYSPNEA, NO DIFFICULTY BREATHING OR SWALLOWING. 6...
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3-10-21PM RASH TO BOTH ARMS - RED/ITCHING. NO SOB/DYSPNEA, NO DIFFICULTY BREATHING OR SWALLOWING. 6:15PM BENADRYL 50MG PO. 6:40PM DECREASED ITCHING AND REDNESS NOTED. HAS SOME RASH AND ITCHING TO ABD AND RT CHEEK. NO DIFFICULTY SWALLOWING. 7:35PM 'FEELS BETTER' NO ACUTE DISTRESS NOTED. PINK, W/D, NO SOB. TO EXIT PER W/C TO BE TAKEN HOME PER DAUGHTER. 3-12-21 10AM TC: 'STILL HAS RASH - TAKING BENADRYL EVERY 4 HRS. STATES ALLERGIST ADVISED HER NOT TO GET DOSE #2, SHE WILL GET ANTIBODY TITER IN 6 WKS'.
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| 63 | 2021-03-14 | injection site pain, skin tightness |
Both upper arms and upper back have extreme burning pain and tightness. All of my muscles ache. Bo...
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Both upper arms and upper back have extreme burning pain and tightness. All of my muscles ache. Both calves felt weak. Extreme fatigue. Increased ear ringing. Sinus and head pressure. Slight queasiness. When the shot was first given, I had immediate pain at the injection site and up my neck. As the day progressed I felt tired, achy all over. The burning, stinging pain increased, in both arms and upper back. It seems worse at night and wakes me up. It is severe enough that it makes me cry. I have used regular strength Tylenol, Regular strength Advil and Allegra, as treatment. The burning pain continues. So does the muscle aching and fatigue.
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| 63 | 2021-03-14 | injection site pain |
Headache; Swollen lymph nodes on her neck; Dizziness; Her feet felt swollen and she hurt when she wo...
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Headache; Swollen lymph nodes on her neck; Dizziness; Her feet felt swollen and she hurt when she would step down; Loss of appetite; She slept all day; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9264B), intramuscular on 01Feb2021 at single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on 11Jan2021 for COVID-19 vaccination. Caller was a consumer that was calling about the Covid-19 vaccine and said that she wanted to report her symptoms after the Covid-19 vaccine. Caller reported that she experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain on, fever, feeling unwell, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day on 01Feb2021, swollen lymph nodes on her neck and dizziness on 02Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the events injection site pain, chills, fever, swollen lymph nodes on her neck, dizziness, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day were recovered and other events were recovering.
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| 63 | 2021-03-14 | hives, rash | Histamine rash on trunk - front and back |
| 63 | 2021-03-14 | itchy skin, hardening, redness |
So-called "Covid Arm" - itchy, hard, warm, red area appeared on Day 7 after vaccination. It was stil...
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So-called "Covid Arm" - itchy, hard, warm, red area appeared on Day 7 after vaccination. It was still present 2 days later (currently)
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| 63 | 2021-03-15 | itchy skin |
The following day after the 2nd vaccine, I felt a small itching on the left side of my neck/shoulder...
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The following day after the 2nd vaccine, I felt a small itching on the left side of my neck/shoulder blade. I didn't scratch but I felt swelling. After softly rubbing my neck, I felt a little bubble as if there was liquid in the bubble area. I thought maybe it was a side effect so I waited a full week. Along with the itching & swelling, there was a small amount of tender pain. The swelling still persists. On the 10th day after the vaccination (March 15th), I saw my doctor. He felt the same area sensation of a bubble around my shoulder blade. So far, there has been no treatment.
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| 63 | 2021-03-15 | hives | Throat hoarseness severe unable to speak and beginning of closure, hives. |
| 63 | 2021-03-16 | injection site pain |
Client c/o burning at the site. When EMT approached client refused to be assessed and stated that s...
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Client c/o burning at the site. When EMT approached client refused to be assessed and stated that she was OK and did not feel any need for them. Client advised to contact PCP or go to the ER if symptoms worsen.
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| 63 | 2021-03-16 | injection site pain |
I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hi...
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I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hit" by a very intense reaction: metallic taste in mouth, nauseous, burning heat throughout my back, sweating, very hot, very anxious/scared. This quieted down after about 10 minutes, but then I got "hit" again, a few minutes after that. This time with burning heat in my chest and then burning heat traveling down my left arm, sweating, very hot, very anxious/scared. I was under observation for 45minutes before they let me drive home (just 4 miles away). Once I got home, I felt extremely exhausted and foggy headed. This lasted for about 6 hours, and then it began to lift. That night, I was woken from sleep suddenly by pain in my arm (at injection site); it was a sort of pain I've never experienced -- it was sharp and moving around. The following day (today) I'm having lingering fatigue, lingering slight nausea, and a sore arm at injection site.
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| 63 | 2021-03-16 | redness |
Pt received vaccine and waited in the store for 15 minutes. She felt fine. After leaving the store...
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Pt received vaccine and waited in the store for 15 minutes. She felt fine. After leaving the store and going out to her car she took her mask off and noticed her face was red under her mask. No swelling or difficulty breathing. She went home and took some diphenhydramine and her issue resolved.
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| 63 | 2021-03-16 | itchy skin |
Tingling around lips in addition to being light headed. Tingling around lips began within an hour an...
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Tingling around lips in addition to being light headed. Tingling around lips began within an hour and has lasted for more than 24 hours. Skin on lower face has also been itchy (chin, cheeks). This developed later in the day and has persisted for more than 24 hours. Feels similar to when I had a reaction to Niacin.
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| 63 | 2021-03-17 | rash |
Immediate taste in mouth. Rash on neck and face. Slight throat swelling, slight difficulty swallowi...
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Immediate taste in mouth. Rash on neck and face. Slight throat swelling, slight difficulty swallowing. Very faint dizziness, fatigue.
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| 63 | 2021-03-17 | redness, skin burning sensation | Red burning ears ..came on in a rush/flush like way |
| 63 | 2021-03-17 | injection site pruritus, injection site swelling, itchy skin |
Site: Itching at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itc...
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Site: Itching at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: swelling and itching at hands-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient called from home to report swelling and itching in both hands, nothing currently reported at site of injection, computer would not let me submit without choosing 1 from that category. Pt was directed to take benadryl and to call primary physician. The symptoms happened after patient left the store after her 15 minutes of monitoring.
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| 63 | 2021-03-17 | injection site pain |
Started with joint and muscle aches at 5:30 on 3/17, by 9:30pm, very painful to take a deep breath, ...
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Started with joint and muscle aches at 5:30 on 3/17, by 9:30pm, very painful to take a deep breath, chills, fever of 100.2, injection site left arm throbbing, tired and weak, slight headache and nausea. Tired and weak, achy and slight headache when woke up on 3/18. Still somewhat painful to take a deep breath and injection arm painful. Tylenol 2 tablets at 8:30 am and 2:30pm on 3/18
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| 63 | 2021-03-17 | injection site redness, injection site swelling, injection site bruising |
The vaccine appears to have been delivered subcutaneously, not IM as prescribed. The individual wa...
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The vaccine appears to have been delivered subcutaneously, not IM as prescribed. The individual was short, stood behind me, and I did not feel the needle enter the muscle as I had during my first injection. I assumed they were more skilled or I was more relaxed during the injection, so I didn't think anything of it. The next day, there was a small bruise at the injection site and a raised red area emanating from the injection site anteriorly approximately 1 inch over the anterior deltoid. The raised area could be palpated just under the skin and on top of the muscle and took nearly 2 weeks to resolve. This was very different than my first vaccine injection experience approx. 3 weeks prior, when I felt the needle enter the middle deltoid muscle, resulting in a round raised red area about the size of a quarter that felt deep in the muscle the next day, and which resolved in a few days. No other signs or symptoms noted. I called the Health Department, as well as Pfizer to advise them of the incident and to request advice. Both suggested filing a report but neither offered any advise other than to contact my MD, who also had no advice to offer. Questions: Given the temperature requirements of the Pfizer vaccine, and if it was not injected into the muscle, would a slower uptake impact my immunity? What is suggested to assess my current immunity status? Might a booster shot may be indicated? Any advice would be sincerely appreciated.
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| 63 | 2021-03-17 | hives |
Three hours after receiving the pfizer vaccine i woke from a nap with a swollen tongue . later I h...
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Three hours after receiving the pfizer vaccine i woke from a nap with a swollen tongue . later I had one hive. The tongue swelling resolved on its own an hour later
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| 63 | 2021-03-17 | injection site reaction |
stiff neck along and above injection site--started next morning after injection and has continued fo...
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stiff neck along and above injection site--started next morning after injection and has continued for 5 days with soreness/stiffness abating somewhat after day 3
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| 63 | 2021-03-18 | bruising |
When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. ...
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When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. I was very lightheaded and uneasy. I stayed about an hour because I was scared to drive. I later got chills and fever for about 24 hours. I eventually developed shortness of breath, headaches, dizziness, tightness in my throat, bruising in my legs and painful lymph nodes in my neck and arms. One day, I felt like I was having a mini-stroke. It only lasted for a brief period and then went away. That has occurred multiple times. My doctor thinks some of my issues were due to anxiety, but I don't agree because I'm fine now.
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| 63 | 2021-03-19 | injection site pain |
Chills started 11pm day of shot.. Headache started shortly after. Aches pains especially in legs , f...
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Chills started 11pm day of shot.. Headache started shortly after. Aches pains especially in legs , fever, and sore injection area.
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| 63 | 2021-03-19 | injection site pain |
I started coughing for about an hour around 10pm while I was on a phone call; then developed a fuzz...
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I started coughing for about an hour around 10pm while I was on a phone call; then developed a fuzziness in my throat and felt like I had mucus in my chest. I took 120 mg Allegra. I started to feel relief after about 10 minutes. I had to relieve my throat of mucus this morning. Other than muscular aches, especially at the site of the vaccine and behind my shoulder, I am ok. About 10 - 11 hours after my first vaccine on 2/26/2021, I developed a similar reaction, however much milder, and took Allegra, which relieved the symptoms.
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| 63 | 2021-03-19 | injection site rash, injection site pruritus | Rash at vaccine site about 1.5? in diameter Itchy and red Still minor symptoms 4 days out |
| 63 | 2021-03-20 | itchy skin | Begin to fell itchy on her arms and chest After 5-10 minutes sensation went away |
| 63 | 2021-03-20 | hives | Disregard, hives, extreme weakness, chills and shaking |
| 63 | 2021-03-20 | injection site pain | Soar arm at the injection site on 3-20-2021 and dry cough starting on 3-21-2021 |
| 63 | 2021-03-21 | redness |
20 MINUTES AFTER THE SHOT I EXPERIENCED REDDENING OF THE FACE AND NECK. A FLUSHED FEELING ALL OVER ...
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20 MINUTES AFTER THE SHOT I EXPERIENCED REDDENING OF THE FACE AND NECK. A FLUSHED FEELING ALL OVER AND TIGHTING OF MY CHEST. I TOOK ORAL BENEDRYL 10 MINUTES AFTER THE SHOT BUT UNFORTUNETLY IT DID NOT HELP. I WAS GIVE IV BENEDRYL IMMEDIATELY AFTER THAT AND WAS MONITORED FOR 4 HOURS AT THE HOSPITAL. ALSO GIVEN TYLENOL FOR A HEADHACHE DURING MY HSPTALIZATION. IT TOOK APPROX. 30 MINUTES FOR THE SYMPTOMS TO SUBSIDE. I WAS RELEASED 4 HOURS LATER.
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| 63 | 2021-03-21 | bruising | Blood forming on left breast About the size of a baseball. Received shot on left arm. |
| 63 | 2021-03-21 | hives | Hives all over face , neck, arms both and thigh both & ear lobes left side more than right ear lobe |
| 63 | 2021-03-21 | injection site rash |
Next afternoon, Wednesday, approx. 26 hours after injection - chilled and tired. Next evening, Wedne...
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Next afternoon, Wednesday, approx. 26 hours after injection - chilled and tired. Next evening, Wednesday, approx. 29 hours after injection - tried to eat some instant mashed potatoes (make with water , butter and a bit of salt) = tasted extremely salty. And two smoked sausages. Forced myself to finish it all (normal serving sizes for me) and about half-way through felt like I was going to throw up! Kept it down. Fell asleep for about 2 hours, got up, used restroom and back to sleep - 12 hours! Friday evening right upper arm itchy - Saturday morning noticed rash on upper right arm - about the size of my hand - to the backside of injection site. Sunday afternoon - upper left arm itchy with rash like right arm.
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| 63 | 2021-03-21 | itchy rash, rash | Persistent Itchy red rash on chest, arms, and legs. Zyrtec and Cortisone cream are not effective. |
| 63 | 2021-03-21 | hives, rash |
Rash started on my neck and chest. Hives spread over entire body for the next two weeks. Dermatolo...
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Rash started on my neck and chest. Hives spread over entire body for the next two weeks. Dermatologist prescribed cream.
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| 63 | 2021-03-21 | hives |
Shortly after sitting down after vaccination, felt as body was exploding, either from sudden drop or...
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Shortly after sitting down after vaccination, felt as body was exploding, either from sudden drop or sudden rise in blood pressure. Then severe vertigo set in, everything started spinning and nausea set in. Waited for 30 minutes and vertigo was better, but not totally gone, but nausea was still there. Left facility and nausea abated after 1.5 hours. Vertigo continued for 48 hours but fairly mild. Caused me to walk like a drunk person but no dizziness any more. Then at 10:30 PM torso broke out in hives that lasted about one hour. No hives on arms and legs.
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| 63 | 2021-03-22 | injection site pain, injection site bruising |
3/14/21 8am noted bruising and pain at injection site; caller reports she was not happy with the per...
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3/14/21 8am noted bruising and pain at injection site; caller reports she was not happy with the person who provided the vaccination; she feels the injection was given improperly
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| 63 | 2021-03-22 | rash, redness, hardening, hives, skin discolouration, itchy skin, skin warm |
After about 12 hours post vaccination, the person vaccinated felt itchiness first over both elbows a...
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After about 12 hours post vaccination, the person vaccinated felt itchiness first over both elbows arms and saw redness discoloration with feeling of warmth over the redness areas. She self-medicated anti-allergic tabs of phenenephrine of 25 mg/tab as necessary which subsided the itchiness. However, the itching and redness kept coming on & off over the weekend which is very disturbing. Monday , she went to consult company clinic where 1 tablet of steroid [ Prednisone 10 mg] was orally taken that day and prescribed for 5 days. The itching subsided and skin rashes mellow down a bit. Yet still persisting on and off itching & redness present but milder since steroid was being taken.
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| 63 | 2021-03-22 | redness |
On both hands have intensive redness since first day of vaccination. And today 5 days after vaccinat...
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On both hands have intensive redness since first day of vaccination. And today 5 days after vaccination various red spots appears on both arms
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| 63 | 2021-03-23 | rash with redness |
1.5-2 hours after first Pfizer Covid vaccine developed fine red itchy rash to L>R arms from elbows t...
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1.5-2 hours after first Pfizer Covid vaccine developed fine red itchy rash to L>R arms from elbows to hands and stomach. Mild headache.. Allergies to latex = similar red splotchy rash similar to this reaction. Food green chili: throat closure; NKDA and does admit to seasonal allergies. Rash persisted for a couple of days. Took Benadryl. No worsening, no resp or GI issues. Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21), HEADACHE(R51).
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| 63 | 2021-03-23 | rash, shingles |
3-11-21 pain in groin on right side/leg weakness around 2:00pm better next day just sore arm., Fatig...
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3-11-21 pain in groin on right side/leg weakness around 2:00pm better next day just sore arm., Fatigue on 3-12 & 3-13. On 3-14 developed intense pain right side lower back and kidney. 3-16 went to Doctor as felt I had kidney infection but urine checked find, she thought it was muscle spasms. 3-19 broke out with shingles and back to doctor on 3-22 and given Acyclovir and Gabapentin. 3-23 went to ER. In as woke with pain so severe I broke out in sweat and threw up. Gave me Hydrocodone, nurse commented was worse break out she had ever seen. Internal pain is worse than the rash which is naval to spine and 3 to 4 " wide.
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| 63 | 2021-03-23 | itchy skin |
First felt coldness in elbow region and a little itchy. Nausea about 30 minutes later and coldness ...
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First felt coldness in elbow region and a little itchy. Nausea about 30 minutes later and coldness crept up arms, back and neck
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| 63 | 2021-03-23 | injection site pain |
Injection of shot was extremely painful with heavy stinging and burning sensation. Approximately 4 ...
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Injection of shot was extremely painful with heavy stinging and burning sensation. Approximately 4 hours after receiving shot on Friday, extreme fatigue, arm ache, full body/joint ache and severe headache. Took Tylenol and slept. Symptoms lasted until Sunday morning, although low grade headache persisted until Monday morning.
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| 63 | 2021-03-23 | sensitive skin |
Saturday morning I woke up feeling fine. About an hour later I had a bad headache and my body starte...
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Saturday morning I woke up feeling fine. About an hour later I had a bad headache and my body started to be achy. That was followed by bilateral eye pain so that the only comfortable thing to do was to put on eye shades. I was exhausted by the afternoon. I had absolutely zero energy to do anything but lie down. By Sunday morning every inch of my skin was sensitive, every joint was sore and every muscle group in my body was painful. The symptoms from the previous day remained; head and eye pain. I used both tylenol and advil a few times but without relief. Monday my body/joints were still achy and I was super tired but not like the previous 2 days. I became very depressed and fearful that it would not let up. Today is Wednesday and its the first day I feel like myself again although I did have to take a nap 3 hours after I woke up today. Body still aches but nothing like it was
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| 63 | 2021-03-23 | injection site pain, rash, hives, rash with redness |
Soreness near injection site for 1.5 days No other symptoms until approximately one week later Arms ...
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Soreness near injection site for 1.5 days No other symptoms until approximately one week later Arms - front and back of both arms have red bumps, hives, red dots, inflamed Legs - front and back of both legs - rash with red dots everywhere I took Benadryl and put aloe lotion on entire body - still have the spots, dots and hives seem to be going down DO NOT ITCH
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| 63 | 2021-03-24 | shingles |
On 3/5/2021 bad stomach ache lasting 5 days. 3/11 noticed what I thought were hives. Burning right ...
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On 3/5/2021 bad stomach ache lasting 5 days. 3/11 noticed what I thought were hives. Burning right side .. (back) then the shingles 3/22 called doctor...
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| 63 | 2021-03-24 | hives |
cankers under her tongue; above her left kneecap it looked like a mushroom hard in the middle water ...
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cankers under her tongue; above her left kneecap it looked like a mushroom hard in the middle water around it; On right leg there was a big red welt the size of her calf.; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A 63-year-old female patient received bnt162b2 (BNT162B2) (at 63 years of age), dose 1 via an unspecified route of administration on 08Mar2021 14:20 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history included allergic reaction now and then to sulphur based medicines. The patient's concomitant medications were not reported. The patient received 1st shot 0220 pm yesterday (08Mar2021), she came home and she was fine, she worked around the house, she took a shower and above her left knee cap it looks like there was another knee cap and it looks like in the shape of a mushroom it was hard in the middle, water around it. On her right leg there was a big red welt that was the size of her cap, she had canker under her tongue. She went to the hospital and the hospital gave her an Epipen. She was curious if she should receive her second shot. Therapeutic measures were taken as a result of the events with Epipen which was given to her as a precaution. The patient was hospitalized due to the events. The outcome of the events was unknown. Information on the batch/lot number has been requested.
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| 63 | 2021-03-24 | injection site pain |
fever/chills/body aches/ painful arm/shoulder injection site feels like stabbed with knife can barel...
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fever/chills/body aches/ painful arm/shoulder injection site feels like stabbed with knife can barely move it or sleep on it, tired feels like a mild flu
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| 63 | 2021-03-24 | rash papular, rash with redness | raised red bumps on arm and lower back |
| 63 | 2021-03-25 | injection site bleeding |
10 min after: shot rush of blood back to site of injection, 11min after: wanting to cough, next mor...
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10 min after: shot rush of blood back to site of injection, 11min after: wanting to cough, next morning: passing out on bathroom floor
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| 63 | 2021-03-25 | pain of skin | Arm very tender Fatigur |
| 63 | 2021-03-25 | itchy skin, rash macular |
Eight days following first shot, my arm started itching near the injection location and two quarter ...
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Eight days following first shot, my arm started itching near the injection location and two quarter sized red spots showed up. This lasted a few days. 2nd shot was Mar 18 at 11 am at same facility. Had severe arm and shoulder blade pain the remainder of the day. Used an ice pack. Mar 19 had slight fever in the morning. Severe arm pain had resolved. Severe achiness in lower back and jaws and general achiness. Started taking Tylenol in afternoon. Vomited at 6pm and 10:30pm. Mar 19-21: Severe headache. Barely ate Mar 19-20. Stayed in bed or resting on couch. Experienced intermittent hiccups. No energy. Headache resolved. Mar 22. Mar 26. Still don't feel 100% normal energy level, but pretty much resolved
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| 63 | 2021-03-25 | bruising |
Five min. after injection: Pulse raced for short period of time (15 sec), during that time felt pre...
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Five min. after injection: Pulse raced for short period of time (15 sec), during that time felt pressure in left wrist, later that day experienced large bruise on the on the left wrist,
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| 63 | 2021-03-25 | injection site reaction, rash macular, injection site swelling, injection site redness |
Red raised welp at injection site. Larger than a quarter but small than a half dollar. Painful to t...
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Red raised welp at injection site. Larger than a quarter but small than a half dollar. Painful to touch but I'm not going to my doctor because of it. Unless it gets a lot worse later.
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| 63 | 2021-03-25 | injection site redness, injection site hardening |
Sight is hard and continues to be red and the circle is getting bigger. Bad headache, body/joint a...
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Sight is hard and continues to be red and the circle is getting bigger. Bad headache, body/joint aches, chills, fatigue.
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| 63 | 2021-03-25 | injection site pain, injection site rash |
same day patient devloped sever shoulder pain in vaccinated arm, chills, fatigue and cough, She was ...
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same day patient devloped sever shoulder pain in vaccinated arm, chills, fatigue and cough, She was unable to work the follwoing 2 days due to severity oif her symptoms. She also reports a mild rash at injection site.
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| 63 | 2021-03-26 | injection site pain, injection site inflammation | I have tenderness and inflammed nodule in left arm pit |
| 63 | 2021-03-26 | injection site redness, injection site warmth |
Patient's right arm turned red and was hot to touch within 10 minutes of vaccine administration. Adm...
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Patient's right arm turned red and was hot to touch within 10 minutes of vaccine administration. Administered IM in the right arm and rechecked patient in 20 minutes. Arm redness and warmth decreased, pt advised they could leave. Told them to put ice pack on the arm throughout today and tomorrow and to move arm around and massage the area. Advised that if any other reaction occurs to call 911 if necessary
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| 63 | 2021-03-26 | injection site pain |
Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest...
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Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest, no care attitude, muscle pain, headache, nausea- emptiness in stomach, possibly swollen lymph nodes. This continued until 6pm the next day (3/25/2021) after receiving the covid vaccine. Should I get the 2nd vaccine, scheduled for 4/15?
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| 63 | 2021-03-26 | injection site swelling |
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness...
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Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Swelling of the injection site, jaw spasm, high blood pressure-Mild, Systemic: Hypertension-Mild, Additional Details: Patient started to have swelled injection site arm after about 30 minutes of vaccination but patient remained responsive. 11:40pm - BP 198/100, HR 72. 12pm- BP 198/100, HR 72 & complained of dystonia symptoms so we called 911 paramedics came within 5 minutes. 12:15pm- BP 240/110, HR 72. Called patient's daughter at 2:01pm (patient still in the ER), at 3:16pm (left message to voice mail). Patient did not mention she has history of dystonia after getting any vaccine when asked prior to vaccination
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| 63 | 2021-03-27 | itchy skin |
7 days after my first vaccine my arm got swollen, a little tender and itchy. I had the typical sore...
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7 days after my first vaccine my arm got swollen, a little tender and itchy. I had the typical sore arm immediately after the injection for about 48 hours and it went away.
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| 63 | 2021-03-27 | injection site bruising | Bruise at injection site going on 18 days. More disturbing is aching neck/upper back. |
| 63 | 2021-03-28 | injection site pain |
At approximately 12:30 pm on the day following the vaccination, I began to feel tired. With about 30...
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At approximately 12:30 pm on the day following the vaccination, I began to feel tired. With about 30 minutes, I began to get chills and felt very cold. Took two Tylenol and went to bed. Fell asleep and slept approximately 5 hours. Woke up feeling very tired but not chilled or headache. Ate soup and a grapefruit. Went back to bed and slept until approximately 06:30 the next morning. I felt great except for the soreness around the injection site. The injection site showed no evidence of swelling or redness at any time.
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| 63 | 2021-03-28 | skin warm, dry skin |
Mild tightness in chest, coldness in fingers bilaterally. No SOB. No numbness and tingling in hands ...
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Mild tightness in chest, coldness in fingers bilaterally. No SOB. No numbness and tingling in hands Vital Signs: B/P: 140/88 HR:63 Resp.: 20 O2Sat:99 Skin Signs: Warm and Dry Circulation: Cap Refill <2Sec Resp.: Breath Sounds Clear Bilaterally Treatment: 11:40 symptoms subsiding, improvement noted. Reassessment @11:45 Vitals: 132/84 HR:60 Resp.: 20 O2Sat: 99 Skin Signs: Warm and dry Circulation: Cap refill <2sec Resp.: Breath sounds clear bilaterally Treatment: Advised patient to call 911 if symptoms return or notify PCP. Symptoms resolved at 11:45, encouraged to monitor symptoms, encourage hydration throughout the day. D/C home by self
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| 63 | 2021-03-28 | itchy rash |
had Parkinson's and my symptoms got worse; Full blown period with clotting/haven't had period since ...
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had Parkinson's and my symptoms got worse; Full blown period with clotting/haven't had period since 18 years so now it's heavy; Headache; Acne/cramping/was very irritable/it was PMS; tremor; an itchy chest including nipples/itchy rash, not swollen but a rash on chest and nipples which were itchy; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 06Mar2021 14:45 (Batch/Lot Number: EL3302) as a single dose for COVID-19 immunization. Medical history included Parkinson's, hypothyroidism, aortic insufficiency, allergies: penicillin, tea tree oil, latex, whey. Patient is not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 1998 and ongoing, carbidopa, levodopa (CARBIDOPA LEVODOPA) taken for Parkinson's disease from Feb2013; and estradiol (VIVELLE DOT) for estrogen therapy. Patient previously took prochlorperazine edisylate (Compazine) and morphine and experienced allergies for both. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has not had a period for 18 years. On 07Mar2021 12:00, patient got an itchy chest including nipples, irritability, acne and a heavy full blown period with clotting, cramping, etc. AE resulted in doctor or other healthcare professional office/clinic visit. Events were also reported as follows: patient experienced itchy rash, not swollen but a rash on chest and nipples which were itchy. Patient had Parkinson's and her symptoms got worse. She just went to her neurologist and thought that was a little strange and patient had headache. It was reported that she was irritable, it was PMS. Then patient had full blown period and patient have not had period since 18 years so now it was heavy. Patient had neurology appointment a short time ago and she was doing great and she also had her urology appointment on 23Feb2021 and everything was fine. Patient did use Vivelle-Dot which is half of a milligram, it is an estrogen therapy, but patient have never had any problems with bleeding at all, "nothing like that ever". Itching started on 06Mar2021, and then over the next couple of days, patient started having headaches, irritability, cramping, just overall Parkinson's symptoms, and tremor (medication wasn't controlling her tremor anymore). Patient has not recovered from the events.
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| 63 | 2021-03-30 | vaccination site pain |
Headache still present began day of vaccine; Chilled afternoon of vaccine; minor arm soreness at inj...
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Headache still present began day of vaccine; Chilled afternoon of vaccine; minor arm soreness at injection site; This is a spontaneous report received from a contactable consumer (patient reported herself). A 63-year-old non-pregnant female patient received first dose of (COVID 19, Pfizer, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration on 05Feb2021 09:30 AM at single dose to her left arm for Covid-19 immunization. The patient's medical history included hypertension controlled with medication. Covid was not tested prior or post vaccination. No known allergies. Concomitant medications included irbesartan, spironolactone, vitamin D NOS (VITAMIN D) and MULTIVITAMIN. On 05Feb2021 02:00 PM, the patient experienced headache still present began day of vaccine now day 5. Chilled afternoon of vaccine administration. Minor arm soreness at injection site for 24 hours. She did not receive any treatment in response to the events. Outcome of the events was not recovered.
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| 63 | 2021-03-30 | vaccination site pain |
really bad headache, excruciating headache; nauseous, nausea/queasy; blurred vision; holes in her vi...
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really bad headache, excruciating headache; nauseous, nausea/queasy; blurred vision; holes in her vision; not right; like an allergic reaction; She had soreness in the arm; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 05Mar2021 16:32 (Lot Number: EN6198; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included allergies to Sulfa drugs, Penicillin, and believes she has allergies to Ploymers (She cannot wear polyester and she has to wear 100% cotton). The patient's concomitant medications were not reported. The patient (at the age of 62-year-old) previously received the second dose of Shingles Vaccine in Jan2021 for immunization. The patient experienced really bad headache, excruciating headache on 09Mar2021 21:00, nauseous, nausea/queasy on 09Mar2021, she had soreness in the arm on 05Mar2021, blurred vision on 09Mar2021, holes in her vision on 09Mar2021, not right on 09Mar2021, like an allergic reaction on 09Mar2021. She developed a "really bad headache" around 9pm on Tuesday 09Mar2021, that caused holes in her vision and pain "straight across my forehead". She did treat with Tylenol and was able to finally sleep around 5am. She states that the headache has persisted, and she's felt "nauseous, queasy, and not right" since the headache started. She is hesitant to get the second dose. She was experiencing headache following. She mentioned she is allergic to sulfa drugs, penicillin, and polymers, and thought maybe the headache was a result of an allergy to the vaccine? Ingredients don't appear to have any of her reported allergens. She had soreness in the arm the first 48 hours, which was to be expected and no big deal for her. However, starting on Tuesday, she had an excruciating headache. She normally does not typically get headaches. She believes in vaccinations and as a teacher the minute she could sign up to get one she did. Now she is terrified to get the second one. When this excruciating headache began she woke her husband up to tell what happened. She thought she was going to die, that is how bad it was and she wanted him to be aware and prepared if anything should happen. The excruciating headache started at 9PM. It was excruciating all night. The headache made her queasy because she hurt so bad. It continued into Wednesday. Today and today the pain is duller in her head, much duller than it was. However, she still feels queasy/nauseous. The headache also started with blurred vision. The blurred vision has gone away. It was like there were holes in the TV. She was thinking it was interesting and did not think much of it at first. She thought one of her contacts had a hole in it, but she did not even have any on. The blurred vision lasted 24 hours. The soreness in arm lasted until Sunday or Monday. She confirmed the pain in arm is gone and was gone by Monday. She initially could not wait to get her shot. Now she is terrified to get the second one. She took Tylenol in the middle of the night on Tuesday and Wednesday for the headache. Has allergies to Sulfa drugs, Penicillin, and believes she has allergies to Ploymers. She cannot wear polyester. She has to wear 100% cotton. She is questioning if the vaccine has polymers in it. From what she heard it does and is wondering if this caused her to have like an allergic reaction. The outcome of the event vaccination site pain was recovered in Mar2021, the events Nauseous and headache was not recovered, other events was unknown.
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| 63 | 2021-04-01 | rash |
rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso...
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rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso, had it on legs/face was so red like the rough sunburn feeling; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Felt dizzy and weak/had less energy today; Dizziness and lightheadedness /felt dizzy and weak; Worst and really sharp Charlie horse between ankle and calf- took forever to walk; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Anaphylaxis due to vaccination; Vomited; Major diarrhea; She was so cold that her toes were purple; Blood Pressure so low: 58, couldn't find a bottom number at first but then at the hospital it was 58/38; Face was extremely pale; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; Too cold to function or do anything; Nauseated- almost like morning sickness/Extremely nauseated/queasy feeling; Nauseated- almost like morning sickness; very extremely tired; creatinine /it was still high; sick; body temperature was low; She thought she was going to die because of the purple toes; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; her body catching up on sleep or she's just tired; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, on 11Mar2021 as single dose in left arm for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (It's under control now, fairly healthy; diagnosed probably when she started menopause in early 50s), ongoing Anxiety (Diagnosed probably when she started menopause in early 50s), ongoing Sinus headache (Worst sinuses; Takes Excedrin because Tylenol does not have an effect on her), ongoing smoker (Pack a day, but smoking about only about half of it each time. started when she was a teenager. She was without a cigarette for 3 days in the hospital, but when she came home she had to start again), menopause (in early 50s), shoulder- torn rotator cuff-operated in 2018. Family history included cardiac and heart disease, Parkinson's and Frontal lobe dementia (husband). Concomitant medication included colecalciferol (VITAMIN D3) 1000 IU, once a day, by mouth (Taken these for as long as she can remember, they kept advising it, husband takes it for Parkinson's so she just throws one in for her), calcium ascorbate (VITAMIN C) 1000 IU, once a day, by mouth (Started at least 2 years ago, doesn't drink enough orange juice, doesn't do fruits, doesn't get enough Vitamin C), linum usitatissimum seed oil (FLAXSEED OIL) 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for cardiac and heart disease, takes as preventative, fish oil 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for family history of cardiac and heart disease, takes as preventative, hydrochlorothiazide, lisinopril 20/12.5 mg, once a day, by mouth (She has been taking this medication for years, under control with this medication) for High Blood Pressure, lansoprazole from 2020 30 mg, once a day, by mouth (Started years ago) for Stomach pill for acid reflux, duloxetine hydrochloride 60 mg, once at bedtime, by mouth (Started forever ago) for just being achy and anxiety, lorazepam .05 mg, 1 tablet 3 times a day, takes one tablet a day at bedtime, by mouth for Anxiety (Started this a while back- with the heart disease and everything else, gave this to help with menopause symptoms too), meloxicam 15 mg, at bedtime as needed from 2017 for back issues- really sore at times, takes if really stressed or she overdoes it. Patient previously took Tylenol for sinus headache and does not have an effect on her. After the first dose of the vaccine the patient reported that she was extremely tired on 11Mar2021. She was completely nauseated most of the day on the second day. On Saturday, she was extremely nauseated (12Mar2021) with vomiting and major diarrhea on 13Mar2021. By 4 PM that afternoon (12Mar2021), she could not function because she was so cold; she felt like she was in a really bad dream and couldn't wake up. She called on 13Mar2021, her blood pressure was so low-they got 58 for the top number, they were unable to pull up bottom number at that point. patient reported that when the ambulance arrived, they described her face as extremely pale on 13Mar2021; her major complaint was that she was so cold- she has never been that cold in her life. When she got to the ER- they had to use the old blood pressure cuff to get her blood pressure because it wasn't coming up on the machine- the kind where you pump it up and watch the needle, they said it was 58/38. patient states that they asked her about the rash that was all over her body in 2021; caller reports that she did not have a rash when she called at 4 PM. patient describes the rash as an extremely red sunburn rash- like you got really bad sunburn, most of it was on her torso, she also had it on legs on 13Mar2021. patient mentioned she remembers them taking off sock and her toes were purple on 13Mar2021. She also had a red on her eyelids- she described as itchy and swollen on 13Mar2021. patient mentions that unbelievably as sick as she was in 2021, she could understand everything that they were telling her. Treatment was given as they prescribed her Prednisone and Benadryl; she was also hooked up to an IV, and they were trying to warm up her body because body temperature was low in 2021. Discharge paper reads as anaphylaxis due to vaccination on 13Mar2021. patient states that she came home from hospital on Monday, 15Mar2021. patient reports she started a diet. 2nd day (12Mar2021)- From the time she got up, she was too cold to do anything; she couldn't walk and she was feeling like she was getting the flu. Saturday (13Mar2021)- She woke up and had the worst Charlie horse between ankle and calf- took forever to walk Charlie horse off. Really sharp Charlie horse. Even had less energy today. Really nauseated. patient reports that yesterday and today, she is just tired. She doesn't know if it's just her body catching up on sleep or she's just tired; she will find out today when she goes to doctor. Caller mentions that she is normally more active than she feels right now. patient reports her eyes have been itchy and she has a rash on her eyelids. patient doesn't know if it's from the shot; patient mentions that she decided on 01Mar2021 she would start a diet, get healthy, and see a nutritionist. patient reports that initially she didn't think her symptoms were from the vaccine and thought it was that she wasn't eating enough food on Friday. She got in touch with the dietitian. patient reiterated she did not attribute this to shot right away. patient reports that she was wondering if she had asymptomatic covid, and it would have been within a 3-month period that she reacted to the shot. She was not sick if she did have asymptomatic covid. There still trying to figure out why her body had this reaction. patient states that every now and then she was still cold, but she doesn't know if its her imagination and plus it is cold outside where she is. She is still on the cuff on that one. patient describes the nausea she first felt as almost felt like morning sickness on 12Mar2021-that's why she attributed it to her diet. patient mentions that the day she started feeling better, late Sunday afternoon, she wanted salty foods. Anything salty, chips, she just really wanted salty stuff. She was not normally a salt person, but the saltier it was, the better it was. patient reports that when she was vomiting with diarrhea and laying down, she would be throwing up in a towel because she couldn't make it to the bathroom when she was laying, it would just gush. patient describes it felt like her body was going to be locked into the position it was in, she doesn't know how to describe it. patient states that she had vomit on her clothes when she called. patient reports the nausea stopped late Monday and the queasy feeling went away. patient reports she stopped vomiting when they gave her Zofran- they had to give her a couple because she didn't stop throwing up right away. patient reports she was extremely dehydrated and her kidneys were showing some damage; her creatinine level was really off on 13Mar2021. The diarrhea was gone, but now she has a mixture of soft stools and semi formed. It is trying to improve but hasn't yet. patient states that because of her creatinine level, they did want her to drink and she might have soft stools because she was drinking so much. patient reports she knows when her husband put the shirt on her she did not have the rash, but when the ambulance arrived, they said she had the rash. Upon discharge, they told her not to receive any further covid vaccines- she cannot get her second one which was scheduled for 01Apr2021. She started experiencing the really cold feeling on 12Mar2021 after receiving the vaccine. She went to bed at 7, that's not like her, she was usually up all hours of the night. symptoms she was experiencing were beyond typical. patient reports she also felt dizzy and weak on 13Mar2021. She thought she was going to die because of the purple toes in 2021- she knew that was a sign of her body shutting down and she got the most scared. patient mentions she is experiencing a residual side effect from the covid and influenza tests-both were negative on 13Mar2021, but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph in 2021. patient reports she feels human today, but she is still sleepy in 2021. She thinks she would feel a whole lot better if her nose stopped running. The tiredness might be from nose blowing and stuff. patient remembers the nurse was thrilled that her toes weren't purple anymore. It started going away when her blood pressure and everything came back up. patient states that she was so scared that she was dying so she remembers everything that happened. patient remembers she was in the ER still when her blood pressure improved. Treatment for her face was so red like the rough sunburn feeling and putting moisturizer on the dried cheeks. patient reports that she doesn't see any patches of red on her. Part of her has a fear that the stuff is not totally out of her system and it will happen again. patient mentions she has heard comments that this was not a typical reaction from the first one and wants to know if it is typical to be that sick from the first dose. patient reports that now her eyes just feel like she's allergic to something. She doesn't know if the redness is from crying now- it was improving, but was still there. Husband has Parkinson's and Frontal lobe dementia and she is his caregiver, she cannot afford to get Covid, she wants to get back to normal. patient reports that she did not take any of her prescriptions the day of the vaccine, she did not want to get a reaction. patient reports she had her shoulder- torn rotator cuff-operated on in 2018. If nose is really stuffed up or allergies, or Fluticasone nasal spray- she can take it 2 times a day, 2 squirts in each nostril, take it as needed. patient reports that she has the worst sinuses- when it gets too bad, she'll go to the doctor and she'll prescribe Flonase, take Metamucil or whatever she thinks will help with sinuses. she still wants to get the second vaccine. patient reports her creatinine came down well enough that she could come home from the hospital, it was still high on 15Mar2021 so they told her to drink lots of water so she does not get dehydrated. Patient was hospitalized from 13Mar2021 to 15Mar2021 for Anaphylaxis, Tiredness, Nauseated, Morning sickness, Vomited, Activities of daily living impaired, Walking difficulty, Flu like symptoms, Pale, Photosensitive rash, Asthenia, Dizziness, Charley horse, Dehydration, Renal disorder, Creatinine low, Cold, Diarrhea, Purple toes syndrome, Blood pressure low, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid. For rash also patient was hospitalised. The outcome of Vomited, Pale, Photosensitive rash, Dizziness, Asthenia recovered on 13Mar2021, Nauseated, Morning sickness recovered on 15Mar2021, Activities of daily living impaired, Walking difficulty, Flu like symptoms recovered on 17Mar2021, Diarrhea, Cold, Blood pressure low, Purple toes syndrome, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid were recovering, Tiredness and Creatinine high were not recovered, while remaining events were unknown. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-04-05 | redness, rash, itchy skin |
AFTER PT LEFT THE PHARMACY AFTER WAITING 15 MINUTES SHE NOTICED HER FACE WAS RED AND HER ARMS HAD A ...
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AFTER PT LEFT THE PHARMACY AFTER WAITING 15 MINUTES SHE NOTICED HER FACE WAS RED AND HER ARMS HAD A RASH, AS SHE DROVE AWAY SHE DECIDED TO DFRIVE TO THE MEDICAL FACILITY ACROSS THE STREET FROM US WHERE SHE WAS TREATED WITH AN EPIPEN AND BENADRYL AND WAS TAKEN BY AMBULENCE TO A HOSPITAL (UNSURE WHICH) WERE SHE WAS MONITORED AND RECEIVED A COURSE OF STEROIDS AND LEFT WITH A RX OF STEROIDS AND BENADRYL. SHE CONTACTED OUR PHARMACY ON 4/6 TO INFORM US OF THE EVENT AND STILL HAD A RASH AND ITCHING AT THAT TIME
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| 63 | 2021-04-06 | injection site pain |
Horrific pain in left arm, shoulder, neck every day since the first injection. Pain is 24/7, ongoi...
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Horrific pain in left arm, shoulder, neck every day since the first injection. Pain is 24/7, ongoing, causes lack of sleep, severe discomfort, inability to function
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| 63 | 2021-04-09 | itchy skin, redness |
arm started swell a little bit; woke me up at 5 O'clock this morning in pain; arm started swell a li...
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arm started swell a little bit; woke me up at 5 O'clock this morning in pain; arm started swell a little bit; woke me up at 5 O'clock this morning in pain; shoulder is kind of swollen; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; arm kind of still stiff and sore; Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613 and expiration date not provided) via an unspecified route of administration administered in the arm, on 23Mar2021 as a single dose for COVID-19 immunization. Medical history included breast cancer survivor. The patient's concomitant medications were not reported. The patient stated that she was trying to figure out what to do. On 26Mar2021, her arm started to swell a little bit. When she woke up, it woke her up at 5 o'clock in pain and her shoulder was kind of swollen, it has got big old knot and it was red and it was apparent itchy and she could not scratch it so, she thought about it and she got an ice pack, so she put ice on it. She was holding ice on it now, trying to sooth it. She was wondering where she would go for reaction, she knew she had reaction like this before so she had a side effect from it, and her arm was kind of still stiff and sore. She did not go to the emergency or urgent care because she looked at left and she looked at the right and like she said, it was swollen and she got big old knot and it was red. She also stated that she did not take Tylenol today. She did not know what she wanted to get through to somebody and she needed to speak to somebody on what she needed to do. She also said that on an unspecified date in Mar2021, in her stool, she found some blood. She had another appointment with her "thyroid" (not clarified) and she does not know the results yet. The outcome of the events was not recovered. Information about lot/batch number has been requested.
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| 63 | 2021-04-09 | vaccination site pain, vaccination site redness |
pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circ...
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pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circle around it and it's hard; she had a little bit of pneumonia; got a fever; felt like she couldn't go to the bathroom, cramps; had trouble breathing; the site was red; swelling/her arm is swelling; it does hurt her, right in that area where the shot was given; arm was sore and achy/her arm started aching; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6208, expiration date unknown), via an unspecified route of administration, administered in left arm on 22Mar2021 at the age of 63 years old at a single dose for COVID-19 immunisation. Medical history included ongoing pre diabetic, ongoing high blood pressure, ongoing non-alcoholic liver disease, edema, to help her breathe, pneumonia, COVID in 2021, respiratory problems, asthma, little bit of obesity, swelling in her legs, varicose veins. Concomitant medications included benzonatate at 100 mg to help her breathe, azithromycin (six pills of that, 200mg, two one day and one pill a day until gone) for pneumonia. Patient had her second dose scheduled on 12Apr2021. She explained after the shot, her "arm was sore and achy" she said she also had "pain". She added she experienced "flu-like symptoms". She specified these adverse reactions are all gone now but her arm is still "a little sore" and she has one area with a "big circle around it and it's hard". She said it could be "swelling". She asked if her reaction was reported as side effects to the vaccine. She expressed being in a rush and is expecting her daughter soon and asked us to be quick. She said she will also consult with her HCP this afternoon. Patient stated she had the first shot on Monday 22Mar2021 and today and last night the site was red, but today in that area she has gotten a big circle around it and its hard. Patient stated she's had it before with shots and just wanted to make, sometimes she has had to be put on medicine for it, wanted to be sure its healing because it does hurt her, right in that area where the shot was given. She also stated that after she has her second shot on 12Apr2021, she would like to talk to somebody and she would like to be able to have people in her home. She was reporting she had COVID three weeks ago, would she be ok after the 2nd shot to go out? She stated her daughter thinks she needs to wait until the end of April. She verified she did receive the Pfizer BioNtech Covid 19 vaccine. Swelling: Patient stated her arm is swelling. Also stated she always gets that and today there's a circle there and it is red and hard. Also stated occurred after the shot. Patient reported that the shot hurt like heck and she couldn't really tell, she has big arms, she knows it was swollen. Reported she took over the counter medicines, last night she noticed it was a circle and it was hard there. Stated area is not swelling anymore, now just one hard red circle. Red and a hard circle: She also reporting her entire arm ached after the shot, she stated she knows her entire muscle was aching. Stated it was swollen quite a bit but now its just red and a hard circle, and it's ongoing. Arm swelling outcome: Patient reporting yesterday afternoon, she was feeling better, except that one spot. She stated it does hurt when she bends it because she had that one little area that's swollen. Also stated the swelling started later that afternoon after the shot. Reported she went for a walk with her daughter and her arm started aching. It felt like she couldn't go to the bathroom, cramps. It felt like she had a little bit of the flu, and it was from the shot but it only lasted a few days. Stated that part went fast, got a fever, other than that, just the one area on her arm. Stated she doesn't even feel sick from the shot or anything. Stated she had Diarrhea: Stated she had diarrhea in the beginning after the shot then had trouble going to the bathroom. Stated she thinks its because she has IBS and that's how her body is. She doesn't know if that's from the shot or not because that's how her body always is. Pfizer BioNtech Covid 19 Vaccine: Patient stated she doesn't want COVID again. She has respiratory problems anyway, she has asthma and a little bit of obesity. She states she was in fear of herself. She doesn't do well with hospitals and being put under with that medicine. Also stated patient knew COVID causes a lot of people having trouble breathing and she doesn't want to end up on a breathing tube where its breathing for her and she never sees her family again. Caller states it kind of scared her. Patient stated her niece and nephew, whos got it worse. She stated she went to the hospital and haven't been back. She stated she was hospitalized about 2 weeks ago, and that's when she was diagnosed with COVID, before she got the first COVID shot. About the medical history, non-alcoholic liver disease: Stated diagnosed about eight years ago, she would say the same time, about 7 to 8 years ago because she had a virus and when she went in the hospital, the virus had attacked her right kidney and liver. She stated with non-alcoholic liver disease, she is overweight, and that causes her to have issues with her liver. The last few times her liver has been okay. Pre-Diabetic: They have been watching that for a while. Stated she gets edema, swelling in her legs, well, all the time. She has had this the last two years because she is pre-diabetic and a lot of overweight people have that. She also has varicose veins so that doesn't help. Stated that was given those to help break up, because she had pneumonia when she got the COVID and she had a little bit of pneumonia and had trouble breathing. The patient was recovering from arm was sore and achy/her arm started aching, swelling/her arm is swelling and for other events it was recovering.
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| 63 | 2021-04-15 | vaccination site pain, vaccination site swelling, injection site redness |
Started with arm being very sore at vaccination site, thrm developed a round red spot at vaccine sit...
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Started with arm being very sore at vaccination site, thrm developed a round red spot at vaccine site which is becoming bigger. Also, have a canker side in my throat-I send to get them as a child, in my throat. Also, broke my knee cap 2 years ago and it had become painful
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| 63 | 2021-04-17 | bruising |
has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart ra...
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has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart rates; She'll have a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night.; When probing for specific event information she reports it's kind of like she coughs a little more and she is a little more short of breath and it's happening more often; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 63 years, via an unspecified route of administration on 27Mar2021 04:06 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history included asthma, hysterectomy, dark chocolate or red dye (she starts coughing and has an allergic reaction and shortness of breath), bursitis (in her right). The patient's concomitant medications were not reported. The patient previously took penicillin, experienced allergy and had really ad hives (several years ago) she was given a cream to put on. She had to get another medication and she doesn't remember the name. That medication made her dizzy and she couldn't even get out of bed so they had to half the dosage. When she had her hysterectomy she learned she couldn't take any types of "cillins" medications. The patient had been watching her heart rate with a device and since getting the Covid 19 vaccine she's noticed her heartrate was always higher than it normally is. Her heartrate was going crazy, the device was not recording right. She reports that for the last 2 days the device has been telling her she has possible atrial fibrillation. This is worrying her. She doesn't feel anything different. She was usually hyper. Her resting heartrate was higher. Normally her resting heartrate was in the 80s (beats per minute) Now it's going up to the 90s (beats per minute) then her heartrate drops to 40 something (beats per minute) Then the device said her heartrate was 118 and 107 and she's not even doing anything. She hasn't even worked out yet. She doesn't like to take medicine. Medications don't work out with her. She had a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night. It was reported that she feels fine. She has no other symptoms. She's been reporting online. Clarified she's reporting online through the V check through the CDC. She's been trying to get the Covid 19 vaccine forever. She did research on all the Covid vaccines and she felt more confident with the Pfizer Covid 19 vaccine. Her daughter was against the Covid 19 vaccine. Her daughter thinks the vaccine was just going to kill her. She reports she was healthy and she works out 6 days a week. She recently tried to get a CT scan for her heart. Her husband's cardiologist recommended her husband have a CT scan of his heart and she decided she needed a CT scan too. She's also watching her heartrate on her watch. Her husband's heartrate is completely normal and stable on the device so she knows the device isn't messed up. It was also reported that the device will tell her she has too much muscle movement and she's standing completely still. Then she'll get the device to record her heart rhythm and it goes sporadic. The device tells her 90 beats per minute at resting then over 100 beats per minute. Her heartrate on the device was going up and down a lot. When she's been watching the device record her heart, it looks like it's going crazy. Her heartrate goes way up and way down like in the 40s (beats per minute) She noticed when her heartrate is in the 40s (beats per minute) and she's never had her heartrate go down that far, it's really really weird. She thinks maybe she'll get back to normal. She keeps watching hear heartrate. She reports she noticed her heartrate right away on Saturday evening after she received the Covid 19 vaccine. Her heartrate was higher than normal for resting, it was in the 90s (beats per minute). Her resting heartrate is usually in the 60-80s (beats per minute) and it was the in 90s. Now the device says possible atrial fibrillation. It was further reported that she received the Covid 19 vaccine in her left arm because she has bursitis in her right. If she hit her arm the second day after the Covid 19 vaccine, her arm would hurt. Her arm felt better the next day. She clarifies, on Sunday, 28Mar2021, she noticed her arm felt like a bruise and that was it. Then the next day on Monday, 29Mar2021, the feeling was gone. She didn't have any redness. The outcome of the events her arm felt like a bruise and arm would get hurt was recovered on 29Mar2021, irregular heart rates, dyspnea, cough was not recovered and unknown outcome for has possible atrial fibrillation. Information on the lot/batch number has been requested.
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| 63 | 2021-04-23 | redness, itchy skin |
face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; face w...
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face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; Continued to worsen all day and night. Eyes and lips swelled shut; entire face and neck brilliant red; max amt of itching; neck still red and bumpy; Have been unable to sleep well; This is spontaneous report from a contactable healthcare professional (patient herself). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246), via an unspecified route of administration on 04Feb2021 at 15:15 PM (at the age of 63-years-old) as single dose in left arm for COVID-19 immunisation. The patient's medical history included diabetes Type 2, hypothyroid, shingles 10 years ago. Patient had known allergies. Concomitant medications included Synthroid, Rosuvastatin, Metformin, Tresiba and Ozempic. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no COVID prior vaccination and was not tested COVID post vaccination. On 04Feb2021 at 20:00 by midnight, the patient's face was swelling, bright red, and very itchy. She took one Benadryl. Her face and neck worsened, got into MD in morning. She prescribed Claritin and make appointment with allergist. Patient did both. Events continued to worsen all day and night. Her eyes and lips swelled shut, entire face and neck brilliant red with maximum amount of itching. Patient kept ice on face and neck all night but continued to worsen. She went into hospital Emergency Room at 9:00 AM, received IV Prednisone, Benadryl and one more. Also, prescribed with Famotidine, Prednisone, Benadryl and Tylenol if needed for home. Itching started subsiding, brilliant red remained everywhere, swelling was still significant around eyes and cheeks, neck was still red and bumpy. Patient have been unable to sleep well. She took appointment with allergist 08Feb2021 morning. She wondered if she should take second vaccine and reported that this has been an expensive and emotional nightmare. The outcome of the events was not recovered.
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| 63 | 2021-04-24 | vaccination site pain |
could not sit down; She could not sit down and sleep before; muscle pain in right leg, from right fo...
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could not sit down; She could not sit down and sleep before; muscle pain in right leg, from right foot and traveled up to knee/It came on and off/the pain was unbearable/The muscle pain at first was on the right leg only and last night it was both legs.; Right arm soreness; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 63 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534) via intramuscular, administered in arm right on 25Mar2021 14:30 as single dose for covid-19 immunisation. Medical history included high cholesterol. She is pretty healthy. No vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Concomitant medications included pravastatin (40 mg tablet) for high cholesterol taking for 2 years and stopped since Friday (unspecified date); Vitamin D. After having the first injection at a hospital, patient did not feel anything, just a little right arm soreness (25Mar2021 14:30). But exactly a week after, on Thursday (30Mar2021), she started to feel muscle pain in her right leg, from right foot and traveled up to knee. It came on and off. She did not take any medication. But Friday (02Apr2021) it got worse, she took only one paracetamol (TYLENOL Arthritis PAIN 650 mg, Count size 24 caplet, Lot: SLA055, Expiration: Jul2023) and felt okay. On Saturday (03Apr2021) happened again, she also took one in the morning and at night. On Sunday (04Apr2021), she felt again in morning took 1 paracetamol and at night she took another one, the pain was unbearable. Next Monday (05Apr2021), she almost called 911 at 7pm but she didn't do it, her neighbor is a nurse for 46 years and she told her to take two paracetamol. Last night (05Apr2021), she took two. She could not sit down and sleep before (Apr2021). She was able to sleep. This morning she felt it again (06Apr2021), her neighbor told her to take 2 for 3 times or every 6 hours. She took 2 this morning. She is scared. She called her doctor. She was going to call 911 last night because the pain was bad and she was scared. The muscle pain at first was on the right leg only and last night (05Apr2021), it was both legs. She needs the right medicine. The doctor said she should call Pfizer and discuss. She wondered if it is okay to take second dose and what the right medication is to take to help with the pain. Patient did not visit emergency room. The patient assessed the report as serious. Outcome of muscle pain in legs was not recovered, outcome of other events was recovering. No follow-up attempts are needed. No further information is expected.
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| 63 | 2021-04-24 | hives, itchy skin |
couldn't get out of the bed as the pain all the way down to her back was killing her, like it was pa...
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couldn't get out of the bed as the pain all the way down to her back was killing her, like it was paralyzing her; allergic reactions; Swelling in the face; hives on her back; itching that was in her back; Neck and back pain were pretty intense; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8729), via an unspecified route of administration on 02Apr2021 at a single dose for covid-19 immunization. Medical history was reported as many medical conditions, names unknown, just a combination of medical problems. The patient was taking unspecified concomitant medications, some of which were taken in the morning. The patient had the vaccine on 02Apr2021 (reported as "Friday or Saturday") in the afternoon and had a bad adverse reaction to it. The patient had swelling in the face, hives on her back, itching that was in her back, and, allergic reactions on 02Apr2021. Due to these, since she was just in a medical facility, doctor and nurses over there were able to inject her with Benadryl that was a strong dose, in a long needle given into the muscle and stuff. It was good enough that she got up and was sent home. She then seemed to be fine but on Monday, 05Apr2021, she couldn't get out of the bed as the pain all the way down to her back was killing her, like it was paralyzing her. She could not even get out of the bed for like hours. The neck and back pain on Apr2021 were pretty intense, and she does not know where and how it came so she was trying to figure that out and realized she just recently had the vaccine injection. She knew that there could be some kind of reaction, but she was not sure if it were from the vaccine. She wanted to make sure she did not get something serious because she already has rare conditions. She added she did not have any prior treatment for these because she did not even think like this was even a side effect of the Pfizer vaccine but now she was wondering if it was because she had not taken anything prior. She does not know if it was related or not and she was concerned about it. She wanted to know what she could do if these were side effects because she knew there were some people that have something to do with the spinal cord and she was not sure if their symptoms were like hers or not. She wanted to know if she would need treatment for it and if it was an adverse reaction. She added that the swelling in her face and, itching that was in her back went away the same day when she was given the vaccine. The outcome of the events swelling in the face and itching that was in her back was recovered on 02Apr2021. The outcome of the other remaining events was unknown.
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| 63 | 2021-04-26 | itchy skin, skin warm |
Itchy face, neck and upper chest. Face is warmer on side that is the itchiest. Injection was at 11:...
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Itchy face, neck and upper chest. Face is warmer on side that is the itchiest. Injection was at 11:14 am, symptoms started at 7:00 pm. I took 10 mg of Cetirizine Hydrochloride at 8:00 pm. It is now 9:27 and symptoms have subsided a bit.
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| 63 | 2021-04-26 | itchy skin, redness, hives |
welts on face; really itchy spots on face and neck; ears were red, hot, and itchy; ears were red, ho...
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welts on face; really itchy spots on face and neck; ears were red, hot, and itchy; ears were red, hot, and itchy; This is a spontaneous report from a contactable consumer(patient).A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 09Feb2021 as single dose for covid-19 immunisation. Medical history was none.Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,lot number EM9810) via unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation, anatomical location was left upper arm muscle. There were no concomitant medications.Patient was took second dose of vaccine on 09Feb2021 and on 12feb2021, night her ears were real hot, she had no other symptoms at all with the vaccine, no headache or fever, her ears were red, hot, and itchy, welts on face are still there and itchy, and her neck, and on 15feb2021, she has 2 spots on two fingers, they have itchy spots on them, little bump on each one. She wondered if this was related to it, it was 3 days after the vaccine, that it started. She was not sure this was an experienced, she was curious to know if it was a side effect. Family medical history relevant to AE was none. she has taken some Benadryl. The outcome of the event was unknown.
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| 63 | 2021-04-27 | vaccination site pain |
her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got ...
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her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got red; could not sallow; her lymph nodes in the neck were swollen, they hurt really bad; Her lymph nodes in the neck were swollen, they hurt really bad; had pressure in the ears; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; This is a spontaneous report received from contactable consumer (patient). A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 63-year-old) for covid-19 immunisation. Medical history included COVID-19, she was tested positive for COVID in Jan2021. The patient's concomitant medications were not reported. On an unspecified date she experienced burning sensation at the site (that went away), later experienced tiredness, achiness all over, and her throat got red and swollen, could not sallow, she felt like getting COVID again after the vaccine. Her lymph nodes in the neck were swollen, they hurt really bad, had pressure in the ears, pain in the shoulder, back of the head, in the back and in the neck. She wanted to know if she should to get the second dose or not, if she can get the shot in the gluteal or other sites. The event her throat got swollen was considered medically significant. The outcome of Vaccination site burning was recovered, of all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 63 | 2021-04-30 | vaccination site rash |
stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has...
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stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has a rash about the size of a quarter at the injection site; temperature of 102 degrees/fever; tightness in her chest; She threw up five times; She felt nauseous; Nightmares; She started coughing; muscle weakness; Her arm is sore; She could barley lift her arms; very very weak; delirious; restless; her head was pounding; has been sleeping an enormous amount.; headache; restless; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm right on 12Apr2021 15:00 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included Neuropathy, Blood pressure abnormal, and allergic to cats, dogs, and everything outside. Concomitant medications included clonazepam taken for neuropathy peripheral, start and stop date were not reported; captopril taken for blood pressure abnormal, start and stop date were not reported; cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 23Mar2021 15:40 (Lot number: EH6204, She has difficulty reading the handwriting, she stated that the second character H, may not be an H.) (at age of 63-year-old) in right arm for Covid-19 immunisation and she felt like she got hit by mac truck, she was that tired and She felt like she could hardly move. There was no additional vaccines administered on same date of the Pfizer suspect or prior vaccinations (within 4 weeks). On the weeks that she received the first and second dose of her COVID vaccine, she skipped getting her allergy shot that week. She normally got her allergy shots every week. Patient weight: 176-178 pounds. It was reported that the patient was fine after she received the second dose, until about 11:00PM on 12Apr2021. She started to get muscle weakness. She was delirious on Monday night (12Apr2021). She also felt restless on 12Apr2021. Her head was pounding on 12Apr2021. She felt nauseous on 13Apr2021, very very weak began on 12Apr2021 23:00 and had tightness in her chest on 13Apr2021. She has only thrown up three times in 50 years. She threw up five times on Tuesday, 13Apr2021. She started coughing Tuesday morning, 13Apr2021. She thought maybe she was coughing because she needed to throw up. She does not know why she is coughing. Over the past few days, she has stayed in her pajamas so she did not look for a rash. She noticed she has a rash about the size of a quarter at the injection site. She did not really pay the rash much attention since she was so sick. She has a rash about the size of a quarter at the injection site, She noticed it on 14Apr2021 whenever she took a shower and took of the band aid. Clarified that it is about the size of a silver dollar. There was also a knot. She began running a fever on 13Apr2021. Yesterday (14Apr2021), she had a fever of 102 degrees. She has been taking 2,000-3,000mg of Tylenol and it has not been helping her fever. Yesterday (14Apr2021), her temperature was the same, and her head was pounding. She was able to eat a little bit, she drank a lot. She has been sleeping an enormous amount from 12Apr2021. Last night (14Apr2021) her temperature was at 100 degrees. It started to come down, before she got up. She normally does not sleep eight hours a night. She has been sleeping more than eight hours. Before she got up out of bed this morning (15Apr2021), she checked her temperature and it was 98.6 degrees. She knows that most people do not consider that a fever, but for her that is. Her temperature is usually 97 something degrees. 98.6 degrees is still sick to her. She was going to work from home today (15Apr2021), but whenever she sat at the keyboard to type, she could barley lift her arms. She could barley lift her arms began about 11:00PM on 12Apr2021. She has not tried to work. She still has a bit of a headache, and her fever broke, so she thought she could work today (15Apr2021). She felt extremely weak. Her stomach was cramping. She drank some tea, and ate a banana. She would describe it as stomach abdominal cramping. She was not expecting to feel this way. Her arm was still sore. Her arm was sore began about 11:00PM on 12Apr2021. She was going to see her doctor next week for a semi annual check up appointment.She was restless all day yesterday (14Apr2021). She has a back back, and has back pain. Whenever she has muscle weakness, her back is bad, and makes her hurt every where. Yesterday (14Apr2021), she was still restless and could not sit still. It is better today (15Apr2021), but has not gone away. On the morning of 13Apr2021, she felt nauseous. Now she feels a different type of nauseous. Before the nausea was in her chest, she thought she was going to have a heart at-tack. She called her husband at work, and asked him to come home because she was so scared. Whenever she threw up, it relived the pressure in her chest. She vomited four times and it gave her immediate relief. She vomited one more time later that evening after trying to eat some chicken broth. She just drank liquids after that. Nauseous intestinal: It feels more intense today (15Apr2021). It feels like it is moving down. Clarified that this is the same feeling as stomach abdominal cramping. She has issues with IBS, and diver-ticulitis. But this is different. She has not eating anything. With IBS, it is eating and the diarrhea. This is more like gassiness. She has had bowel movements, they are more intense with abdominal con-tractions. Very weak: Began about 11:00PM on 12Apr2021. She knew that night that she was not going to be able to go to work the next day. It is better. She thought that is was resolved this morning (15Apr2021), but then she could not get up the stairs. Her office is upstairs. Whenever she got to her office, she lifted her her arms to type and it was hard for her to hold her arms up. She has been sleeping an enormous amount: She did not do anything but drink, use the bathroom and sleep on 13Apr2021. Whenever she was sleeping, it was not a good sleep. Her temperature was 102 degrees, and her head was pounding. She was having nightmares. She was in a constant state of dreaming that she could not get out of. She still has been sleeping a lot. She has been trying to walk around. She put on a lidocaine patch, and is wearing a back brace. She was sleeping less than she was but it is still an enormous amount for her. She normally sleeps about five to six hours a night. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken. The outcome of events muscle weakness, restless, 'Her head was pounding', Weakness, cough, was recovering, of delirious was recovered on 14Apr2021, of 'tightness in her chest' was recovered on 13Apr2021, of nightmares was recovered on 14Apr2021, of other event was unknown.
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| 63 | 2021-05-04 | hives, itchy skin |
Itching; Hives on her forehead and ear; This is a spontaneous report from a Contactable consumer. A ...
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Itching; Hives on her forehead and ear; This is a spontaneous report from a Contactable consumer. A 63-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) (Lot number, expiry date not reported) via intramuscular on left arm on 19Jan2021 at 24:00 as Single dose for COVID-19 Immunization. Patient medical history included she stated that she had hives on and off since her 30s and adds she was menopausal, allergy, Blood pressure from unspecified date. No prior vaccination taken within 4weeks. Patient concomitant medication included Zyrtec (CETIRIZINE HYDROCHLORIDE) 10mg one twice daily by mouth, taking a year and half; Aldactone (PIRONOLACTONE) taking for over a year, Singulair (MONTELUKAST SODIUM) 10mg; take once daily by mouth at night for allergy,taking for a year and half from unspecified date and still ongoing. On 22Jan2021, patient experienced broke out in hives; came on her forehead and right ear after receiving first dose of vaccine. She experienced itching from unspecified date. Hive came three days later on her forehead and right ear. Six days visited clinic. Treatment was given by Pepcia and Atarax for the itching and it worked definitely; All of her hive cleared up the next day. She was scheduled for the second dose on 09Feb2021. The Outcome of events was recovered on 30Jan2021. Follow-up attempts are completed. No further information is expected.
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| 63 | 2021-05-07 | skin discolouration, bruising |
DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right sh...
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DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right shoulder; very warm; swelling rapidly; sever left arm pain; nausea; Floating Bruising; Charlie horses on right leg calf; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL 3249) as SINGLE DOSE for covid-19 immunisation, at 63 years old. Medical history included caesarean section from 1988, and allergy to animal (Cat and Dog dander) from an unknown date. Patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 30Dec2020 17:00 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunisation. There were no concomitant medications. The patient previously took tramadol and experienced drug hypersensitivity (allergies). On 08Apr2021, while patient was reclining in her chair, she felt a tingling feeling on her right leg. She pulled up her pants leg and found her leg was severely black and blue, very warm and swelling rapidly. She went to the ER they did a CT scan and Chest Xray (Apr2021). The ER Doctors (mostly Medical Students at a Teaching Hospital) suspected she had a DVT. Patient was also experiencing severe left arm pain, left hand tingling and severe nausea. They said patient was fine on all accounts and told to get rays of her right leg and for her to follow up with her primary Doctor who is an NP with Hospital. After doing everything as instructed by all the Physicians, 16 days of the bruising and ER visit, patient is still experiencing "Floating Bruising" appearing on her right leg, right ankles and Charlie horses on right leg calf. Today patient now have black and blue on her right shoulder. Patient commented "Someone help me please. This is scary". Events occurred on 08Apr2021 17:00. Treatment was received for the events and required emergency room and physician office visit. Outcome of the events was not recovered.
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| 63 | 2021-05-07 | rash with redness |
Entire body covered in a red rash; This is a spontaneous report from a contactable consumer (patient...
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Entire body covered in a red rash; This is a spontaneous report from a contactable consumer (patient). A 63-year-old (non pregnant) female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266 and expiration date was not reported), dose 2 via an unspecified route of administration, in left arm on 23Feb2021 12.30 as single dose for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265 and expiration date was not reported), via an unspecified route of administration, in left arm on 02Feb2021 16.45 as single dose for COVID-19 immunization. Medical history included Type 2 diabetic (recent A1C is 6.1) and soap sensitive. The concomitant medications included Januvia, Jardiance, Glipizide and Rouvest. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination and the patient was not tested positive for COVID-19, since the vaccination. On 25Feb2021 at 21:00, the patient had entire body covered in a red rash. The outcome of the event was reported as not recovered.
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| 63 | 2021-05-07 | rash with redness |
Swollen face; red rash on face and torso front and back; This is a spontaneous report from a contact...
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Swollen face; red rash on face and torso front and back; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non pregnant female patient received second dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as single dose for covid-19 immunisation. Medical history included Post hemopetic stem cell transplant in 2016 and allergic to Penicillin. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]). Historical Vaccine included first dose of BNT162B2 (Batch/Lot Number: EL3246) in left arm on 14Jan2021 09:00. The patient experienced swollen face and red rash on face and torso front and back on 10Feb2021 12:00. Therapeutic measures were taken as a result of the events with antihistamine said by occupational health nurse. Outcome of the events was not recovered.
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| 63 | 2021-05-07 | itchy skin |
incredibly horrible itching under her Fitbit; whelp; her lips had started swelling; her tongue was t...
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incredibly horrible itching under her Fitbit; whelp; her lips had started swelling; her tongue was tingling; she thinks that it was the beginning of anaphylactic reaction; she was just tired; type 1 hypersensitivity; a little soreness; It was like heaviness on her chest; having trouble breathing; allergic contact dermatitis; This is a spontaneous report from a contactable consumer (patient) and a physician. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 10:00 (lot number: EP7533) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing nickel allergy for decades which was under control and panic attacks. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021, it was reported that the patient didn't have any of the normal side effects such as fevers or chills but she was just tired and went to sleep early that night. She woke up on 15Apr2021 at 05:00 with incredibly horrible itching under her Fitbit that she wears to bed. She has a history of nickel allergy and she bought this particular Fitbit on purpose because it doesn't have any nickel in it that touches her skin and she has had no problems all year with the Fitbit. The itching was unbelievably bad and when she took the Fitbit off she had a horrible whelp under a tiny piece of metal that isn't even supposed to touch her skin. She thought well if it has exacerbated her nickel allergy then maybe it is doing something else to her body. On that day (15Apr2021), she thought that she had a panic attack and upon reading some information online, she thinks that it was the beginning of anaphylactic reaction because the symptoms are the same. She was thinking that the vaccine is doing something with her nickel allergy. It had used to be bad until she got it under control and she had it under control for many years. But with the things under the Fitbit she was blaming or associating it with the COVID vaccine so she took it off and then finally fell asleep again. But when she woke up in the morning, just a few hours later (15Apr2021), the bad whelp was still there and then her lips had started swelling and her tongue was tingling so she decided to look some more on google and she thinks that this is another version to an allergic reaction. She has had panic attacks before and she knows what they are now and she has learned through a therapist on how to get past and manage them but this was different for her. It was like heaviness on her chest and it felt like something was on top of her chest and she was having trouble breathing; both on an unspecified date in 2021. Her husband knows when she has a panic attack but this one was different she can't really explain it. She asks, what is the difference between a panic attack breathing and this type of breathing and later mentioned that she also had a little soreness (2021). In addition, the physician also called to report that this patient was complaining about 2 types of symptoms. The first was more an allergic contact dermatitis (2021) which the physician is not worried about. The second was lip swelling and tongue tingling which could be a type 1 hypersensitivity (2021). The physician is more concerned about the latter and would like to know if it is okay to pre-medicate the patient with Benadryl before getting the second dose. The outcome of the event 'she was just tired' was recovered on 14Apr2021; incredibly horrible itching under her Fitbit; whelp was recovering; her lips had started swelling and her tongue was tingling was recovered on 15Apr2021. The outcome of the other events was unknown.
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| 63 | 2021-05-11 | skin spots, bruising |
Platelet count of 4, bleeding (nose, urine. stool), petechiae & bruising over body. Patient given p...
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Platelet count of 4, bleeding (nose, urine. stool), petechiae & bruising over body. Patient given platelet transfusion, high dose dexamethasone and IVIG. Platelet count rose to 29. Discharged and follow-up with hematology
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| 63 | 2021-05-13 | rash, blister, shingles |
immune system is obviously compromised; shingles; pain; Rash; Nerve Pain; back ache; hip ache; not f...
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immune system is obviously compromised; shingles; pain; Rash; Nerve Pain; back ache; hip ache; not feeling well; blistering; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration, administered in Arm Left on 07Mar2021 18:00 as 1st dose, single for COVID-19 immunization. The patient has no medical history and concomitant medications. No history of previous vaccinations. No vaccinations in four weeks. On 13Mar2021, 6 days after vaccination, the patient had nerve pain, back ache, hip ache, was not feeling well, and had blistering. The patient went to the urgent care/emergency room because of the back pain and was given Capscian which burned and acyclovir. On 17Mar2021, the patient had pain and rash. The patient's visited a dermatologist due to symptoms and was diagnosed with shingles which developed on the right side of her body on 21Mar2021. The dermatologist changed the acyclovir to valacyclovir at 1 gram three times a day and Triamcinolone Acetonide: ointment Dose: 0.1%, twice a day both starting on 23Mar2021. The patient was also given Lidocaine patch and Biofreeze. Patient states steroid ointment was very amazing and that was just yesterday it was started, already her rash is disappearing, blistering is going away. Dermatologist also said she hadn't been given the right antiviral. The patient requested reassurance that the first dose received would still be effective even though the patient thinks her immune system is obviously compromised (no treatment was reported), says her immune system took away guard for other virus, triggered but not caused it. Maybe just a theory my immune system is working overtime to produce antibodies from having received vaccine and maybe wasn't protecting from dormant chicken pox virus. Patient wanted to make sure the efficacy of first shot is still intact. Patient also stated second dose is scheduled for 29Mar2021 and she was wondering if she would be able to receive the second dose or if she would have to wait a period of time. The outcome of the event immune system is obviously compromised was unknown while for the rest of the events was recovering.
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| 64 | 2021-01-02 | hives, itchy skin |
Right side of lip started swelling about 7:30 pm on 12/31/2020. Took Benadryl and picked up Epi pen...
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Right side of lip started swelling about 7:30 pm on 12/31/2020. Took Benadryl and picked up Epi pen at pharmacy. Swelling increased overnight up into right cheek and jaw. Right side eye and cheek and mouth drooping with a crooked smile. On 01/02/2020 started itching from up under right ear down towards neck with redness and hives. Got RX from pharmacy for Prednisone and am currently taking that
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| 64 | 2021-01-04 | injection site pain |
ON 12/31, DEVELOPED BODY ACHES, NAUSEA, SWOLLEN LYMPH NODES UNDER ARMS AND NECK. INJECTION SITE WAS ...
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ON 12/31, DEVELOPED BODY ACHES, NAUSEA, SWOLLEN LYMPH NODES UNDER ARMS AND NECK. INJECTION SITE WAS VERY SORE. RESOLVED AFTER 48 HOURS.
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| 64 | 2021-01-04 | hives, rash |
rash, hives type things on face/rash on the face after the COVID vaccine; rash, hives type things on...
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rash, hives type things on face/rash on the face after the COVID vaccine; rash, hives type things on face; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; NDC/UPC/batch/lot number and expiration date were unknown), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. Concomitant medications included mometasone furoate (ASMANEX) inhaler, pramipexole, simvastatin, montelukast, and gabapentin. The patient stated that she didn't know if she was having side effects from the vaccine or not since for the last three days, she had been getting almost like a rash, hives type things on face; nowhere else, just on her face from 25Dec2020. The patient believed it just started in the last couple of days and it didn't happen right at first and wanted to know what it's from. The patient considered herself as a first responder as she worked at the court house and did protection from abuse orders for people in domestic violence situations. The patient was still experiencing the problems and seemed to happen in the afternoon, every afternoon she seemed to get it. The patient further reported that she experienced rash on the face after the COVID vaccine and it happened in the afternoon. She got the COVID (19) vaccine on Wednesday and on Friday afternoon (also reported as the "25th, Christmas day"), she experienced rash on the face; she said it was not bad, but it happened in the afternoon. She still had it at the time of the report and it's just on her face. The patient did not receive any treatment for the events. The patient had no investigation assessment. The patient was not recovered from the events "rash, hives type things on face/rash on the face after the COVID vaccine." Information on the batch/lot number has been requested.
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| 64 | 2021-01-05 | hives, itchy skin, rash macular, itchy rash |
Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hiv...
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Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hives/welts came up on right ear and behind neck/welts under buttocks and behind knees, welts were large and red; Slight chills; Tenderness in injection arm; was just a little cold; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PAA156571), via an unspecified route of administration in left deltoid on 28Dec2020 10:00 at 0.3 mL single for covid-19 immunization; sulfamethoxazole, trimethoprim (BACTRIM DS), at twice a day for 10 days for perineal cyst. The patient was on her last day of sulfamethoxazole, trimethoprim on the day she got the COVID-19 vaccine (28Dec2020). Medical history included perineal cyst, COVID-19 in Apr2020 with no problem, only had a cough. Husband had COVID-19 and had loss of taste and smell, had fever, but he was not serious. Both her and her husband got tested for antibodies and were positive. Family medical history was none. The patient had unspecified flu vaccine (Lot: UJ428AB) on 18Dec2020 injected in left deltoid in two weeks prior to COVID-19 Vaccine. Checked with three different people who stated the Flu vaccine would not interfere with COVID-19 Vaccine. Checked with two pharmacists who stated Bactrim DS would not affect her taking the COVID-19 Vaccine. She received COVID-19 Vaccine through her work in a nursing home. There were no additional vaccines administered on same date of Pfizer suspect. On 28Dec2020 about 7 to 8 hours after vaccination, patient had slight chills and tenderness in her arm: was just a little cold. Thirty-six hours after injection, midnight on 29Dec2020, her scalp itched like crazy, broke out in hives. On 30Dec2020, rash developed on both lateral sides of her breast, welts came up on right ear and behind neck. On 31Dec2020, welts under buttocks and behind knees, welts were large and red. Rash on lateral breasts: felt a bit of itching. The patient had blotchy rashes, rash up in her hair above her neck and back of ear, had intense itching; which subsided. It was a little pink on her chest, little itching on her head. Her ear was better. Symptoms were most mild because she was still able to function. Clarified as not serious. The patient was taking diphenhydramine (BENADRYL, Lot: SMF011, Exp: May2022) at 25mg every 3.5 to 4 hours, cortisone cream 10 Maximum Strength (Lot: 20K434, Exp: Sep2023) for rash and welts; and doing tepid soaks. It was tolerable and faded. Rash had subsided, but was a little red. Her greatest concern was what to do in regards to the second dose in three weeks. The reporter considered events were related with COVID-19 Vaccine. The action taken in response to the events for sulfamethoxazole, trimethoprim was unknown. The outcome of events was unknown.
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| 64 | 2021-01-06 | itchy skin |
Five minutes after receiving the Pfizer Covid-19 vaccine, the pt. informed the RN that she was feeli...
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Five minutes after receiving the Pfizer Covid-19 vaccine, the pt. informed the RN that she was feeling "itchy" on her right arm, her right scapula and across her abdomen. She was given the vaccine in her left arm. The pt did not have any rash or hives noted. The PA spoke with the pt and 50 mgs Benadryl was given p.o.(@ 1450). The pt stayed to be observed and after an additional 40 minutes (@ 1531) she said she was feeling better and was going to her unit to work (eve shift). The pt. spoke to her Nurse Manager upon arrival back to her unit and was sent home instead of working. Her unit was called at 4pm and we were informed that the pt went home, as she was concerned of being too tired to work.
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| 64 | 2021-01-06 | injection site pain |
Mild headache, pressure over forehead/eyes. Feeling feverish. Temp 97.6 oral. Generalized aches and ...
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Mild headache, pressure over forehead/eyes. Feeling feverish. Temp 97.6 oral. Generalized aches and pains. Slight dizziness. The next day, all symptoms gone. Injection site/sore arm for 3 days.
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| 64 | 2021-01-07 | injection site pruritus, injection site swelling |
8 days after injection site of the injection became swollen and itchy. Had been fine until then. 9th...
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8 days after injection site of the injection became swollen and itchy. Had been fine until then. 9th day still some swelling and itching but not as bad.
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| 64 | 2021-01-07 | hives, injection site redness, injection site swelling |
No injection site issue from elbow to wrist swallen red fevered area hand was difficult to be used...
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No injection site issue from elbow to wrist swallen red fevered area hand was difficult to be used for 12-24 hours to subside . Very large arm left 2 - inches red a swallen 12-24 hours welts all over body three to five inches. Continuing every day . 120 dexitrun Cycles 16th day woke up intergestion roof of mounth Employee health hospialize Adverse event allergiest umulize hopital, clarifein, swelling
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| 64 | 2021-01-07 | rash |
Rash occurred approx 48 hrs after receiving vaccine. Both arms, lower legs, feet, neck.; This is a ...
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Rash occurred approx 48 hrs after receiving vaccine. Both arms, lower legs, feet, neck.; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899) intramuscular at first dose on 17Dec2020 at single dose for covid-19 immunisation in left arm in hospital. Medical history was not reported and no known allergy, no allergies to medications, food, or other products. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), atorvastatin, fish oil and 'women's 50+ MV'. The patient experienced rash occurred approximately 48 hours after receiving vaccine, both arms, lower legs, feet, neck on 19Dec2020. No treatment for event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of event was resolving.
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| 64 | 2021-01-07 | vaccination site swelling, vaccination site pain |
pain on the injection site; swelling; Inflammation; This is a spontaneous report from a Pfizer-spons...
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pain on the injection site; swelling; Inflammation; This is a spontaneous report from a Pfizer-sponsored program, reported by a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown) via an unspecified route of administration on 02Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had the vaccine yesterday (02Jan2021) around 6 O'clock and then late in the afternoon she was experiencing pain on the injection site and she is asking if that is normal or if she can take Ibuprofen to relieve the pain. It was further reported that there was also a little bit swelling and inflammation. The outcome of events was unknown. Information on the lot/batch number has been requested.
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| 64 | 2021-01-07 | vaccination site pain, vaccination site swelling, vaccination site redness |
redness at injection site; Mildly tender injection site; slight swelling at injection site; This is ...
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redness at injection site; Mildly tender injection site; slight swelling at injection site; This is a spontaneous report from a contactable nurse. A 64-year-old non-pregnant female patient received bnt162b2 (BNT162B2 also reported as COVID-19 vaccine; lot number: EL 3246; expiration date: unknown), via an unspecified route of administration left arm on 02Jan2021 15:45 at a single dose for covid-19 vaccination. Medical history included HTN (hypertension) and controlled PAT (paroxysmal atrial tachycardia). Concomitant medication included unspecified medication. The patient previously took cephalexin [reported as Cephlexin]. The patient was not patient diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the COVID-19 vaccine in a public health clinic/facility. It was reported that the patient had mildly tender injection site, slight swelling and redness at injection site on 02Jan2021 08:00 PM. The reporter did not consider the event serious. The patient was not tested for COVID-19 since the vaccination. The patient did not received treatment for the adverse event. The outcome of the events was not recovered.
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| 64 | 2021-01-08 | shingles, itchy skin | Developed shingles on right side at waist. Pain, nausea, ltching |
| 64 | 2021-01-09 | injection site pain | Fever (100.5 F oral temp) Body Aches Headache Chills Fatigue Pain at Right Deltoid Injection site |
| 64 | 2021-01-10 | redness, skin burning sensation |
At 15 minutes developed abdominal pain, facial redness, heat and burning. Lasted 2 hours and self ab...
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At 15 minutes developed abdominal pain, facial redness, heat and burning. Lasted 2 hours and self abated. On day 4 developed new onset food and flower allergies which lasted until day 10. These were lip tingling, eye swelling and redness and burning.
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| 64 | 2021-01-10 | cellulitis, injection site redness |
Circumferential erythema overlying left deltoid just distal to injection site consistent with cellul...
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Circumferential erythema overlying left deltoid just distal to injection site consistent with cellulitis
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| 64 | 2021-01-10 | blister, redness | Developed red raised painful vesicles on bil. hands/fingers. Approximately 15 pustules. |
| 64 | 2021-01-10 | injection site mass, injection site warmth, injection site pain, injection site redness |
Lump at injection site, pain with touch and redness; 1 week later - Lump at injection site with 2in...
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Lump at injection site, pain with touch and redness; 1 week later - Lump at injection site with 2in x 2in round with warmness and redness. Has begun to fade since yesterday 01/10/21; lump is not there anymore
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| 64 | 2021-01-10 | itchy skin |
Pt was vaccinated at 0845 - she was in observation x30 min . After 30 minutes she started complaini...
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Pt was vaccinated at 0845 - she was in observation x30 min . After 30 minutes she started complaining of itching and was observed scratching her forearms and chest. She self medicated with benadryl 50mg caps - she was observed for an additional 40 minutes - all symptoms had resolved. Pt was instructed to follow fact sheet and take action on any additional allergic symptoms.
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| 64 | 2021-01-10 | itchy skin, redness, hives |
The lip starting ripping and the face started itching; The lip starting ripping and the face started...
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The lip starting ripping and the face started itching; The lip starting ripping and the face started itching; It started spreading from the ear to the neck, it started itching bad and getting hive in that area; having trouble in breathing because it was swelling up; having trouble in breathing because it was swelling up; The lip was swelled to red and then it started to going up the jaw; The lip was swelled to red and then it started to going up the jaw; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1686, expiration date: Mar2021) via an unspecified route of administration on the arm right in Dec2020 at single dose for COVID-19 immunisation. Medical history included ongoing blood pressure high. Concomitant medication included lisinopril taken for blood pressure high. The patient had the BNT162B2 on Thursday morning (Dec2020) and Thursday evening the patient had a reaction to that, the lip was swelled to red and then it started to going up the jaw. So the next day it was in the jaw and in the lip and then the lip starting ripping and the face started itching and that's didn't go away and then yesterday it started spreading from the ear to the neck, it started itching bad and getting hive in that area. The patient went to the emergency room, consumer stated that she had nurse practitioner that called her on a steroid (treatment). The consumer stated, "the thing she called her also in an Epi Pen in case she has started having trouble in breathing because it was swelling up. The patient didn't have to end up using that but she just has to use in case she has". Treatment was received for the events. The outcome of the events was unknown.
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| 64 | 2021-01-10 | skin warm |
blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot;...
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blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot; sore left arm; This is a spontaneous report from a contactable nurse for herself. This 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at single dose on left upper arm (lot: EKS730), via an unspecified route of administration on 05Jan2021 14:30 at single dose (lot: EL1284 or EKI284) for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it is sore. The patient had the sore left arm both times that she got the vaccine. She got second dose of vaccine on 05Jan2021 at 2:30pm and had a blasting headache and just had chills that went away about hour ago on 05Jan2021. She did not have a fever but her skin felt hot on 05Jan2021. She stated that she had dry heaves on 05Jan2021. The patient started that she had a blasting headache within a few hours of the vaccine and it gradually got worst by the time she went to bed. Stated that the chills and dry heaves started then and throughout the night. The chills stopped an hour before she got up. Stated that she went to check her temperature and did not have a fever despite having chills and her skin feeling hot. Stated that nausea started about 10 at night on 05Jan2021. Seriousness for blasting headache, chills and dry heaves was disabling, for nausea was medically significant, for other events was non-serious. The patient took Ibuprofen for the headache. Stated that she was going to try to drink something. The outcome of sore left arm was not recovered; of chills was recovered on 06Jan2021. The outcome of other events was recovering. The causality for blasting headache, chills, dry heaves, nausea and skin felt hot was related (Source of assessment: Primary Source Reporter, Method of assessment: Agency Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the headache, chills, dry heaves and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-01-10 | cellulitis, redness | circumferential erythema just distal to injection site consistent with cellulitis for 3 days |
| 64 | 2021-01-11 | injection site redness, injection site pruritus, injection site swelling, injection site pain, injection site warmth |
APPROXIMATELY 30 HOURS AFTER VACCINE I NOTICE SORENESS AND A VERY HOT, RED, SWOLLEN, ITCHY AREA AT...
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APPROXIMATELY 30 HOURS AFTER VACCINE I NOTICE SORENESS AND A VERY HOT, RED, SWOLLEN, ITCHY AREA AT INJECTION SITE APPROXIMATELY 3 INCHES ACROSS. THIS KEPT SPREADING UNTIL 12 HOURS AFTER THAT WHEN I TOOK BENEDRY L AND THAT TOOK AWAY A LOT OF REDNESS, HEAT, AND RECEEDED SLIGHTLY. THE BENEDRY HELPS BUT HAS NOT TAKEN IT AWAY. ALSO HAD THE EXPECTED REACTION 14 HOURS AFTER VACCINE OF FEVER, CHILLS, BODY ACHES, & HEADACHE FOR 48 HOURS WHICH IMPROVED EACH DAY.
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| 64 | 2021-01-11 | injection site pruritus, injection site redness, injection site swelling, injection site warmth |
Rt arm from shoulder - elbow, red, swollen, hot to touch. C/o pain and itching to whole area. Start...
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Rt arm from shoulder - elbow, red, swollen, hot to touch. C/o pain and itching to whole area. Started small area day after vaccination and gradually grown in size.
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| 64 | 2021-01-11 | injection site redness, injection site hardening, injection site pruritus, injection site warmth |
left arm: pain, swelling, redness, warmth, itching: after 5 days: still a bump at injection site (b...
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left arm: pain, swelling, redness, warmth, itching: after 5 days: still a bump at injection site (but smaller than in previous days), still warmth (but less than in previous days), redness has become pinkness in a smaller area, also less itching, minor pain at touch puffy eyelids and inflammation but this may have been blepharitis which I have had in the past
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| 64 | 2021-01-11 | itchy skin, hives |
patient stated prior to vaccination that she has many allergies and has had anaphylactic reactions i...
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patient stated prior to vaccination that she has many allergies and has had anaphylactic reactions in past to aspirin, penicillin, motrin, yellow dye #5 and Iv contrast dye. writer called Dr to discuss benefit vs. concern for reaction. he advised for patient to receive 50 mg benadryl at 1250 and then be vaccinated. vaccinated her at 1258 and by 1305 complaints of itching and visible hives. walked patient to er room 1 met by nurse.
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| 64 | 2021-01-12 | pain of skin |
Arm soreness @ 11pm 1/11/2021; continual headache starting @ 2am 1/12/2021 accompanied by chills,...
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Arm soreness @ 11pm 1/11/2021; continual headache starting @ 2am 1/12/2021 accompanied by chills, low grade temp of 99.7 , skin hurt all over & generally feeling unwell. These symptoms continued until 11 pm 1/12/2021. Took Tylenol, wet to bed & woke up 1/13/2021 without symptoms.
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| 64 | 2021-01-12 | injection site pain | PAIN INJECTION SITE,TIRE,MUSCULAR PAIN,JOINT PAIN,COUGH AND TARDICARDIAC. |
| 64 | 2021-01-12 | injection site redness |
Patient states her arm is sore and red at the injection site. It started a week after she received ...
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Patient states her arm is sore and red at the injection site. It started a week after she received the vaccine. She has been advised by her physician to ice the affected area and take Tylenol for any pain.
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| 64 | 2021-01-12 | rash |
Received Covid 19 vaccine on 1/6/2021 Left arm. Immediately had left arm pain and next day had numb...
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Received Covid 19 vaccine on 1/6/2021 Left arm. Immediately had left arm pain and next day had numbness and tingling,along with rash upper chest and neck.
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| 64 | 2021-01-12 | blister, redness, itchy skin |
Vaccine was administered on 12/30 at around noon. I felt fine that day but was aware that a previou...
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Vaccine was administered on 12/30 at around noon. I felt fine that day but was aware that a previously diagnosed but inactive area of contact dermatitis on my right knee was flaring up - becoming very pruritic and active. Over about 48 hours it became red, blistered and eventually weepy. The area had been biopsied in September of 2020 ("spongiatic dermatitis"), treated with topical steroids and for the most part resolved. I saw my dermatologist on 1/6 - repeat biopsy was done ("severe allergic reaction") and it was treated again with topical steroids and is resolving. On 1/12 I began experiencing generalized pruritus. I have patchy erythema, dermatographism, and a few scattered solitary urticarial lesions. There are no respiratory symptoms - specifically no shortness of breath, cough, bronchospasm, swelling of mouth, lips or tongue. No joint pain. No fever. I took zyrtec 10 mg with minimal improvement. I contacted my dermatologist today who feels this is an Id reaction and suggested reporting the reaction to VAERS. I have also contacted my primary physician and have a telehealth visit scheduled. The biggest question is whether to have the second dose of the vaccine, as I am a physician actively seeing sick outpatients.
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| 64 | 2021-01-13 | redness |
45 min after injection face became red and flushed and headache began, redness left in about 4 hour...
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45 min after injection face became red and flushed and headache began, redness left in about 4 hours, headache still remains 24 hours later but mild. joints ache for 24 hours and neck slightly stiff after about 12 hours
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| 64 | 2021-01-13 | itchy skin, redness, rash | Bilateral Axilla, dominant on vaccinated arm rash, itch Redness, Swelling |
| 64 | 2021-01-13 | injection site pain, redness |
Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion;...
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Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion; chest tightness by day 3- increased swelling of arm with redness; hot to touch; increased pain radiating to under arm.
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| 64 | 2021-01-13 | vaccination site pain |
says in her arm where her shot was given is sore; This is a spontaneous report from a contactable co...
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says in her arm where her shot was given is sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL0140; expiration date: not known), via an unspecified route of administration on right arm on 18Dec2020 10:00 at single dose for covid-19 prevention. Medical history included ongoing arthritis probably since ten years ago (2011), ongoing osteoporosis at least since five years ago, maybe longer, and ongoing Barrett's esophagus probably since five years ago (2016). Family included ongoing high cholesterol diagnosed probably 20 years ago (2001), her whole family has it and was managed or lowered with medication. There were no concomitant medications. The patient said in her arm where her shot was given was sore on an unspecified date. The first time she got the injection in her right arm, but the second time her right was still hurting. The outcome of the event was not recovered.
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| 64 | 2021-01-13 | vaccination site pain |
soreness to arm injection site; might have lymph node swelling or something; a sharp pain/soreness r...
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soreness to arm injection site; might have lymph node swelling or something; a sharp pain/soreness right below her left ear; sharp pain below left ear that comes and goes; the first dose on 18Dec2020 10:00 AM/ second dose on 06Jan2021 13:00; the first dose on 18Dec2020 10:00 AM/ second dose on 06Jan2021 13:00; This is a spontaneous report from a contactable consumer for self. This 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 13:00 on left arm at single dose (Lot # EL1284) for COVID prevention. Medical history included ongoing arthritis in some form probably since 2011 (reported as ten years ago, as of 07Jan2021), ongoing Osteoporosis had it probably at least since five years ago, maybe longer, ongoing Barrett's esophagus had it probably since 2016 (reported as five years ago, as of 07Jan2021) High cholesterol this is managed or lowered with medication, and was diagnosed in 2001 (reported as probably 20 years ago, as of 07Jan2021) her whole family has it. Concomitant medications were none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 10:00 AM at age of 64-year-old on right arm at single dose (Lot # EL0140) for COVID prevention. She says that the first time she got the injection in her right arm, but the second time her right arm was still hurting, which she has arthritis over there also, this time she got the injection in her left arm. She says that the soreness or sharp pain under her left ear could be or not be related. She experienced soreness to arm injection site. She says that the area below her left ear doesn't feel swollen, it just feels like not a sore throat, but every so often she has a sharp pain, and it could be that she slept on it wrong. She says she was wondering if that goes away fast or is connected, like a possible side effect. The patient received the 2nd dose of the vaccine 06Jan2020 13:00 and reported to have a sharp pain/soreness right below her left ear on 07Jan2021, sharp pain below left ear that comes and goes. She read that swollen lymph nodes were a side effect and is asking if that area is a lymph node and would that be considered a side effect and is asking how long it will it take before it goes away. She is wondering since side effects said might have lymph node swelling or something. She says in her arm where her shot was given is sore, and also kind of right below her left ear, which she thinks that is where a lymph node is. She says every so often she has a sharp pain there that goes away, and she wanted to know if this could be a part of it, since she is guessing that is where a lymph node is, or wondering it this is something even related that could be a side effect. Treatment included she took Tylenol Rapid Relief Extra Strength a while ago, dose queried but not provided. EXP: Jul2022, LOT: SJA072, this is not on the bottle, it must have been on an outer box which was discarded. Treatments received for the events pain, pain in ear, vaccination site pain and swollen lymph nodes. Outcome of the events were unknown.
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| 64 | 2021-01-14 | injection site redness, injection site pain, injection site hardening |
Fever 101, chills, Arthralgia, red,hard sore painful left deltoid. Treated with Tylenol, Doxycycline...
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Fever 101, chills, Arthralgia, red,hard sore painful left deltoid. Treated with Tylenol, Doxycycline started on 1/15
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| 64 | 2021-01-14 | vaccination site pain |
chills; extremely painful injection site and was unable to lift affected arm over head easily; extre...
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chills; extremely painful injection site and was unable to lift affected arm over head easily; extremely painful injection site and was unable to lift affected arm over head easily.; This is a spontaneous report from a contactable nurse. A 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular (anatomical location: arm left) from 07Jan2021 18:00 to 07Jan2021 18:00 at SINGLE DOSE for an unspecified indication. Medical history included known allergies: PCN. There were no concomitant medications. On 08Jan2021 at 12:00, The patient experienced extremely painful injection site and was unable to lift affected arm over head easily and then chills. The patient did not received any treatment for the events. Outcome of the events was recovering.
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| 64 | 2021-01-18 | hives |
Hives that began 11 days post vaccine, that is progressively getting worse including swelling of lip...
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Hives that began 11 days post vaccine, that is progressively getting worse including swelling of lips after taking 50 mg, Benadryl. EE referred to ER.
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| 64 | 2021-01-18 | hives |
Hives to trunk, arms, groin face neck and lip area began 11 days post vaccine. Treatment include Be...
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Hives to trunk, arms, groin face neck and lip area began 11 days post vaccine. Treatment include Benadryl with no improvement.
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| 64 | 2021-01-18 | injection site warmth, injection site redness, cellulitis, injection site swelling |
Left arm, near injection site, was reddened, raised and warm to touch 9 days after the day of inject...
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Left arm, near injection site, was reddened, raised and warm to touch 9 days after the day of injection. approximately 3x3 inches. Was seen in the ER where I work and it was recommended that I start Cephalexin 500mg 1 capsule 4 times per day x 10 days. Diagnosed as a Cellulitis.
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| 64 | 2021-01-18 | vaccination site pain |
Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, esp...
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Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, especially shoulder blades; tired/sleepy; tired/sleepy; chills; This is a spontaneous report from a contactable other HCP (patient). This 64-year-old female other HCP reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL128H), via unspecified route at right arm on 08Jan2021 07:45 AM at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included elevated blood pressure and atrial septal defect repair 2008. Concomitant medications included olmesartan medoxomil and hydrochlorothiazide. Historical vaccine included the first dose of BNT162B2 (lot# EH9899) on 18Dec2020 at age of 64 years old for COVID-19 immunization and having arm pain. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. On 08Jan2021 07:00 PM, patient experienced pain at injection site, swelling (size of her palm), warm to touch all over body and muscle aches, especially shoulder blades, very tired/sleepy with chills. No treatment was received. It was reported normal temperature for patient was 97.2 (+) or (-) 98.6. Outcome of events was recovering.
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| 64 | 2021-01-18 | redness |
right groin became red and develop lymph node; right groin became red and develop lymph node; Fever/...
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right groin became red and develop lymph node; right groin became red and develop lymph node; Fever/ temperature went up around 101.4; Chills; This is a spontaneous report from a contactable nurse (patient). This 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was a nurse anaesthetist who received the COVID-19 vaccine on the 19Dec2020 and on 22Dec2020 after she got home from work that afternoon in the evening, her temperature went up around 101.4 and had the chills and the fever. Later that evening and next morning (23Dec2020) her right groin became red and develop the lymph node that patient did not never felt before. Patient called physician and they put her on Antibiotics Keflex (treatment) for four times a day for 10 days. After the reaction, patient had a COVID test and Flu A and Flu B test and all of them were negative. The outcome of events was unknown.
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| 64 | 2021-01-19 | skin warm, bruising, injection site nodule |
On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore...
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On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore with a knot at injection site. Nausea and fever of 101.8-patient took Zofran=8mg. All over body aches and joint tenderness and soreness. Day 3-1/9/21-extreme fatigue and body aches, no fever or chills. Day 4 and 5 only had headaches, and on Day 6 no symptoms at all.
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| 64 | 2021-01-20 | injection site swelling |
She reports receiving Covid-19 vaccine on 1/9/2021 on left arm at "Infusion Center". She states that...
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She reports receiving Covid-19 vaccine on 1/9/2021 on left arm at "Infusion Center". She states that "immediately" after she received vaccine she felt "tongue tingling". About 10 min later she felt "lip tingling" and started to develop "large red bump" at injection site. She advised nurse observing patients and physician on site was advised. Pt reports she was administered EPI and Benadryl IM and "felt better almost immediately". Pt states "tingling" resolved within the hour and she felt "scalded tongue" for about 24 hrs. Large local reaction slowly resolved over a 3 day period. She denies any visible skin rash / hives or AE. No throat sx. No resp sx. No GI sx. Pt denies a hx of adverse reactions to any injected medication or to any vaccine in the past. She reports that 30+ years ago she had "facial swelling" on day 10/10 of Dirucef which she was taking orally for sinus infection. Since then, she avoids cephalosporins. Tolerates penicillins. She also c/o vomiting after taking Codeine in the past w/o any other sx. *Neg hx of Covid - 19 infection
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| 64 | 2021-01-20 | itchy skin |
She was observed scratching and when questioned stated she was itchy on her chest and forearms; This...
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She was observed scratching and when questioned stated she was itchy on her chest and forearms; This is a spontaneous report from a contactable pharmacist. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) intramuscularly at right arm on 11Jan2021 08:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EK5730) intramuscularly on 21Dec2020 at single dose for COVID-19 immunization. Patient received vaccine at 08:45, she was observed for 30 minutes - during which time she took 50mg diphenhydramine hydrochloride (Benadryl) (patient's own med) - she was observed scratching and when questioned stated she was itchy on her chest and forearms. She denied any difficulty breathing, swelling around face, lips, tongue or itchiness anywhere other than her chest and forearms. She was observed for minutes after diphenhydramine hydrochloride and all symptoms had resolved. Patient was instructed to read Fact sheet and report additional allergic symptoms and to follow up if any symptoms worsen. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the event was recovered on 11Jan2021.
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| 64 | 2021-01-21 | rash with redness |
Rash on left cheek. Appeared to be like a herpes zoster patch., but atypical. Vesicles on a red ba...
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Rash on left cheek. Appeared to be like a herpes zoster patch., but atypical. Vesicles on a red base.
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| 64 | 2021-01-21 | pain of skin | chills, skin hurts, headache, nausea, body aches, muscle aches |
| 64 | 2021-01-22 | hives | Hives,achy,fever,nausea,headache,diarrhea |
| 64 | 2021-01-24 | hives |
Hives on shoulder, face and arms; This is a spontaneous report from a contactable consumer (patient)...
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Hives on shoulder, face and arms; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), via an unspecified route of administration on 12Jan2021 12:45 at a single dose on the left arm for COVID-19 immunization. Vaccine was administered on a hospital. The patient had no other vaccine in four weeks. Medical history included polycythemia vera, diabetic, bronchiectasis and allergies to penicillin and yellow dye #5. The patient was not tested for Covid prior and post vaccination. Concomitant medications included zolpidem tartrate (AMBIEN), empagliflozin (JARDIANCE), montelukast and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). The patient previously took acetylsalicylic acid (ASPIRIN) and ibuprofen (MOTRIN) and experienced allergies to both. The patient experienced hives on shoulder, face and arms on 12Jan2021 13:15. The patient had an emergency room/department or urgent care visit. The event was treated with Epi Pen, steroids and Benadryl. The outcome of the event was recovered on Jan2021.
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| 64 | 2021-01-24 | vaccination site pain |
bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time)...
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bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time) confusion; lightheadedness; headache/slight headache; This is a spontaneous report from a contactable nurse, reporting for herself. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EL1284), intramuscularly on the left arm on 05Jan2021 18:30 at a single dose for COVID-19 immunization. Medical history included received immunotherapy injections for environmental allergies from an unknown date and unknown if ongoing. Concomitant medication included diltiazem, spironolactone, trazodone, lorazepam, colecalciferol (VITAMIN D), zinc and fish oil. On 05Jan2021, the patient received Pfizer COVID-19 vaccine and experienced (time) confusion, and lightheadedness within one hour of receiving. Later that evening, the patient experienced headache. On 06Jan2021, the patient experienced injection site soreness x 2 days, continued with slight headache, lack of energy. On 08Jan2021, resolved injection site soreness of left arm, continue with slight headache. On 11Jan2021, The patient woke up with bloodshot left eye after having had headaches x 5 days which began the same evening of receiving the Pfizer COVID-19 vaccine. Blood pressure was 125/80. No headache or eye pain. BP was 128/89 on 10Jan2021, 11 PM. No headache. BP was 120/80 on 11Jan2021, 10 AM. The patient had never had a bloodshot eye before. The patient underwent lab tests and procedures which included Blood pressure:125/80 mmHg on an unspecified date, 128/89 mmHg on 10Jan2021 and 120/80 mmHg on 11Jan2021. The outcome of the event injection site soreness/injection site soreness of L arm was recovered on 08Jan2021 while the outcome of all other events was unknown.
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| 64 | 2021-01-24 | vaccination site pain, rash |
rash all over her stomach; a little pain at injection site; This is a spontaneous report from a cont...
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rash all over her stomach; a little pain at injection site; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at 15:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Jan2021, the patient experienced rash all over her stomach (7 hours after vaccination) and a little pain at injection site. The patient outcome of the events was unknown. The information on the batch number has been requested.
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| 64 | 2021-01-25 | hives, itchy skin |
Eyes itching after 1 hour, palms of hands became itchy then developed neck hives and along both wris...
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Eyes itching after 1 hour, palms of hands became itchy then developed neck hives and along both wrists Benadryl taken which resolved the hives and itchiness
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| 64 | 2021-01-25 | itchy skin, rash |
My left arm developed a rash at the antecubital site which spread upward to my shoulder. It appeared...
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My left arm developed a rash at the antecubital site which spread upward to my shoulder. It appeared on my right arm, within two hours, same location. It continued to spread down to my wrists and remains today, 1/26/21. The rash is red with small pruritus bumps. On 1/21/21, it appeared on my throat.
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| 64 | 2021-01-26 | vaccination site warmth, vaccination site pain |
Headache and body aches for 24 hours; Headache and body aches for 24 hours; edema left arm pit and l...
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Headache and body aches for 24 hours; Headache and body aches for 24 hours; edema left arm pit and left collarbone and neck; edema left arm pit and left collarbone and neck; tingling down the back of neck to shoulder blade for 1 week; All left side, pain at injection site with warm to touch for three days; All left side, pain at injection site with warm to touch for three days; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via intramuscular in left arm on 08Jan2021 13:15 at second single dose for covid-19 immunization. Medical history included diabetes type 2, allergies. Concomitant medication included metformin, simvastatin, semaglutide (RYBELSUS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose BNT162B2 (LOT# EL1685) on 20Dec2020 01:15 PM, via intramuscular in left arm for Covid-19 immunization. The patient experienced headache and body aches for 24 hours, edema under left arm pit and left collarbone and neck with tingling down the back of neck to shoulder blade for 1 week. All left side, pain at injection site with warm to touch for three days. Adverse event start date/time: 09Jan2021 06:00 AM. Events were considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. Outcome of the events was recovering.
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| 64 | 2021-01-26 | itchy skin, hives, injection site swelling, injection site redness, redness |
Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving d...
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Patient received Covid Vaccine Dose 1 on 01/25/2021. Patient states within 15-20 mins of receiving dose, felt extreme coldness from shoulder to tips of fingers for about 30 mins and then resolved. Then afterwards, started to develop redness/itching/hives on back. Patient also felt very lightheaded and blood pressure taken and elevated at 188/84. (20-25 mins after injection). Injection site did swell and got red after. Also had mild HA after arriving home but didn't last long & nauseous feeling the whole day after getting vaccine. Patient did not take any medications and all symptoms resolved on own.
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| 64 | 2021-01-26 | hives, itchy skin |
isolated hives/generalized hives; generalized itching/itchy from head to toe; contact Dermatitis had...
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isolated hives/generalized hives; generalized itching/itchy from head to toe; contact Dermatitis had worsened/reactivations of contact dermatitis that flared up on her right knee; contact Dermatitis had worsened/reactivations of contact dermatitis that flared up on her right knee; This is a spontaneous report from a contactable physician. A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on deltoid left from 30Dec2020 to 30Dec2020 at SINGLE DOSE for covid-19 immunisation. Medical history included contact dermatitis. There were no concomitant medications. The reporter stated that the patient had mentioned that she had contact dermatitis for several months now and before taking the COVID-19 vaccine, it has settled within a month. 6-12 hours after getting the COVID-19 vaccine, her contact dermatitis had worsened dramatically on 30Dec2020. She was prescribed high dose topical steroids by her doctor. She also developed generalized itching and isolated hives on 12Jan2021. She is trying to avoid systemic corticosteroids because it might affect the vaccine. She is also taking antihistamines but she said these interventions don't seem to be working. Stated that it has not responded to anything. The patient also stated stated that she has not taken steroids because her second dose is due in a week. Stated that the doctors do not think that it is due to the vaccine but due to reactivation (immune system reactivity) of something that had happened. Stated that they are treating it with high dose topical steroids, pepcid and hydroxyzine. Wanted to see if there was information on this sort of reaction and if they had guidance on the second shot. Had the Pfizer BioNTech Covid 19 vaccine. Outcome of the events urticaria and pruritus was not recovered while outcome of the remaining events was recovering.; Sender's Comments: The reported generalized itching and isolated hives occurred 13 days after the first dose of COVID 19 vaccine, BNT162B2. Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect. However, the pre-existing contact dermatitis might have provided alternative explanation towards the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 64 | 2021-01-26 | rash macular |
red splotches; lymph nodes could swell under the arm on the side the shot was given; the area are so...
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red splotches; lymph nodes could swell under the arm on the side the shot was given; the area are sore/Currently there is still soreness with the lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration in left arm on 09Jan2021 at a single dose for COVID-19 immunization administered in a hospital. The patient has no medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EKS or 5730) on 18Dec2020 for COVID-19 immunization and no events were experienced. The patient experienced lymph nodes swelled on the arm and the area are sore/currently there is still soreness with the lymph nodes on 10Jan2021, red splotches on 12Jan2021. It was explained that patient got the second dose on 09Jan2021. She read that the lymph nodes could swell under the arm on the side, the shot was given and it did plus the area were sore, this was on 10Jan2021. On 12Jan2021, in the morning, is when she noticed that in the lymph area and going to the outer breast there are red splotches. It was not tender or warm to the touch and she can tell it will fade on its own but she thought it was weird. It might have been there the day before; she didn't really look. Currently there was still soreness with the lymph nodes but she would have to press to feel it, she would say that was over. She has a picture if needed of the red splotches. Patient stated that she is healthy for her age. She has no medical conditions or takes no medications. The events did not require a visit to Emergency Room or Physician Office. The outcome of the lymph node pain was not recovered while for the other events was unknown.
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| 64 | 2021-01-27 | injection site pain | Fever, diarrhea. Vomiting, body aches, headache, back of neck aches, pain at site of shot |
| 64 | 2021-01-27 | rash, rash vesicular, shingles |
Started with itchy left eye 6 days (Friday) after 2nd shot then within the next 2 days I developed a...
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Started with itchy left eye 6 days (Friday) after 2nd shot then within the next 2 days I developed a painful rash around the left eye and left forehead going up to hairline. Next day rash became blistery so I went to see my PCP and she said I have shingles, ordered Valtrex and gabapentin.
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| 64 | 2021-01-28 | injection site pain |
Patient was found with AMS 1 day after receiving vaccine. Patient had pain at the injection site an...
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Patient was found with AMS 1 day after receiving vaccine. Patient had pain at the injection site and fever of 103.
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| 64 | 2021-01-29 | redness, skin warm |
One day after vaccine arm became red and swollen, no pain reported patient states is warm and swoll...
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One day after vaccine arm became red and swollen, no pain reported patient states is warm and swollen 5 days after shot. Patient is having no issues moving arm and any other issues. Told patient they should followup with md as well.
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| 64 | 2021-01-30 | itchy skin |
Approximately 18 hours after the injection, I felt like I had been hit by a truck. My arm hurt like...
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Approximately 18 hours after the injection, I felt like I had been hit by a truck. My arm hurt like blue blazes, itched intensely, and I had a fever of 102.4. To get my temperature down to 100 degrees I had to alternate Motrin and Advil. I continued to have a fever, headache, body aches, chills, and lethargy for the next 48 hours and stayed in bed because I felt so awful. Unable to do normal activities of daily living.
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| 64 | 2021-01-30 | itchy skin, rash with redness, itchy rash, rash papular, redness |
a few minutes after getting vaccine patient started to have left knee redness/itching and then whol...
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a few minutes after getting vaccine patient started to have left knee redness/itching and then whole body itching. has a erythematous papular rash that is also very itchy on her back had chills that night
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| 64 | 2021-01-31 | hives, itchy skin, rash |
Patient had itching/rash/hives within 15-20 min after vaccine on 1/29/2021. Sent to emergency center...
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Patient had itching/rash/hives within 15-20 min after vaccine on 1/29/2021. Sent to emergency center by observation but rash was improving. She opted to not stay at emergency center and went home. Took Benadryl 25 mg PO x2, rash resolved. 2nd dose deferred.
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| 64 | 2021-01-31 | skin irritation |
Within a half hour of receiving vaccine, I started feeling prickly from my torso down. When I got h...
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Within a half hour of receiving vaccine, I started feeling prickly from my torso down. When I got home I realized that I had felt this before and immediately removed my scrubs. I had raised red areas on my bilateral thighs and torso. I took Benadryl po.
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| 64 | 2021-02-01 | itchy skin |
Patient received her vaccine and waiting for 30 minutes following vaccine with no issues reported. ...
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Patient received her vaccine and waiting for 30 minutes following vaccine with no issues reported. About 2 hours after patient returned home, patient's outside of her mouth started to burn. She continued to wait to see if it resolved and when it didn't, she returned to vaccine clinic. Nurse practitioner at vaccine clinic administered 25mg PO Benadryl and had her wait another hour. Patient was able to be discharged but continued to have itchiness and burning. She was seen by her PCP the next day and was given a steroid shot and instructed to continue Benadryl every 6 hours.
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| 64 | 2021-02-01 | injection site pain |
Pfizer-BioNTech COVID-19 Vaccine EUA: Was perfectly fine for the first 10 hrs following injection. T...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Was perfectly fine for the first 10 hrs following injection. Then 11pm Sar night sudden intense pain at inj site spreading rapidly around back of neck and down other arm and up to head. Wracking chills for about 8 hours. Shaking uncontrollably, aches and pains, very weak, exhausted, nauseous. About 8 hours later, 7am Sunday, fever developed, eye pain with severe headache. In bed 30 hours. Monday morning felt much better but still fever @100 and weirdly dizzy. Ate and drank water. Today, almost 72 hours later fever gone, still very dizzy. Drinking water to see if that will help.
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| 64 | 2021-02-01 | redness, itchy skin, hives, rash macular |
broke out in hives on her face, arms, and chest; warm feeling; Itching; face was really swollen; fac...
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broke out in hives on her face, arms, and chest; warm feeling; Itching; face was really swollen; face was really swollen and red; skin was blotchy; This is a spontaneous report from a contactable consumer reported for herself. A 64-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) at single dose via an unknown route at right arm on 16Jan2021 about 11:00 for vaccination against Covid. No additional vaccines administered on same date of the Pfizer Suspect. Medical history included anxiety, high blood pressure, and ongoing physical urticaria (with no investigation assessment) where if she gets warm her arms itch and she breaks out in a little bit of hives, but never to this extent. Concomitant drugs included lisinopril at 20mg, 1 tablet by mouth once daily for high blood pressure, and sertraline at 50mg, 1 tablet by mouth once daily for anxiety, both ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as "none". No other vaccines given the same day and none 4 weeks prior. No history of problems with vaccines in past. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine was "none". No events following prior vaccinations. Family medical history relevant to the event was reported as "none". Patient reported an adverse event/side effect to the Covid vaccine, and was not sure if she should go ahead with the second dose or not. Patient received the vaccine on 16Jan2021 (reported as Saturday as of 18Jan2021) about 11am and at 5pm she started getting a warm feeling and changed to cooler clothing. Patient started itching and then broke out in hives on her face, arms, and chest. Patient used a cool cloth to face to cool off and sat under the fan. Her daughter got her some diphenhydramine hydrochloride (BENADRYL) within that 15minutes and about 20-30 minutes of taking the diphenhydramine hydrochloride it was calming down. Patient only took 1 diphenhydramine hydrochloride to help and that took care of it. This was the only occurrence. Her face was really swollen and red, she looked like she was sun burnt, skin was blotchy, but she didn't have any trouble with breathing or heart palpitations. The event onset date was 16Jan2021. The events did not require a visit to Emergency Room/ Physician Office. No relevant tests performed. Outcome of the events was resolving.
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| 64 | 2021-02-02 | redness, itchy skin |
Pt walked up to us stating that she feels itchy in her arms, chest and legs. Pt also reported her f...
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Pt walked up to us stating that she feels itchy in her arms, chest and legs. Pt also reported her fingers feeling "fat". Pt has a history of allergic reactions and was at minute 17 of her 30 min wait. Pt presented with her chief complaint along with redness on her arms and chest. Symptoms persisted for 10 minutes and resolved on their own. Pt never had sob, swelling of lips/tongue.
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| 64 | 2021-02-02 | injection site pain |
Symptoms started at 5 PM on February 1, 2021 pain at the injection site then lead to severe headache...
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Symptoms started at 5 PM on February 1, 2021 pain at the injection site then lead to severe headache pain in the neck and shoulders tiredness Fever 100.5Nasal congestion and a dry cough
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| 64 | 2021-02-02 | hives |
muscle swelling; welts/hives; muscle pain; eyes swelling; tongue swelling; shut throat; blood pressu...
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muscle swelling; welts/hives; muscle pain; eyes swelling; tongue swelling; shut throat; blood pressure elevated; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: eh9899, expiration date not reported), via an unspecified route of administration on 17Dec2020 15:15 at single dose on right arm for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing. No Known allergies to the patient currently. The patient was not pregnant. Concomitant medication in two weeks included Rosuvastatin. The patient received the vaccine in hospital. No other vaccine administered in four weeks. The patient experienced muscle swelling, welts/hives, muscle pain, eyes swelling, shut throat/tongue swelling, and blood pressure elevated hospitalization continued symptoms now for 35 days. All adverse events (AEs) started on 17Dec2020. AEs resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization for two days. Patient received treatment (medications, IV's EKG many test) for AEs. No COVID prior vaccination. Patient did COVID tested post vaccination, COVID test post vaccination included Nasal Swab on 02Jan2021 with result of Negative. The outcome of events was not recovered.
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| 64 | 2021-02-03 | bruising |
Patient's arm was sore and bruised; some of the fluid dripped down her arm/"all of the vaccine came ...
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Patient's arm was sore and bruised; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; some of the fluid dripped down her arm/"all of the vaccine came out and dripped down to her wrist"; it hit the bone/ it was given in bone; it hit the bone and after the nurse pulled back the needle, some of the fluid dripped down my arm; "it hit the bone"/When it was given it felt like cracking in her bone; patient's arm was sore and bruised; This is a spontaneous report from a contactable nurse. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EL3248), via an unspecified route of administration in the left arm, on 16Jan2021 08:15 at SINGLE DOSE for COVID-19 immunization. Patient had no relevant medical history. The patient's concomitant medications were not reported. The patient stated that during vaccination last Saturday(16Jan2021), "it hit the bone". The nurse pulled back the needle and after that some of the fluid dripped down her arm. Then it was further reported that it was given in bone and "all of the vaccine came out and dripped down to her wrist". Hence, they wanted to know if patient should get it re-administered or get another half dose. Patient's arm was sore and bruised, the first day was so sore but it was getting better. When it was given it felt like cracking in her bone and she thought the needle broke. After the nurse withdrew the needle, she was told it was not broken but said the needle must have gone to the bone. The outcome of event "patient's arm was sore and bruised" was recovering whereas the outcome of all other events was unknown. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 64 | 2021-02-03 | injection site swelling, injection site nodule, injection site redness |
Shortly after the vaccination I developed a really bad headache for the first 2 days. Stopped for a...
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Shortly after the vaccination I developed a really bad headache for the first 2 days. Stopped for a day and returned for another day and went away on its own. I had inside body chills, felt weak and tired and had a little sinus pressure but no fever which lasted for about 2 or 3 days. I took aspirin to help with the discomfort and today I still have just a little nagging headache that comes and goes but all other symptoms has since subsided. The injection site swole and developed a knot which stayed about a week and is still a little red.
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| 64 | 2021-02-03 | injection site swelling | Site: Swelling at Injection Site-Medium |
| 64 | 2021-02-03 | vaccination site swelling, itchy skin, vaccination site pain |
dizziness; severe injection site pain and swelling; severe injection site pain and swelling; swollen...
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dizziness; severe injection site pain and swelling; severe injection site pain and swelling; swollen neck glands; scattered itching; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 12Jan2021 at 14:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included end-stage renal failure and bipolar and the patient had known allergies to penicillin, sulfa, fish, shellfish, broccoli, and cauliflower. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medication included apixaban (ELIQUIS) from an unknown date at an unknown dose for an unknown indication. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 12Jan2021 at 01:15 (as reported) the patient experienced severe injection site pain and swelling, swollen neck glands, scattered itching, and dizziness. The patient was treated for the arm pain with paracetamol (TYLENOL). The clinical outcome of the severe injection site pain and swelling, swollen neck glands, scattered itching, dizziness was recovered on an unknown date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
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| 64 | 2021-02-03 | vaccination site pain |
more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; Th...
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more tired; Weakness; increased heart rate; Diarrhea; soreness at the injection site; Runny nose; This is a spontaneous report from a contactable Nurse (patient). A 64-year-old female patient received BNT162B2 (Pfizer BioNTech COVID-19 vaccine), intramuscularly on 15Jan2021 at single dose into the left arm for COVID-19 prophylaxis. Medical history included asthma; blood pressure abnormal (she takes blood pressure medication); palpitations at times; having mild chest discomfort, had experienced this before, that she was attributing to her wearing a mask, she wore 2-3 masks; stated that she had Covid once and she did not want it again. Concomitant medications included some blood pressure medication, and salbutamol (ALBUTEROL) inhaler periodically. Caller is a LPN nurse that was calling about the Covid-19 vaccine and reported that she received it Friday 15Jan2021 and just wanted to report some mild side effects. Caller clarified that she was more tired, had weakness, had diarrhea for 2 days, increased heart rate, and a runny nose, soreness at the injection site . She stated that she was not in a lot of distress. More tired started from 17Jan2021 and soreness at the injection site started from 16Jan2021. Weakness started from 17Jan2021: She stated that went home straight from work and went to the couch and slept about 6 hours. She had been up since 0300 and it was almost 1200 now. She stated that her energy level and weakness was pretty good right now. Diarrhea started from 16Jan2021: She said that she had the urgency to go and it was definitely soft and foul like when you had the flu. She stated that she has had it once since this morning. It was semisolid. Increased heart rate started from 17Jan2021: she felt palpitations at times. She said that she did not know if they were related, but stated that they were aggravating yesterday. She stated that she took blood pressure medication. She stated that she used a inhaler albuterol. She was using her inhaler periodically and said that it could be because of the albuterol inhaler. Runny nose started from 15Jan2021: Runny nose started about 8-10 hours after her injection. Stated that it was not bad, she would just have to blow her nose really good every so often. She said that she has not had to blow her nose today since she had been up. She said that the vaccine was sitting on the table and they just told her it was the Pfizer BioNTech vaccine. She did not have her vaccination card with her at the time of the call. The patient had recovered from weakness on 18Jan2021, recovered from increased heart rate and soreness at the injection site on 17Jan2021; she was recovering from more tired, runny nose, and she had not recovered from diarrhea. Reporter seriousness for increased heart rate, runny nose and soreness at the injection site was not serious. The reporter (nurse) considered the events more tired, weakness, diarrhea, runny nose and soreness at the injection site were related to bnt162b2, and relatedness of bnt162b2 to reaction increased heart rate was unknown. Information on the lot/ batch number has been requested.
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| 64 | 2021-02-03 | itchy rash, rash with redness |
rash on chest/It is just itching/she noticed it was a little worse. It is more red; rash on chest/It...
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rash on chest/It is just itching/she noticed it was a little worse. It is more red; rash on chest/It is just itching/she noticed it was a little worse. It is more red; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization, reported as "prevent COVID 19". Medical history included ongoing allergy to penicillin. There were no concomitant medications and investigation assessment. On 19Jan2021, the patient developed rash on chest. She wanted to know if she can put something topical in it or if she could take antihistamines to treat the rash. 20Jan2021 (today), it was not hurting but reported that it was just itching. Patient was wondering if she can put a topical on it. Patient has had no trouble breathing. She gets the same rash when she was in the sun too much. Patient signed up for V-safe. The patient does not have her doctor information. She just got a new doctor. Patient reported that it got better last night, but then this morning she noticed it was a little worse. It was more red. She drove with her husband when he got his, and they offered her a vaccine too. She got it to not get COVID 19. Outcome of the event was not recovered (reported as ongoing). Information on the lot/ batch number has been requested.
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| 64 | 2021-02-04 | rash with redness, itchy skin, rash, hives |
20 mins. after injection itching of face and gradual body. approx. 1 hour throat itching, approx. 4 ...
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20 mins. after injection itching of face and gradual body. approx. 1 hour throat itching, approx. 4 hours mild headache, some rash only on neck and chest but within less than 8 hours full body rash, some milder aches but NEXT morning horrible pain all over like I had been thrown into my worst ever fibromyalgia flair. Complete muscle, joint, entire deep body. WORST i ever had. then a few welps and even though 90% was under the skin rash husband and I could feel the 10 % was red, small pimple like IF not the neck welps and then on the 4 day had a few hives on face only. Worst itching I have ever had and I have had chicken pox and antibiotic rashes. I think the problem has been came off of antibiotic and gradually got ok but can not get this out of system so easy of course. Today is 1 week. rash is better but not gone and itching is some better but still not good. I did not take benadryl or anything since I DO NOT want to interfere with me getting as much benefit from the injection since I now can not have number 2.
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| 64 | 2021-02-04 | skin warm, injection site pain, injection site hardening, injection site redness |
Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injecti...
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Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injection site red the size of a quarter, hot and sore to the touch and hard. Arm aches into shoulder.
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| 64 | 2021-02-04 | itchy skin, rash macular |
Muscular pain in the shoulder, arm and neck through the evening and following day, enough that it li...
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Muscular pain in the shoulder, arm and neck through the evening and following day, enough that it limited my lifting my arm. Further I began feeling extremely itchy on my arms, hands, and face. Checking later in the evening, I did have red blotches all over both arms and shoulders. Took a benadryl and by morning the red blotches were gone as well as the itching.
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| 64 | 2021-02-04 | vaccination site pain |
Pain in the arm of the injection; muscle pain; fatigue; This is a spontaneous report from a contacta...
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Pain in the arm of the injection; muscle pain; fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3249), via an unspecified route of administration on the right arm on 22Jan2021 08:45 am at single dose for COVID-19 immunisation. Medical history included hyperthyroidism, BP elevation, hyperlipidaemia and allergies to chocolate, coconuts, pineapple, and red dye from an unknown date. Patient previously took codeine, statins, Diflucan, and experienced allergies. Concomitant medication included methimazole, dexlansoprazole (DEXILANT), amlodipine, ezetimibe (ZETIA), evolocumab (REPATHA) from unspecified date and indication. On 22Jan2021 at 08:45 pm, it was reported that the patient experienced pain in the arm of the injection, muscle pain, and fatigue. No treatment was received. The events were considered as non-serious and did not resulted in death, life threatening condition, prolonged hospitalization, disability, and congenital anomaly or birth defect. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since vaccination. No other vaccines were received within the last 4 weeks prior to receiving the COVID-19 vaccination. The patient was reported to be not pregnant at the time of vaccination. The outcome of the events were not recovered.
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| 64 | 2021-02-04 | injection site pain, redness |
Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tirednes...
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Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tiredness & fatigue, foggy brained, extreme body aches and pain, unable to walk from weakness, nausea, excruciating headaches, irregualar heartbeat, nausea. Reddness and swelling in arm for over 1wk. Nausea about 10 days.
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| 64 | 2021-02-04 | injection site redness, injection site swelling |
WAS TOLD THAT MY ARM WOULD BE MORE SORE AFTER THIS SECOND SHOT BECAUSE i CHOSE TO GET IT IN THE SAME...
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WAS TOLD THAT MY ARM WOULD BE MORE SORE AFTER THIS SECOND SHOT BECAUSE i CHOSE TO GET IT IN THE SAME ARM AS THE 1ST DOSE. WHILE I DIDNT FEEL THAT SORE IN MY SHOULDER on 2/3 THE FOLLOWING DAY AFTER A HIGH FEVER AND GENERAL/ALL OVER MUSCLE ACHE, CHILLS my left armpit began to hurt like I'd pinched or been punched in it, today my armpit is swollen with a knot under the skin and very sore to the touch and slightest movement (injection site is red and swollen with a knot in that area as well. *my son also received his second shot on same day & he is reporting to me the exact same issue.* icing the area is not helping.
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| 64 | 2021-02-04 | skin discolouration, injection site pain | razor sharp pain at injection site delirious with fever chills whitening of skin lasting 5 hours |
| 64 | 2021-02-05 | shingles |
Pain in L forehead and face, superficial. Started 2/2/2021, called MD 2/6/2021. MD diagnosed likely...
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Pain in L forehead and face, superficial. Started 2/2/2021, called MD 2/6/2021. MD diagnosed likely shingles reactivation (have had once before). Prescribed valcyclovir.
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| 64 | 2021-02-06 | injection site redness, injection site pruritus, injection site pain, injection site hardening |
Injection site: Bright Redness 2 inches in diameter, hardness, moderate pain, itching ; malaise; nau...
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Injection site: Bright Redness 2 inches in diameter, hardness, moderate pain, itching ; malaise; nausea; vomiting x 1; headache; chills; low-grade fever; myalgia; fatigue
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| 64 | 2021-02-07 | shingles | Approx 10 days after the second Covid vaccine symptoms of shingles began to develop |
| 64 | 2021-02-07 | hives | Hives starting 36 hours after injection, lasting 3 days, used antihistamines with modest improvement |
| 64 | 2021-02-08 | hives, itchy skin |
Itchiness and hives within 15 min of vaccine. Took (2) 25 mg Benadryl and symptoms were improving af...
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Itchiness and hives within 15 min of vaccine. Took (2) 25 mg Benadryl and symptoms were improving after 30 min. Patient left feeling better.
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| 64 | 2021-02-09 | vaccination site rash, vaccination site swelling |
Oval rash at vaccination site which appeared about nine days after the vaccination. Not painful, jus...
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Oval rash at vaccination site which appeared about nine days after the vaccination. Not painful, just red and slightly swollen.
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| 64 | 2021-02-09 | pain of skin, skin peeling, skin discolouration, dry skin |
Skin Lesion on right back of calf. It is about 3/4" in size, flaky, dark red and purple, tender to t...
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Skin Lesion on right back of calf. It is about 3/4" in size, flaky, dark red and purple, tender to touch, dry; Skin Lesion on right back of calf Skin Lesion on right back of calf. It is about 3/4" in size, flaky, dark red and purple, tender to touch, dry; Skin Lesion on right back of calf Skin Lesion on right back of calf. It is about 3/4" in size, flaky, dark red and purple, tender to touch, dry; Skin Lesion on right back of calf Skin Lesion on right back of calf. It is about 3/4" in size, flaky, dark red and purple, tender to touch, dry; Skin Lesion on right back of calf Skin Lesion on right back of calf. It is about 3/4" in size, flaky, dark red and purple, tender to touch, dry; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female non-pregnant patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration on 18Jan2021 11:00 at SINGLE DOSE at left arm for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included allergies to Penicillin. The patient had no other medical history. The patient's concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced skin lesion on right back of calf from 19Jan2021. It was about 3/4 in size, flaky, dark red and purple, tender to touch, dry and after several days of careful care and cleaning it had not gotten better or gone away. Outcome of the events was not recovered. No treatment received for the adverse event.
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| 64 | 2021-02-10 | rash | Rash on chest and arms. Difficulty swallowing for 2 days. Denies difficulty breathing. |
| 64 | 2021-02-14 | skin spots | 1 Petechiae spot on forearm of arm that was injected with vaccine |
| 64 | 2021-02-14 | shingles |
Patient came to the clinic over two weeks after pfizer-bionTech Covid vaccine with shingles and trea...
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Patient came to the clinic over two weeks after pfizer-bionTech Covid vaccine with shingles and treated with Valtrex 1000mg po TID for 7 days. Her next scheduled dose is in two days, 2/17/2021.
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| 64 | 2021-02-14 | injection site warmth, injection site swelling, injection site pain |
fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, ...
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fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, back of the neck/headaches and pain, disoriented, injection site swelling, tenderness, and hot to the touch, fever, sinus infection like symptoms ( stuffiness, difficulty breathing, ear pain, sinus/facial pain )
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| 64 | 2021-02-14 | rash |
first 48 hours fatigue, nausea, headache Day #9 post vaccine rash on Left upper arm and upper chest ...
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first 48 hours fatigue, nausea, headache Day #9 post vaccine rash on Left upper arm and upper chest Day #18 rash on Right arm
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| 64 | 2021-02-15 | rash |
1/31 - rash on her chest, no sob. Wasn't seen for it. Still has the rash on her chest, but no sob, ...
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1/31 - rash on her chest, no sob. Wasn't seen for it. Still has the rash on her chest, but no sob, no swallowing difficulties. Rash hasn't spread since the 1/31. Today can see a black spot lower forearm.
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| 64 | 2021-02-17 | itchy skin |
Swollen and blistered lips; Swollen and blistered lips; Itching inside my mouth and throat, and on m...
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Swollen and blistered lips; Swollen and blistered lips; Itching inside my mouth and throat, and on my hands and legs; Itching inside my mouth and throat, and on my hands and legs; Itching inside my mouth and throat, and on my hands and legs; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiration date was not reported) given at 64 years of age, via an unspecified route of administration in the left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history included known allergies. Concomitant medication included thyroid (ARMOUR THYROID), aluminium hydroxide gel, dried, magnesium carbonate (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]), and metronidazole. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested for COVID-19 since the vaccination. It was reported that less than one hour after receiving the vaccine on 25Jan2021 at 04:00 PM, the patient developed itching inside her mouth and throat, and on her hands and legs. The itching stopped with BENADRYL. Four days later on 29Jan2021 14:30, she developed swollen and blistered lips. The outcome of the events was recovering and were reported non-serious. Treatment received for the events included steroid injection five days after the vaccine. The events resulted to doctor or other healthcare professional office/clinic visit then emergency room/department or urgent care.
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| 64 | 2021-02-18 | redness, hives, itchy skin |
Patient presented with hives /itchiness and redness on arms ,legs and body Patient received Hydroco...
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Patient presented with hives /itchiness and redness on arms ,legs and body Patient received Hydrocortisone cream 1% Symptoms resolved and was localized checked on patient after an hour and she confirmed that no further symptoms
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| 64 | 2021-02-19 | rash, redness |
Within a few minutes of sitting in waiting zone, I had what I thought was severe heartburn. Simulta...
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Within a few minutes of sitting in waiting zone, I had what I thought was severe heartburn. Simultaneously I felt my heart racing and feeling flush. I raised my hand to alert attendant. Took pulse and it was very high. They called EMT. Upon connecting me to heart monitor is was erratic, Very high blood pressure. When they touched chest it hurt more. They said I was bright red. They transported me via residue to Hospital. Residual mild rash under skin for several days. Had severe headache for 14 hours.
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| 64 | 2021-02-21 | rash, skin discolouration, hives, itchy rash |
I developed a severe rash that traveled throughout my body after receiving the second dose of the Co...
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I developed a severe rash that traveled throughout my body after receiving the second dose of the Covid-19 vaccine. It started 3 days after the dose as a rash and within 12 hours it spread to hives and then covered my entire chest, back, neck, arms and face - my ears became swollen. Over the course of several days, the rash spread down my torso and down my legs. The rash turned black and blue in certain areas. It was very itchy. I was seen at Hospital ER, seen by a dermatologist,seen by an allergist and seen by my primary care phsyician. I was treated with prendisone, Hydroxyzine, Benadryl and Zyrtec. I was required to get blood work to check my platelets and liver. Doctors report that this was an allergic reaction. After the one week the rash subsided, and at this time although it is not fully resolved, the rash does not make me uncomfortable.
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| 64 | 2021-02-21 | itchy skin |
Patient initially described superficial itiching of hands. Upon observation, was scratching all over...
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Patient initially described superficial itiching of hands. Upon observation, was scratching all over her torso and arms as well as neck. Benadryl 50 mg provided with improvement in superficial itching but endorsed internal abdominal itching and continues to touch her throat.
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| 64 | 2021-02-22 | itchy skin |
10 mins after 2nd dose, pt started having upper back itchy feeling. Came to nurse observation area....
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10 mins after 2nd dose, pt started having upper back itchy feeling. Came to nurse observation area. no rash observed. BP elevated.
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| 64 | 2021-02-22 | skin laceration |
I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt d...
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I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt dizzy nausea and wanted to vomit. Then I passed out, I fell down and hit my face on the floor. My family called 911 paramedica. They ,measured d my blood pressure and it was too low. The area around my right eyebrow was swollen and my neck hurt as precaution I went to the hospital. I suspect the incident and its symptom are side effects of the vaccine given the timing. Later on I had headache off and on and brain fog.
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| 64 | 2021-02-23 | rash | For 8 days: heavy fatigue, headache, For 3 days: rash For 5 days: nausea |
| 64 | 2021-02-23 | skin burning sensation |
Psoriasis came back all over my body. Psoriasis on hands for the first time! Extreme burning on sk...
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Psoriasis came back all over my body. Psoriasis on hands for the first time! Extreme burning on skin lesions. Headache, weak, overall feeling sick. I had Covid over thanksgiving 2020. I still had antibodies when I got my Covid vaccine.
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| 64 | 2021-02-23 | vaccination site mass |
arm was very black and blue where the shot was administered and way around it/severe black and blue ...
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arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; yeast infection from it; incredible arm pain/arm was really hurting bad; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 12:00 at a single dose on the arm for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she was fine but on 23Jan2021 at 16:00, she experienced an incredible arm pain and fatigue. Her arm was really hurting bad. On 25Jan2021, the patient stated that her arm was very black and blue where the shot was administered and way around it. There was a severe black and blue mark and bump like a golf ball on the arm where she got vaccinated and had yeast infection from it. She never had this before since she never had a vaccine when she was a little kid. She wanted to know if they have heard about this before. She wanted to know if this was normal and if she needs go to the doctor. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient can't get appointment for second shot. The patient was not pregnant at the time of vaccination. The outcome of the events incredible arm pain and fatigue was recovering while the other events was not recovered.
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| 64 | 2021-02-24 | hardening, redness, blister |
swelling, erythema, induration, blister formation, 7 days after vaccine Vaccine given by Health Depa...
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swelling, erythema, induration, blister formation, 7 days after vaccine Vaccine given by Health Department on 2/17, presented by video visit 2/25 due to symptom onset on 2/24, referred to Allergy on 2/25, recommended anti-histamine and otc analgesic
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| 64 | 2021-02-25 | injection site pain | Normal arm soreness, very achy, tiredness |
| 64 | 2021-02-25 | rash | RASH, DYSPNEA, CHEST PAIN, FEVER JOINT PAIN, CHILLS, FEVER. TREATMENT: KENALOG, BENADRYL, PEPCID. |
| 64 | 2021-02-25 | injection site rash, injection site redness, injection site pruritus |
REDNESS, ITCHINESS, RASH AT SITE OF INJECTION ONE WEEK AFTER SHOT. USED CORTIZONE TO NO AVAIL. I ADV...
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REDNESS, ITCHINESS, RASH AT SITE OF INJECTION ONE WEEK AFTER SHOT. USED CORTIZONE TO NO AVAIL. I ADVISED HER TO USE BENADRYLL NOW AND EVENING AFTER 2ND DOSE.
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| 64 | 2021-02-25 | cellulitis |
cellulitus around left eye which spread down left cheek, across chin and started up the right cheek;...
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cellulitus around left eye which spread down left cheek, across chin and started up the right cheek; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on the left arm, on 16Jan2021 at 12:00, at a single dose for Covid-19 immunization. The patient has no medical history and no known allergies. Concomitant medication included amoxicillin. On 24Jan2021, the patient experienced cellulitis around left eye which spread down left cheek, across chin and started up the right cheek. The adverse event resulted in doctor or other healthcare professional office/clinic visit, hospitalization. The patient was hospitalized for 6 days. The patient has no Covid prior vaccination and was Covid tested post vaccination. The patient had a nasal swab on 28Jan2021 and result was negative. The patient was recovering from the event. Information on lot/batch number has been requested.
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| 64 | 2021-02-26 | itchy rash |
I got a very fine, very itchy rash across the top of my back and on my right leg/shin that eventuall...
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I got a very fine, very itchy rash across the top of my back and on my right leg/shin that eventually went to my left leg. I applied lotion. It didn't go down. It lasted for several days.
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| 64 | 2021-02-27 | itchy skin, rash | Itchy rash on my body and extremities |
| 64 | 2021-02-27 | injection site pain |
Next day following vaccine - site injection pain (right arm). Arm pain has continued and progressed ...
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Next day following vaccine - site injection pain (right arm). Arm pain has continued and progressed limiting mobility. In the past 7 days patient has progressively declined in from independent to requiring assistance with walking. Pain and limited mobility in legs
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| 64 | 2021-02-27 | injection site pain |
Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; ...
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Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; exhaustion 2/26 extreme fatigue; 2/27 extreme fatigue; nausea; diarrhea; headache
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| 64 | 2021-02-28 | vaccination site pain |
Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spo...
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Headache; left arm is hurting from the shoulder; tired; Nauseous; injection site pain; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at arm left on 09Feb2021 at 14:10 (at the age of 64 years) at single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease, ongoing allergies, ongoing blood cholesterol abnormal. Concomitant medication included mesalamine (strength: 400 mg) oral at 400 mg twice daily for Crohn's disease, atorvastatin oral at 400 mg once a day for blood cholesterol abnormal, azathioprine oral at 50 mg twice daily for Crohn's disease, cetirizine oral at 10 mg for allergies, vitamin D at 1000 iU daily for supplementation, ketotifen fumarate (strength: 0.025 %) ophthalmic twice daily for allergies and ipratropium bromide (strength: 0.06%) nasal daily for allergies, all from an unknown date and ongoing. The patient experienced sore at the injection site on 09Feb2021, headache on the left side and her left arm was hurting from the shoulder down and she feels really tired and nauseous, all on 12Feb2021. The patient outcome of injection site pain was recovered on 09Feb2021; the outcome of the other events was not recovered. The information on the batch number has been requested.
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| 64 | 2021-02-28 | injection site reaction |
Post vaccination return of CRPS/RSD related numbness and burning in each site where history of CRPS....
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Post vaccination return of CRPS/RSD related numbness and burning in each site where history of CRPS. Have not been on any medications for the CRPS for over 2 years with minimal to no exacerbation of CRPS events. I have a long history of flair ups with insults to my body (e.g. post accident, post surgery, extensive dental work). The numbness and burning started to return within 2 hours of injection to the right side of my face and my right hand. Then these symptoms started to return to other locations on my body throughout the week (lower back, left knee and right ankle). The only site that has subsided 1 week post injection is my right hand though all symptoms have not resolved there either. The burning in my lower back got so bad on Thursday that I had issues sitting and scheduled an appointment with Dr. for Monday 3/1/21. Telehealth visit with Dr. this AM and returning to medication to treat CRPS/RSD till episode resolved.
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| 64 | 2021-03-01 | itchy skin, injection site swelling, redness |
Extreme edema at injection site, area about 4? x 6? Hot to the touch, itchy, red, still swollen afte...
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Extreme edema at injection site, area about 4? x 6? Hot to the touch, itchy, red, still swollen after 5 days. Overall itchy, but no rash. Thursday-Saturday diarrhea and lethargy Some intermittent vertigo. Rest, fluids, Tylenol and benedryl
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| 64 | 2021-03-01 | hives | hives, congestion, swelling |
| 64 | 2021-03-01 | injection site bleeding |
upon receiving the vaccination I had a stinging pain and I bleed down my arm. The administer wiped i...
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upon receiving the vaccination I had a stinging pain and I bleed down my arm. The administer wiped it with a cotton ball. The person who administered the vaccine did not pull out or start over again. I believe she hit a vein. Now i have a scar on my arm. it is still painful and since it may not have been on a muscle I am not even sure I am vaccinated.
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| 64 | 2021-03-02 | bruising |
mild headache; tiredness; bruised arm not at injection site; This is a spontaneous report from a con...
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mild headache; tiredness; bruised arm not at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 64 -year-old female (not pregnant at time of vaccination) patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Ek9231), via an unspecified route of administration (on the left arm) on 07Jan2021 14:30 (at the age of 64-years-old), single dose for COVID-19 immunization. Relevant medical history included Allergies, mvp, hbp, thalassemia all from an unknown date. The patient's concomitant medication was not reported. The patient experienced mild headache, tiredness and bruised arm not at injection site, all from an unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test on 10Jan2020, 15May2020 and 01Oct2020, all negative. Patient has no other vaccine in four weeks. No covid prior to vaccination. No treatment received for the adverse events. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021143321 same reporter/patient/drug, different events separated with time
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| 64 | 2021-03-03 | itchy skin, injection site redness |
Approx. day 12 post injection noticed uneven redness adjacent to and in front injection site. Today...
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Approx. day 12 post injection noticed uneven redness adjacent to and in front injection site. Today, day 14, redness has spread and raised. Resembles a figure 8 with a broad bottom. Slightly itchy.
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| 64 | 2021-03-03 | skin burning sensation |
skin is burning up, her arms, her face, her stomach, her back, and her chest are burning up/burning ...
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skin is burning up, her arms, her face, her stomach, her back, and her chest are burning up/burning skin has probably gotten worse; Nausea; no appetite; Headache; bad sore throat; felt sick since she got it; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL9262), via an unspecified route of administration on left arm (at the age of 64 years) on 24Jan2021 at single dose for covid-19 immunization. Medical history included type 2 diabetes (borderline about 15 years ago/started taking a medication a year ago for her high sugar numbers/had some blood tests, her A1C was normal, her diabetes was the same way it always has been); hypertension from 2012 (diagnosed about 9 years ago); sleep apnea from 2020 (uses a C-PAP machine/diagnosed approximately a year ago); Epstein Barr from 1995 (diagnosed when she was 39); high cholesterol (sometimes she didn't take her medication for that); cataract and cataract surgery in Jan2021 (had this last month/they used anesthesia/didn't know which type/had some eye drops for this). Concomitant medication included an unspecified high blood pressure medication (she thinks she tried a few times). The patient called about Pfizer COVID-19 vaccine and she had questions and side effects. She did get one shot, and was not due for her second for a couple weeks. The patient felt sick since she got it, some side effects have been less, some stayed the same or got worse. Her skin was burning up, her arms, her face, her stomach, her back, and her chest were burning up. She has done no treatment, because she didn't know what to do to treat it and it was difficult to be able to get in to see a doctor. The burning skin has probably gotten worse. She also had nausea and no appetite, though she has gotten a little better, it has been at least a full week or so. She had a headache and a bad sore throat also. She got home from getting the shot, probably maybe 5 or 6 hours after getting the shot. The patient's weight was 145-150lbs. The outcome of the event skin burning sensation was not recovered while for the remaining events was unknown.
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| 64 | 2021-03-04 | injection site pain |
As the needle was being inserted and while the vaccine was being injected, I immediately felt intens...
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As the needle was being inserted and while the vaccine was being injected, I immediately felt intense pain like none I've had during any prior vaccine administration . The needle was inserted very high on the arm about 1/2 inch below the shoulder. About 4:00 pm that afternoon, new pain developed in the same shoulder, along with very limited range of motion, gradually worsening during next few hours. By 9:00pm the pain was excruciating, like there were multiple knives in all directions in my shoulder. By then I could not lift or move my arm any amount in any direction without excruciating pain. I suspected a severe inflammatory response. This pain level continued for the next 2 days. On the 3rd day the pain was a little less severe and I had slightly more range of motion, but was still unable to lift my arm without pain. On the 4th day (Feb. 18) the pain was a little better but I still had severe sharp pain if I lifted my arm in certain directions. I began to suspect a torn muscle or tendon. Today (March 5, almost 3 weeks after the vaccine), the pain and limited range of motion are the same as Feb. 18. It is relieved only by complete rest of the arm, and easily aggravated by any basic activity (grocery shopping, dressing, etc.) I believe my shoulder was injured by improper administration.
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| 64 | 2021-03-04 | shingles |
shingles; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female (als...
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shingles; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female (also age at vaccination) patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL3248), via an unspecified route of administration at the left arm on 19Jan2021 at SINGLE DOSE for covid-19 immunization. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) on 29Dec2020 10:00 AM at the left arm for covid-19 immunization. The patient is not pregnant at time of vaccination and was vaccinated at a hospital. Medical history included breast cancer, lichen planus, hypothyroid, allergies to Sulfa drugs and environmental. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient also received other medications within 2 weeks of vaccination (unspecified). The patient experienced shingles on 28Jan2021 08:00 AM (diagnosed on 02Feb2021). The event resulted in Doctor or other healthcare professional office/clinic visit. It was reported that treatment received for the adverse event includes: clinic visit and medication. The outcome of the event was recovering. Case was considered as non-serious.
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| 64 | 2021-03-06 | redness |
Within 10-15 minutes of receiving the shot, my face and ears became very flushed and hot; I felt as ...
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Within 10-15 minutes of receiving the shot, my face and ears became very flushed and hot; I felt as if I had a large dose of a Medrol Dose-pak/steroid. I did not have any difficulty breathing, nor did I feel my throat constricting or other symptoms of anaphylaxsis. Since my symptoms were relatively minor, I did not alert the volunteers at the vaccine site that I needed to see the paramedic on duty. The only concession I made to my symptoms was that I allowed my adult daughter, who came with me for a vaccine, to drive us home. My symptoms subsided within 30 minutes and have been gone ever since.
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| 64 | 2021-03-07 | injection site redness, injection site pruritus, injection site rash |
At 10:45 5 minutes after receiving vaccine patient complained of itching at the left upper arm rash ...
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At 10:45 5 minutes after receiving vaccine patient complained of itching at the left upper arm rash and redness noted.
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| 64 | 2021-03-07 | injection site swelling, injection site warmth |
Felt nauseated two hours after shot until the next day. Left arm had fever and swolen at injection ...
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Felt nauseated two hours after shot until the next day. Left arm had fever and swolen at injection site for six days. I'm feeling better now. I am frightened of getting the second shot. I had Covid in October and was quite ill. I don't want that feeling again. I was totally surprised by having an issue with first shot.
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| 64 | 2021-03-07 | injection site pain | Injection site very sore; Fatigued; headache; nausea |
| 64 | 2021-03-07 | injection site pain | Soreness at injection site. Ice pack to site and acetaminophen taken |
| 64 | 2021-03-08 | redness |
Face turned red, and then numb, hard to breathe, and felt like heart beat quicken, and felt like pas...
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Face turned red, and then numb, hard to breathe, and felt like heart beat quicken, and felt like passing out. Lasted for about 3 minutes.
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| 64 | 2021-03-08 | injection site pain | Fever of 100 degrees, pain at injection site, fatigue, muscle aches, difficulty breathing |
| 64 | 2021-03-08 | skin warm, rash, itchy rash |
RASH STARTED @ 1.5 DAYS LATER...STARTED ON CHART ALL ACROSS/GOT WORSE AS DAY PROGRESSED ALL OVER BOD...
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RASH STARTED @ 1.5 DAYS LATER...STARTED ON CHART ALL ACROSS/GOT WORSE AS DAY PROGRESSED ALL OVER BODY.. NOT ON LEGS PAST KNEE AND ONLY ON INSIDE OF BOTH ARMS...OTHERWISE ALL OVER BODY NOT FACE EITHER HOT AND ITCHY.. FRIDAY WENT TO URGENT CARE THEY GAVE ME STEROID METH PAK 4 MG GOT WORSE OVER WEEKEND AND WENT TO EMERGENCY ROOM MONDAY MORNING 3/8 AT @ 6 AM I WAS GETTING CHEST SPASMS IN FRONT CHEST AND BACK/MY RASH WAS THE WORST ON CHEST. HOSPITAL CHECKED OUT HEART...ALL GOOD/PLATELETS ALL GOOD I FORGOT TO MENTION EARLIER THAT I WAS ALSO ON AMOXICILLIN DUE TO A ROOT CANAL DONE DAY BEFORE VACCINE HOSPITAL GAVE ME STRONGER PREDNOZONE PILLS TO TAKE 6 FOR 2 DAYS THEN 5 FOR 2 DAYS...ETC. SOMEWHAT LIGHTER ON DAY 2 TODAY IN RASH..STILL ALL OVER...BUT GETTING DARKER IN COLOR.
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| 64 | 2021-03-08 | injection site pruritus, injection site warmth, injection site redness, injection site swelling | Redness, swelling, itching, and warmth at the injection site |
| 64 | 2021-03-08 | rash, rash macular | low grade fever, blotchy rash on neck and chest area |
| 64 | 2021-03-09 | itchy skin, rash macular |
48 hours (Feb 26) after receiving the shot, I had anaphylaxis symptoms... red blotches around mouth,...
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48 hours (Feb 26) after receiving the shot, I had anaphylaxis symptoms... red blotches around mouth, swelling face, swelling lips, ants-crawling feeling on face, neck and scalp. Went to Urgent Care, given benadryl and steroid shot. Rx Prednisone 20 mg x2, 5 days. Anaphylaxis happened again the next day (Feb 27) just prior to taking the first prednisone. Went back to Urgent Care, another shot. Meds kept full on allergic reactions at bay on Monday and Tuesday. Had swelling face, lips and tongue happen in Primary Care office on March 3, received another shot and increased prednisone rx to 30 mg x2, with taper. On March 5, happened again, went to ER, where doc changed timing of prednisone to 60 mg all in one dose. All in conjunction with hydroxyzine 25 mg every 12 hours and 50 mg of benadryl every six hours. Situation continues with mild swelling, itchy sensations happening just before it is time to take new meds .
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| 64 | 2021-03-10 | itchy skin, redness |
10 x 10 sonometer flair Itchy and swelling of area Began of 3/7/21 Itchiness has subsided as of -3/1...
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10 x 10 sonometer flair Itchy and swelling of area Began of 3/7/21 Itchiness has subsided as of -3/11/21 Redness remains as of 3/11/21
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| 64 | 2021-03-10 | bruising, skin mass |
I developed a 3?x4? bruise 5-6 inches away from my injection site 10 days after my 2nd dose. It?s p...
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I developed a 3?x4? bruise 5-6 inches away from my injection site 10 days after my 2nd dose. It?s painful and has a dime size lump inside, looks like it?s getting bigger every day. I have a hex of low platelets, last December is 145 , took it again 3/1/21 and it?s 116 , I don?t know what?s going on , Saw my PC , he sent me for ultrasound. Please advise what to do.
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| 64 | 2021-03-10 | rash | Patient is experiencing a rash on her body away from injection site. |
| 64 | 2021-03-10 | itchy skin |
Pt was giving a vaccine at 11:45. Patient started having itchy feeling on her back and neck at 12:16...
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Pt was giving a vaccine at 11:45. Patient started having itchy feeling on her back and neck at 12:16. No hives or redness on skin.. No complaints of difficulty breathing or shortness of breath. Itchy feeling went away 1226. Vs 133/61 spo2 98% reps 18. Hr 73
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| 64 | 2021-03-10 | hives | SEVERE HIVES, GANGLION CYST, FEVER, HEADACHE |
| 64 | 2021-03-10 | injection site pain |
Sore injection site, fatigue, low grade fever, sore armpit ( radiating to left breast ). Fatigue. A...
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Sore injection site, fatigue, low grade fever, sore armpit ( radiating to left breast ). Fatigue. And Temperature lasted approximately 24 hours. Pain in at injection site and armpit pain lasted 3 days.
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| 64 | 2021-03-10 | injection site nodule, injection site bleeding | The injection site immediately bled and a 1-2cm welt formed. |
| 64 | 2021-03-10 | itchy skin | itching |
| 64 | 2021-03-11 | bruising |
64 yo female with hx bipolar disorder on multiple psych meds, Htn, here for same day visit. Pt repor...
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64 yo female with hx bipolar disorder on multiple psych meds, Htn, here for same day visit. Pt reports got her second covid vaccine on 3/92021 in the left arm, Pfizer. Yesterday (3/10/21) woke up with severe right knee pain, felt like she could not bear weight/ws going to fall. She went to son's apartment who is in same building and then went to lie down in bedroom. Because she drinks a lot of water, she had to get up to go to bathroom to urinate. She was about to sit down on toilet, when she felt both her legs go numb as well as her arms and her vision was blurred. She tried to grab the tub but fell forward on the floor. She states she urinated on the floor. She was on the floor for about 30 mins until her son got her up and back to bed. Later in the day she needed to urinate again and when she got up, she felt unsteady and fell on the bureau bruising the left arm. Since she feels a bit unsteady with gait and used a walker to come hre today. She denies feeling dizzy before her falls. She denies striking her head. She denies convulsions or hx of seizure disorder. She reports no new meds, only recent change an increase in her alprazolam dose. She does report a headache day after her vaccine.'She denies vomiting or diarrhea or antecedent illness. No longer has headache. She denies positional changes Of note she is on propranolol (prescribed by psych) as well as lisinopril-hydrochlorothiazide for HTN 64 yo female with bipolar disorder on multiple psych meds, htn on propranolol 20 mg bid and lisinopril-hydrochlorothiazide, s/p recent Pfizer covid vaccine, s/p presyncope episode after experiencing severe right knee pain and attempted micturition. Pt felt like her sight was affected and experienced numbness/weakness in legs and arms causing a fall. Did not hit head. The history is most suggestive of a vagovagal episode.
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| 64 | 2021-03-11 | itchy skin |
Patient received her first dose of the Pfizer COVID-19 vaccine and during the post-vaccination wait ...
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Patient received her first dose of the Pfizer COVID-19 vaccine and during the post-vaccination wait period she stated that she felt tingling, numbness and itching on the front part of her tongue. She has a history of allergies and is allergic to eggs, cats, pollen and Benadryl. During examination by the nurse, she stated that she felt ?sweaty? and her neck was itching. She however stated that she did not want the EMT called, but would wait and let us know if the symptoms were getting worse. She waited for half an hour and stated that she was feeling better and was ready to leave. She was asked to call ?911? if the symptoms returned and she voiced understanding.
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| 64 | 2021-03-12 | injection site redness, injection site pain, injection site pruritus, injection site swelling, injection site rash |
12 hours after -- fever around 100 degrees F, chills, headache, body aches, nausea - cleared in a d...
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12 hours after -- fever around 100 degrees F, chills, headache, body aches, nausea - cleared in a day. Sore at site of shot. 6 days after - still sore at site, but now red, rash, intense itching, swollen, and swollen lymph nodes under arm at the site of shot. This continues 5 days later despite treating with Benadryl and Aleve and topically with hydrocortisone cream.
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| 64 | 2021-03-12 | itchy skin |
15 minutes after face flush. Later about 1:30 am, sore arm returned and face itching and 1 degree of...
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15 minutes after face flush. Later about 1:30 am, sore arm returned and face itching and 1 degree of temperature
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| 64 | 2021-03-12 | injection site pain | Bad headache, pain and muscle stiffness at injection site |
| 64 | 2021-03-13 | hives, rash |
Rash and hives-forearms, calves, chest, stomach so far. Trying to keep on top of it with Benadryl a...
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Rash and hives-forearms, calves, chest, stomach so far. Trying to keep on top of it with Benadryl and Fluocinonide cream that I already had on hand. Clears up in one area, pops up in another.
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| 64 | 2021-03-14 | skin warm |
1318: Received 2nd Covid Vaccine 1330: Pt c/o chest tightness & throat swelling but had similar reac...
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1318: Received 2nd Covid Vaccine 1330: Pt c/o chest tightness & throat swelling but had similar reaction w/1st vaccine so took own pre-med and began own nebulizer tx immediately following administration of 2nd vaccine. Chest tightness and throat swelling not as bad as after 1st vaccine. Denies need for Epi pen or Benadryl 1333: BP 124/80 HR 78 RR 18 SpO2 100% NAD, voice sl hoarse, lungs CTAB, cardiac RRR, skin pale, warm, dry, no rash 1338: HR 76 RR 18 SpO2 99% 1340: Released home
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| 64 | 2021-03-14 | injection site bruising | Bruise/Scarring around injection site on left arm |
| 64 | 2021-03-14 | injection site pain | Soreness at injection site, chills, headache, nausea, tiredness |
| 64 | 2021-03-14 | injection site rash, injection site pain, injection site bruising |
Sudden appearance of circular rash around injection site, area is tender (feels like a bruise), now ...
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Sudden appearance of circular rash around injection site, area is tender (feels like a bruise), now fading
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| 64 | 2021-03-14 | bruising |
The NEXT day: chills, headache, heavy nausea, dry cotton mouth, but couldn't drink. Dizzy. Couldn't...
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The NEXT day: chills, headache, heavy nausea, dry cotton mouth, but couldn't drink. Dizzy. Couldn't barely lift legs to walk. No bladder control. Hard to get to bathroom. Fell twice. Second time hitting head. Then, Difficulty breathing. And heart racing. (Please note: I did actually have Covid last summer from July through August).
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| 64 | 2021-03-14 | itchy skin, rash |
angioedema; Face & tongue tingling; Face & tongue tingling; Itching all over; rash on limbs & chest;...
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angioedema; Face & tongue tingling; Face & tongue tingling; Itching all over; rash on limbs & chest; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration on 11Feb2021 11:15 (at the age of 64-year-old) at single dose in right arm for covid-19 immunisation. The patient other medical history included seizure disorder, hypertension, obesity, IBS (Irritable bowel syndrome), chronic rhinitis, atrial fibrillation. The patient had known allergies. No other vaccine in four weeks. The patient had received other medications in two weeks. The patient experienced face & tongue tingling. Itching all over, angioedema, rash on limbs & chest, swollen lymph nodes on 11Feb2021 12:00 PM. The patient received the treatment of events included diphenhydramine (BENADRYL). The outcome of the events was recovering.; Sender's Comments: The causal association between the reported event angioedema and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-03-15 | hives |
I have had my urticaria in remission for 7 years. By the morning after the injection, I had hives c...
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I have had my urticaria in remission for 7 years. By the morning after the injection, I had hives covering back qnd upper arms. I took 10 Mil prednisone for 3 days and hives subsided.
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| 64 | 2021-03-15 | redness, itchy skin |
Large, warm oval lump and redness a little larger than the bump. The redness continued to grow a l...
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Large, warm oval lump and redness a little larger than the bump. The redness continued to grow a little larger for 2 days and the lump began to itch. It has been 4 days and the lump and itching are still there. The redness seems to have retuned to the size of the lump currently about 2 inches by 1 inch. It is still warm to the touch. There is a little tenderness.
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| 64 | 2021-03-16 | itchy skin |
10 days after the 1st vaccine my lip and tongue started swelling and I took benadryl. Spoke to an a...
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10 days after the 1st vaccine my lip and tongue started swelling and I took benadryl. Spoke to an allergist and they did not think it came from the vaccine . 2nd vaccine which I had on Tuesday, early Thursday morning I woke up with itching and tingling all down my legs which is still continuing.
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| 64 | 2021-03-16 | redness, injection site bruising | Redness, swelling, bruising at injection site, pain in armpit lymph glands, chills & body ache |
| 64 | 2021-03-16 | redness, rash |
With in 5 minutes of the shot my chest and left arm pain and heart started to race,,face turned rash...
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With in 5 minutes of the shot my chest and left arm pain and heart started to race,,face turned rashy red and hot, had the shakes, nauseous dizzy and short of breath, blood pressure was high, with in hour my heart rate started to slow down, I took a Benadryl, felt ill. Tuesday started having diarrhea then around 11:30 pm had same reactions as Monday after shot was given. Took another Benadryl. Wednesday still bouts of diarrhea, tired,weak.nauseous.
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| 64 | 2021-03-17 | shingles, skin burning sensation |
Developed burning in L buttock and labia on the evening of the vaccine (3/13). This progressed to s...
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Developed burning in L buttock and labia on the evening of the vaccine (3/13). This progressed to shingles with urinary retention by 3/17
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| 64 | 2021-03-17 | rash | Rash on stomach |
| 64 | 2021-03-17 | skin peeling |
Skin started peeling on palms and fingers of both hands from Sunday PM. No pain, no itching. Almos...
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Skin started peeling on palms and fingers of both hands from Sunday PM. No pain, no itching. Almost back to normal by Tuesday. By Wednesday, it was gone. Very minor side effect with no discomfort. Just thought I'd report it. Attached a picture.
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| 64 | 2021-03-17 | rash | Swelling of eyes and face. Light rash on face, neck, chest, and arms |
| 64 | 2021-03-17 | injection site pain |
Today marks 2 weeks since my shot and my right arm is as sore as it was on day one. It?s primarily ...
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Today marks 2 weeks since my shot and my right arm is as sore as it was on day one. It?s primarily in the right bicep I feel like muscle is getting weak. I have iced it and taken Advil and Tylenol. Nothing takes the pain away. Additionally the pain wakes me up from sleep.
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| 64 | 2021-03-17 | shingles |
Within 10 hours of receiving the first vaccine I had a robust reaction with a high fever that resolv...
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Within 10 hours of receiving the first vaccine I had a robust reaction with a high fever that resolved within 24 hours. On 3/12 /21 I got symptoms of Shingles. It was at the same site as a previous bout in 2019. It did not develop beyond pain and high fever and lasted 3-5 days. I got but one shingles blister at the site. I still have a very slight pain at the shingles site rated at 1/10 on pain scale. I suspect that the shingles reaction was triggered by the Covid shot. I am aware that if one searches the internet hard enough one will find the answer one seeks. Sure enough I found a newspaper article written by a dermatologist in LA that wondered if there is a link between Covid vaccine and shingles. He had treated 2 patients in a timeframe that suggested this link. There is no research available on this. I am a little concerned about getting the second Covid vaccine as it typically provokes a stronger immune system response than the first one. I believe that I had Covid-19 in July with typical symptoms but I tested negative. They say that the first Covid vaccine can cause a greater reaction if one has already had the Covid virus. I am hoping that this is the case and my second vaccine will provoke a milder reaction.
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| 64 | 2021-03-17 | rash |
Within approximately 25 minutes, began feeling very flushed in my face (face felt very, very hot). R...
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Within approximately 25 minutes, began feeling very flushed in my face (face felt very, very hot). Rash on my cheeks and some on neck. For about five minutes, I felt an "awareness" of my throat (around the area in the front where the Adam's apple would be located. This went away. I had the flushed rash for approximately 3 hours and then it resolved and had no further issues. I did not seek medical treatment. I had mild symptoms from the actual vaccine. Soreness in right arm for approximately 1 day.
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| 64 | 2021-03-18 | skin irritation, dry skin, redness |
Areas appeared on face and neck that are red, swollen, and irritated dry skin. Describes as the sam...
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Areas appeared on face and neck that are red, swollen, and irritated dry skin. Describes as the same but much worse than her allergic reaction that she has to some foods
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| 64 | 2021-03-18 | pain of skin, skin warm, hardening |
Current: Severe pain and swelling in left armpit; feels as if it is cut open. Swelling is visible, a...
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Current: Severe pain and swelling in left armpit; feels as if it is cut open. Swelling is visible, and armpit is hard and hot to the touch. Yesterday (resolved): fever of 102, profound chills, skin was painful all over, mild headache and low backache, exhaustion.
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| 64 | 2021-03-18 | vaccination site pain, itchy skin, itchy rash |
Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little...
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Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little fatigue; Severe arm/injection site pain; Severe arm/injection site pain/very sore arm; Chills; Low grade fever; Headache; Lightheaded; Weakness/really weak; Itchy rash on chest/has a rash on her chest/little rash on my back; Nausea; Loss of appetite; She is flushed; tested positive for Covid and 6 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (Solution for injection, Batch/Lot: EL9265) in right arm via an unspecified route of administration on 08Feb2021 07:45 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included osteoporosis, Inappropriate sinus tachycardia, known allergies. Concomitant medication included estradiol benzoate (ESTRADIOL [ESTRADIOL BENZOATE]), calcium (CALCIUM), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), naproxen (NAPROXEN), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) all at once a day. The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient had the first vaccine on 08Feb (complete date not clarified), two days after that it had most of the side effects, with the one very sore arm, headache, fever chills, nausea, feeling very tired, about 6 days after that she tested positive for Covid and 6 days after the first vaccine. She tested positive for Covid so for the last couple of weeks. She had Covid, the fever broke about 5 to 6 days ago, she had a low grade fever after that, also the symptoms were gone now, there was little fatigue and little rash on back. She was scheduled to take second shot now and was trying to find in research about taking the second shot inspite of having covid. She cant find anything, most of the people never heard this and primary care physician said to go ahead and take the shot, but some people and some researchers said you should not, because she might have symptoms later and she should wait. The treatment was not received for the adverse events. Outcome of tested positive for Covid and 6 days was unknown and for other events it was recovering.
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| 64 | 2021-03-18 | skin burning sensation |
Flushed face, burning and tingling, tight. Started within 8 minutes of injection. 30 minutes later i...
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Flushed face, burning and tingling, tight. Started within 8 minutes of injection. 30 minutes later it spread to back of the neck and went up through the scalp at the back of the head to the crown of the head. Headache the whole time. Face returned to normal in 90 minutes. Scalp in 2 1/2 hours. Muscles aches starting in left arm, moved to left leg and then to right leg. Headache is persistent but mild 4 hours later.
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| 64 | 2021-03-18 | injection site pain |
Pain on injection site with fever at night on the first day. Right arm pain has not subsided until n...
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Pain on injection site with fever at night on the first day. Right arm pain has not subsided until now (3/19/2021). I have ROM but there is a lingering muscular pain??? Pain with certain movement such as raising Right arm or swinging the right arm.
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| 64 | 2021-03-18 | itchy skin, redness |
Shot was given at 1:12pm, immediately could taste the vaccine in the back of my throat. Went to wait...
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Shot was given at 1:12pm, immediately could taste the vaccine in the back of my throat. Went to waiting area for 15 minutes. Left to go home, my face cheeks started to turn red within the next 30 minutes. A couple of hours later my skin was tingling, itching, even inside my ears, around my ankles. Took some Benadryl, knowing that it was an allergic reaction, but it didn't help. Couldn't sleep, felt like my skin was crawling. Around 4 am my skin finally calmed down. Sent a message to my Dr. to let him know what happened. Still some lingering itching the next day. Today is Friday March 19, most everything is back to normal.
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| 64 | 2021-03-18 | vaccination site pain |
extreme congestion; Loss of appetite; nausea; fever; chills; headache; fatigue; dry cough; injection...
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extreme congestion; Loss of appetite; nausea; fever; chills; headache; fatigue; dry cough; injection site pain; pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiry date: unknown), via an unspecified route of administration on 09Feb2021 at 03:00 PM (at the age of 64-year-old) on Left arm at single dose for covid-19 immunisation. The patient's medical history was not reported. Patient had unspecified other medications in two weeks. The patient previously took first dose of BNT162B2 (Lot number: EL9262) on 22Jan2021 at 02:30 PM on Left arm at single dose for covid-19 immunisation and had vancomycin and experienced drug allergy. The patient experienced Loss of appetite, nausea, fever, chills, headache, fatigue, dry cough, extreme congestion, pain at injection site and aches on 10Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 64 | 2021-03-19 | redness |
Chills, body aches, redness in arms, shaking, some neurological issues appearing to be related to sh...
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Chills, body aches, redness in arms, shaking, some neurological issues appearing to be related to shock (shaking, rapid eye movements)
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| 64 | 2021-03-19 | itchy skin |
I woke up on the second day after first dose (not the very next day) and my face was swollen and eye...
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I woke up on the second day after first dose (not the very next day) and my face was swollen and eyes swollen, Right eye swelling more prevalent. I itched all over at various times and took Benadryl for 3-4 days. I also had slight headache, nausea, malaise.
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| 64 | 2021-03-20 | injection site mass, injection site pain |
Fever 101.3 Migraine head pain Joint muscle aches Fatigue- 48 hrs Left arm still hurts at injection...
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Fever 101.3 Migraine head pain Joint muscle aches Fatigue- 48 hrs Left arm still hurts at injection site and there is a small lump
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| 64 | 2021-03-20 | injection site pain |
Pain at injection site Chills Achiness Fatigue Stomach discomfort About 4 hours after injection, g...
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Pain at injection site Chills Achiness Fatigue Stomach discomfort About 4 hours after injection, getting better the next evening, now feeling some fatigue. Slight pain at injection site. Took Tylenol.
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| 64 | 2021-03-20 | redness, injection site swelling, injection site pain | Redness Warm to touch Swollen knot Tender |
| 64 | 2021-03-20 | itchy skin |
itching all over difficulity in breathing wheezing tightness in chest had to take benadryl for ...
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itching all over difficulity in breathing wheezing tightness in chest had to take benadryl for 4 days due to itching
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| 64 | 2021-03-21 | rash |
Rash from shoulder to elbow. It wasn?t itchy or irritated. The rash has reduced. I did not contact ...
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Rash from shoulder to elbow. It wasn?t itchy or irritated. The rash has reduced. I did not contact my doctor since I didn?t feel it was serious. I wanted to report this possible side effect.
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| 64 | 2021-03-21 | rash | Rash- face, neck, torso |
| 64 | 2021-03-22 | itchy skin |
Pt complains of itching/tongue swelling. MD on site assessed pt, advised pt to take 50mg Benadryl. P...
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Pt complains of itching/tongue swelling. MD on site assessed pt, advised pt to take 50mg Benadryl. Pt monitored for additional 30 minutes, swelling improved, vitals stable, lung sounds clear. MD released pt to home
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| 64 | 2021-03-22 | hives |
approximately ten minutes after getting shot the patient report hives on inner thighs. Also observed...
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approximately ten minutes after getting shot the patient report hives on inner thighs. Also observed hives on face. Benadryl 50 MG IM was given. Hives improved. Patient requested water due to dry mouth. Was able to drink water without any problems. Vital signs were monitors. Initial bp 153/90 hr 89 resp 15. Vital signs remained in this range. Dischage vital signs bp 146/91 hr 75 resp 15. Husband present and drove patient home. Informed to continue Benadryl 25mg every 4-6 hours today.
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| 64 | 2021-03-22 | itchy skin |
itchy feet, hands, eyes, voice became hoarse within 15 minutes of shot; took Benadryl immediately (a...
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itchy feet, hands, eyes, voice became hoarse within 15 minutes of shot; took Benadryl immediately (as I do for food allergies); cleared up symptom of voice, but not itchiness; took 3 Benadryl spaced out over 1.5 hours, under care of nurses/EMT at site, but hadn't cleared up symptoms, so nurses directed me, with my accompanying friends, to an ER, where physician gave me Pepcid (rather than a steroid which he said would compromise the effect of the vaccination) and told me to take Benadryl every 8 hours for next 3 days
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| 64 | 2021-03-22 | hives | urticaria, throat closing |
| 64 | 2021-03-23 | itchy skin, injection site pain |
Aside from the soreness of the left arm where I was injected, the left side of my neck and esophagus...
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Aside from the soreness of the left arm where I was injected, the left side of my neck and esophagus is sore and I have numbness on the left side of my face. The numbness is on the left jaw, the cheek, the eye brow and forehead. It's itchy and tingly. It feels somewhat like when a part of the body is coming out of being asleep and it tingles. This is the second day of the numbness. I did not expect this reaction to this COVID-19 vaccination and I have never had such a reaction to vaccinations in the past. I read on the internet of people getting Bell's palsy from the COVID-19 shot and wondered if this is similar. With this reaction from the first COVID-19 shot, I'm concerned what my reaction might be if/when I have the 2nd vaccination.
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| 64 | 2021-03-23 | hives |
First dose 3/2/21 chills and sore arm. Second dose 3/23/21 sore arm, achy muscles and joints, heada...
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First dose 3/2/21 chills and sore arm. Second dose 3/23/21 sore arm, achy muscles and joints, headache, hives Allergist Dr. recommended Allegra
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| 64 | 2021-03-23 | hives | covered in hives throughout the body besides face, hands, and feet. Feeling under the weather, |
| 64 | 2021-03-23 | itchy skin, rash with redness |
fatigue( 5 days- slept and did nothing but lay on the couch) , whole body muscle aches ( 2 days), l...
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fatigue( 5 days- slept and did nothing but lay on the couch) , whole body muscle aches ( 2 days), left arm itchy and red bumps(2 days put cold compresses on it) , very sleepy( slept on couch-3/4 days) , serve headaches (3 days- took Advil every 8 hours and drank 64 ounces of water daily)
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| 64 | 2021-03-23 | injection site pain | headache, tiredness, low fever, muscle aches, injection site pain. |
| 64 | 2021-03-24 | itchy skin | Itch in throat, cough, swelling in throat and body itching |
| 64 | 2021-03-24 | itchy skin |
Patient experienced shortness of breath and itching after receiving first dose of Pfizer vaccine. Wa...
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Patient experienced shortness of breath and itching after receiving first dose of Pfizer vaccine. Was administered Benadryl 25 mg, P.O. Onsite provider recommended EMS transport for eval, but patient refused.
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| 64 | 2021-03-25 | skin spots |
1st COVID vaccine 2/10/2021 . Dx with COVID 2/17/2021. 2nd dose COVID vaccine 3/22/2021. On 3/24/2...
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1st COVID vaccine 2/10/2021 . Dx with COVID 2/17/2021. 2nd dose COVID vaccine 3/22/2021. On 3/24/2021 developed petechial rash. On 3/25/2021 presented to ER for evaluation. Platelet count 4,000. Patient admitted to hospital with ITP. Started on IV steroid and given platelet transfusion.
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| 64 | 2021-03-25 | injection site pain |
Arm pain at injection site, Severe Nausea with vomiting and diaherrea, mild shortness of breath, ext...
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Arm pain at injection site, Severe Nausea with vomiting and diaherrea, mild shortness of breath, extreme fatigue
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| 64 | 2021-03-25 | skin discolouration |
Felt fine for about 6 minutes after receiving vaccine. Then started feeling sick and got worse quic...
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Felt fine for about 6 minutes after receiving vaccine. Then started feeling sick and got worse quickly. Told nurse felt bad and also pulse was fast. When nurse took my pulse it was 100. Regularly my pulse is around 60. She then took my blood pressure and it was 179/? My B/P is normally 106/65. The nurse said my color was bad. Gradually over an hours time started feeling better and went home. Next day I felt malaise and tylenol helped. Today I am a bit weak but better. That was my 1st shot
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| 64 | 2021-03-25 | rash, shingles |
Pain and tingling in my lower left back started 2 days after the second vaccine. By 5 days after th...
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Pain and tingling in my lower left back started 2 days after the second vaccine. By 5 days after the second vaccine. I had a rash diagnosed on 3/29/21 as shingles. I had never had shingles before.
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| 64 | 2021-03-25 | injection site pain |
RIGHT ARM PAIN AND SORENESS X 1 WEEK LATER S/P VACCINATION, WHICH RADIATES TO HAND AND FINGERS, AND ...
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RIGHT ARM PAIN AND SORENESS X 1 WEEK LATER S/P VACCINATION, WHICH RADIATES TO HAND AND FINGERS, AND RIGHT UPPER BACK. MD AT URGENT CARE PRESCRIBED OTC MOTRIN.
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| 64 | 2021-03-26 | itchy skin |
After a 30 minute wait from the shot upon driving home I had a feeling of a very tight grip on the ...
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After a 30 minute wait from the shot upon driving home I had a feeling of a very tight grip on the back of my neck at the base of my skull. It was really tight. My ears itched. This lasted 20 minutes. That night I had severe bone and muscle pain in my upper legs. I cried all night. the next day I started taking Tylenol. This helped. My upper legs still hurt but I can stand it now.
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| 64 | 2021-03-27 | rash with redness, injection site hardening, injection site warmth |
Large, red rash below injection site; hard, hot area got larger as time progressed Took Tylenol, us...
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Large, red rash below injection site; hard, hot area got larger as time progressed Took Tylenol, used ice pack.
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| 64 | 2021-03-27 | injection site rash, rash | Rash at site of injection. Swelling of bottom lip. Rash on hip area--left and right sides |
| 64 | 2021-03-27 | injection site swelling, injection site pruritus, injection site redness | Swollen/red itchy arm below injection site |
| 64 | 2021-03-28 | injection site bruising, injection site nodule, injection site pruritus, injection site pain |
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Additional Details:...
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Additional Details: Patient complains of tenderness at injection site as well as itching. She also complains of a knot in her shoulder at the injection site.
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| 64 | 2021-03-28 | itchy skin |
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specif...
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Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
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| 64 | 2021-03-30 | vaccination site pain, vaccination site mass |
A few days later Soreness and lump under arm receiving vaccine; A few days later Soreness and lump u...
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A few days later Soreness and lump under arm receiving vaccine; A few days later Soreness and lump under arm receiving vaccine; This is a spontaneous report received from a contactable consumer (patient). A 64-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL9269), via an unspecified route of administration administered in left arm on 06Feb2021 at single dose for COVID-19 Immunization. Medical history included physical urticaria past 12 years. Concomitant medications included lisinopril from an unspecified date (several years) and ongoing for high blood pressure, and sertraline from 31Dec2020 and ongoing for anxiety. The patient previously took the first dose of bnt162b2 (Lot number/Expiry Date: EL3248) administered in right arm on 16Jan2021 at single dose for COVID-19 immunization and experienced warm feeling/Getting a warm feeling and changed to cooler clothing, used cool cloth sat under fan; itching; face was really swollen/face was really swollen and red, looked like sun burnt, skin was blotchy; broke out in hives on her face, arms, and chest; a few days later Soreness and lump under arm receiving vaccine; skin was blotchy/face was really swollen and red, looked like sun burnt, skin was blotchy, took quercetin to prevent hives, and took loratadine (CLARITIN)/famotidine (PEPCID) from 17Jan2021 to an unspecified date. Patient had a history of physical urticaria and had been taken the supplement quercetin for several years to prevent hives when warm, On 17Jan2021 patient began taken loratadine (CLARITIN)/famotidine (PEPCID) again instead of quercetin. Before taking second dose on 06Feb2021 the allergist advised that 2 days before, on 04Feb2021 patient took loratadine 3 x a day and continue famotidine 2 x a day. Her vaccine was scheduled for 11:20 am. Patient took one loratadine 08:00 am and one at 11:00 am. The pharmacist there advised that patient also take one diphenhydramine hydrochloride (BENADRYL) before her vaccine. Patient had no occurrence of hives with the second dose of vaccines. A few days later (2020) soreness and lump under arm receiving vaccine same for second vaccine on alternate arm. The adverse events did not require a visit to emergency room and physician office. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051378 same patient, different events on different dose of vaccine
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| 64 | 2021-03-30 | hives, redness, itchy skin, rash, vaccination site rash |
head and ears were itchy; but she has gastrointestinal issues; A little bit of erythema; diarrhea; O...
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head and ears were itchy; but she has gastrointestinal issues; A little bit of erythema; diarrhea; On her neck she had hives up to her face and down her chest a little bit/urticaria eye lid; rash on neck up to her face; rash on shoulder that she had injection in; This is a spontaneous report from a contactable other hcp (nurse). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6206), via intramuscular route of administration, in the right arm on 05Mar2021 09:30 (at the age of 64-years-old) as single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, anaemia, cardiac disorder, rash (She has had a reaction to IVP dye. She has to pre-medicate with benadryl and a steroid 10 hours before, then 8 hours before, then 1 hour before procedure prior to receiving IVP dye. When querying NDC/Lot/Expiry for IVP dye, caller states she does not have that information, it happened years ago. She always pre-medicates when she has to have have x-rays with the dye). The patient did not have history of all previous immunization with the BNT162B2 vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Concomitant medications included tofacitinib citrate (XELJANZ XR) via oral route of administration from an unspecified date (been on for 2 years) and ongoing at a dose of 11 mg daily for rheumatoid arthritis; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) for an unspecified indication; tramadol (TRAMADOL) via unspecified route of administration from an unspecified date and ongoing at a dose of 50 mg daily (in morning) for rheumatoid arthritis; gabapentin (NEURONTIN) via unspecified route of administration from an unspecified date and ongoing at a dose of 300 mg twice daily for rheumatoid arthritis and Multivitamin for an unspecified indication. The patient previously took buprenex and experienced drug hypersensitivity, buprenex and experienced nausea and vomiting, avelox and experienced angioedema. The patient did not underwent any Lab tests.The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than BNT162B2 Vaccine prior to the event being reported.The patient did not received any other vaccines around the time of BNT162B2 vaccination. She was calling about the Covid vaccine. She had her first dose this past Friday, clarified 05Mar2021. It's been a week. On the evening about 8 hours after the Covid 19 injection she got a rash on her shoulder that she had the shot in. The rash went across her chest to the other shoulder. On her neck she had hives up to her face and down her chest a little bit. She has been taking Benadryl for the past 6 days. She is very concerned what is going to happen with the next dose. She contacted her primary health care provider and it was recommended that the caller pre-medicate. The caller states it says not to pre-medicate. She has her next Covid 19 vaccine in 2 weeks and she was nervous. She did file a report with the government. It was in the information she received from the hospital where she got her Covid 19 injection. Every day at 2:00PM she gets a text message. They monitor her for up to a year. Every day she checks in and says how she feels, is she having trouble completing daily activities, did you have to call your doctor. They gave her a paper at the hospital where she had it done. When querying if this government program had given her a report number she states she doesn't have a report number, she deletes the text messages every day. She is due for the second Covid vaccine on 26Mar2021. It was reported that several hours after the injection in the evening, maybe 8 hours after she had the injection is when her symptoms began. She does feel like she is improving. Today was the first morning that she didn't take the Benadryl. She had no respiratory problems. But she was very concerned because the hives were pretty prevalent. It was very uncomfortable. She was taking 50mg of Benadryl for 5 days. When she went to the pharmacy to pick up a cream too, the pharmacist thought that a steroid would be good. She was concerned. She emailed her primary care doctor with pictures. When querying seriousness of events, caller states it was bad enough that she went to the pharmacy and called her primary care doctor and sent her pictures. If she had developed any respiratory issues she would have gone to the emergency room. If she was non medical she would have gone to the emergency room but because she's a nurse she thought she would ride it out. When querying information for the Pfizer Covid 19 Vaccine data capture aid, the caller reports the hives were 48 hours later. She also reports urticaria, her head and ears were itchy. She is using steroid cream on it. It is driving her crazy today. Still going to be using the cream. A little bit of erythema, worst part was her neck. When querying red and itchy eyes, she reports only the eyelid. When querying gastrointestinal issues, she reports she has diarrhea, but she has gastrointestinal issues. The diarrhea is nothing worse than what she normally has. She doesn't think this has anything to do with the vaccine. The patient did not visited to emergency room and physician office. The patient was not hospitalized or admitted to an intensive care unit. Therapeutic measure were taken with Benadryl 25-50mg (Lot Number:P134952, Expiration date: Sep2021) and Hydrocortisone cream 1% maximum strength for the events. It was reported that Benadryl makes her hyper and her heart racey.The outcome of the event diarrhea, gastrointestinal issues were repoorted as unknown, event head and ears were itchy was not recovered and recovering for other events. The events rash on shoulder that she had injection in, hives on neck, rash on neck up to her face were assessed as serious (medically Significant) by the reporter. The causality of the events rash on shoulder that she had injection, hives on neck, rash on neck up to her face were reported as related to vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-03-30 | rash macular |
she found out later it was an allergic reaction to the vaccine; blotches/rash all over right side of...
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she found out later it was an allergic reaction to the vaccine; blotches/rash all over right side of face; She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches are.; swelling of the face; throat was a little swollen but not bad; little bit of weakness; didn't feel all that great; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 10Mar2021 (Lot Number: EN6208) (at the age of 64-year-old) as single dose for COVID-19 immunisation. The patient medical history included hearing problem from an unknown date and ongoing. Concomitant medications were not reported. On Mar2021, the patient reported that she started getting blotches all over her face, clarified on the right side of her face, she found out later it was an allergic reaction to the vaccine. 2 days later, she had a few blotches on the left side of her face. She clarifies the blotches have not gone away completely. She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches were. The symptoms that she had were swelling of the face, her throat was a little swollen but not bad. She had a rash on her face. She had a little bit of weakness. She didn't feel all that great. She wasn't sure if she had muscle pain or joint pain, she may have had a little bit of that. Therapeutic measures were taken as a result of the events and included treatment with NEOSPORIN (formulation: cream, Lot: 164012, Expiry date: May2022) and BENADRYL (formulation: cream, Lot: 3290LZ, Expiry date: Oct2022) and she mentioned she also took BENADRYL tablets. The patient outcome of the events was unknown.
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| 64 | 2021-04-01 | vaccination site pain |
continued throwing up; diarrhea; Nausea; Slight fever; Difficult breathing/ shortness of breath; sli...
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continued throwing up; diarrhea; Nausea; Slight fever; Difficult breathing/ shortness of breath; slight pain at injection site; tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 64-years-old, administered in Arm Left on 26Feb2021 09:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included allergies: sulfites. The patient was not pregnant. There were no concomitant medications. The patient experienced slight pain at injection site and tired on 27Feb2021 12:00, nausea, slight fever, and difficult breathing on 28Feb2021, continued throwing up, diarrhea, shortness of breath on 01Mar2021. The patient experienced slight pain at injection site, tired on Saturday, then on Sunday nausea, slight fever, difficult breathing, and on Monday continued throwing up, diarrhea, and shortness of breath. The patient was hospitalized for 1 day for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 08Mar2021.Therapeutic measures were taken as a result of the events which included steroid and meds for stomach. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The outcome of the events was recovered on an unspecified date. Facility type vaccine was Hospital. No other vaccine in four weeks. No other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. Information on the lot/batch number has been requested.
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| 64 | 2021-04-06 | hair loss |
she is disabled and lives in chronic pain.; Hair is falling out; was too tired; This is a spontaneou...
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she is disabled and lives in chronic pain.; Hair is falling out; was too tired; This is a spontaneous report received from contactable consumer, the patient. A 64-year-old adult female received the first dose of BNT162B2 (solution for injection; Lot EN6204 expiry 30Jun2021) as a single dose in the left deltoid (left shoulder) on 22Mar2021 (at 64-years-old), for COVID-19 immunization. Relevant medical history included a failed back surgery. The patient had no family history. Concomitant medications included many [unspecified] medications that the patient has taken for years. The patient denied receiving any prior vaccinations within four weeks of the vaccination, and the patient denied any adverse events (AE) following prior vaccinations. The patient reported that very early in the morning on 24mar20201, she did not know what time as she was too tired to look at the clock, she noticed her hair was failing out. The patient also mentioned that she is disabled and lives in chronic pain from an unspecified date (pending clarification). There was no emergency room visit required and the patient denied any physician office visit though commented she made an appointment with dermatologist for Friday. The outcome of the events too tired, hair is falling out, and disabled and lives in chronic pain was unknown.
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| 64 | 2021-04-09 | hives, itchy skin, redness |
horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; horrible hives...
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horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; horrible hives and hoarseness and itching; she was a little bit red; blood pressure lowered a little bit; This is a spontaneous report from a Pfizer sponsored Program . A contactable Physician reported for herself that. A 65-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 14Feb2021 15:00 (Batch/Lot Number: FL9267) as SINGLE DOSE for covid-19 immunisation (Age at vaccination was 64 years). Medical history included immunocompromised and she is a very allergic person and can treat allergies. Concomitant medications were not reported. On an unspecified date patient experienced horrible hives and hoarseness and itching, she was a little bit red and blood pressure lowered a little bit. It was reported that after the 1st dose of the Pfizer COVID Vaccine, it seems like she was a little bit red and she did not pay much attention to it then at night on the 2nd day and that night became horrible hives and hoarseness and itching; caller states these symptoms are not ongoing and lasted about 4-5 days; states the 2nd day the hives started at night about 24 hours over. Caller states then the symptoms disappeared and she used an antihistamine Benadryl and every time she takes it is 50mg and she then used Zyrtec 10mg and only used the Zyrtec twice and had terrible side effects from the Zyrtec and did not like it and prefers the Benadryl; no further details provided by the caller. Caller states because she was an allergic subject, she always has Benadryl at home. the first night after she had the Pfizer Covid vaccine, she had her epipen with her but was following her blood pressure and pulse and the blood pressure lowered a little bit but not terribly and the pulse was the maximum of 99 so she decided not to go to the emergency room and she stayed home and did not do the epipen; states she decided to stay home and monitor herself but she was ready to go to the emergency room if needed and by 9:00pm she seemed fine and only her blood pressure had slowed a little bit and her pulse at one time went to 99 and she did not do the epipen; despite further attempts at clarification, the information is captured as stated by the caller. Caller states the 2nd dose (lot number EN6204) was administered on 13Mar2021 around 12:00pm. The patient underwent lab tests and procedures which included blood pressure measurement: lowered a little bit, heart rate: maximum of 99 on, sars-cov-2 antibody test: negative on 29Mar2021. Reporter seriousness for antibody test that was done came back negative was Medically significant. Outcome of the events was recovered on unspecified date.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-04-14 | hardening | My arm is hard, disfigured larger looks like a big muscle |
| 64 | 2021-04-16 | rash |
Rash on face, sensitivity to light, headaches. Sore mouth -- these disappeared after a week and tre...
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Rash on face, sensitivity to light, headaches. Sore mouth -- these disappeared after a week and treatment with Advil and cortisteroid cream. Chilblains on fingers continue to be a problem. Doctor has done blood test for Lupus and report is negative.
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| 64 | 2021-04-23 | itchy skin |
itchiness/itching on both legs; body malaise; This is a spontaneous report from a contactable consum...
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itchiness/itching on both legs; body malaise; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3242), second dose via an unspecified route of administration in right arm on 03Feb2021 as SINGLE DOSE for covid-19 immunization. The historical vaccine included First Dose of BNT162B2 which was on 02Jan2021 (Lot: EL3302) in right arm. The patients medical history included diabetes mellitus and blood pressure. Concomitant medications included LISINOPRIL taken for blood pressure and METFORMIN taken for diabetes mellitus, both on unspecified date. On 04Feb2021 the patient experienced body malaise and itchiness/itching on both legs. Outcome of the events was not recovered.
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| 64 | 2021-04-24 | rash |
Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms las...
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Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Headache; distorted facial sensory; slight torso rash; tremor; spasticity; cognitive fog; fatigue; joint/tendon stiffness/inflammation; joint/tendon stiffness/inflammation; slightly increased temp; sensory distortion; cutaneous vasculitis on feet (aka "COVID toes"); slow digestion; This is a spontaneous report from a contactable consumer. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 10Mar2021 13:00 (Batch/Lot Number: EN6200) at single dose (at the age of 64 years old) for COVID-19 immunisation. Medical history included known allergies: oats, also saturated fats (trigger multiple sclerosis symptoms), intolerant of many drugs but not allergic, Multiple sclerosis/fibromyalgia, systemic rheumatoid disease, Raynaud's, underweight and very low bone density . Concomitant medications included naltrexone taken for an unspecified indication, start and stop date were not reported. On 11Mar2021, the patient experienced headache and distorted facial sensory, slight torso rash, flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing. Includes tremor, spasticity, cognitive fog, fatigue, joint/tendon stiffness/inflammation, sensory distortion, cutaneous vasculitis on feet (aka "COVID toes"), slow digestion, slightly increased temp. No new symptoms yet. Postponed 2nd dose due to flare. The patient received no treatment. The outcome of the events was recovering.
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| 64 | 2021-04-24 | redness |
Tested Positive for Covid19 after receiving the Covid vaccine.; little bump and a little redness on ...
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Tested Positive for Covid19 after receiving the Covid vaccine.; little bump and a little redness on the left arm; little bump and a little redness on the left arm; Tested Positive for Covid19 after receiving the Covid vaccine.; This is a spontaneous report received from a contactable consumer. A 64-years-old female patient (consumer) received first dose of BNT162B2 (Solution for injection), (Batch/Lot Number: LOT:ER8727), on 23MAR2021 at 10:40 (24 hour clock) and second dose (Batch/Lot Number: LOT: EP7533.) on 13Apr2021 at 09:00 via an unspecified route of administration as a single dose for covid-19 immunisation. The medical history of patient included Hypothyroid (ongoing), Cholesterol (ongoing). The Concomitant medications included Hypothyroid Pill (ongoing). The patient reported little bump and a little redness on the left arm from 13 Apr2021 (ongoing). The seriousness for little bump and a little redness on the left arm was unspecified. Patient further explained she had 4 negative tests for Covid19 after that, this past Tuesday, 13APR2021, she had her second shot. At same time, she had a test done for Covid19 on that day. Patient received the results and they said she was positive for Covid19 (13APR2021). Patient was wondering if because she had the virus in her system [from the vaccine] if that is what caused her to test positive? patient stated she had no fe-ver, no headache, or any symptoms. She just had a little bump and a little redness on the arm and got the vaccine, no pains or nothing. patient was wondering if because she already had the first vaccine, if when they did the test at same time as she got the second shot, did that cause her to test positive? Patient wants to know what she should do? Patient reported usually sleeps on that arm and maybe she was pressing to hard on it. Patient did not received any treatment. Also patient did not require any visit to emergency Room and Physician Office. Patient further reported description of productcom-plaint: Patient stated she tested positive for Covid19 on 13APR2021, the same day she received her second dose of the vaccine. The outcome of the event was unknown. Follow up attempts are required. Further information was expected.
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| 64 | 2021-04-30 | itchy skin |
body is responding to food, water and medicine like it is foreign; she is frustrated; elevated heart...
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body is responding to food, water and medicine like it is foreign; she is frustrated; elevated heart rate/rapid heart rate; Angioedema; having a hard time finding food to eat; water makes tongue swell and tingle; lip swelling; respiration changes from clothing; extreme hypersensitivity; heart racing; tongue tingling; rapid breathing/rapid respirations; nervousness; chills; burning sensation in her body; skin itches; bumps on back and abdomen; lock jaw at night; skin feels like it is thinning out; breathing stops and starts at night; electrical charges that were prickly in her body; warm flush; high blood pressure/blood pressure went up; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 08:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. On an unspecified date, the patient experienced body is responding to food, water and medicine like it is foreign and she is frustrated. On 17Mar2021, the patient experienced high blood pressure/blood pressure went up (which required an emergency room visit), electrical charges that were prickly in her body, and warm flush. On 18Mar2021, the patient experienced angioedema, extreme hypersensitivity, heart racing, tongue tingling (which required an emergency room visit), rapid breathing/rapid respirations (which required an emergency room visit), nervousness, chills, burning sensation in her body, skin itches, bumps on back and abdomen, lock jaw at night, skin feels like it is thinning out, breathing stops and starts at night, having a hard time finding food to eat, water makes tongue swell and tingle, lip swelling (which required an emergency room visit), and respiration changes from clothing, elevated heart rate/rapid heart rate (which required an emergency room visit). The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date, blood pressure measurement: had gone down on 17Mar2021, blood pressure measurement: 164/100 on 17Mar2021, blood pressure measurement: 176/100 on 17Mar2021, blood pressure measurement: went up on 17Mar2021, heart rate: rapid on 18Mar2021, heart rate: elevated on 18Mar2021, respiratory rate: rapid on 18Mar2021. Therapeutic measures were taken as a result of high blood pressure/blood pressure went up (hypertension). The outcome of electrical charges that were prickly in her body, body is responding to food, water and medicine like it is foreign, warm flush and frustrated was unknown. The outcome of the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427769 Pfizer
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| 64 | 2021-04-30 | skin burning sensation |
she has been having some sore throat or tightness of the throat issues that she felt should be looke...
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she has been having some sore throat or tightness of the throat issues that she felt should be looked at.; she has been having some sore throat or tightness of the throat issues that she felt should be looked at.; she feels like her voice is getting either strange or raspy or something and had worsened; events are getting worse/Feels like she is going downhill/debilitating; Discomfort; She is in pain constantly and is scared and had worsened; Burning skin; She is in pain constantly and is scared and had worsened; electrical sensation/electrical sensations on most of the left side of the body and had worsened; severe neurological burning pain and getting worse; She can't walk straight, has a rocking feeling when she walks which is really weird; it is not a balance problem it's more like something is not firing telling her left side to work, which is very strange and was worsened; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Right Arm on 08Mar2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE (at the age of 64 years) for covid-19 immunisation. Patient had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 17Feb2021 for covid-19 Immunization Batch/lot number EN9804, as single dose into right arm. Medical history included hypersensitivity from an unknown date and unknown if ongoing , allergy to animal from an unknown date, skin burning sensation and paraesthesia from an unknown date following unspecified brand shingles vaccine following first dose, Lot/NDC/Expiry: unknown. Concomitant medications included loratadine (LORATADINE) taken for an unspecified indication and flecainide acetate (FLECAINIDE ACETATE) taken for an unspecified indication. The patient experienced severe neurological burning pain and getting worse (medically significant) on 08Mar2021 23:00 with outcome of not recovered , she can't walk straight, has a rocking feeling when she walks which is really weird; it is not a balance problem it's more like something is not firing telling her left side to work, which is very strange and was worsened (medically significant) on 08Mar2021 23:00 with outcome of not recovered , she has been having some tightness of the throat issues that she felt should be looked at (medically significant) on an unspecified date with outcome of unknown , she is in pain constantly and is scared and had worsened (medically significant) on 08Mar2021 23:00 with outcome of not recovered , electrical sensation/electrical sensations on most of the left side of the body and had worsened on 08Mar2021 23:00 with outcome of not recovered , she has been having some sore throat that she felt should be looked at on an unspecified date with outcome of unknown , burning skin on 08Mar2021 23:00 with outcome of not recovered , she feels like her voice is getting either strange or raspy or something and had worsened on an unspecified date with outcome of not recovered , she is in pain constantly and is scared and had worsened on 08Mar2021 23:00 with outcome of not recovered , and discomfort (discomfort) (non-serious) on an unspecified date with outcome of not recovered. The events are getting worse/feels like she is going downhill/debilitating and she is not recovered. She has been trying to get help for these events for about a month, but events are getting worse and no one seems to know what to do. Therapeutic measures were taken as a result of she is in pain constantly. She has seen several doctors and no one can seem to help her. She is trying to get into a neurologist as referred by caller's primary care physician, but the neurologist can't see her for 5 weeks. She was seen in the hospital emergency room last night, 13Apr2021 but not admitted to the hospital. No one there seems to know what to do. ER did some blood work which turned out fine in the hospital and put her on Gabapentin. They told her to take Gabapentin 300mg 3 times daily for 2 weeks. She mentioned that next Tuesday, 20Apr2021 they are sending her in for a thyroid ultrasound but that was at her own request. Blood work done in the hospital on 13Apr2021 came back fine. The patient is not in a study or programme. No additional vaccine was administered on same date of the Pfizer Suspect. She has not taken any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No follow-up attempts are needed. No further information is expected.
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| 64 | 2021-04-30 | vaccination site pain |
soreness in her left arm for 2 to 3 days that she thought was going to get better but stated it has ...
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soreness in her left arm for 2 to 3 days that she thought was going to get better but stated it has worsened.; She believed she was injected improperly.; pain and felt that her arm has been "rendered useless".; she had a limited range of motion above her head and wrapping her arm around, she cannot put her arm over her head, she can't put her arm around her back; difficulty sleeping due to the pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 (Lot Number: ER2613) (at the age of 64-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing obesity. The patient's concomitant medications were not reported. The patient experienced soreness in her left arm for 2 to 3 days (on 20Mar2021) that she thought was going to get better but stated it has worsened. Caller stated that she had a limited range of motion above her head and wrapping her arm around, she cannot put her arm over her head, she can't put her arm around her back. She reported difficulty sleeping due to the pain and felt that her arm has been "rendered useless". She stated that this has been ongoing for 3 weeks after her first injection. She stated that because of this, she felt like she may need physical therapy in the future. She believed she was injected improperly. She thought that happens more with people overweight, like her, because it is not quite so easy to see the muscle. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen and TYLENOL, the patient stopped taking NORCO (she did not like taking it). Despite treatment, it just didn't get any better/did not work and finally she couldn't take it and she ended up going to her doctor, she was told it hasn't been verified it was an injury. The patient outcome of the events was not recovered.
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| 64 | 2021-05-03 | itchy skin, rash, redness |
Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotensio...
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Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotension; Weakness feeling; Generalized erythema; Generalized pruritus with skin rash; Generalized pruritus with skin rash; Diarrhoea; Vomiting; Throat closed in; the sides of the throat, down my neck , straight over my chest felt as if someone was squeezing me, chest felt heavy; Potential anaphylactic reaction; Difficulty breathing; severe brain fog; Severe chest pain hard to breath felt as if being smothered; difficult to sleep nights before as felt wired after the shot; bp slightly elevated 140/80; Became very groggy; eyes heavy, had about 3 sleep attacks; 3 sleep attacks; This is a spontaneous report from a contactable Health Care Professional (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN4206) at single dose, intramuscularly, in the left arm, on 05Mar2021 at 10:00 AM, for COVID-19 immunization. The patient also received hylan g-f 20 (SYNVISC), via an unspecified route of administration, in knee, on 04Mar2021, at single dose, for an unspecified indication. Relevant medical history included narcolepsy from an unspecified date, in 1973, cataplexy from an unspecified date, complex regional pain syndrome (CRPS) from an unspecified date, in 2003, osteoporosis from an unspecified date, gastrooesophageal reflux disease (GERD) from an unspecified date, hypertension from an unspecified date and arthritis from an unspecified date, in 2003. Concomitant medications included methylphenidate hydrochloride (RITALIN), imipramine, baclofen, atenolol, rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA), imipramine hydrochloride (TOFRANIL), montelukast sodium (SINGULAIR), acetylsalicylic acid (BABY ASPIRIN) and clonidine, all taken for an unspecified indication, start and stop date were not reported. The patient reported allergy for drugs like lisinopril, spirolactone, ghb (gamma-Hydroxybutyric acid), epinephrine and all seizure type medications. The patient became very groggy, felt eyes heavy, had about 3 sleep attacks, on 06Mar2021, at 13:00. Also reported difficulty to sleep nights before as felt wired after the shot (insomnia) and bp was slightly elevated 140/80 on 07Mar2021. On 27Mar2021 at 13:00, throat closed in, felt the sides of the throat, down her neck, straight over her chest felt as if someone was squeezing her, chest felt heavy (severe chest pain hard to breath, felt as if being smothered, throat closing in severe chest heaviness). Severe brain fog. Potential anaphylactic reaction and difficulty breathing were reported. On an unspecified date, the patient experienced angioedema, shock, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus with skin rash, diarrhoea and vomiting. Decrease level of consciousness and loss of consciousness were not reported. The patient underwent lab tests and procedures which included oxygen saturation: normal on 06Mar2021 and blood pressure measurement: 140/80, slightly elevated, heart rate: 99, respiratory rate: 20 on 07Mar2021. The patient was not hospitalized and was not admitted to an Intensive care unit. The patient did not have COVID prior to vaccination and the patient did not test COVID post vaccination. The patient recovered from throat constriction, chest heaviness, potential anaphylactic reaction and difficulty breathing. Clinical outcome of angioedema, shock, chest pain, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus, skin rash, diarrhoea and vomiting was unknown. Outcome of the other events was reported as recovering. Follow up attempts are completed. No further information is expected. Follow up (26Mar2021): New information received from a contactable Health Care Professional includes: adverse events added, clinical course and case seriousness updated from non-serious to serious. Follow-up (20Apr2021): New information received from a contactable Health Care Professional includes: medical history, concomitant medications details and additional adverse events added (Potential anaphylactic reaction and difficulty breathing added as additional adverse events). Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known safety profile and/or temporal association, the contribution of the suspect drug to the onset of serious events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 64 | 2021-05-04 | vaccination site pain, itchy skin, vaccination site swelling |
Kidney infection; UTI; tightness around her rib cage; size of her arm at the injection site is down ...
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Kidney infection; UTI; tightness around her rib cage; size of her arm at the injection site is down to 2.5 inches by and inch.; allergic reaction; when they injected the vaccine that it burned; lethargic; half a bandage was covered in blood; it felt like three baseballs are sitting on her arm.; The muscles were so tight in her ribcage that she couldn't take a deep breath.; She states that the front of her shoulder, the sides, and the back of her arm was all hard and tense.; teeth chattered after getting the vaccine; Dizziness; difficulty breathing/hard time breathing; headache; fatigue; can still feel where the injection went; feels like an electrical shock; arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting; nerves were jerking starting at her temple going down throughout her body to her arms and fingers; itching; muscle aches; joint aches; arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting; arm pain that radiated under her arm to her rib cage; nerves were jerking starting at her temple going down throughout her body to her arms and fingers; hit a nerve upon vaccination; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6206), dose 1 , single dose via an unspecified route of administration in the right arm on 27Mar2021 at 11:00 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included hypertension from an unknown date and unknown if ongoing History: Caller states that she does have health problems but they are not relevant to this event. She takes high blood pressure medication and is diabetic, diabetes mellitus from an unknown date and unknown if ongoing History: She has health problems but they are not relevant to this event. She takes high blood pressure medication and is diabetic. Hostorical vaccine included tired when she gets flu shot and got the thing where she couldn't lift her arm up and it hurt down the ribcage; still hurts in the lower quarter along the back side of the rib cage; still tender and goes to the bottom where the rib cage ends when she got the pneumonia shot . She is not sure if it effects the lungs more. The patient had no family history relevant to the adverse events. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient experienced kidney infection, urinary tract infection (UTI), itching all over and that lasted two days and didn't get hives, muscle aches and in the beginning she couldn't get out of bed, fatigue, arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting, hurts down her arm, nerves were jerking, feels like an electrical shock in her, would feel like her eyebrow or her nose would twitch in the center; it was so bizarre, starting at her temple going down throughout her body to her arms and fingers, it was jerking like lightening fire, the jerking started at the temple on right side and went down the face, it made her knees and ankles jerk, her arm was jerking, she still has some jerking in her left hand so it jerks over to the thumb, she can't control that, the nerves were doing their own thing, her leg and knee would move with out her wanting it to, that the moving is still happening in her shoulder, arms, knees, leg, and foot and joint aches, they hit a nerve upon vaccination and can still feel where the injection went on 27Mar2021, headache and difficulty breathing/hard time breathing and changed her position to sitting up more than laying down on 28Mar2021, dizziness on 29Mar2021, really tired for a good week and a half, size of her arm at the injection site is down to 2.5 inches by and inch, arm felt like it was big in the front, on the side and the back, it felt like three baseballs are sitting on her arm, allergic reaction, it burned when they injected the vaccine, more lethargic than normal on an unknown date. It was also reported that she had difficulty breathing, described as tightness around her rib cage on day 3 and was having a harder time breathing when laying down on day 2.5-3. She states that it still hurts down her arm. It took 4 days for her to be able to lift her arm to her head. She didn't want to lift up because it was still tender around the chest area, especially on right side. it was still tender around the chest area, especially on the right side. The muscles were so tight in her ribcage that she couldn't take a deep breath. On an unknown date, half a bandage was covered in blood and the front of her shoulder, the sides, the back of her arm was all hard and tense and teeth chattered after getting the vaccine. There was no laboratory tests performed. Treatment was received for difficulty breathing/hard time breathing and fatigue. She used her inhaler for her breathing and took ibuprofen (ADVIL, lot: RA467, expiration date: Jul 2022) liquid gel minis at night for her pain. She was prescribed cephalexin. She had an albuterol inhaler on the 28th, 29th, 30th, and 31st, so she took that treatment for 3 days. She was only trying to use one dose of the albuterol inhaler because it can raise the blood pressure, but she also wanted to breathe easier. The muscles were so tight in her ribcage that she couldn't take a deep breath. She still has that in the right lower quarter from her back side ribcage under the arm to the side of the leg. The events did not require emergency room or a physician's office visit. The clinical outcome of Itching was recovered on 29Mar2021 and dizziness was recovered on 30Mar2021, headache recovered around 31Mar2021, unknown for her leg and knee would move with out her wanting it to, felt like three baseballs are sitting on her arm, hit a nerve upon vaccination, half a bandage was covered in blood, kidney infection, urinary tract infection (UTI), fatigue, tightness around her rib cage, size of her arm at the injection site is down to 2.5 inches by and inch, allergic reaction, injected the vaccine that it burned and lethargic and recovering for muscle aches, joint aches, difficulty breathing/hard time breathing, pain in arm, nerves were jerking and feels like an electrical shock, arm pain that radiated under her arm to her rib cage and the front of her shoulder, the sides and the back of her arm was all hard and tense.
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| 64 | 2021-05-12 | hives |
arm soreness; tiredness; hives that is getting worse on legs, stomach, breast, on head, arms back an...
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arm soreness; tiredness; hives that is getting worse on legs, stomach, breast, on head, arms back and thigs; constriction of the windpipe; This is a spontaneous report from a contactable consumer who reported for herself. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, at the age of 64 years, on 09Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included back pain, fibromyalgia, restless legs syndrome, depression from 1987 to an unknown date, headache, hyperthyroidism. Concomitant medications included gabapentin (GABAPENTIN) taken for restless legs syndrome, start and stop date were not reported; hydrocodone (HYDROCODONE) taken for an unspecified indication, start and stop date were not reported; fluoxetine (FLUOXETINE) taken for depression, start and stop date were not reported; methimazole (METHIMAZOLE) taken for an unspecified indication, start and stop date were not reported; topiramate (TOPIRAMATE) taken for headache, start and stop date were not reported and apixaban (ELIQUIS) taken for an unspecified indication from Feb2021 to an unspecified stop date. The patient received first dose of COVID vaccine BNT162B2 on 19Mar2021 for COVID-19 immunization and experienced hives on legs, top of the arm and swollen lips/lip swelled really big. The patient stated, "I have had both shots of the COVID Pfizer and that the first time I had it, I had some symptoms about a little over a week out. What I had was hives. It is not that real big. This time, I have been about a week out. I was starting to have have hives and I keep having them. They are not just complete blocks just all over but spreaded and I am having kind of constriction of my wind pipe also (14Apr2021). Is that a symptom to that with the COVID virus, the shot. Yes, last I had was April 9th and I am still having spots coming out of me and I am taking Benadryl like crazy and today I have still got them on me, you know the spots and I have like something is cutting my wind pipe off, you know, constriction, you know it's not all the time but its quite a few times a day on that and I am wondering if that. When I started having the problem. The first vaccine I had on night on March 19th and about a week and a half, I had about, I would say 8 to 9 days after that. I started having the hives and then I had a real bad frozen layup out of that (further not clarified) but the second time I had the vaccine also the night and I had the hives about a week out and then I have had constriction of the wind pipe that just completely chocked me out." The patient stated that after the second dose she had arm soreness, tiredness, hives that is getting worse on legs, stomach, breast, on head, arms back and thigs and constriction in the wind pipe. She took Benadryl and Phenergan for it. Therapeutic measures were taken as a result of constriction of the windpipe and urticaria. The outcome of the event constriction of the windpipe was not recovered while other events were unknown.
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| 64 | 2021-05-13 | vaccination site pain, shingles |
urinary tract infection; the vaccine stung when it went in and the site was tender; shingles / shing...
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urinary tract infection; the vaccine stung when it went in and the site was tender; shingles / shingles rash; the vaccine stung when it went in and the site was tender; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 23Feb2021 at 12:00 (Batch/Lot number: EL9269) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included pain, eye condition, Prediabetes, immunosuppressive - she is also taking immunosuppressive medication that is lowering her immunity: Mycophenolate since Dec2020. She also had a pain in her lower back on about 19Feb2021. Concomitant medications included prednisone (PREDNISONE) taken for eye condition from Aug2020 and ongoing-her immune system is attacking her retina, started a high dose in Aug2020 and has titrated down since then; mycophenolate mofetil (MYCOPHENOLATE) taken for eye condition and immunosuppressive from Dec2020 and ongoing; metformin (METFORMIN) taken for Prediabetes from an unspecified start date and ongoing and been on it about 6 years; and gabapentin for pain. The patient developed shingles on 03Mar2021. She is on prednisone, mycophenalate, and pain medications. She wants to know if it's ok to get the second dose since she is immunosuppressed. The patient was calling about the Covid-19 vaccine and reported that she got the first dose on 23Feb2021 and about 3.5 days later she got a shingles rash. She wanted to know if it is ok to get the second vaccine or if that is contraindicated. The patient said that she is also taking immunosuppressive medication that is lowering her immunity (Mycophenolate) and she has been on it since Dec2020. The patient said that she was on another immunosuppressive medication before this for a month that she had a reaction to. She said that was when she was switched to Mycophenolate. The doctor had her on an antiviral for shingles rash that she started on 03Mar2021. She clarified that it is Valacyclovir HCL 1 pill 3 times a day for 7 days, and she was given pain medicine called Gabapentin 100mg 1 pill 3 times a day by mouth. Her next dose of the Covid-19 Vaccine was scheduled for 16Mar2021. The patient said that the vaccine stung when it went in and the site was tender. Her arm is still a little tender at the site. She said that it seems since she has the shingles stuff it is a little tender. The patient said that she had a pain in her lower back on about 19Feb2021. She went to the doctor on 01Mar2020 because it was not going away. The doctor thought it was a urinary tract infection and gave her an antibiotic that she stopped on 04Mar2021 after being diagnosed with the shingles. The event shingles / shingles rash required a visit to Physician Office; she did a telehealth visit with her doctor for her shingles rash. The event shingles / shingles rash had not resolved while the outcome of the rest of the events was unknown.
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| 65 | 2021-01-03 | injection site pain |
Jan 3, 2021 mild pain at injection site, diarrhea all day, chills in morning , no fever, temp 97.6 J...
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Jan 3, 2021 mild pain at injection site, diarrhea all day, chills in morning , no fever, temp 97.6 Jan 4, 2021 significant arm pain at injection site (awakened by it at 3 am) with chills, temp 99.6. Took One tablet ALEVE followed by temp 98.6
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| 65 | 2021-01-03 | injection site pain | sore arm at injection site for about 1 day |
| 65 | 2021-01-04 | vaccination site pain |
I had a temperature of 103.8; nauseated and dizzy; eyes hurting; headache; chills; tired; nauseated ...
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I had a temperature of 103.8; nauseated and dizzy; eyes hurting; headache; chills; tired; nauseated and dizzy; pain at the site; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 23Dec2020 at 10:30 as single dose for covid-19 immunization. Medical history included covid-19 from May2020. The patient's concomitant medications were not reported. The patient reported that " I had a temperature of 103.8 " on an unspecified date with outcome of unknown; pain at the site on 23Dec2020 with outcome of unknown; tired on 24Dec2020 with outcome of unknown; nauseated and dizzy on 24Dec2020 with outcome of unknown; chills on 24Dec2020 with outcome of unknown; eyes hurting on an unspecified date with outcome of unknown; headache on 24Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 101.8 Fahrenheit; temperature: 102.4 Fahrenheit; temperature: 101.3 Fahrenheit; temperature: 100.6 Fahrenheit; temperature: 99.2 Fahrenheit; temperature: 103.8 Fahrenheit on 24Dec2020; sars-cov-2 test: positive in May2020, sars-cov-2 test: negative in 23Dec2020. Therapeutic measures were taken as a result of " I had a temperature of 103.8 ". Details were as follows: the nurse received the vaccine on a Wednesday 23Dec2020 at 10:30am. That night at her night shift, she had pain at the site. After midnight, the patient felt tiredness and felt like she had to lay down. At 6:00 she felt nauseated and dizzy. She had a temperature of 103.8. Thursday night, she went home at 7:10 and called her private doctor. The temperature was 101.8 and then it went down. The nurse had been administered the first of 2 dose series of Pfizer BioNTech COVID-19 Vaccine on 23Dec2020. She had received mandatory COVID-19 testing on 23Dec2020, prior to being administered the vaccine; she received the negative results of that COVID-19 testing on 25Dec2020. After being administered the vaccine she was monitored for 15 minutes and then went home. She was fine, had no allergy or anything. She reported that after she was administered the vaccine, she had pain, was really tired, nauseous, chills, high temperature, and her eyes hurting. She mentioned history of COVID-19 in May2020. She works as nightshift nurse at a rehab facility. She woke up that night of 23Dec2020 around 9:00pm-10:30pm and had onset of pain in right arm at injection site which she did not take too seriously because when you get a shot you get pain. Around midnight that night 24Dec2020, she went to work and had onset of being really tired like she just wanted to sit or lay down; she felt like she had to sit down and could not stand well. She continued working that shift on 24Dec2020 but kept getting so tired and had onset of chills and was supporting herself with her med cart. She drank a little sip of ginger tea she brought to work think maybe that would help her feel better. She felt that if she drank more ginger tea she would throw up because she felt nauseous. She was really busy at work 24Dec2020 so she did not check her temperature until after 6:00am which was 103.8 degrees Fahrenheit; and thought no wonder she feels like throwing up. She finished her shift at like 7:00am. For 2 days her temperature was turning high temperature so every 6 hours she was taking Motrin 2-200mg and that would make her temperature go down. Then temperature would go back up to like 102.4 degrees Fahrenheit, she would take ibuprofen (MOTRIN) again, temperature would come down to like 101.3 degrees Fahrenheit. She continued feeling nauseated, having chills, headache and feeling nauseous which she felt all of which could be related to the temperature. She reported to her employee health at work. She thinks it's better. Saturday morning of 26Dec2020, she woke up with temperature of 100.6 degrees Fahrenheit at 7:00am which was the first time her temperature had gown down like that so she did not take the ibuprofen. She checked it again later at like 1:00 pm and temperature was 101.8 degrees Fahrenheit so she took 2 Motrin again. After that her temperature did not go up like that anymore, it was like 99.2 degrees Fahrenheit. As soon as she came from work on 24Dec2020 she called her doctor's office and was seen by Nurse Practitioner who let her out of work for like 2 days. She reported her eyes also have been hurting, mostly her right eye is still hurting, the top is hurting like when you have a small pimple so she keeps checking but does not see anything with her eye. She couldn't even put a cold compress on for the temperature because of her headache and her eyes hurting. She could not even put cold compress to bring her temperature down. Seriousness criteria of all events was unknown. The patient has had no rash, no breathing problems, no coughing, no sore throat or other serious events. She was scared because she wondered if she had COVID-19 again with these events. She mentioned if people do not know these are side effects they would be scared, but she knows from the information she got with the Pfizer BioNTech COVID-19 Vaccine that these are normal for everyone. The only thing she wondered about is if the tiredness she is having is serious or not. She reported prior to getting the COVID-19 vaccine she tested positive for COVID-19 in May2020 and was very sick at that time because she works in a health field with COVID-19 patients. Pfizer BioNTech COVID-19 Vaccine. The patient indicated that she was fine before she got the vaccine; she had no cold, no coughing, no sore throat. The ibuprofen tablet was administered as 200 mg, 2 of the tablets at a time. : The outcome of all the events was unknown. The relatedness of the event, pain to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, really tired to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, nauseous to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, chills to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, high temperature to the suspect drug was reported as related from the reporter using the assessment; relatedness of the event, eyes hurting to the suspect drug was reported as related from the reporter using the assessment. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 65 | 2021-01-04 | vaccination site redness, vaccination site itchiness, vaccination site pain |
On day 8 arm again was sore and now itchy with reddened area larger than injection site 3x4 inches.;...
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On day 8 arm again was sore and now itchy with reddened area larger than injection site 3x4 inches.; On day 8 arm again was sore and now itchy with reddened area larger than injection site 3x4 inches.; Reported soreness at injection site and some soreness which was gone by day 5 or 6. On day 8 arm again was sore and now itchy with reddened area larger than injection site 3x4 inches.; Reported soreness at injection site and some soreness which was gone by day 5 or 6; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on left arm on 17Dec2020 15:30 at single dose for COVID-19 immunization. Medical history included hypothyroid, osteoporosis, and known allergies to sulfa and tetracycline. The patient was not pregnant. The patient reported soreness at injection site and some soreness on Dec2020 which was gone by day 5 or 6. On day 8 (25Dec2020) arm again was sore and now itchy with reddened area larger than injection site 3x4 inches. No treatment was given for the events. The COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received unspecified medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event pain was recovered and not recovered for the rest of the events.
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| 65 | 2021-01-04 | vaccination site redness, vaccination site pain |
Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 ...
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Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Myalgia; headache; anorexia; fatigue; weight loss; sweats; This is a spontaneous report from a contactable physician (patient). A 65 years old years female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9899) via an unspecified route of administration at Left arm on 22Dec2020 01:15PM at single dose for COVID-19 immunization. The patient's medical history included hypertension, body mass index (BMI) 30, hypothyroidism and Covid-19. Known allergies: penicillin, sulpha drugs, seasonal allergies. No other vaccine in four weeks. The concomitant was reported as hydrochlorothiazide, losartan potassium (HYZAAR), levothyroxine sodium (SYNTHROID), Metformin. The patient experienced pain, edema and erythema in 4 cm circumference around injection site myalgia, headache, anorexia, fatigue, weight loss, sweats, all started from 24Dec2020. No treatment received for events. The outcome of the events was recovering.
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| 65 | 2021-01-04 | injection site pain | advanced stiff neck that is not going away pain from bottom of ear down neck to injection site |
| 65 | 2021-01-04 | rash, itchy skin, redness |
swollen arm swollen shoulder and swollen clavicle; lymphadenopathy; hands swelled, were red and itch...
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swollen arm swollen shoulder and swollen clavicle; lymphadenopathy; hands swelled, were red and itchy/swollen arm swollen shoulder and swollen clavicle; body rash to her arms, legs, abdomen with bubbly, clear bumps the size of a pea; hands swelled, were red and itchy; hands swelled, were red and itchy; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 17Dec2020 (at the age of 65 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced hands swelled, were red and itchy, she took a shower and then experienced a "body rash to her arms, legs, abdomen with bubbly, clear bumps the size of a pea, as well as lymphadenopathy". The next day (19De2020) she started having a "swollen arm swollen shoulder and swollen clavicle". The clinical outcome of "body rash to her arms, legs, abdomen with bubbly, clear bumps the size of a pea, as well as lymphadenopathy" and "swollen arm swollen shoulder and swollen clavicle" was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 65 | 2021-01-05 | injection site bruising, injection site warmth |
Patient reported experiencing extreme bruising and warmth at the injection site. Patient could not s...
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Patient reported experiencing extreme bruising and warmth at the injection site. Patient could not sleep on right side due to pain.
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| 65 | 2021-01-06 | hives, itchy skin | Pt got hives around neck in complete circumference. Looked like mosquito bites. Itchy |
| 65 | 2021-01-06 | rash, hives |
Rash; Welts; she had a very sore arm; This is a spontaneous report from a contactable nurse (patient...
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Rash; Welts; she had a very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 65-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid Vaccine, lot EH9099 or EH9899), via an unspecified route of administration in her left deltoid on 22Dec2020 09:32 at single dose for Covid-19 immunisation. Medical history included broken toe for 3 weeks. This was from her taekwondo and doesn't complain. No history of all previous immunization with the Pfizer vaccine considered as suspect drug. There were no additional vaccines administered on same date with Covid-19 vaccine. There were no concomitant medications. On 24Dec2020, she broke out in a rash on different parts of her body. She said the rash would come and go. She said she then had welts appear on different parts of her body and the welts would come and go. She said on the 3rd day, she had rash and welts together only on her trunk. She said on days 4, 5, and 6, she would have either a rash or welts come and go on different parts of her body. She clarified she had the rash and welts on her hands, wrists, ankles, and body. She reported that the rash and welts were serious-medically significant. On 22Dec2020, she had arm soreness and was just inconvenient and uncomfortable. She said she was not saying that what she was experiencing was related to receiving the COVID-19 Vaccine, but she doesn't know what else can be causing the rash and welts. She said she hasn't changed anything she has been eating or doing. She said she was worried about taking the 2nd COVID-19 Vaccine dose. She used Hydrocortisone 1% cream, Equate brand (reported to be expired) and took an oatmeal bath. She also took Benadryl and brand of Zyrtec called Wal-Zyr. Her height was 175cm, weight was 63kg. The rash and welts recovered on 30Dec2020; arm soreness recovered on 23Dec2020. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events rash and urticaria cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-01-07 | redness, rash vesicular, itchy skin |
my hands swelled up/My hands, my feet swollen; My hands, my feet swollen, red and itchy/my hands swe...
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my hands swelled up/My hands, my feet swollen; My hands, my feet swollen, red and itchy/my hands swelled up, they were red and they were itchy; My hands, my feet swollen, red and itchy/my hands swelled up, they were red and they were itchy; Lymphadenopathy under both arms, red, swollen; the shoulder was swollen and the clavicle area was also swollen; sore arm; It was red like a bubbly rash like a size of pea; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 17Dec2020 17:00 at single dose for COVID-19 immunisation. Medical history included hypertension, hyperlipidaemia. Concomitant medications included lisinopril, amlodipine besilate (NORVASC), ezetimibe (ZETIA), rosuvastatin, fexofenadine, ergocalciferol (VITAMIN D), vitamin a [retinol], vitamin c [ascorbic acid], tocopherol (VITAMIN E), thiamine (VITAMIN B1) , vitamin b2 [riboflavin], niacin, vitamin b6, folic acid, cyanocobalamin (VITAMIN B12) , biotin, pantothenic acid. Registered Nurse stated, "I received the first dose of Pfizer vaccination on Thursday, 17Dec2020 at 5 PM. I began to have an adverse reaction on Friday, 18Dec2020 at 11 PM and then until the Saturday, 19Dec2020 until after dinner I had (Incomplete sentence). You want me to break it down like what the time and what the affect was? Okay 11 PM on Friday 18th my hands swelled up, they were red and they were itchy. I couldn't get the itching to stop. Hand cream or cold water they finally subsided with cold water and I was able to get sleep. Then I woke up Saturday, 19Dec2020 at 6 AM then was my hands, my feet swollen, red and itchy. Itching was just like, I did not know what to do about it. Used cold water and that rested for about 4 hours. After that stopped I had a rash on my arms, my leg and my abdomen and it just came out of nowhere. It was red like a bubbly rash like a size of pea. You think I looked at I thought what I was going to do. I went I got a cool shower another 4 hours that subsided not completely but enough where it wasn't scary anymore, it was bearable. Closer to dinner time I had Lymphadenopathy under both arms, red, swollen then I took another 4 to 5 hours to subside. During this I have sore arm that was slightly swollen. The arm was swollen, the shoulder was swollen and the clavicle area was also swollen and that's my reaction. I work in healthcare and I was just at a point I went to work, I reported the incident and I filed a VARIS report. I talked to my administrator she said I should call Pfizer, let them know. I spoke to my primary doctor, to let him know. I just wanted to report this to someone."Registered Nurse stated, "My work place. It was offered in '(Name)' hospital (not clarified)." Treatment: Registered Nurse stated, "I took Tylenol. I took it three times and that would have been a '1000 mg' each time (Not clarified)."When probed for the Causality, Registered Nurse stated, "Yes." The outcome of the events was unknown.
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| 65 | 2021-01-08 | injection site pain |
Expected: low grade tenderness at vaccine site, identified at 10 hours post injection, slightly wor...
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Expected: low grade tenderness at vaccine site, identified at 10 hours post injection, slightly worse on awaking 22 hours post injection. 0700 (22 hours post injection) visual swelling of left supraclavicular lymph node, Node is palpable, slightly tender, mild swelling around the node.
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| 65 | 2021-01-09 | injection site pain, itchy skin |
Vaccinated at 8 am,at about 7 pm I had site and muscle pain 12/31/20,then 48 hours I had loss of s...
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Vaccinated at 8 am,at about 7 pm I had site and muscle pain 12/31/20,then 48 hours I had loss of smell and taste,body aches,I was itchy all over,could not sleep that nite,I called did the Conversation at work and told me not to go to work,the next day 1/3 /21,employee health called me to get tested and tested positive on 1/4/21,I was place on quarantine for 10 days,I tried calling your office with 800 number and left my number nobody called me,I also experienced eye irritation,cough ,short of breath,low grade fever,nausea fatigue
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| 65 | 2021-01-10 | injection site pain |
4 days post dose 1, arm pain at injection site, unable to move arm that continues for 21 days past d...
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4 days post dose 1, arm pain at injection site, unable to move arm that continues for 21 days past dose 1.
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| 65 | 2021-01-10 | redness | Symptoms started on 1/16/21 with redness, swelling, pain, warm to the touch, spreading down arm. |
| 65 | 2021-01-10 | hives |
urticarial rash on chest and posterior neck. recommend 1st and 2nd gen antihistamines as well as top...
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urticarial rash on chest and posterior neck. recommend 1st and 2nd gen antihistamines as well as topical corticosteroid
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| 65 | 2021-01-11 | injection site pain | Palm tingling enough to wake from sleep Sore arm Site injection pain |
| 65 | 2021-01-11 | itchy skin |
Sporadic itching in multiple parts of the body/ Itchiness sporadic multiple places of my body; This ...
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Sporadic itching in multiple parts of the body/ Itchiness sporadic multiple places of my body; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 05Jan2021 at 16:45 on Arm left at single dose for COVID-19 immunization. The patient medical history included Cholesterol y Triglycerides high. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergy, no allergies to medications, food, or other products. Concomitant medications included Multivitamin, ascorbic acid (VITAMIN C), ergocalciferol (VITAMIN D), Zinc, ibuprofen sodium (IBUPROFEN). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sporadic itching in multiple parts of the body (also reported as itchiness sporadic multiple places of her body) on 05Jan2021 at 17:30. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
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| 65 | 2021-01-11 | vaccination site pain |
non stop diarrhea; nausea; chills; joint pain; sore at the injection site; This is a spontaneous rep...
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non stop diarrhea; nausea; chills; joint pain; sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 02Jan2021 07:30 at single dose for covid-19 immunization. The patient's medical history was none, and there were no concomitant medications. The first dose patient received on 02Jan2021 morning, and she just had symptoms she expected, she was sore at the injection site and she had some joint pain on 03Jan2021, but those disappeared on 04Jan2021. On 05Jan2021, she woke up and had non stop diarrhea with a little bit of nausea. Patient had not had a fever, but did feel chilled. Patient didn't think she ate anything bad. She was suspecting this may be a side effect of the vaccine. Patient didn't have a prescribing doctor. She got it at the hospital she worked at. She received it the 02Jan2021 7:30 am. Patient started the diarrhea on 05Jan2021 morning at 8:30. The nausea was on and off, but started this morning as well. Patient didn't take any ongoing medication. Outcome of events sore at the injection site and joint pain was recovered on 04Jan2021, outcome of event diarrhea was not recovered, and outcome of events nausea, and chills was recovering.
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| 65 | 2021-01-12 | injection site pain |
24 hr after vaccine developed body aches in shoulders, hip and back. Moderate to severe fatigue and...
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24 hr after vaccine developed body aches in shoulders, hip and back. Moderate to severe fatigue and sore left arm at site of injection. Symptoms remained for 36 -48 hrs. Took Tylenol for body aches , increased fluid intake and rested for 2 days. Completely resolved by day 3
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| 65 | 2021-01-12 | injection site pain | Slight sore arm at injection site, headaches, body aches, fatigue |
| 65 | 2021-01-13 | hives, itchy skin |
Awoke on 1/8/21, about 18 hours after injection with body aches and aching joints persisting for the...
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Awoke on 1/8/21, about 18 hours after injection with body aches and aching joints persisting for the rest of the day, taking ibuprofen every four hours. 1/9/21 I woke with moderate itching of scalp, body aches continue. Throughout the day I had large itching whelps at different places on my body. At 11:00am my temperature was 100.5, at which time I also had moderated chills for about an hour. I took ibuprofen and tylenol and benadryl at 4 hour intervals. after the chills stopped (about an hour) symptoms began to calm down. Sunday I woke with no symptoms at all.
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| 65 | 2021-01-13 | vaccination site warmth, itchy skin, vaccination site redness, vaccination site swelling |
her arm is beginning to itch; warmth, redness, and swelling in the area where her injection was; war...
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her arm is beginning to itch; warmth, redness, and swelling in the area where her injection was; warmth, redness, and swelling in the area where her injection was; warmth, redness, and swelling in the area where her injection was; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 06Jan2021 07:30 via intramuscular at left arm at single dose for some other people who have had COVID and she didn't want to take any chances (because of her age and knowing she works in the medical field). Medical history and concomitant medication were none. The caller states she works in healthcare, clarifies she is a medical assistant. She is calling in regard to Pfizer's COVID-19 Vaccine. She received her first dose on Wednesday and she was having no side effects until last night. Her arm started getting hot in the area where the injection was. Her arm began to get warm, red, and was swelling (07Jan2021 21:00). She took a couple of paracetamol (TYLENOL, lot number: SHA101, expiration date: Jun2024 at 500mg) and put an icepack on it. However, this morning, her arm is still the same. Caller wanted to know if she can still continue to take paracetamol and use the icepacks and just give it some time or what. She knows the redness, swelling, warmth are some side effects but she wanted to just follow-up to see if she can continue to take the paracetamol. Caller verifies she received her first vaccine on 06Jan2021. Last night, 07Jan2021, around 9 pm, she started to get the warmth, redness, and swelling. She states her arm looks the same as it did last night. However, her arm is beginning to itch (08Jan2021). It wasn't itching last night. She explains the vaccine was available to her. She took it because of her age and knowing she works in the medical field, she is around a lot of young people and patients, and also for her family and friends. She knows some other people who have had COVID and she didn't want to take any chances. None of additional vaccines administered on same date of the Pfizer Suspect. Event was not required a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. Relevant Tests was none. Patient was not recovered from the events.
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| 65 | 2021-01-14 | injection site swelling, injection site redness |
Pt reports receiving Covid-19 vaccine on 1/9/2021 on left arm. She states that "immediately" after s...
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Pt reports receiving Covid-19 vaccine on 1/9/2021 on left arm. She states that "immediately" after she received vaccine she felt "tongue tingling". About 10 min later she felt "lip tingling" and started to develop "large red bump" at injection site. She advised nurse observing patients and physician on site was advised. Pt reports she was administered EPI and Benadryl IM and "felt better almost immediately". Pt states "tingling" resolved within the hour and she felt "scalded tongue" for about 24 hrs. Large local reaction slowly resolved over a 3 day period. She denies any visible skin rash / hives or AE. No throat sx. No resp sx. No GI sx. Pt denies a hx of adverse reactions to any injected medication or to any vaccine in the past. *Neg hx of Covid - 19 infection
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| 65 | 2021-01-14 | redness | red swollen arm |
| 65 | 2021-01-17 | rash |
12 hours after receiving the second vaccine I developed a temp of 103 that lasted approximately 36 h...
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12 hours after receiving the second vaccine I developed a temp of 103 that lasted approximately 36 hours. I also developed a rash on my forearms 24 hours after the vaccine which lasted approximately 24 hours
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| 65 | 2021-01-17 | redness, skin warm |
Patient reports re-occurrence of Left arm pain, redness, swelling and warmth 10 days post vaccinatio...
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Patient reports re-occurrence of Left arm pain, redness, swelling and warmth 10 days post vaccination. States she had these same symptoms up to 3 days after vaccine but they resolved. She is also reporting onset of headache, joint pain yesterday (9 days post vaccine) and low grade temp today (10 days post vaccine).
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| 65 | 2021-01-19 | itchy skin, rash maculo-papular |
Diffuse maculopapular rash- minimal itching on torso- ? started after 2nd vaccine? Noticed worsening...
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Diffuse maculopapular rash- minimal itching on torso- ? started after 2nd vaccine? Noticed worsening on 1/19/21
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| 65 | 2021-01-19 | injection site pain | Fever of 101.5 Headache Pain at injection site Body aches Chills, extreme fatigue |
| 65 | 2021-01-19 | rash | fever, myalgia, rash, headache, nausea, fatigue |
| 65 | 2021-01-19 | injection site pain |
passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe head...
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passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe headache; vomiting x 2; cold; experienced orthostatic hypotension; This is a spontaneous report from a contactable other HCP. A 65-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine , intramuscular in the left arm on 07Jan2021 11:00 at single dose for Covid-19 immunisation . Medical history included rubber sensitivity (Latex). The patient's concomitant medications were not reported. On 09Jan2021 12:00 the patient experienced orthostatic hypotension , passed out with outcome of recovered , dizzy with outcome of recovered , hit the ground with outcome of recovered. These events were considered serious because medically significant. On 09Jan2021 12:00 the patient also experienced the following non serious events: nausea with outcome of recovered , pain at injection site with outcome of recovered , fever with outcome of recovered , chills with outcome of recovered , tired with outcome of recovered , severe headache on with outcome of recovered , vomiting twice with outcome of recovered , cold with outcome of recovered. The reporter stated the patient attempted to get out of bed and she passed and hit the floor. Caller states she think she may have experienced orthostatic hypotension. Caller stated if she had stayed in bed she probably would not have fallen. Her husband found her laying in vomit The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on unknown date.; Sender's Comments: Based on a chronological temporal association a causal relationship between events orthostatic hypotension , passed out dizzy and falling down and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-01-20 | injection site pruritus, injection site redness |
Red and Itchy at the injection site (arm). Started day after vaccine. Still is itching 2 days late...
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Red and Itchy at the injection site (arm). Started day after vaccine. Still is itching 2 days later.
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| 65 | 2021-01-20 | injection site pain | Severe chills, fever, lower stomach pain, headache, injection site pain |
| 65 | 2021-01-20 | injection site swelling | Swelling at injection site, swelling of hands, next day runny nose |
| 65 | 2021-01-20 | rash | generalized rash, tickle in throat sensation |
| 65 | 2021-01-21 | itchy skin |
Angioedema, which consisted of tingling/pressure in lips, chin, roof of mouth, tongue, and pharynx; ...
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Angioedema, which consisted of tingling/pressure in lips, chin, roof of mouth, tongue, and pharynx; feeling of swelling and burning in throat; slight difficulty swallowing; hoarseness; pruritus
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| 65 | 2021-01-21 | itchy skin |
First: headache for 6 days. Body aches and low grade temp intermittently. Itching on day 8? Second:...
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First: headache for 6 days. Body aches and low grade temp intermittently. Itching on day 8? Second: chills and low grade temps x 10 days. Joint pain x 10 days. Itching on day 13. Intermittent headaches and brain fog x 10 days.
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| 65 | 2021-01-21 | itchy skin |
First: headache x 6 days . Pruititis day 10 which incurred eruption on finger. Generalized muscle...
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First: headache x 6 days . Pruititis day 10 which incurred eruption on finger. Generalized muscle and joint pain x 7 days with low grade temp and chills. Fatigue Second dose: low grade temp and chills and body aches x 10 days. Fatigue. Brain fog
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| 65 | 2021-01-21 | injection site pain | sore arm at the site of injection, mild muscle aches |
| 65 | 2021-01-22 | rash |
Swollen lower face with rash, swollen lips, swollen throat, swollen tongue, throat hot on inside and...
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Swollen lower face with rash, swollen lips, swollen throat, swollen tongue, throat hot on inside and outside, throat tightening, lungs heavy , not, and tightening. Body heavy. Mind disconnected. Happened with in 5 minutes of injection.
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| 65 | 2021-01-24 | skin warm, redness |
Employee states she received her second vaccination on Friday, January 22nd at 11:30 am to left delt...
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Employee states she received her second vaccination on Friday, January 22nd at 11:30 am to left deltoid. Noticed redness that day. Has become more red and swollen each day. States 1/4 of arm is swollen. Very red and hot to touch. Does not fell like she has a fever but has not checked. Note: Vaccine documentation record indicates that vaccine given on 1/18/2021, not 1/22/2021
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| 65 | 2021-01-25 | injection site swelling, injection site swelling | HA, chills, fever, body aches, swelling at injection site. Symptoms resolved after 48 hrs |
| 65 | 2021-01-25 | injection site tingling | Tingling in vaccination arm |
| 65 | 2021-01-26 | injection site pain |
1/20/21: Headache; slight nausea with flip-flop stomach feeling; no appetite; sore arm injection are...
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1/20/21: Headache; slight nausea with flip-flop stomach feeling; no appetite; sore arm injection area 1/21/21: Lingering headache but only slight; sore arm injection area 1/22/21: Lingering sore arm but dramatically decreased
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| 65 | 2021-01-26 | rash, hives | After 40 minutes burning in my eye, swelling in my eyelid, facial rash, small puffy welt under eye |
| 65 | 2021-01-26 | injection site pain |
I had chills, body aches and a headache. I also had pain at the injection site. I went to bed and ...
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I had chills, body aches and a headache. I also had pain at the injection site. I went to bed and when I woke up the next day, I only had a slight headache which was gone by noon.
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| 65 | 2021-01-26 | rash |
Rash began on back, moved to neck and chest, arms, hands and tops of legs. My dr. advised to take...
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Rash began on back, moved to neck and chest, arms, hands and tops of legs. My dr. advised to take Claritin.
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| 65 | 2021-01-26 | vaccination site pain, vaccination site mass, vaccination site warmth |
Sore injection site, lump and warm; Sore injection site, lump and warm; Sore injection site, lump an...
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Sore injection site, lump and warm; Sore injection site, lump and warm; Sore injection site, lump and warm; This is a spontaneous report from a contactable Other-HCP. A 65-year-old female patient reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL12F3), at single dose into the right arm on 14Jan2021 at 01:15 PM for COVID-19 immunization. Medical history was none. The patient had no history of allergies to medications, food, or other products. The patient had a negative Covid test Nasal Swab on 20Nov2020. Concomitant medications included Omeprazole, Atorvastatin, Buspirone, Lisinopril. On 15Jan2021 at 9:00 AM the patient experienced sore injection site, lump and warm. No treatment was received. The events were considered non-serious. The outcome of the events was not recovered.
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| 65 | 2021-01-27 | itchy skin | Chills; Fever; itchy skin; nervousness |
| 65 | 2021-01-27 | redness |
Had very red face and hands. My BP felt high, and my heart rate was a bit higher. Took 1 Benadryl a...
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Had very red face and hands. My BP felt high, and my heart rate was a bit higher. Took 1 Benadryl and waited an additional 15 minutes. When I got home I used my rescue inhaler. Felt much better and more relaxed . Took BP. Systolic was elevated to 147. Diastolic was in good range. Heart rate was in good range.
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| 65 | 2021-01-27 | rash, itchy skin |
Rash under the skin that is itchy; Rash under the skin that is itchy; This is a spontaneous report f...
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Rash under the skin that is itchy; Rash under the skin that is itchy; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142), via an unspecified route of administration on the left arm on 29Dec2020 09:00 at a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high, ongoing diabetic, and metal and copper allergies. Concomitant medication included unspecified regular medications. No other vaccines were administered on the same date. No vaccinations were received four weeks prior. On 10Jan2021 23:00, the patient reported that she broke out in a rash under her skin that was so itchy. She noticed the rash around 11PM and had been taking Benadryl around the clock. She can still see the rash on her skin, it was not raised or bumpy, but it itches like crazy. She clarified the rash was located on both of her arms, trunk, chest, back, and neck. She believed the COVID-19 vaccine was related to the rash that was itchy that she was having. She cannot think of anything she has done differently to cause this itching. It started Sunday and at the time of reporting, it was Thursday and she still had it. She stated she was trying to go to the doctor to be looked at, but no one called her back. She has been taking Benadryl around the clock from the beginning of when it was needed. It seemed like the Benadryl has not phased her at all as she was wide awake. The next dose was scheduled for Monday 18Jan2021 and she did not know if she wanted to get the second dose of the vaccine. The vaccine was given at a hospital, not military facility. The adverse events did not require a visit to the emergency room or to the physician's office. The patient underwent lab tests and procedures which included rapid COVID test: negative on 13Jan2021. Outcome of the events was recovering. The events were reported as non-serious and related to the suspect drug.
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| 65 | 2021-01-28 | hives, rash, itchy skin |
2nd dose 1/26/2021 on the morning of 1/29/2021 Woke up with intense rash and hives all over my neck ...
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2nd dose 1/26/2021 on the morning of 1/29/2021 Woke up with intense rash and hives all over my neck , inner arms and groins. I was very itchy. After concluding nothing has really changed in my diet, toiletries etc... I read the notice from the vaccine, and went to emergency . Here I was treated for an allergic reaction.
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| 65 | 2021-01-28 | redness |
Redness and flushing to face, neck and chest beginning 45 mins after receiving the vaccine. Took be...
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Redness and flushing to face, neck and chest beginning 45 mins after receiving the vaccine. Took benadryl with good effect. Symptoms completely resolved by the following morning.
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| 65 | 2021-01-28 | injection site pain |
Very sore shot site and muscle soreness like when I had Covid a little better today but yesterday it...
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Very sore shot site and muscle soreness like when I had Covid a little better today but yesterday it was rough.
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| 65 | 2021-01-31 | rash |
Rash on face and neck starting within 10 minutes of vaccine. Swelling in cheeks and left neck, and t...
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Rash on face and neck starting within 10 minutes of vaccine. Swelling in cheeks and left neck, and tightness starting in left neck. Itching in the eyes.. Benadryl 50 mg po taken and pepcid 40 mg po taken at home. To emergency room within 1 hour after the vaccine due to tightening and swelling in the neck. They gave me Solumedrol IM and po zyrtec and observed me for awhile. Tightening in the neck eased up and I went home. By bedtime I turned pastey white color, no rash. In the morning I broke out in another rash on my face and neck. Rash resolved by the second day.
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| 65 | 2021-01-31 | blister, hives | immediate blisters , welts and vesicles both fore arms |
| 65 | 2021-02-01 | itchy skin | initial more pain, swelling lasting 1 week with itching, then upper arm pain shoulder pain |
| 65 | 2021-02-02 | injection site pain, rash |
Heart palpitations 45 minutes after shot , only lasted a few minutes, shortness or breath at random ...
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Heart palpitations 45 minutes after shot , only lasted a few minutes, shortness or breath at random times . First time 1&1/2 hours after injection without any asthma triggers, then 4-5 times lasted a few minutes each time during first 24 hrs, coughed more frequently, only used my rescue inhaler 3x during the first 48 hrs, fine rash on my face the next morning, lasted 48 hrs. I had body aches, chills , didn?t feel well for first 48 hours after the shot, ok now, just still tender at injection site, that is improving. Concerned I may have had a mild allergic reaction, worried about getting 2nd dose, but my doctor told me to take Benadryl prior to second dose & have someone drive me to the appointment, and get the second dose.
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| 65 | 2021-02-02 | injection site pain | Injection site pain & headache |
| 65 | 2021-02-02 | bruising, rash with redness, skin spots |
Patient received covid vaccine #1 Jan 7, 2021. On Jan 14th started having severe red rash? with pet...
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Patient received covid vaccine #1 Jan 7, 2021. On Jan 14th started having severe red rash? with petechiae and ecchymosis with some capillary oozing of blood on bilateral arms and lower extremities. Was seen by oncologist and had blood work done with no major abnormalities. Rash and bruising continued to spread and employee visited clinic on Jan 20th and she was instructed to contact oncologist ASAP for reevaluation. Patient had surgery for rt breast cancer few months ago currently finishing up radiation therapy to rt chest. To start po chemotherapy next week. Patient returned to clinic today January 26th to report that physician had meeting with other physicians and feels that the episode is related to the Covid vaccine and recommends employee not receive dose #2.
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| 65 | 2021-02-02 | itchy skin, bruising, redness |
have a bruised appearance in the left palm; Itching; redness; puffiness; prominent bright blue vein ...
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have a bruised appearance in the left palm; Itching; redness; puffiness; prominent bright blue vein in palm of left hand; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1283), via an unspecified route of administration in left arm on 15Jan2021 14:30 at first single dose for COVID-19 immunization. Medical history included hypertension, high cholesterol. No COVID prior vaccination. No known allergies. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ), rosuvastatin, celecoxib (CELEBREX), ergocalciferol (VIT D). No other vaccine received in four weeks. On 15Jan2021 15:00, the patient experienced Itching, redness, puffiness, and prominent bright blue vein in palm of left hand. This subsided somewhat after about an hour, but even three days later she had a bruised appearance in the left palm. Treatment included longer post-vaccination observation and Benadryl. COVID was not tested post vaccination. Outcome of the events was recovering.
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| 65 | 2021-02-03 | shingles | Developed Shingles on my forehead, scalp and eye |
| 65 | 2021-02-04 | hardening |
About 1/2 hour of the vaccination, I felt mild tingling of the lips. Very gradually, that got worse...
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About 1/2 hour of the vaccination, I felt mild tingling of the lips. Very gradually, that got worse (over the nest few hours) and I had tingling of hands and feet. I gradually developed facial swelling (my lips were enlarged and felt firm, as did my nose). I checked my pulse ox, and it remained above 97%. I never had rash or trouble breathing. But about 5 hours after receiving the immunization, I took some Benadryl, and over about 1/2 hour I could feel that things were improving. Over the next 24 hours I took Benadryl again two times, due to return of the tingling sensation of my lips. I also felt very cold, and had a hard time getting warm. This also improved with the Benadryl.
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| 65 | 2021-02-04 | vaccination site pain |
Injection site very sore; arm swollen; Feverish; This is a spontaneous report from a contactable con...
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Injection site very sore; arm swollen; Feverish; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL8982), via an unspecified route of administration in the left arm, on 21Jan2021 at 10:15 (at the age of 65-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFIB), shellfish allergy, allergy to pain medications, cancer, diabetes, high blood pressure, and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks of vaccination, included amlodipine (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), and esomeprazole magnesium (ESOMEPRA). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arm swollen and feverish on 21Jan2021 at 19:30 and injection site very sore on 23Jan2021. The events were reported as non-serious. It was reported that the injection site was very sore on the third day. Therapeutic measures were taken as a result of the events, which included paracetamol (TYLENOL) and icing arm. The clinical outcome of injection site very sore, arm swollen, and feverish was not recovered.
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| 65 | 2021-02-04 | injection site redness, injection site pruritus, injection site hardening |
Itching on injection site for1 week Red streak about an inch along injection site Small lump at inj...
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Itching on injection site for1 week Red streak about an inch along injection site Small lump at injection site
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| 65 | 2021-02-04 | hives |
Small welt between breast /hives across pelvis area/ Hives and back red spots on back / Dr advis...
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Small welt between breast /hives across pelvis area/ Hives and back red spots on back / Dr advised take 25 mg Benadryl immediately as long as breathing was ok...In 4hrs take an additional benadryl 25mg All hives went away approximately bedtime at 1030 pm..................2 days later some hives appeared took 1 benadryl 25mg ( NO other symtoms in the 30 min wait at the premises where shot was given )
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| 65 | 2021-02-05 | injection site pain | Sore arm at injection Fever of 102 |
| 65 | 2021-02-05 | injection site pain |
Soreness at injection site, Extreme chills and fatigue, beginning about 8am Feb 5, chills continued ...
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Soreness at injection site, Extreme chills and fatigue, beginning about 8am Feb 5, chills continued until evening but were not as bad in afternoon. Low grade fever, migraine and nausea began around 2:00. Woke up with migraine at 6:30 am on February 6 which has subsided since taking sumatritam. Some fatigue and lethargy this morning but ok otherwise
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| 65 | 2021-02-05 | hives, itchy skin, rash |
Terrible itching started on left side of torso Rash and hives on my back that are still present 5 ...
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Terrible itching started on left side of torso Rash and hives on my back that are still present 5 days after shot
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| 65 | 2021-02-06 | injection site rash | Dark red bump next to injection site that increased in size from about 1 inch to 3 inches in size |
| 65 | 2021-02-06 | injection site redness, injection site swelling |
Red, Very swollen injection site, including axillary area, fluid filled. Injection site very close ...
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Red, Very swollen injection site, including axillary area, fluid filled. Injection site very close to shoulder joint.
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| 65 | 2021-02-06 | hives |
Right side of tongue tingling and slight swelling, hives on right inside of mouth, right eye slight ...
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Right side of tongue tingling and slight swelling, hives on right inside of mouth, right eye slight swelling, right side of face tingling, and a dime sized hive on my right temple area.
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| 65 | 2021-02-07 | pain of skin |
Chills, headache, body aches, joint pain , neck and low back pain, eye and mouth pain, skin sore to ...
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Chills, headache, body aches, joint pain , neck and low back pain, eye and mouth pain, skin sore to touch all over, excessive tiredness, lethargy, loss appetite.
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| 65 | 2021-02-07 | injection site swelling |
Within 15-minutes of vaccination, the patient reported arm swelling around injection site. EMS monit...
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Within 15-minutes of vaccination, the patient reported arm swelling around injection site. EMS monitored the patient's condition on-site.
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| 65 | 2021-02-07 | vaccination site pain |
feeling like I had the flu without the high fever; had a very bad headache; soreness in the arm wher...
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feeling like I had the flu without the high fever; had a very bad headache; soreness in the arm where I received the shot; This is a spontaneous report from a contactable consumer reported for self. This 65-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL8982) at single dose in right arm on 20Jan2021 at 10:30 AM for COVID-19 immunization. Medical history included hypothyroidism. Allergies to medications, food, or other products were unknown. Concomitant medications included duloxetine; levothyroxine; montelukast; trazodone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient felt fine the day she received the vaccine, with only soreness in the arm where she received the shot. The next day at 11:00 AM, she started feeling like she had the flu without the high fever. The worse symptom was that she had a very bad headache. These symptoms were continuing 48 hours after the vaccine was administered. She was generally very healthy, had a very active life, and didn't get headaches. She was rarely sick. She just didn't seem to be feeling any better. Seriousness was no: not results in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. There was no treatment received for the adverse events. The adverse events was not resolved.
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| 65 | 2021-02-08 | injection site pain |
My right arm at the injection started aching during the first night. The next day my underarm and s...
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My right arm at the injection started aching during the first night. The next day my underarm and shoulder started hurting and feeling stiff. Hurts to raise my arm.
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| 65 | 2021-02-08 | hardening |
my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like ...
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my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like a deep wide black spot and it is hard; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included amlodipine, metformin and propranolol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization and experienced severe headache and diarrhea. On 13Jan2021, the patient reported that: "my body collapsed, I had a pulmonary embolism. I had to go to the hospital in ambulance. When I was there, they find out that I have clot in my lung. I was in an intensive care for 2 days or 3 days and about 5 days in the hospital (from 13Jan2021 to 17Jan2021). I have behind my knee like a deep wide black spot and it is hard, my body did not have anything like that". Therapeutic measures were taken as a result of event pulmonary embolism/ clot in lung and included treatment with "some medications", one of which ELIQUIS. The patient outcome of pulmonary embolism and "clot in lung" was recovered on an unspecified date and of deep wide black spot was unknown. The information on the batch number has been requested.
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| 65 | 2021-02-09 | redness |
Face and chest became bright red; felt very hot; sinus pressure increased; blood pressure was up 155...
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Face and chest became bright red; felt very hot; sinus pressure increased; blood pressure was up 155/94; pulse rate up; This is a spontaneous report received from a contactable consumer (the patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL 9261), via an unspecified route of administration in the left arm on 21Jan2021 15:45 (at the age of 65-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol, indoor and outdoor allergies, and allergies to latex and contrast. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously took and had allergies to: amoxicillin/ clavulanic acid (AUGMENTIN), sulfamethoxazole/ trimethoprim (BACTRIM), levofloxacin (LEVAQUIN), and gabapentin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Within 5 minutes of receiving the dose on 21Jan2021, at 15:45 (as reported), the patient's face and chest became bright red, felt very hot, sinus pressure increased. The EMT's took her blood pressure- was up 155/94, and her pulse rate was up (21Jan2021, 15:45 (as reported)). Her temperature and blood sugar were within normal limits (21Jan2021). The patient did not receive any treatment for the events. The clinical outcome of face and chest became bright red, felt very hot, sinus pressure increased, blood pressure was up 155/94, and pulse rate up was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 65 | 2021-02-09 | rash, rash with redness |
Shot given 10:19pm on 2/6/21. Noticed rash on 2/8/21 11:55am. Rash was bilateral on face along mad...
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Shot given 10:19pm on 2/6/21. Noticed rash on 2/8/21 11:55am. Rash was bilateral on face along madibles from TMJ to about 1" from lips and was 2" superior from jaw line towards the eyes. Rash was very red over skin area with multiple darker spots and by 2/7/21 those spots appeared open though no blisters or pustules were seen. Rash had burning sensation which was relieved by Vaseline. Once doctor was seen (PA), Tacrolimus ointment was prescribed BID. Rash no longer burns 2/9/21 pm and it appears to be resolving. Spots are still evident but erythemic area is gone.
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| 65 | 2021-02-09 | redness, rash |
Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm wa...
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Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm was red; arm was hurting; arm red with a red bump; diarrhea; she has arthritis and her pain has gotten worse; This is a spontaneous report from a Pfizer-sponsored program. A nurse aide (consumer or other non hcp) reported for herself that the 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E13302), intramuscular injection in the left arm on 20Jan2021 at single dose for COVID-19 prophylaxis. Medical history included ongoing arthritis from an unknown date. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and ibuprofen for arthritis. The patient got the vaccination on 20Jan2021 and experienced redness, pain and nausea on an unspecified date in Jan2021. She said that that night (on 20Jan2021) and the next morning her arm was hurting and it was red with a red bump. On Thursday (21Jan2021) and Friday (22Jan2021), she felt joint pain, no fever, and did not feel good. The patient experienced more tired and did not feel good on 21Jan2021. The patient experienced headache on 23Jan2021. Saturday (23Jan2021) she was more tired than usual and on Sunday (24Jan2021) she was home and felt completely tired and had stomach pain, joint pain, nausea, headache, but did not have a fever. She was feeling the same today (on 25Jan2021) and worse. The patient said that her arm was not red anymore, but it still had a small bump. Stomach pain comes and goes. She stated that she had some diarrhea, but not much in Jan2021. Her nausea comes and goes as well. She said that it was like you want to throw up, but she had not thrown up. She said that you just know that something was not right. She said that her headache was like a heaviness on top of her head and forehead. She said that it was bothering her but it was not terrible. Next dose is due on 10Feb2021. The patient said that she worked in a facility with elderly people. She said that she has arthritis and her pain has gotten worse in Jan2021. She said that even with the medication. She did not take her medication until Thursday evening to see if she had any effects from the vaccine. She took Ibuprofen 800mg and CYMBALTA for her arthritis. She said that her tiredness had nothing to do with her medications. She said that it was very rare that she even had a headache. The reason that she called was to see if she should she do anything, is it safe for her to go back to work. Event Joint pain, more tired and did not feel good were reported as worsened. The outcome of event arm was red was recovered on an unspecified date in Jan2021. The outcome of events arm was hurting, arm with a red bump, diarrhea was recovering. The outcome of events Joint pain, did not feel good, more tired than usual, Stomach pain, Nausea, headache was not recovered. The outcome of the other events was unknown.
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| 65 | 2021-02-09 | vaccination site pain |
When I raised my arms up there was soreness (3-4 times in an hour or 2 hour period) where they gave ...
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When I raised my arms up there was soreness (3-4 times in an hour or 2 hour period) where they gave the vaccine; This is a spontaneous report from a contactable Nurse (self). A 65-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 (at 65 years of age), as single dose for COVID-19 immunisation. Medical history was lung disease, scar tissue in lungs and Sarcoidosis. Concomitant medication was not reported. After reading the documents she realized the second dose should be scheduled 21 days after first dose. Her schedule for the second dose is 28 days after the first dose. The patient experienced "Yesterday evening (22Jan2021) when I raised my arms up there was soreness (3-4 times in an hour or 2-hour period) where they gave the vaccine." Outcome of event "When I raised my arms up there was soreness (3-4 times in an hour or 2 hour period) where they gave the vaccine" was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
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| 65 | 2021-02-09 | redness, rash, rash macular, skin warm |
eyeballs, eyelids swollen, then face swollen and blotched, then second layer of skin became scalding...
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eyeballs, eyelids swollen, then face swollen and blotched, then second layer of skin became scalding on fire hot but no temp. then whole face and ears swollen. then swelling and blotch moved down into neck and upper chest. had been having trouble breathing from beginning of symptoms was getting worse.
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| 65 | 2021-02-09 | vaccination site pain |
feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed;...
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feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed; pain in the injection site; joint pain; muscle pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3247), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient thinks she could have COVID last Mar2020. She was not sure because her doctor's office was close for around a month and she couldn't get tested. There were no concomitant medications. On that day, 19Jan2021, after she received the vaccine she started feeling pain in the injection site, joint pain, muscle pain and fatigue. On 25Jan2021, she was feeling pretty bad, she doesn't want to eat, her back hurts, she's irritable and depressed. The patient would like to know if these side effects could be associated with the vaccine in someone who had the virus. She felt awful and she felt like she has gone right back to where she was 8 months ago, 10 months ago and started over with fatigue and everything. It was awful. She thinks she could have had COVID in Mar2020 and the symptoms she was having now, she had then and when she has had basically the whole time and that would just come back worse. There was no treatment received for the events. The outcome for the events was unknown.
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| 65 | 2021-02-09 | vaccination site pain, vaccination site mass, vaccination site itchiness |
vomited; chills; headache; had some itching, ongoing soreness and lump at site; had some itching, on...
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vomited; chills; headache; had some itching, ongoing soreness and lump at site; had some itching, ongoing soreness and lump at site; had some itching, ongoing soreness and lump at site; nauseous; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 19:00 at a single dose for COVID-19 immunization. She takes thyroid daily (as reported) as it was removed when she was 20. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to vaccination. The patient had not been tested for COVID post vaccination. The patient has not received any vaccine in 4 weeks. Concomitant medication included teriparatide (FORTEO) daily injection, diphenhydramine hydrochloride (BENADRYL). The patient previously took codeine and experienced allergies: codeine. The patient reported that no one knew if she should inject with teriparatide. On 22Jan2021, she received teriparatide at 4pm and bnt162b2 at 7pm. She took a diphenhydramine and had some itching, ongoing soreness and lump at site. She took teriparatide at 3:30pm at about 7pm she was nauseous and vomited. She had chills but felt better afterwards. She went to bed and have headache, not sure if she should discontinue teriparatide or discontinue before next shot. According to the reporter, the events started on 23Jan2021 19:00; vomited started on 23Jan2021 21:00. The outcome of the event was recovering.
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| 65 | 2021-02-10 | rash, itchy skin |
3 MINUTES AFTER VACCINE, LEFT ARM STARTED ITCHING AND RASH. HAS SINCE RESOLVED, NO SOB OR RESPIRATOR...
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3 MINUTES AFTER VACCINE, LEFT ARM STARTED ITCHING AND RASH. HAS SINCE RESOLVED, NO SOB OR RESPIRATORY DISCOMFORT. PATIENT ALERT AND ORIENTED. ENCOURAGED TO CALL OR VISIT HER PCP AS NEEDED.
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| 65 | 2021-02-10 | injection site bruising |
Approximately 30 minutes after receiving the vaccine I lost complete hearing in my left ear. I waite...
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Approximately 30 minutes after receiving the vaccine I lost complete hearing in my left ear. I waited until the next morning to see if hearing would return. It did not and I contacted my doctor at the Clinic and was referred for an audiology test on Thursday at 9:30am followed by a appointment with an ENT. My hearing loss was profound and I was started on high dosages of steroids for a 14 day course of action. I also had a head MRI done on Monday February 8 with no significant findings. My hearing has begun to improve but at this point is not back to normal and it may never be the same. My biggest question is whether or not I should take the second vaccine. I also have a significant bruise at the injection sight that I still have 10 days later.
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| 65 | 2021-02-10 | injection site pain |
Left arm was sore to move for one day after the shot. I began developing a dull headache and low gr...
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Left arm was sore to move for one day after the shot. I began developing a dull headache and low grade fever around 1:00 pm the day after the shot. My fever started at 100.3 degrees F and rose to 101.9 degrees F by 10:00 pm. I did not take any pain reliever until midnight. The fever was gone by 3:00 am on 2/6/21, and the headache dissipated by noon the same day. My left arm has continued to be sore to the touch and pressure (like a bruise) at the shot site, but there has never been any redness or swelling. This pain is going away slowly each day.
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| 65 | 2021-02-10 | rash with redness, rash | Red, inflamed rash on both arms and chest. I took Benadryl and applied anti-itch cream. |
| 65 | 2021-02-10 | skin warm |
Vac administered at 10:30am yesterday. In Observation >10:45am.. no side effects at that time. While...
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Vac administered at 10:30am yesterday. In Observation >10:45am.. no side effects at that time. While in a store buying flowers... approximately 11:45am... experienced sudden and overwhelming onset of profuse heat and perspiration. Eyeglasses immediately fogged up, perspiration ran down my back and ran under my face mask. I felt lightheaded and faint. My husband confirmed that my back was "on fire". Last night, I was awakened by extreme chills and shivering... every muscle and joint tense and painful. This continued for some time and then I became feverish with bed cloths and bedding soaked. Had a temp of 102 @7:30 am with HA and muscle & joint pain.
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| 65 | 2021-02-10 | rash maculo-papular |
developing a diffuse rash on her body/it is a maculopapular rash mostly on her torso, chest, abdomen...
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developing a diffuse rash on her body/it is a maculopapular rash mostly on her torso, chest, abdomen and it is now extending to her upper thighs; lesions on her chest; This is a spontaneous report from a contactable physician (patient). A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899, expiry date: unknown), intramuscular on 08Jan2021 09:00 at single dose (left upper arm) for COVID-19 immunization (prevent covid). Medical history included ongoing Hypertension (diagnosed a couple of years ago), ongoing Osteoporosis (diagnosed about 5 or 10 years ago, she does not take any medication for this), ongoing Grover's disease (diagnosed about 5 or 10 years ago). There were no concomitant medications. The patient received her first dose of bnt162b2 on 18Dec2020 around 13:30, in the upper left arm for COVID-19 immunization. She confirms she received the same lot number for both doses. Vaccination facility type was hospital. The patient received vaccine about 10 days ago. She is developing a diffuse rash on her body (Jan2021). She would like to know if there is any guidance on how to treat rash. She has a history of Grover's and she had lesions on her chest about a week ago (Jan2021), she put some cortisone cream on it. She noticed that her whole abdomen had the rash, states it is not itchy. She really noticed the rash yesterday. She stated that it is a maculopapular rash mostly on her torso, chest, abdomen and it is now extending to her upper thighs. States the lesions occurred about one or two weeks ago and she is not sure if that was before or after the second dose of the vaccine. She clarified that she received the second dose of the vaccine twelve days ago, not ten days ago. When querying causality, states there is no other reason for the rash, so it is probably related to the vaccine. The outcome of the event developing a diffuse rash on her body/it is a maculopapular rash mostly on her torso, chest, abdomen and it is now extending to her upper thighs was not recovered, while for other event was unknown. Therapeutic measures were taken as a result of lesions on her chest.
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| 65 | 2021-02-14 | injection site pain |
Injection site soreness; headache (front of forehead across top of head all the way back to ears); s...
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Injection site soreness; headache (front of forehead across top of head all the way back to ears); sinus ache under eyes; muscle ache across shoulders; hint of nausea; early morning awoke to profuse sweating; tired.
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| 65 | 2021-02-14 | injection site pain, injection site redness |
Sore arm, slightly red at injection site. The shot hurt more than the first one. Had small waves of ...
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Sore arm, slightly red at injection site. The shot hurt more than the first one. Had small waves of stomach upset, headache, chills, lethargy but none lasted longer than an hour. All symptoms are gone now, 3 days later.
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| 65 | 2021-02-14 | skin peeling |
neuropathy; Day 4 after injection, heat sensitivity in hands and feet; tingling in hands/feet; sharp...
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neuropathy; Day 4 after injection, heat sensitivity in hands and feet; tingling in hands/feet; sharp burning needles sensation up arms and legs; Tips of fingers and toes were numb and felt swollen; Tips of fingers and toes were numb and felt swollen; Hands then started peeling, palms became thickened and rough; This is a spontaneous report from a contactable healthcare professional, the patient. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the right arm on 22Dec2020 at 08:30 (at the age of 65-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included A-fib (atrial fibrillation), GERD (gastroesophageal reflux disease) and osteoporosis. Concomitant medications included atenolol, calcium, acetylsalicylic acid (ASPIRIN), famotidine (PEPCID) and omeprazole. Past drug history included known allergies: fexofenadine (ALLEGRA) and codeine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26Dec2020, day 4 after injection, the patient experienced heat sensitivity in hands and feet, followed by tingling in hands > feet, with sharp burning needles sensation up arms and legs. Heat sensitivity continued. Tips of fingers and toes were numb and felt swollen for several days, while neuropathy continued. Hands then started peeling, palms became thickened and rough. For the events neuropathy, heat sensitivity in hands and feet, tingling in hands/feet, burning needles sensation, tips of fingers and toes were numb and felt swollen, and hands then started peeling an emergency room visit and physician office visit was required. Unspecified treatment was provided for the events neuropathy, heat sensitivity in hands and feet, tingling in hands/feet, burning needles sensation, tips of fingers and toes were numb and felt swollen, and hands then started peeling. The outcome of the events neuropathy, heat sensitivity in hands and feet, tingling in hands/feet, burning needles sensation, tips of fingers and toes were numb and felt swollen, and hands then started peeling was recovering. Since the vaccination, the patient has been tested for COVID-19. Nasal Swab on 13Jan2021 was negative and on 19Jan2021 was negative. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of neuropath, cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-02-15 | hives |
3 days after I received the 2nd vaccine, I developed hives in both lower arms and a few on my left s...
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3 days after I received the 2nd vaccine, I developed hives in both lower arms and a few on my left shoulder, right chest and upper legs. I was prescribed prednisone
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| 65 | 2021-02-15 | itchy skin |
Itching all over body, trouble breathing, asthma. Relieved with rescue inhaler and Benadryl. 2 epis...
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Itching all over body, trouble breathing, asthma. Relieved with rescue inhaler and Benadryl. 2 episodes.
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| 65 | 2021-02-15 | skin tightness |
Patient received first dose of the COVID vaccine and was monitored for 30 minutes, felt fine at that...
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Patient received first dose of the COVID vaccine and was monitored for 30 minutes, felt fine at that time and was allowed to leave. Approximately one hour after receiving the vaccine patient experienced right side of neck and face up to eye becoming numb and tight. Tongue got a little numb also. Over the next two hours the symptoms lightened up and by morning just felt like she had a numbing agent at the dentist along right lip, nostril and check.
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| 65 | 2021-02-15 | injection site pruritus, injection site reaction, injection site redness, injection site pain, rash macular, injection site warmth, injection site swelling |
Received vaccine on 2/9. Only sore arm until 2/12. Woke up that morning with extremely sore arm, re...
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Received vaccine on 2/9. Only sore arm until 2/12. Woke up that morning with extremely sore arm, red, blotchy patch of skin around injection site about the size of the palm of my hand. It was hot to the touch. At the injection site itself, there was an area about the size of a quarter that was slightly swollen. The entire area was extremely itchy! Today is 2/16 and the red area is just disappearing. It still itches. My arm is still sore. I have also been running a low grade fever since the injection.
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| 65 | 2021-02-16 | redness |
On February 11, 2 days after my vaccination, I woke up with pain and swelling under my left eye. Ov...
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On February 11, 2 days after my vaccination, I woke up with pain and swelling under my left eye. Over the next 2 days, the left side of my face under the eye experienced redness and swelling then subsided and localized into a large stye on the lower left eyelid. Now, a week later, the stye is still red and pus filled but has improved and is slowly resolving. I would not normally think that this affliction had anything to do with getting a vaccine but it does seem strange that something like this could occur in someone who is very healthy and and does not experience any side effects from vaccines. The last time I had a stye was in my 20's and it wasn't nearly as bad as the one I am now experiencing. Since the Covid vaccine is so new and however unrelated this coincidental affliction seems, I thought I should report it regardless.
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| 65 | 2021-02-16 | injection site rash, injection site pruritus |
Rash, itching around injection site about 5 to 8 days after injection - has continued- over 24 hours...
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Rash, itching around injection site about 5 to 8 days after injection - has continued- over 24 hours - "Covid arm"
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| 65 | 2021-02-18 | injection site pain |
1 PM I received the vaccine and withing 5 minutes had a slight pain on the left side of my head whic...
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1 PM I received the vaccine and withing 5 minutes had a slight pain on the left side of my head which then continued to a pain in my neck. also left side, then back pain, then slightly short of breath. I remained in the waiting area for over a half hour and felt no worse, but did report it to the young woman at the exit who said that was odd and seemed the kind of response with the second dose. I presumed it might be due to my already having antibodies. As I continued my day those symptoms quickly dispersed and I felt fine, albeit with a light soreness at the site on my left arm. At approximately 6pm I felt very fatigued and rested until 10pm, when I began to have chills, a headache and nausea. My left arm was also so sore I could not lay comfortably. I took Tylenol and aspirin both at 11:30 pm and attempted to sleep, which was fitful and disturbing. I had strange neurological events, such as odd visions in my half sleep and bizarre semi dreams but could not waken. At 4:00 AM I finally was able to pull out of this state and the last thing in my mind was a conversation with someone trying to explain what was happening to me, in my mind not vocal, that was in Italian. That is my second language. All day I had unwanted words, ideas etc. floating about in my brain. I could no longer sleep and was very weak, had terrible head and body aches and my legs also ached terribly. I was also slightly nauseous.These were all symptoms, minus the disturbing neurological one, that I had with Covid. I was too weak to leave the bed until much later in the day. I am still having effects but much less and I am at the 72 hour mark. I remained at rest all day and ran a low fever, then again a fever
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| 65 | 2021-02-18 | injection site swelling, injection site pain |
Day one after vaccine, swelling and soreness of the arm that was vaccinated. 10 days after the vac...
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Day one after vaccine, swelling and soreness of the arm that was vaccinated. 10 days after the vaccine: muscle aches, hand/wrist swelling and pain, and diahrrea on day 13. This has lasted 3 days and has started to subside with the use of ibuprofen every 4 hours. Reported to Dr. on Day 12.
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| 65 | 2021-02-18 | rash |
Patient expressed to Clinical Site RN that she was feeling nausea and flushing 15 minutes after admi...
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Patient expressed to Clinical Site RN that she was feeling nausea and flushing 15 minutes after administration of COVID vaccine. Upon assessment, patient's blood pressure was 187/110. Patient began to develop rash across chest and arms. Mobile response called and patient was escorted to ED.
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| 65 | 2021-02-18 | itchy skin |
Tasted vaccine within minutes of dose. Within 15 minutes had itching of face and forearms which las...
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Tasted vaccine within minutes of dose. Within 15 minutes had itching of face and forearms which lasted about 8 hours. For 2 nights, but especially the first night, had vivid dreams and woke up every 2 hours. Had some minor fatigue day after shot. All resolved by themselves. Was totally back to normal after 2nd nights sleep.
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| 65 | 2021-02-21 | rash |
At 11:50 am (1 hour and 50 minutes) after receiving the shot my eyes started swelling. I took a Ben...
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At 11:50 am (1 hour and 50 minutes) after receiving the shot my eyes started swelling. I took a Benadryl immediately which relieved some of the swelling. At approximately 9:30 p.m. I noticed a rash on my left cheek which was gone by the following morning.
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| 65 | 2021-02-21 | injection site redness, injection site discomfort |
I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over a...
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I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over all my body (joint/muscle pain) that started about 10 PM the night. I woke up Saturday morning with a bad headache, felt like I was pass out, I had chills. Saturday afternoon I noticed under right armpit the lymph nodes were swollen. The pain radiates throughout my chest and shoulder but most severe under the armpit. As of today 22nd I feel tired and I am still experiencing the swollen lymph nodes under my right arm pit. All the other symptoms have went away. The lymph node feels warm to touch, there is also a small area of redness around the injection site. I am still having post COVID-19 symptoms as well which include nasal issues, weakness and brain fog. I have had all these symptoms since November.
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| 65 | 2021-02-21 | skin warm |
all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness...
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all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness but hot to touch, periodic cough, runny nose, throat felt like it was closing up, extreme fatigue and body weakness, unable to sleep first night
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| 65 | 2021-02-22 | hives, itchy skin |
First vaccine on 1/30, 10 days later started with a few hives. Thought it was new medication, took b...
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First vaccine on 1/30, 10 days later started with a few hives. Thought it was new medication, took benadryl but lasted on and off for 10 days. Didn't think it was related to the vaccine. On 2/18 had more severe hives called my dr. She didn't see a reason not to get the second vaccine. 2 vaccine on 2/20 at 1:15. Sunday around 9:00 the hives started again. By 2:00 am it was severe, took benadryl everyd 4 hours after a few hours of sleep decided to go to the ED. Hive were severe from ankles to collar bone. very itchy. Was given epi injection and iv solumedrol and pepcid. Stopped itching and was discharge with prescriptions for Prednisone and pepcid. No more hives or itching at this time.
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| 65 | 2021-02-23 | redness |
My cheeks were red and hot.; My cheeks were red and hot.; This is a spontaneous report from a contac...
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My cheeks were red and hot.; My cheeks were red and hot.; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9263/expiration date: not provided), via an unspecified route of administration, on 23Jan2021 at 14:30 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included allergic reaction to almonds and brewers yeast in Sep2019, being pre-diabetic, and osteoporosis. The patient had allergies to codeine (all forms), almonds, brewers yeast, mold and dust. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin, alendronate sodium (FOSAMAX), and multivitamin, other supplement. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 at 15:15, the patient experienced that her cheeks were red and hot. The clinical course was as follows: because of a prior significant allergic reaction (Sep2019 determined to be primarily almonds and to a lesser extent brewers yeast), she waited 30 min. and she didn't notice anything until she left the property and removed her mask. Her cheeks were red and hot. She had a diphenhydramine (BENADRYL) tablet (OTC) which within 30+ min reversed it. The outcome of the events cheeks were red and hot was recovered on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.
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| 65 | 2021-02-23 | rash papular |
pt developed rash on b hands that appeared to be chillblains, along with usual side effects of myalg...
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pt developed rash on b hands that appeared to be chillblains, along with usual side effects of myalgias, fever, chills, arthralgias. rash lasted a little over a week and resolved on its own.
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| 65 | 2021-02-24 | bruising | Bruising on lip and stomach after 28 hours and light headed |
| 65 | 2021-02-24 | redness |
Hot red face and neck; Hot red face and neck; possible slight swelling of face and eyes (minor); pos...
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Hot red face and neck; Hot red face and neck; possible slight swelling of face and eyes (minor); possible slight swelling of face and eyes (minor); chills; headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 15:15 at a single dose for COVID-19 immunization. Medical history included hypertension and kidney disease, and was allergic to bee stings, penicillin, aluminum chloride. Patient was not pregnant at the of vaccination. There were unspecified medications received within 2 weeks of vaccination, and no other vaccine in 4 weeks prior to. The patient experienced hot red face and neck, possible slight swelling of face and eyes (minor), chills and headache on 29Jan2021 15:30. Outcome of the events was recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 65 | 2021-02-24 | injection site pain |
Monday, February 22, in the evening, I started feeling lightheaded, then more debilitating dizzy, ...
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Monday, February 22, in the evening, I started feeling lightheaded, then more debilitating dizzy, worsening, nauseas . Went home from work that evening around 9:30 p.m. I Vomited as soon as I got home. Felt better but still lightheaded, dizzy, not as bad. No fever. Couldn't sleep. Tuesday, February 23 felt pretty weak, tired some lingering lightheadedness. Stayed home from work. Next day, Wednesday, my right arm around the injection site was pretty sore. Hard to sleep last night. Took Tylenol for arm. Still somewhat sore today, Thursday.
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| 65 | 2021-02-24 | dry skin, skin warm, itchy rash, rash, redness |
Red, Itchy rash on face & neck, skin hot to touch, burning sensation on face day after shot - also s...
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Red, Itchy rash on face & neck, skin hot to touch, burning sensation on face day after shot - also some edema under right eye - small sack of fluid - lasted a few days - took benadryl to relieve itching - dissapated after 4 days but skin was very dry & chapped for about 10 days after
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| 65 | 2021-02-24 | rash |
She did not have any reactions initially, but noticed the morning after the vaccine that her regular...
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She did not have any reactions initially, but noticed the morning after the vaccine that her regular cup of coffee did not taste good. She then had a rash that started on the left side of her neck, went towards the back now. This started a few days after the vaccine, all on the left side. She also got a cold sore on her lip which she had all the time as a child, but not as an adult, which has pretty much resolved. She has been cold, chills and some dizzy spells. She did get a bump on her head concussion in December. One day last week she just stayed on the sofa with a blanket due to feeling poorly. 3 days ago on her back by her shoulder blade an area has been really sore. She did take some Tylenol for the back pain which did not help so she stopped this. She did not call her doctor. The rash is still there but not as intense. It has not itched, but she has felt it.
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| 65 | 2021-02-24 | rash, itchy skin |
The rash is up under arm, in armpit and is in the same arm of injection but there is no rash at the ...
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The rash is up under arm, in armpit and is in the same arm of injection but there is no rash at the injection site.; because there was some itching under the arm. I went to see a dermatologist who says it has nothing to do with vaccine. I also had a slight headache; I also had a slight headache a day or two after the shot; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration on 14Jan2021 on left arm at a single dose for COVID-19 immunisation. Medical history included chronic kidney disease. The patient had chronic kidney disease and its real important for someone with her disease to get the vaccine, because if she got the actual virus it would hit the kidneys hard. The patient had no positive covid or antibody test prior to the vaccine. Concomitant medications were none. The patient stated that only thing she thinks would be related was that, she noticed this rather after using the hot tub, her husband just cleaned the hot tub and put chemicals in it, maybe she had a reaction to chemicals used to clean the hot tub. On 24Jan2021, the patient was reported after 10 days the patient had rash was up under the arm, near the arm pit, in the same arm of injection but there was no rash at the actual injection site, however her skin was beautiful, there was no spot except under the armpit. She got the injection a week ago Friday, she noticed the rash days later, on Sunday with itching under the arm. The Dermatologist says it has nothing to do with vaccine. The patient also had a slight headache a day or 2 (on 15Jan2021) after the shot, not a migraine, it was a slight dull headache, but went away. The patient went to the dermatologist yesterday, and he said it had nothing to do with the vaccine. She went to the dermatologist on 26Jan2021. Caller again stated that there was no rash at the injection site, but there was a rash underneath the arm in the arm pit. She still has it, she just started to use medicine last night. It's getting better. The Dermatologist prescribed a topical cream and its some kind of cortisone. The patient did not have any severe reaction like head swelling or swelling. The patient was scheduled for her second dose on 05Feb2021. The patient recovered from headache on 16Jan2021, recovering from rash, and for itching it was unknown.
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| 65 | 2021-02-25 | itchy rash |
Developed pruritic rash 4 days after second COVID vaccine injection that continued to progress for t...
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Developed pruritic rash 4 days after second COVID vaccine injection that continued to progress for the next week despite the use of Benadryl
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| 65 | 2021-02-25 | injection site pruritus |
Starting at bedtime, the patient felt itchiness at the injection site. The sensation started to feel...
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Starting at bedtime, the patient felt itchiness at the injection site. The sensation started to feel so intense that it felt like her skin was crawling. Shortly after she developed a rash and with raised, red pustules. The scratching led to bleeding and eruption of the pustules. The sensation went away after a few hours and left small scabs that are now healing.
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| 65 | 2021-02-26 | rash |
Approximately an hour after receiving my second vaccine, I developed an extensive rash across the ba...
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Approximately an hour after receiving my second vaccine, I developed an extensive rash across the backs of both of my legs. I called my local emergency department and was referred to the poison control hotline for my area. They instructed me to take a Benadryl, which cleared up the rash within about an hour. Poison control continued to monitor me for the next 12 hours.
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| 65 | 2021-02-27 | injection site pain |
1. Pain on the injection site (left arm) for 36 hours. I was able to move the arm, there was no swel...
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1. Pain on the injection site (left arm) for 36 hours. I was able to move the arm, there was no swelling. 2. Wrist pain on the left hand, with any movement for 36 hours. I do not have carpal tunnel syndrome. I was not able to do any work because of the pain on one side of the wrist. Pain went away after the second night.
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| 65 | 2021-02-27 | rash, rash with redness |
103.1 Fever, Extreme Migraine Headache, Chills, Extreme Body Aches, fatigue, Nausea and on second da...
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103.1 Fever, Extreme Migraine Headache, Chills, Extreme Body Aches, fatigue, Nausea and on second day: 101 fever, chills, terrible fatigue and a red rash over entire body.
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| 65 | 2021-02-27 | injection site pain, injection site redness, injection site swelling |
injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swell...
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injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, malaise
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| 65 | 2021-02-28 | itchy skin |
Intense Itching and swelling; Intense Itching and swelling; Pain but not severe, moderate; This is a...
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Intense Itching and swelling; Intense Itching and swelling; Pain but not severe, moderate; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3247), via an unspecified route of administration on 18Jan2021 17:30 at a single dose on left arm for COVID-19 immunization. Medical history included itchiness from fake eyelash glue. There were no concomitant medications. The patient previously received flu vaccine for immunization and experienced itchiness. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no any other medications received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. On 20Jan2021, the patient experienced intense itching and swelling and pain but not severe, moderate. The events resulted in visit to emergency room/department or urgent care. The patient was treated with antihistamine for the events. The patient was recovering from the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.
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| 65 | 2021-02-28 | itchy skin |
Started with itching on left neck; swelling below left eye; hands were swelling; This is a spontaneo...
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Started with itching on left neck; swelling below left eye; hands were swelling; This is a spontaneous report from a contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 27Jan2021 14:30 at a single dose for covid-19 immunization. The vaccine was administered at the pharmacy. Patient was not pregnant at the time of vaccination. Medical history included sarcoidosis and hypertension both from an unknown date, and one unknown anaphylaxis a year ago (2020). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amlodipine besylate. On 27Jan2021 16:30, it was started with itching on left neck, then swelling below left eye and hands were swelling. The patient was concerned enough she took a Benadryl. The events result in doctor or other healthcare professional office/clinic visit. Treatment received for the events was Benadryl. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 65 | 2021-02-28 | itchy rash, rash with redness |
started developing a rash. Like red patches on her arms/showed up on her stomach, chest and thighs. ...
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started developing a rash. Like red patches on her arms/showed up on her stomach, chest and thighs. They flare-up.; It's a little bit itchy; This is a spontaneous report from a contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC8982), via an unspecified route of administration on 21Jan2021 at a single dose for Covid-19 immunization. Medical history included blood pressure high, thyroid disorder (reported as thyroid), and cholesterol high. Concomitant medications included lisinopril and hydrochlorothiazide both for blood pressure high, levothyroxine, and atorvastatin for cholesterol high; all were taken from an unspecified date. On 26Jan2021 afternoon, the patient started developing a rash. Like red patches on her arms, she put the Cortisone on her arms and it went away. But then it showed up on her stomach and chest and thighs. They flare-up. It's a little bit itchy. The outcome of the events was not recovered.
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| 65 | 2021-03-01 | cellulitis |
2/3 rehab visit: PA - 02/03/2021 12:25 PM CST Formatting of this note might be different from the or...
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2/3 rehab visit: PA - 02/03/2021 12:25 PM CST Formatting of this note might be different from the original. NURSING HOME ACUTE VISIT 6/24/1955 MD SUBJECTIVE: Chief Complaint Patient presents with ? Cough Pt has COVID 19 and she is coughing and congestion. This is an acute visit with pt. Status and changes discussed with staff. Advanced directives on file. Allergies reviewed at NH, though may not be fully updated in electronic record. Problem List reviewed. ROS: Gen: Denies fever CV: Denies chest pain Resp: Denies dyspnea GI: Denies abdominal pain. GU: Denies dysuria. Psych: Denies depression. OBJECTIVE: VITALS: Vitals: 02/03/21 1226 BP: (!) 94/54 Pulse: 79 Resp: 18 Temp: 37 °C (98.6 °F) SpO2: 96% PHYSICAL EXAM: General: Alert, awake, no acute distress Skin: Intact HEENT: Grossly normal Neck: Supple Lungs: Within normal limits/clear CV: RRR Abdomen: Soft, BS active Extr: WNL Neuro: Unchanged and nonfocal ASSESSMENT/PLAN: Reviewed and signed orders. Recheck in 60 days. Patient was seen today for cough. Diagnoses and all orders for this visit: COVID-19 Cough CXR 2 view. Plan to start melatonin, vit D3, zinc. Rehab nurse note: Table of Contents for Miscellaneous Notes Telephone Encounter - RN - 02/09/2021 9:30 AM CST Telephone Encounter - 02/09/2021 9:16 AM CST Telephone Encounter - RN - 02/09/2021 9:30 AM CST Discussed with Dr. and he recommended that patient go to ER for urgent evaluation/treatment with dyspnea and low O2 levels even with supplemental oxygen. Electronically signed by RN at 02/09/2021 9:32 AM CST Back to top of Miscellaneous Notes Telephone Encounter - 02/09/2021 9:16 AM CST Rehab called, they stated PT was having trouble breathing and her O2 was 80 with oxygen. They wanted to know if they should bring her in but PT is Covid positive. Staff recommended that she go to the ER. Electronically signed at 02/09/2021 9:17 AM CST 2/9 ER-> admission note: (6day admission) History The patient is a 65 y.o. female with a past medical history notable for History of anemia, anxiety, cirrhosis, COPD, CHF, diabetes, reflux, hypertension. The patient presents for evaluation of Worsening issues of cellulitis in addition to the patient's history of recent Covid 19 infection. Patient also tested positive for influenza. Patient was started on steroids at skilled care facility. Patient was already on breathing medications. Patient has had issues with CHF and lower extremity swelling. Patient was taking a diuretic for this. Due to patient's cerebral kidney function patient is not a candidate for certain medications or either influenza, Covid 19 and we are limited on antibiotics. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. 3/1/21 er to admission note: currently inpatient History The patient is a 65 y.o. female presents for evaluation of altered mental status. Notable PMHx: CHF, morbid obesity, diabetes, Patient is 3 weeks out from hospitalization for COVID-19 pneumonia. She has been more confused over the couple of days before admission. Because of altered mental status, patient was transferred to the emergency room. Patient also had some shortness of breath. In the ER, she had a chest x-ray which showed moderate interstitial infiltrate secondary to pulmonary edema or pneumonia. Lab work did show a UTI. BNP was normal at 45. Creatinine was near her baseline at 1.8. She did have elevated alkaline phosphatase at 452. White count was elevated at 14.7. Patient was difficult to arouse in the ER. On my exam, patient is difficult to arouse. After shaking her shoulder and yelling at her, she did open her eyes and say to me "I'm ok" before closing her eyes again. She is satting well on nasal canula oxygen.
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| 65 | 2021-03-01 | injection site redness, injection site swelling |
At site of injection: redness of skin about 2 inches in diameter lasting 4 days, swelling, soreness ...
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At site of injection: redness of skin about 2 inches in diameter lasting 4 days, swelling, soreness decreasing in severity over the days until 6 days after injection. Fever 99.5 degrees and fatigue for 24 hours after injection.
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| 65 | 2021-03-01 | hives |
Patient received the first dose of the Pfizer COVID-19 vaccine and subsequently developed hives on h...
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Patient received the first dose of the Pfizer COVID-19 vaccine and subsequently developed hives on her mouth, neck, and chest. Associated with mild chest discomfort and throat swelling, but not with shortness of breath. Patient was given epinephrine and Benadryl by medics and pharmacist on scene. Patient took Benadryl 25mg prior to vaccine. Patient was given Solu-medrol and Pepcid in ED. Normal EKG and no further allergic reaction noted.
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| 65 | 2021-03-01 | injection site pruritus, injection site redness |
Redness and itchy at injection site. Big red mark at site of injection. It is about 3 inches in di...
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Redness and itchy at injection site. Big red mark at site of injection. It is about 3 inches in diameter. It appeared 6 days after getting second Pfizer shot. Had no reaction to first shot.
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| 65 | 2021-03-01 | hives, itchy skin |
Woke up 48 hours after injection with itchy palms(hives) and both lips burning. Very anxious and agi...
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Woke up 48 hours after injection with itchy palms(hives) and both lips burning. Very anxious and agitated, light headed. History of anaphylactic results requiring medical intervention in the past. Drank a lot of water and took a Zyrtec then laid down and slept 2-3 hours. Exhausted for over a week.
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| 65 | 2021-03-01 | rash | developed rash 3 hours after receiving vaccine, consistent with erythema multiforme, persistent |
| 65 | 2021-03-02 | skin burning sensation |
About 2 hours after the vaccination, starting low on right side of neck, felt a mild burning sensati...
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About 2 hours after the vaccination, starting low on right side of neck, felt a mild burning sensation move up into my right side of face. Swelling on right side was noticeable for two days. Mild numbness also occurred that went away as swelling subsided. However on 3/3/21 I am noticing numbness in upper lip and jaw... also mild.
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| 65 | 2021-03-02 | shingles | Herpes Zoster developed on 2/26/21 |
| 65 | 2021-03-02 | injection site pain |
Pronounced pain at injection site started around 6pm, the day of the shot, 3/2/2021. After 8pm, sta...
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Pronounced pain at injection site started around 6pm, the day of the shot, 3/2/2021. After 8pm, started going downhill with chills and some sneezing. Managed to get to sleep, but woke up at 1:15 am and could not get back to sleep. Feeling chilled all night. At 5:30 am, got out of bed to take Tylenol and experienced dizziness (briefly blacked-out), sweats, nausea (vomited) and slight diarrhea. After that episode, started to feel a little better, though still a bit woozy and exhausted from lack of sleep.
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| 65 | 2021-03-02 | hives, redness, itchy skin |
Severe headache, joint pain, nausea, muscle pain, tiredness, chills with second shot. four days la...
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Severe headache, joint pain, nausea, muscle pain, tiredness, chills with second shot. four days later: itching, redness and welts on over both elbows, knees and ankles.
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| 65 | 2021-03-03 | itchy rash |
2days after second dose I broke out into a extremely itchy rash over most of my body; This is a spon...
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2days after second dose I broke out into a extremely itchy rash over most of my body; This is a spontaneous report from a contactable Consumer. This consumer reported for self that the 65-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand Pfizer), via an unspecified route of administration from 16Feb2021 14:00 on left arm at single dose for covid-19 immunization. Medical history included Chemo for breast cancer 6 years ago. Concomitant medication included metoprolol (METOPROLOL) ER100mg, vitamin d3 (VITAMIN D3), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and multi vitamin. The patient previously took first dose of bnt162b2 (COVID 19, brand Pfizer) on 26Jan2021 03:00 PM, on Left arm for covid-19 immunization. No reaction with first dose. The patient experienced "2days after second dose i broke out into a extremely itchy rash over most of my body" (medically significant) on 18Feb2021 20:00 with outcome of not recovered. The patient underwent lab tests and procedures which included white blood cell count: remains low on unknown date. Therapeutic measures were taken as a result of 2days after second dose i broke out into a extremely itchy rash over most of my body (rash). She is not pregnant. No other vaccine in four weeks. Treatment received. "Claritin helps a little but it is not subsiding. It's been four days since I had the shot". No covid prior vaccination. No covid tested post vaccination. None known allergies.
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| 65 | 2021-03-03 | rash |
5 days after my shot, I broke out with a rash (from my elbow down to my wrist) on the arm in which ...
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5 days after my shot, I broke out with a rash (from my elbow down to my wrist) on the arm in which I received the vaccine. I took some "Benadryl" yesterday and put a cream called "Betamethasone Dipropionate" on the rash area. It looks about the same today. The Benadryl makes me drowsy, so I didn't take it, but I put the cream on today. What do you recommend?
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| 65 | 2021-03-03 | redness |
First Reaction: Three minutes after receiving injection felt lightheaded and dizzy. Symptoms resolve...
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First Reaction: Three minutes after receiving injection felt lightheaded and dizzy. Symptoms resolved with food, water, and time Second Reaction: About 36 hours later while doing dishes, felt prickly on both sides of my neck. Both sides of my neck turned pink as though I had a sunburn. Broke out in profuse sweating. Called my doctor who was on call that night. He told me to get Benadryl right away and to keep taking it until symptoms subsided. If they did not subside or got worse I was to go to urgent care, or ER. Treatment: Benadryl every 4-6 hours for 2 days. As each dose wore off I waited to see if the symptoms came back and then took more Benadryl. Issue lasted until Saturday night - 2 days.
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| 65 | 2021-03-03 | injection site pain | Nauseous, pain at injection site, fatigued, feeling unwell. |
| 65 | 2021-03-03 | rash | Rash that extends from under left arm to side of left chest ; stopping before the breast |
| 65 | 2021-03-03 | hives, itchy skin, rash, itchy rash |
about 3 days after vaccine 1, hive like, extremely itchy burning rash on torso, around waist. For 3...
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about 3 days after vaccine 1, hive like, extremely itchy burning rash on torso, around waist. For 3 days, evenings strong, days lighter. Went away on its own.
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| 65 | 2021-03-03 | hives, rash with redness, rash |
general Urticaria, flat red rash to the neck, arms, trunk. started within 15 minutes and lasted a...
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general Urticaria, flat red rash to the neck, arms, trunk. started within 15 minutes and lasted about 30 minutes. treated with diphenhydramine 25mg oral, and started to slowly resolve after about 30 minutes.
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| 65 | 2021-03-03 | itchy skin | itchy all over, flushing. Evaluated by EMS-Cleared |
| 65 | 2021-03-04 | injection site pain, hives, itchy rash, rash with redness |
Approximately one hour after shot was given, client noticed large, red, non-tender welts on L arm, a...
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Approximately one hour after shot was given, client noticed large, red, non-tender welts on L arm, around her wrist. Later she developed bilateral lower extremity, red, itchy rash. Severe pain and tenderness noted in L arm where shot was given.
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| 65 | 2021-03-04 | itchy skin, redness |
Face and ears turn bright red. Total body flushing; "pens-and-needles" and then itching. Throat cons...
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Face and ears turn bright red. Total body flushing; "pens-and-needles" and then itching. Throat constricted but didn't have a problem with breathing. 8 days later still have "pens-and-needles" in face chest and arms some numbness in my face.
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| 65 | 2021-03-04 | injection site pain | Feeling generally well, malaise, tired Injection site sore |
| 65 | 2021-03-04 | injection site rash, rash, injection site pain |
On 2/21/2021, I had minor muscle pain following the injection at the injection site. On 2/23/2021, ...
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On 2/21/2021, I had minor muscle pain following the injection at the injection site. On 2/23/2021, I developed a warm rash that somewhat resembled pityriasis rosea (I had that illness October 2017 - June 2018) which covered the skin of the muscle of the injection site. Both the rash and the muscle pain were completely gone by 2/26/2021. I did not have this reaction with the first injection.
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| 65 | 2021-03-04 | itchy skin, rash |
about 24 hours later, I started feeling chill, tire and rash on my stomach, feel itchy on my back bu...
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about 24 hours later, I started feeling chill, tire and rash on my stomach, feel itchy on my back but very small area. Rash got spread out little by little as day go by, and the chill and tirdness are the same. Rash spread my whole from but not the breast area and the part of the back , my inner upper arm and inner thigh but not a big area. I went to see doctor on the 5 of March and doctor give me Hydroxyzine to take.
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| 65 | 2021-03-04 | vaccination site itchiness |
started feeling quite itchy at and around the area of the injection site in the upper left arm/It is...
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started feeling quite itchy at and around the area of the injection site in the upper left arm/It is a distinct tingly itchy sensation; . It has been pretty much continuous since yesterday and continues today. It is a distinct tingly itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 65-year old female non-pregnant patient received first dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: unknown) via unspecified route of administration, on left arm at 11:45, on 23Jan2021, at single dose for COVID-19 immunisation. The patient medical history included heart attack, high blood pressure, high cholesterol. The concomitant medication included carvedilol, rosuvastatin, glycine, glucosamine, colecalciferol (D3) and msm. The patient previously took tylenol and experienced allergies. It was reported that about a week after the injection on 30Jan2021, I started feeling quite itchy at and around the area of the injection site in the upper left arm (as reported). It has been pretty much continuous since yesterday and continues today (as reported). It is a distinct tingly itchy sensation. It was reported that patient didn't see anything unusual in this around the area of the injection site. The patient used cortisone which helped slightly. The patient was not sure if it was safe to take second dose. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she was not overweight at all. The outcome of the events was recovering Information on the lot/batch number has been requested
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| 65 | 2021-03-05 | injection site pruritus, injection site rash, injection site reaction |
1) 25 minutes from injection: fluttering heartbeat, hot flush spreading from arm throughout body, we...
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1) 25 minutes from injection: fluttering heartbeat, hot flush spreading from arm throughout body, weakness in arm and then all over, shaking, dry mouth and tongue. The worst of it lasted about 5 minutes but weakness and shaking continued for about an hour. 2) Over the course of several hours developed sore arm and headache which worsened over the next 12 hours but was not terribly bad. 3) Days 3-6 had stiffness which began at injection site and went up left shoulder into the left side of neck. Resolved by day 7. 4) ON DAY EIGHT I developed a rash and itching at the injection site. Also had a dry cough and sinus drainage but cannot be certain this was from the vaccination but the rash and itching definitely was. The rash resolved by day 12. It was not terribly bad and no drugs were needed to calm the itch.
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| 65 | 2021-03-05 | injection site swelling, injection site pruritus, injection site pain, injection site mass, injection site redness |
Injection site was very sore and raised for 2 days. Then that subsided. Two days after that, the sit...
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Injection site was very sore and raised for 2 days. Then that subsided. Two days after that, the site started to itch, got lumpy again, and was very red - 2 inches in diameter. This lasted for a week. Everything finally subsided 13 days after the injection.
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| 65 | 2021-03-05 | injection site pain |
Vaccine was administered extremely high on arm, actually on shoulder. Much higher than it should be ...
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Vaccine was administered extremely high on arm, actually on shoulder. Much higher than it should be given. I have photo to show where it was given. Extreme pain in injection site. Pain level at 10. Unable to move arm without assistance and great increase in pain.
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| 65 | 2021-03-05 | injection site pain |
patient is stating aside from arm pain their whole left side is in pain and feels like they are bein...
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patient is stating aside from arm pain their whole left side is in pain and feels like they are being stabbed by a nail, total vaccination side pain, arm, legs, buttocks
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| 65 | 2021-03-06 | injection site pain | Pain in arm at injection site. Painful to touch and to movement of the arm. |
| 65 | 2021-03-06 | itchy skin, rash |
Pt felt mild itchiness on both cheeks on her face. Pt came into the medical room. Pt?a vs were taken...
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Pt felt mild itchiness on both cheeks on her face. Pt came into the medical room. Pt?a vs were taken and normal. Pt itching went to her arms and back. Small rash was noticed on her back and shoulders and chest. Pt was given 50 mg of oral benadryl. Pt has he of allergies to many substances. Pt denies sob pt rested for 25 mins on stretcher and her car were monitored and normal. Pt felt better and rash was gone. Pt was released back to observation area and pt checked out.
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| 65 | 2021-03-06 | rash, hives, itchy rash, rash with redness, rash papular |
Red raised rash from jaw line down chest - lasting 24 plus hours. Still a bit itchy after 3 days. ...
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Red raised rash from jaw line down chest - lasting 24 plus hours. Still a bit itchy after 3 days. Looked like hives.
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| 65 | 2021-03-07 | itchy rash |
Flat rash on belly, lasted a few hours Raised rash on upper back, itchy, lasted 3-4 days. Treated to...
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Flat rash on belly, lasted a few hours Raised rash on upper back, itchy, lasted 3-4 days. Treated topically with hydrocortisone
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| 65 | 2021-03-07 | injection site pain | Headache, chills, nausea, fatigue, soreness at injection site |
| 65 | 2021-03-07 | redness |
Patient got a pimple the day after vaccine. Redness in both cheeks a few days after first dose of th...
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Patient got a pimple the day after vaccine. Redness in both cheeks a few days after first dose of the vaccine. No swelling of tongue or face. No shortness of breath. On occasion without known precipitant, she has had swelling of the uvula. One time with ammonia exposure had swelling of her uvula. She has epi pen and Benadryl and is very competent. This is her second vaccine and no anaphylaxis after the first. No swelling of uvula. Will continue with vaccination and observe for 30 minutes.
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| 65 | 2021-03-08 | rash, itchy rash |
Fever of 3 degrees, muscle aches and pains, chills, some loss of hearing, brain processing slowness,...
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Fever of 3 degrees, muscle aches and pains, chills, some loss of hearing, brain processing slowness, headache, loss of appetite, dizziness.rash and itchiness of arm.
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| 65 | 2021-03-08 | pain of skin |
Headache by 1am 3/4/21, by noon body aches, chills, skin tenderness to touch, by 4pm fever 100.5 and...
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Headache by 1am 3/4/21, by noon body aches, chills, skin tenderness to touch, by 4pm fever 100.5 and felt very bad. Was taking Tylenol every 4-6 hours but headache continued to get worse throughout the evening and into the night 3/4-3/5/21. Left arm began hurting too on 3/4/21 but no swelling or redness, just sore. Finally began feeling a little better by late evening on 3/5/21 and headache was beginning to ease but did not fully go away until 3/6/21. Was able to manage the side effects at home without going to my Dr.
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| 65 | 2021-03-08 | redness | Headache, dizziness and red knot under right knee |
| 65 | 2021-03-08 | hives |
Mouth Ulcers lasting 5 days so far, hives from chin to waist 6 days so far, swollen right eye one da...
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Mouth Ulcers lasting 5 days so far, hives from chin to waist 6 days so far, swollen right eye one day
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| 65 | 2021-03-08 | itchy skin, hives |
Starting Saturday 3/6 I have had hives and itching everyday. I have never had a hives in my life unt...
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Starting Saturday 3/6 I have had hives and itching everyday. I have never had a hives in my life until this. I have been taking Benedryl which helps a little but gave not gotten complete relief , now going on 5 days.
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| 65 | 2021-03-08 | injection site pain |
approximately 1 1/2 hours after vaccination, I developed transient nausea, followed by a strange sen...
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approximately 1 1/2 hours after vaccination, I developed transient nausea, followed by a strange sensation in my head, fullness in the ears, ringing associated with nausea, the following day it was worse, upon waking and walking my legs felt rubbery which spontaneously resolved after briefly walking, the nausea, supratentorial symptoms, fullness in the ears persisted, no vomiting, today is the 4th day post injection without improvement. Injection site pain lasted 2 days-not bothersome. Consider my symptoms moderate and interfering with daily activities.
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| 65 | 2021-03-09 | vaccination site pain |
Extreme pain at the injection site; This is a spontaneous report from a contactable consumer (patien...
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Extreme pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 14:00 at single dose for COVID-19 immunization. Medical history included atrial fibrillation. Concomitant medication included apixaban (ELIQUIS). The patient previously took iodine and experienced allergies to Iodine. The patient experienced extreme pain at the injection site on 05Feb2021 14:00. No Treatment received for the event. The patient was not pregnant. The patient had no COVID prior vaccination. She had no COVID tested post vaccination. There was no other vaccine received in four weeks. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
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| 65 | 2021-03-09 | rash, itchy rash, itchy skin |
Patient reports itchy rash with eruptions on trunk and arms. Has been taking benadryl which helps bu...
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Patient reports itchy rash with eruptions on trunk and arms. Has been taking benadryl which helps but when that wears off it flares up again. She also applys OTC hydrocortisone.
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| 65 | 2021-03-10 | redness |
12:25 pm Pt called and reported red face. Emt was notified, symtoms resolved after 10 minutes. Pt wa...
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12:25 pm Pt called and reported red face. Emt was notified, symtoms resolved after 10 minutes. Pt was released. RN
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| 65 | 2021-03-10 | itchy skin |
Member c/o generalized itching 30 min post Pfizer vaccine. Member with hx of allergic reaction to ab...
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Member c/o generalized itching 30 min post Pfizer vaccine. Member with hx of allergic reaction to abx. Reports typical reaction is hives and/or itching. Denies difficulty breathing, no hives present. 25 mg PO Benadryl given per Dr. Pt instructed to remain in observation for additional 30 minutes. Pt declined further observation. Per Dr, pt educated to monitor reaction, if progresses to hives will need allergy eval prior to receiving 2nd dose. Pt discharged with companion. Dr to f/u with phone appt for eval.
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| 65 | 2021-03-10 | itchy skin |
My symptoms were I was dizzy; my mouth and tongue swollen and burning; my scalp very itchy the same...
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My symptoms were I was dizzy; my mouth and tongue swollen and burning; my scalp very itchy the same day as vaccine. Called my primary care Doctor. She advised that I take my second vaccine and get observered for one hour.
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| 65 | 2021-03-10 | dry skin, itchy skin, skin spots |
Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fat...
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Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fatigue extreme/felt tired; Myalgia; Pain; This is a spontaneous report from a contactable Nurse. A 65-year-old female patient received first dose of BNT162B2 (BNT162B2; Lot number EL0140 for both doses, expiry date not reported) via an unspecified route of administration to right deltoid on 23Dec2020 at 15:00 single dose, and second dose via an unspecified route of administration to right deltoid on 13Jan2021 15:15 at single dose for covid-19 immunization, hepatitis a vaccine (HEPATITIS A) intramuscular on 29Dec2020 at single dose for immunization and varicella zoster vaccine rge (cho) (SHINGRIX) intramuscular from 29Dec2020 at single dose for immunization. Medical history included osteoporosis from 2011, osteoarthritis from an unknown date, Knee replacement (Reported due to the osteoarthritis, she had her one knee replaced in 2004 and her other knee replaced in 2011), Spinal compression fracture in 2011 (Reported she fell at work and had a spinal compression fracture in 2011. She said the spinal compression fracture was repaired by a vertebroplasty in 2011) and Hypothyroidism (she has had hypothyroidism for a long time, since either 1998 or 2000). The patient's concomitant medications were not reported. The patient experienced rhabdomyolysis on 06Feb2021, fatigue extreme/felt tired on 30Dec2020, myalgia on 30Dec2020, pain on 30Dec2020, petechia on 06Feb2021, muscle cramps/muscle spasms on 17Feb2021, dry skin on Feb2021, itching on Feb2021 and her cpk was over 2400 on an unspecified date. The patient was hospitalized for rhabdomyolysis from 06Feb2021 to 09Feb2021 and reported to have caused disability. All the other events were reported as medically significant. She said she wanted to report to Pfizer that she was admitted to the hospital on 06Feb2020. She said she was in rhabdomyolysis, and the rhabdomyolysis was really bad. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she was given a lot of fluids while she was in the hospital. She said her CPK was over 2400 when she was admitted to the hospital on 06Feb2021. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she has a petechia rash, cramps, muscle spasms, dry skin and itching now. Reported she literally saved herself from dialysis by going to the hospital. She said she kept putting off her symptoms, and took Tylenol and Naproxen for the whole month of Jan2021. She said her symptoms started brewing up from day 1, clarifying that her symptoms were not really bad until 30Dec2020 and 31Dec2020. She clarified on 30Dec2020 she took Naproxen, Ibuprofen, and Tylenol for her symptoms, and nothing helped her. She said she knew her symptoms were not normal for her, and she went for the whole month of Jan2021 with her symptoms. She said finally there came a time when she said "oh no, this is not normal at all", and she told herself she needed to check in at the hospital. She said she took Naproxen and Tylenol, and felt a little better, and drove herself to the hospital. Reported she kept walking and taking medicines, and while at work she diverted her mind from her symptoms, but when she came home she felt tired, and would tell herself she couldn't do it anymore. She said she doesn't know if what she experienced was from the COVID-19 Vaccine, but that definitely she had a reaction to either the Hepatitis A booster, the Shingrix Vaccine, or the Pfizer COVID-19 Vaccine. Reported she received 11 bags of Normal Saline (1000ml per bag) while she was in the hospital. She said fluid resuscitation was the only way to bring her CPK levels down and to treat the rhabdomyolysis. Reported her symptoms have improved. She said her last CPK was 134 on Wednesday, 17Feb2021. Reported she had cramps and severe muscle spams in her right leg on 17Feb2021, and then had cramps and muscle spasms in her left leg the following day. She said the cramps and muscle spams have not gone away completely. Reported she has a small petechia rash on her lower legs. She said at the moment the petechia rash shows up on her leg, she knows she is going to have a muscle spasm in that area. She said last night she had 2 petechia rashes show up on the lateral side of her right ankle. She said the petechia rash started to burn, and her right leg calf muscle became heavy. She said she could tell her right leg calf muscle was going to start to spasm, so she took some coconut oil and applied the coconut oil to her right leg calf muscle and massaged her right calf muscle. She said she had 2 areas of petechia last night (23Feb2021). She said the first time the petechia was noticed was when she went to the Emergency Room on 06Feb2021. She said the petechia has been persisting since that time. She said prior to being admitted to the hospital she never had dry skin or itching, but now she has dry skin and itching. She said she was using coconut oil to keep her skin moist. She stated she had 2 telehealth calls (11Feb2021 & 18Feb2021) because of a petechia rash and muscle cramps and was asking her doctor is she may need to go back to the hospital. The patient underwent lab tests and procedures which included blood work, CBC and Thyroid level on 06Jan2021 with unknown results (she had regular blood work done for her yearly checkup on 06Jan2021 (BMP, CBC, and Thyroid level). Also included CPK on 06Feb2021 greater than 2400, CPK on 09Feb2021 566 and CPK on 17Feb2021 134 (units were unspecified), She said her last CPK was 134 on Wednesday, 17Feb2021. Therapeutic measures were taken as a result of rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain, muscle cramps/muscle spasms, her CPK was over 2400. Outcome of the event rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain and her cpk was over 2400 was recovering. Outcome of petechia, muscle cramps/muscle spasms, dry skin and itching was not recovered.; Sender's Comments: Based on the information currently available, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The Hepatitis A booster and the Shingrix Vaccine may have also played a contributory role. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-03-10 | skin mass | lump appeared on back of neck, cough, post nasal drip |
| 65 | 2021-03-11 | itchy skin |
Started itching all over body with no rash. Went on for 10 days. Didn't think much about it at first...
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Started itching all over body with no rash. Went on for 10 days. Didn't think much about it at first until I talked to another Pfizer person and they had the same thing happened about 5 weeks after second shot like I did. Don't know if it was the shot but never had that happened before. It burned and itched but couldn't see a rash.
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| 65 | 2021-03-12 | rash | Arm rash |
| 65 | 2021-03-12 | itchy skin |
Patient developed itching of arms, scalp 15 minutes after vaccine; no shortness of breath; VSS. This...
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Patient developed itching of arms, scalp 15 minutes after vaccine; no shortness of breath; VSS. This is a frequent reaction after antibiotics and takes benadryl with resolution. Gave 25 mg benadryl po; monitored in ED for an hour; symptoms improved/near resolution. Reminded to not receive second dose per Pfizer recommendation; to discuss with provider.
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| 65 | 2021-03-13 | rash, redness, itchy skin, rash macular, rash papular |
Developed macular papular rash on upper left trapezius about 1 in in diameter with small clear fl...
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Developed macular papular rash on upper left trapezius about 1 in in diameter with small clear fluid papules and another spot over the left scapula with clear fluid papules over left scapula about 1 in in diameter including area of erythema around lesions at 72 hours post second shot. At 96 hours 4 spots of rash on upper middle chest and left lateral upper chest. Clear fluid oozes from papules and lesions scab over. Severe itching. Also tenderness and tightness over left trapezius.
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| 65 | 2021-03-13 | skin warm, rash |
Slight headache right after. I took Tylenol. After 12 hrs, rash on chest, stomach and legs. I too...
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Slight headache right after. I took Tylenol. After 12 hrs, rash on chest, stomach and legs. I took Benadryl. 2nd Day, Next morning: headaches. Tylenol. Foggy and not clear headed. L arm hot and hurts, Hip, knee and ankle on L side painful. Very tired. Rash is gone. Mid day: anxiety and feeling down. Called Dr. and got nurse and then called therapist. headache still continues. I took a nap, I never take naps unless very sick. Eve: Rash came back. Benedryl Headache. Tylenol 3rd day: Diarrhea. headache, still foggy and tired.
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| 65 | 2021-03-13 | rash, hives |
The minute I stood up after vaccine, I was very dizzy and my heart started pounding. Then I got naus...
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The minute I stood up after vaccine, I was very dizzy and my heart started pounding. Then I got nausea. Was sent to Urgent Care office where I got EKG, which showed no problems with my heart. Went home, weak. Woke at 2:00 am with night sweats. When I got up I noticed swelling on face, throat, hands & feet. Faint pink rash ran up both fore arms and I had welts rising on my wrists. Nurse line I called said to to to ER asap, Took me a few hours to find a ride, my throat was closing up more by that point. I could tell over a few hours that my throat was swelling up. Went to nearest ER where I was very mentally confused. They gave me a shot of steroids and Benedryl. Later that night I got chills and was VERY weak. Had night sweats again. After a few days of rest, am still weak.
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| 65 | 2021-03-13 | injection site pain |
Very severe headache, pain at injection site, chills, sweating, cough, malaise, R hip pain (osteopen...
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Very severe headache, pain at injection site, chills, sweating, cough, malaise, R hip pain (osteopenia), fatigue
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| 65 | 2021-03-14 | injection site bruising, injection site mass |
1830 Caller states on march 1 got 2nd shot. had a little lump under the skin that went away. today...
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1830 Caller states on march 1 got 2nd shot. had a little lump under the skin that went away. today at around 1800 was taking a shower rubbed area where shot was given left deltoid . Lump was back , looked in mirror and area is bruised today . No other symptoms. advised any other symptoms or if bruising increases or occurs on other parts of the body seed medical attention without delay.
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| 65 | 2021-03-14 | injection site bleeding |
After her first dose, patient reported today that she still has a scab after her first COVID injecti...
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After her first dose, patient reported today that she still has a scab after her first COVID injection that she received on 2/21/21. Her injection site scabbed and has not fully healed. She did state that she has scratched it multiple times and noticed it was bleeding so this could be perpetuating the issue. She has not felt any itching, warmth, or pain at the site. She has tried applying antibiotic ointment and has been covering the scab to prevent further skin deterioration. The injection site area has not grown in redness and did not appear to be infected. Patient stated that she tends to take longer to heal and just wanted to let us know.
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| 65 | 2021-03-14 | injection site warmth, injection site redness |
Client vaccinated 3/1/2021, approximately 3 days after vaccine client with c/o redness and skin warm...
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Client vaccinated 3/1/2021, approximately 3 days after vaccine client with c/o redness and skin warm to touch at injection site. Redness increasing in size and still present 3/15/2021. Client has MD appt today to r/o cellulitis. Client had no other symptoms after receiving first dose of Covid 19 Pfizer vaccine.
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| 65 | 2021-03-15 | vaccination site pain |
COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent los...
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COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent loss of smell; loss of taster intermittent loss of smell; coughing; congestion; sore throat; headache; Exposure to SARS-CoV-2; Nausea; injection site pain; lightheadedness; Stomach pain; extreme exhaustion; This is a spontaneous report received by Pfizer from Agency, (Mfr. Control No: 2020US004529) through a contactable physician. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 29Dec2020 (at the age of 65-year-old) as a single dose for Covid-19 immunisation and also started to receive abaloparatide (TYMLOS, Formulation: injection, Lot number: RT01102, Expiration date: Dec2022) via subcutaneous from 20Dec2020 to an unknown date, at 80 ug, once a day for osteoporosis. The patient medical history, included autoimmune disease-Behcet's disease causing ulcers, osteoporosis and constipation, and all were ongoing. The patient concomitant medication was not reported. On 29Dec2020, the patient experienced injection site pain, fatigue, nausea, Stomach pain and Light headness and the patient believed these symptoms were due to the vaccine. On 04Jan2021, the patient was Exposure to SARS-CoV-2. It was also reported that on 16Jan2021, the patient experienced coughing, fatigue, lost taste/smell, congestion, sore throat, headache, respiratory symptoms, general achiness and also had COVID-19 on an unknown date. It was reported that general achiness and respiratory symptoms possibly related to Covid-19 which resulted in emergency room visit on 16Jan2021. The cough was treated with benzonatate pearls. The following relevant laboratory tests were performed: Rapid COVID-19 (12Jan2021), negative, COVID 19 PCR test (15Jan2021), negative, and chest x-ray (16Jan2021), clear, negative. The action taken in response to the events for abaloparatide was unknown. The outcome of the events COVID-19, light headedness, stomach pain, exposure to sars-cov-2 was unknown, for the events nausea, general achiness, respiratory symptoms, loss of taster intermittent loss of smell, coughing, congestion, sore throat, fatigue, headache was not recovered and for the events injection site pain, extreme exhaustion was recovered on 31Dec2020. Information on batch/lot number was requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020, and contracted COVID on an unspecified date. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.
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| 65 | 2021-03-15 | itchy skin |
I am wondering different parts and areas of my body itching/itchiness; This is a spontaneous report ...
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I am wondering different parts and areas of my body itching/itchiness; This is a spontaneous report from a contactable consumer (Patient). A 65-years-old female patient received first dose of (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1283, NDC number; UPC number; Expiry Date: unknown) via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Covid-19 vaccine was a Pfizer product. Covid-19 vaccine manufacturer was unspecified. The patient's medical history included high blood pressure. Concomitant medication included valsartan for High blood pressure. The patient stated "I had my first vaccine, Pfizer Covid vaccine on the 19th of Jan (19Jan2021) and on the 12th day (12 days after) on Monday (01Feb2021) she began to feel itchiness, she wondering different parts and areas of her body were itching." She stated, "I have no idea if it's related, I haven't used any other detergents or anything that would have caused and so I thought it may be related to the vaccine." No investigation assessment. The second dose was due on 16Feb2021. No laboratory test was reported, she would go next week. No treatment was received for the events. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.
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| 65 | 2021-03-15 | injection site pain |
Left arm swelled, pain at injection sight all the way down outside of arm stopping at wrist, then t...
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Left arm swelled, pain at injection sight all the way down outside of arm stopping at wrist, then traveling up inside of arm to arm pit. pain subsided but arm is still swollen as of today 03/16/2021.
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| 65 | 2021-03-15 | injection site pain |
Patient reported the vaccine was injected more superior than typically just lateral to the left acro...
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Patient reported the vaccine was injected more superior than typically just lateral to the left acromion. 1 day afterwards she developed L shoulder pain with range of motion. She was seen 2 weeks later and has findings of rotator cuff syndrome. She is overall improving with conservative management
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| 65 | 2021-03-15 | injection site pain |
Prior to vaccine took 2 acetominophen. Upon injection had sensation of an angry bee sting that subs...
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Prior to vaccine took 2 acetominophen. Upon injection had sensation of an angry bee sting that subsided in a few minutes. Left shoulder, neck & arm very sore, iced injection site within 1 hour of receiving. Early evening, didn't feel well-- upset stomach, loss of appetite, head ache, lethargic. Ended up sleeping abnormal amount over next 3 days with aches in joints, specifically in hands & knees.
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| 65 | 2021-03-15 | injection site pain |
Time of injection felt a stinging sensation, lasted a few minutes. Within hour, iced arm as was qui...
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Time of injection felt a stinging sensation, lasted a few minutes. Within hour, iced arm as was quite sore. Woken during night with chills, sweats and feeling of numbness from shoulder down to elbow and unable to raise arm. Took 2 acetominophen and iced arm, able to fall back to sleep. Very sore and difficulty in raising arm for 2 days.
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| 65 | 2021-03-16 | rash with redness, itchy rash |
About an hour after receiving the vaccine patient experienced "tightness" in throat, no swelling pre...
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About an hour after receiving the vaccine patient experienced "tightness" in throat, no swelling present. Two hours after receiving vaccine patient experienced a "prickly sensation" and broke out in red bumps on back, arms, wrists, stomach, legs, and behind knees. Bumps were red in color at itchy. Patient took a dose of diphenhydramine and that helped throat tightness, but did not relieve rash. Patient bathed in Dawn Dish soap, which helped to calm the itch temporarily. Rash has not completely gone away, as of 3/17/21 patient still suffers from itchy bumps on legs.
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| 65 | 2021-03-16 | rash, itchy skin | Facial rash and itching |
| 65 | 2021-03-16 | injection site pain |
Severe vomiting within 45 minutes of receiving vaccine. I had 4 distinct vomiting episodes, vomitin...
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Severe vomiting within 45 minutes of receiving vaccine. I had 4 distinct vomiting episodes, vomiting 3 or 4 times during each episode. I took a single dose of Zofran at about 2 pm and had last vomiting episode around 4 pm. Vomiting episodes lasted a total of about 6 hours. I had chills for about an hour right after 1st vomiting episode. I had significant left arm pain that prevented use of arm for 2 days. I also had extreme weakness the 1st day, I couldn?t get out of bed except to vomit. I got the vaccine on Wednesday and didn?t feel fully recovered until Sunday.
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| 65 | 2021-03-17 | vaccination site pain, vaccination site swelling, vaccination site redness |
Fever 100.7; chills; headache; nausea; injection site pain redness & swelling; injection site pain r...
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Fever 100.7; chills; headache; nausea; injection site pain redness & swelling; injection site pain redness & swelling; injection site pain redness & swelling; exhaustion; This is a spontaneous report from a contactable 65 reporting for herself. A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6201/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 11:00 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Hashimoto's hypothyroidism. The patient has allergies to halibut and sea kelp. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via an unspecified route of administration, on 22Jan2021 at 03:30 PM (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID), rosuvistatin, acetylsalicylic acid (ASPIRIN), probiotic, and vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 at 23:00, the patient experienced fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion. The events did not require hospitalization. The outcome of the events fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 65 | 2021-03-17 | redness |
Patient reports shortly after receiving her first Pfizer COVID-19 vaccine on 2/23/21, she developed ...
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Patient reports shortly after receiving her first Pfizer COVID-19 vaccine on 2/23/21, she developed flushing of the face followed by erythema of the body, warmth and tingling. This was accompanied by numbness, a change in her vision and mental alertness. Patient reports similar symptoms occurred in the past when she experienced anaphylactic reactions, such as with bee stings.
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| 65 | 2021-03-17 | rash, injection site bruising, bruising |
Small rash on abdomen day of and resolved in a few days. Bruising at injection site started the even...
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Small rash on abdomen day of and resolved in a few days. Bruising at injection site started the evening of vaccination and progressively spread down the same arm to antecubital, small bruises on arms, and large one on left leg.
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| 65 | 2021-03-17 | injection site pain, injection site bruising |
The morning after the shot I began to feel achy in joints, headache, upset stomach and slight nause...
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The morning after the shot I began to feel achy in joints, headache, upset stomach and slight nausea, my arm hurt at the site, Temp 98.9 temporal. I took Ibuprofen, worked and 6 hours later felt the same so repeated Ibuprofen and then it was over with. No further untoward problems. The injection site still hurt 2 days and was bruised 3 days.
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| 65 | 2021-03-18 | hives |
Fatigue; severe headache but lasting only moments, hives chest area came to top of skin like poison ...
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Fatigue; severe headache but lasting only moments, hives chest area came to top of skin like poison ivy and broke open. Was starting to go away until second dose. Came back and took double dose Benadryl
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| 65 | 2021-03-18 | injection site pain | Injection site soreness Extremely tired Headache Low grade fever Muscle and joint pain |
| 65 | 2021-03-18 | rash |
Mild soreness below injection site the day of injection. Fever started day after injection lasting 5...
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Mild soreness below injection site the day of injection. Fever started day after injection lasting 5 days, above 100 everyday, 101 to 102.2 on the 4th and 5th days, then back to normal (97.8). Chills and shaking on 3rd and 4th days. Mild nausea and dizziness. Stayed in bed 2nd to 4th day with fatigue. Coughing mostly when temperature was high. Still some coughing now after 10 days. Severe allergic reaction with rash starting at groin area the day after injection, moving up sides to underarms the 3rd day, then hands and feet the 4th day. Dermatologist recommended not getting 2nd shot.
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| 65 | 2021-03-18 | redness |
Pt. states that she received the 1st pfizer covid vaccine to left arm at 0930 on 3/19/21. Pt. states...
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Pt. states that she received the 1st pfizer covid vaccine to left arm at 0930 on 3/19/21. Pt. states that she started to have heart palpitations around 15 minutes after receiving the covid vaccine. Patient noticed arm redness to bilateral arms. Pt. states that heart palpitations have resolved. Pt. denies shortness of breath, denies chest pain, denies difficulty breathing.
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| 65 | 2021-03-18 | rash, itchy skin |
Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face a...
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Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; This is a spontaneous report from a contactable Nurse. This 65-year-old female Nurse (patient) reported that she started to receive bnt162b2 (BNT162B2, Solution for injection, Lot# EL9265), via an unspecified route of administration from 29Jan2021 10:30 to 29Jan2021 10:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergy to venom from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), calcium (CALCIUM), lisinopril (LISINOPRIL), omeprazole (PRILOSEC [OMEPRAZOLE]). On 29Jan2021 10:45 the patient experienced rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck (pruritus), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck, rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (swelling face), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (muscle tightness). The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as recovering. Therapeutic measures were taken as a result of rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (pruritus), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (swelling face), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (muscle tightness).
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| 65 | 2021-03-18 | redness, skin peeling |
a large sore under her bottom lip on left side; a large cystic thing that is now a large sore under ...
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a large sore under her bottom lip on left side; a large cystic thing that is now a large sore under her bottom lip; a large sore under my bottom lip on left side/it's really on my chin/kin around it is red and my entire chin is peeling; her skin around it was red and her entire chin was peeling; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN3518), via an unspecified route of administration in Arm Left on 30Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included meniere's disease, interstitial cystitis, psoriasis. Concomitant medication included amitriptyline (AMITRIPTYLINE), clonazepam (CLONAZEPAM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Known allergies: cefaclor (CECLOR), gadolinium, lactose intolerant, lansoprazole (PREVACID). On 03Feb2021, the patient had a large cystic thing that is now a large sore under her bottom lip on left side. She would say it was really on her chin. As well, her skin around it was red and her entire chin was peeling and had been for several days. She'd never had anything like this before. No treatment was received for the events. The outcome of the events was not recovered.
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| 65 | 2021-03-18 | vaccination site pain |
uncomfortably hot ankles and feet; Low grade fever; soreness at injection site; tiredness; headache;...
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uncomfortably hot ankles and feet; Low grade fever; soreness at injection site; tiredness; headache; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL9266), via an unspecified route of administration in the right arm on 19Feb2021 at 12:00 PM (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included atenolol (ATENOLOL), pravastatin (PRAVASTATIN), eicosapentaenoic acid ethyl ester (VASCEPA) and multivitamin, all were taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 (lot number: EL9264), via an unspecified route of administration in the left arm on 29Jan2021 at 01:15 PM (at the age of 65-years-old) for COVID-19 immunisation, prochlorperazine maleate (COMPAZINE) and experienced Compazine allergy and codeine and experienced codeine allergy. The patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced low grade fever, soreness at injection site, tiredness, headache, muscle and joint pain, including uncomfortably hot ankles and feet on 19Feb2021 at 11:00 PM. The patient did not receive treatment for the events. The outcome of events, low grade fever, soreness at injection site, tiredness, headache, muscle and joint pain, including uncomfortably hot ankles and feet was recovering.
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| 65 | 2021-03-19 | injection site bruising, injection site pain |
Pfizer-BioNtech COVID-19 Vaccine EUA: 3/16 Left arm was sore at injection site, ached when I moved m...
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Pfizer-BioNtech COVID-19 Vaccine EUA: 3/16 Left arm was sore at injection site, ached when I moved my arm, No Treatment. But, not as sore as it was after 1st injection. 3/17 Day after injection, very tired all day. Went to bed at 7:30pm. Arm soreness waning. No Treatment. 3/18 Noticed slight dizziness, sometimes. Not as tired. Arm pain almost gone, just a bruised feeling at injection site. No Treatment. 3/20 Dizziness more noticeable, today. My head feels like it's full of cotton. No Treatment.
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| 65 | 2021-03-19 | itchy skin, rash with redness |
Vaccine injection (right arm) 1015 am 3/17/21. Felt sore arm (right) , dull headache and slight chi...
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Vaccine injection (right arm) 1015 am 3/17/21. Felt sore arm (right) , dull headache and slight chills and enlarged lymph on right side neck below ear ~7pm. Following day 10/18 had dull headache and sore arm but minor significance. Friday 10/19, slight sore arm, no headache. Around 7pm felt sore right nipple. Upon examination it appears to be a small 2mm cyst-like bump -- white, round, mildly painful, a bit itchy. Inside of right breast felt itchy and became rash like red when rubbed/scratched to relieve irritation. Saturday 10/20 Noon, right nipple still sore and a bit itchy, bump still there, rash from rubbing night before has subsided some but still there. No recurrence of headache, pain in arm at injection site or sore lymph node on right neck. Have not consulted with a medical professional but will do so if condition persists on Monday.
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| 65 | 2021-03-20 | injection site pain |
About 12 hours after my 2nd dose of Pfizer vaccine I had extreme chills, fever of 102 degrees, vomit...
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About 12 hours after my 2nd dose of Pfizer vaccine I had extreme chills, fever of 102 degrees, vomiting, and severe headache. Most lasted about 36 hours and all gradually went away. Severe headache was the last symptom to go away but receded about 6 hours after other symptoms . About a week after 2nd dose my injection site became very sore for 3 days. Had not been very sore prior.
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| 65 | 2021-03-20 | rash, rash with redness |
Day 3 post vaccine (3/10/21)began with tingling of lower lip and full sensation, red rash neck, uppe...
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Day 3 post vaccine (3/10/21)began with tingling of lower lip and full sensation, red rash neck, upper chest,back and thighs. Seen by PCP and communicated with my rheumatologist . By next day upper lip felt tingly and full Dri increased my daily medrol to 8 mg .as throat felt tight . Noted next day mucoid eruptions on upper lips ,palate. Enlarged bilateral axillary lymph nodes. Rash dissipated by 3/14/21. Still have tight right throat feeling. Still on 6 mg medrol. Still have left shoulder and clavicular discomfort, intermittent tingling both hands and right leg, muscular weakness and fatigue.
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| 65 | 2021-03-20 | injection site pain |
March11,12,13 injection site pain /March14 -21 tiredness,severe headache,muscle pain chills, joint p...
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March11,12,13 injection site pain /March14 -21 tiredness,severe headache,muscle pain chills, joint pain, fever,nausea, feeling unwell
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| 65 | 2021-03-20 | skin warm, injection site pain |
Site pain. - Tiredness. - Left sided posterior neck pain with headache that was also left sided. T...
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Site pain. - Tiredness. - Left sided posterior neck pain with headache that was also left sided. Through the night then experienced the following: Muscle and joint pain, in shoulders and collar bone, elbows, hands and fingers. Hips, legs, and extreme hot feeling in knees with an extreme throbbing pain that lasted briefly. Then same hot throbbing pain in soles of feet, briefly. This followed by sharp stabbing pain in right heel, that also was a brief passing sensation. The following day, used Tylenol for headache. Felt extremely cold, especially hands. Continued with knee and ankle soreness. By mid day on 3/21. Felt more normal.
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| 65 | 2021-03-20 | itchy skin, blister, shingles |
Two weeks after 2nd Covid shot (3/17), a couple of blemishes appeared on rt. cheek of face. Started ...
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Two weeks after 2nd Covid shot (3/17), a couple of blemishes appeared on rt. cheek of face. Started to experience intense pain in lower jaw. Saw the dentist on 3/18 to rule out a tooth issue. Dentist found a small crack in lower molar & crowned it that day. He felt that was the issue. The following day, more blemishes/blisters appeared on cheek & face. More pain was experienced radiating from ear, across cheek & in the mouth. Saw the Dr. on 3/19 & was diagnosed with Shingles. Prescribed Valacyclovir HCL & Prednisone. Now (3/21), the blisters are prevalent on my eary, running across the cheek, chin, lower lip, tongue & gums. Pain is intense -stabbing, tingling & itching.
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| 65 | 2021-03-20 | injection site swelling, injection site redness, injection site pruritus |
about 8 days after first shot my right arm at injection site was itchy, swollen and red. It's day...
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about 8 days after first shot my right arm at injection site was itchy, swollen and red. It's day #3 since the itching started. Seems a little bit better, but thought I should let someone know about this since it didn't happen until 8 days of having the shot. Will get my 2nd shot on April 1st but will tell them to put it in the left arm this time. Please notify me if I should do or not do anything else.
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| 65 | 2021-03-21 | redness, rash, itchy skin |
Developed a rash where the itching got increasingly worse. Skin red and very itchy. Finally went to ...
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Developed a rash where the itching got increasingly worse. Skin red and very itchy. Finally went to the emergency room on February 8 and was prescribed two medications Famotidine and Hydroxyzine. Everything cleared within 3-4 days.
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| 65 | 2021-03-21 | rash | Rash on face , ear and neck - Zyrtec and Benadryl |
| 65 | 2021-03-21 | itchy rash | Same as reported in 03/22/2021 report, itchy rash. Still experiencing itchy rash. |
| 65 | 2021-03-21 | rash, rash with redness, itchy rash | Three days after the second shot, I am completely covered in a red itchy rash all over my body. |
| 65 | 2021-03-21 | rash with redness, skin warm |
When I got home to shower noticed 3 large spots, 2 appeared(upside down snowman) red in color and f...
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When I got home to shower noticed 3 large spots, 2 appeared(upside down snowman) red in color and felt warm to touch. I contacted my doctor when into the walk in clinic stated it might be cellulitis told to take Allegra first if not better to fill prescription for Keflex.
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| 65 | 2021-03-21 | injection site pain, sensitive skin |
experienced body aches, skin sensation to touch, nasal drainage, injection site tenderness, eyes wat...
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experienced body aches, skin sensation to touch, nasal drainage, injection site tenderness, eyes watering, headache, vomiting x6 over period of 10 hrs. Spent all day March 18 in bed due to vomiting , and above symptons. Continued with low grade nausea and HA on March 19. Felt fine on March 20. Treated self with Tylenol and restarted routine meds March 19 PM. Unable to take any meds on March 18 due to vomiting. Did not require seeing healthcare.
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| 65 | 2021-03-22 | shingles, rash |
Got a rash on my right eyebrow, right brow and right side of scalp Monday March 15, 2021. Diagnosed ...
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Got a rash on my right eyebrow, right brow and right side of scalp Monday March 15, 2021. Diagnosed with shingles on Thursday March 18 by Urgent Care. Doc prescribed 500 mg Famciclovir. Monday March 22, 2021 PCP confirmed shingles diagnosis and prescribed Gabapentin 100 mg and Methylprednisolone 4 mg. Applying Calamine lotion to ease itching. Visited ophthalmologist Monday March 22, 2021 to check if shingles has affected my right eye. No effects were found on my eye. Not yet. FYI, I had the Shingles vaccine in 2018.
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| 65 | 2021-03-22 | itchy rash, rash with redness, rash |
I experienced a red, itchy rash/hives on my stomach about 1-week after receiving my first dose of va...
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I experienced a red, itchy rash/hives on my stomach about 1-week after receiving my first dose of vaccine. Over the next 2-3 days, the systemic rash and itchiness was present on my hands, legs, and face. I took 1 dose of 10mg Zyrtec and the rash subsided, but 2-3 days later the systemic rash and itchiness would reappear anywhere on the body. I took a dose of Zyrtec and the rash subsided. On the day before my scheduled second dose shot (apprx 3-weeks) systemic rashes on my stomach, hands, and face appeared, but were less red, itchy, not as large. I received my second dose on March 22, 20201. I did not experience any allergic symptoms immediately after the shot, however, in the evening (approx 7 hours) after receiving the shot, I experienced a red, itchy, large rash on my stomach. I took 1 dose of Zyrtec, and the rash subsided for 24hours. I am planning to continue to take Zyrtec for the next few days and monitor the rash and itchiness.
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| 65 | 2021-03-22 | redness | Left arm soar and red circle size of a large pancake |
| 65 | 2021-03-23 | rash | Rash on both arms, both legs from knees down, and also small patch on upper chest. |
| 65 | 2021-03-23 | shingles | Shingles (self diagnosis - have had shingles 2 times prior.) |
| 65 | 2021-03-24 | rash |
(note I had half the dose in each arm because my first shot had caused reactions of rash, lightheadn...
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(note I had half the dose in each arm because my first shot had caused reactions of rash, lightheadness and swelling tongue). This time I am having more effects. Immediately I had blurred vision in my right eye and facial muscle tightening. Upon arriving home I became severely fatigued and and still am 24 hours later. As of 16 hours later I developed severe pain in the right arm only, body aches, loss of taste and various facial tightening sensations and swelling tongue (I took Zyrtec for the latter and that helps). NO anaphylaxis. THese may go away in the next day or so but that is as yet unknown.
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| 65 | 2021-03-24 | cellulitis |
PHYSICIAN CALLED THE PHARMACY ON 3.24.2021 AND STATED THAT THE PATIENT HAD CELLULITIS WITH SYMPTOMS ...
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PHYSICIAN CALLED THE PHARMACY ON 3.24.2021 AND STATED THAT THE PATIENT HAD CELLULITIS WITH SYMPTOMS BEGINNING ON MONDAY 3.22.2021
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| 65 | 2021-03-24 | skin warm | Patient reported feeling dizzy, light headed, clammy and warm with mild shortness of breath |
| 65 | 2021-03-24 | injection site pain |
Soreness at injection site A few days after 2nd dose stomach cramps with diarrhea. Two weeks after ...
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Soreness at injection site A few days after 2nd dose stomach cramps with diarrhea. Two weeks after still having stomach pain and diarrhea
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| 65 | 2021-03-24 | rash |
Started about 3am Saturday Morning March 6 with extreme pain between shoulder blades. Took 2 Advil a...
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Started about 3am Saturday Morning March 6 with extreme pain between shoulder blades. Took 2 Advil and was able to go back to sleep. Woke in the morning feeling fine. Then started becoming ill early afternoon. Fever every day for 2 weeks. Nausea, vomiting, lose of appetite, extreme fatigue, headache, light sensitivity, rash, nagging slight cough and some nasal stuffiness mostly when talking (this might be because of the pollen) We were told it was an unidentified virus that would have to "run its course". Even though we are vaccinated, we continue to quarantine because we provide child care for my grandson. There was virtually no circumstance where I would have been exposed to a virus. Also, my husband had to care for me because I could do almost nothing for myself and he did not contract the virus.
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| 65 | 2021-03-25 | injection site pain |
103.9 fever, excruciating headache, lymph nodes under both arms swollen and hurt, fatigue, hurt all ...
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103.9 fever, excruciating headache, lymph nodes under both arms swollen and hurt, fatigue, hurt all over my body, nausea, injection site sore
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| 65 | 2021-03-25 | redness, rash |
3-25-21 @ 2:30PM PT STATES SHE HAD 'HIVES AND RASH TO CHEST, ARMS AND LEGS THAT STARTED ON 3-14-21'...
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3-25-21 @ 2:30PM PT STATES SHE HAD 'HIVES AND RASH TO CHEST, ARMS AND LEGS THAT STARTED ON 3-14-21' NO SOB, NO DYSPNEA. STATED SHE' WENT TO HOME TOWN URGENT CARE AND MISSED WORK AND WAS UNABLE TO GIVE PLASM'. PT VERY ANGRY AND STATES IT IS 'COSTING HER MONEY!'. AS OF TODAY THE HIVES ARE GONE AND SHE STILL HAS SOME REDNESS AND RASH TO BOTH ARMS AND CHEST.
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| 65 | 2021-03-25 | redness, hives | Hives and redness to both arms, given 25mg of Benadryl PO, after 30 minutes hives began to decrease. |
| 65 | 2021-03-25 | hives, itchy skin | Itchy arm persisting to this day with small hived |
| 65 | 2021-03-25 | injection site discomfort, injection site redness, injection site pain, injection site pruritus, injection site swelling, injection site warmth |
Mar 24, 2021 very slight soreness, spose noted burgundy, swollen area R deltoid site. assoc with sli...
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Mar 24, 2021 very slight soreness, spose noted burgundy, swollen area R deltoid site. assoc with slight h/a, very slightly swollen glands in posterior neck. March 25, 2021 warm to touch, increased size and soreness at site 69.85mm x 76.2mm, swelling with no discoloration 95.25mm with and slight soreness axillary nodes. March 26, 2021 No change size, hot to touch, uncomfortable, less red, itchy entire pink area.
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| 65 | 2021-03-25 | itchy skin |
evening after the vaccine given, started having discomfort in the vulvar area of my body, perhaps a...
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evening after the vaccine given, started having discomfort in the vulvar area of my body, perhaps a little itching and began spreading to entire perineal region eventually over the next day or so. That evening I had intense discomfort in one area of the vulva but that relented after a few days. Then it became more of a sensitivity of the entire perineal area such as when I took a shower and cleaned myself in that area. Has basically gone away now.
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| 65 | 2021-03-26 | injection site pain | Chills and body aches, achinesss at injection site. |
| 65 | 2021-03-26 | injection site swelling, injection site reaction, injection site pruritus, injection site bruising, hives, injection site pain, injection site redness |
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injec...
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Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Big swelt close to the injetion site , per patient the area is stiff-Medium
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| 65 | 2021-03-27 | hives |
Chest pain, projectile vomiting, hives and swelling of the face, mouth and throat. Benedryl, steroid...
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Chest pain, projectile vomiting, hives and swelling of the face, mouth and throat. Benedryl, steroids, Nitroglycerin 3 times. I was not aware of any other test or results.
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| 65 | 2021-03-27 | injection site swelling, injection site hardening, injection site pain, injection site discolouration |
I had a classic "COVID arm" -- woke up with a perfectly round, darkened, raised area around the inje...
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I had a classic "COVID arm" -- woke up with a perfectly round, darkened, raised area around the injection site, maybe 3 inches in diameter and 1/2 inch raised. It was firm to the touch and felt as if it were filled with liquid. It went down in about 24 hours, and there was lingering soreness. I had absolutely no reaction after the 2nd shot given on 03/19/2021, not even any appreciable soreness.
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| 65 | 2021-03-27 | redness |
Turned red few 3 days later lasting a few 3-4 days which turned to a scab and week later have a scar...
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Turned red few 3 days later lasting a few 3-4 days which turned to a scab and week later have a scar similar to Polio vaccine scar which to the date remains a round scar.
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| 65 | 2021-03-27 | injection site pruritus, injection site reaction |
local injection site reaction, and itchy. told patient to apply cold compress and take Benadryl. wil...
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local injection site reaction, and itchy. told patient to apply cold compress and take Benadryl. will follow up with patient
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| 65 | 2021-03-28 | rash |
On the day after my 2nd dose, I had the typical low grade fever, chills, and aches. But on the 2nd d...
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On the day after my 2nd dose, I had the typical low grade fever, chills, and aches. But on the 2nd day, I woke up with a red rash all around my torso and down both arms. It did not itch and was gone by the 3rd day.
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| 65 | 2021-03-28 | hives, itchy skin | Pruritus and urticaria within 1-2 hours of receiving vaccine dose #1 |
| 65 | 2021-03-28 | vaccination site pain |
feeling sick to my stomach ended up fainting onto bathroom floor; feeling sick to my stomach; arm fe...
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feeling sick to my stomach ended up fainting onto bathroom floor; feeling sick to my stomach; arm felt mildly painful as injection went in; severe chills; fever; fatigue; restless sleep; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 65-years-old via an unspecified route of administration on 08Mar2021 08:15 (lot number: EN6203) as single dose for covid-19 immunisation. Medical history included covid-19 (covid prior vaccination: yes) from 10Jan2021 to an unknown date. There were no known allergies. Concomitant medication included acetaminophen taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 65-years-old, administered on the left arm on 15Feb2021 08:15 (lot number: EL9264) for covid-19 immunisation and experienced very painful injection site, chills, fever and fatigue. The patient reported that when she had her second vaccine on 08Mar2021, her arm felt mildly painful as injection went in, as though never healed from previous shot. This time, within 3 hours of vaccine, she began to feel fatigue, then began to experience chills and fever. She drank plenty of fluids, and took acetaminophen about 6 hrs after injection. In the evening her temp was up to 101.2 (her normal 97.2) and she took Acetaminophen at bedtime. Had very restless sleep, and at 5 AM on 09Mar2021, she got up feeling sick to her stomach ended up fainting onto bathroom floor. Luckily uninjured, and felt better upon "coming to". She was very fatigued rest of day, then normal next day. The patient underwent lab tests and procedures which included body temperature: 101.2 on 08Mar2021. No treatment was received for the events. The patient recovered from the events on an unspecified date.; Sender's Comments: Linked Report(s) : Same reporter,patient,product/ 2nd dose;US-PFIZER INC-2021269674 Same reporter,patient,product/ 2nd dose
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| 65 | 2021-03-28 | injection site pruritus |
pt complaint of itching at vaccine site to left upper arm, lowered to floor as she became lighthead...
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pt complaint of itching at vaccine site to left upper arm, lowered to floor as she became lightheaded, 911 called
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| 65 | 2021-03-30 | injection site pain |
Headache; It hurts and ache all over; If I bump it(injection site) or roll over on it, it hurts; Thi...
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Headache; It hurts and ache all over; If I bump it(injection site) or roll over on it, it hurts; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 at 09:00 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, she got shot yesterday morning on 28Jan2021 about 9 o'clock 23 hours ago. And yesterday she felt fine right before she went to bed, started getting a headache. The injection site, if she bump it or roll over on it, it hurts otherwise it was okay, but she was just achy all over and she was wondering what she could take for it. The patient experienced headache, it hurts and ache all over and if i bump it (injection site) or roll over on it, it hurts on 28Jan2021. Outcome of the event was unknown. Information about lot/batch number has been requested.
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| 65 | 2021-03-30 | rash vesicular |
blisters and vesicles with rash both forearms; blisters and vesicles with rash both forearms; This i...
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blisters and vesicles with rash both forearms; blisters and vesicles with rash both forearms; This is a spontaneous report from a contactable physician. A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Jan2021 00:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol (VIVELLE DOT) taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported. The patient experienced blisters and vesicles with rash both forearms (rash vesicular) (non-serious) on 15Jan2021 12:30 and blisters and vesicles with rash both forearms (rash vesicular) (non-serious) on 15Jan2021 12:30. Therapeutic measures were taken as a result of blisters and vesicles with rash both forearms (rash vesicular), blisters and vesicles with rash both forearms (rash vesicular). The outcome of the events were reported as Recovered/Resolved with Sequel. Information on the lot/batch number has been requested.
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| 65 | 2021-03-30 | hives |
itchy hive at injection site; This is a spontaneous report from a contactable female consumer (patie...
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itchy hive at injection site; This is a spontaneous report from a contactable female consumer (patient herself) of 65-years-old received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number EL9269) via an unspecified route of administration on 05Feb2021 at 04:45pm in right arm as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Patient was reported to known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was on Lexipro and Pravistatin within two weeks of vaccination. On 12Feb2021, approximately day 8 patient experienced an itchy hive at injection site. No therapeutic measures were taken. The outcome of the event was not recovered.
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| 65 | 2021-03-31 | hair loss |
Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every ni...
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Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day; like she had arthritis; Her hair has been falling out/Hair loss; Joint pain; Fingers were frozen; Couldn't eat; barely hydrated; Pain she had in her fingers/ Her toes hurt when she walks; It was hard for her to cook, wash clothes, and do anything; This is a spontaneous report from a contactable Nurse (Patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscular, administered in Deltoid Left on 16Feb2021, 13:15 (Batch/Lot Number: elg267) as SINGLE DOSE for covid-19 immunisation, at 65 years old. Medical history included ongoing Irritable bowel syndrome, she was diagnosed with IBS (irritable bowel syndrome) 15 years ago (unspecified date); Blood pressure high from 2000 and ongoing, High cholesterol from an unknown date (she has had high cholesterol for about 4-5 years or longer), depression from an unknown date (she was diagnosed with depression in her 30s after a car accident. She said she has had post-traumatic stress and depression for years); type 2 diabetes mellitus from an unknown date (she has had Type 2 Diabetes for a while. She said she couldn't take the diabetes medicine. She said she didn't say much to her doctor about the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now); post-traumatic stress from an unknown date. Patient received the first dose of BNT162B2 on 29Jan2021 13:15, 65 years old, (lot number el9262) for covid-19 immunisation and experienced back pain, fatigue, alopecia, malaise, arthralgia, nausea, vomiting, feeling abnormal, musculoskeletal stiffness, arthritis, illness, hypersomnia and fluid intake reduced. There were no concomitant medications. The patient had her second COVID-19 vaccine on 23Feb2021. On 23Feb2021, patient experienced feeling unwell. She has never been so sick; and severe fatigue/fatigue extreme. She got her second COVID-19 Vaccine shot her tiredness was worse. Reported with the regular flu vaccine she had felt bad for maybe 3-4 days, but nothing like how she felt after getting the COVID-19 Vaccine. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. Reported it had been 10-12 days since she had her second COVID-19 Vaccine, and she was still so tired. She is tired all of the time. Her tiredness was worse. She was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad; she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she woke up at 5:30AM today. She said she was exhausted from just going to a doctor's appointment. On 25Feb2021, patient experienced nausea and vomiting. She said she had severe nausea and vomiting, clarifying that the nausea and vomiting lasted 2 weeks. Treatment was Phenergan Syrup 6.25mg/5ml every 6 hours, as needed. She said the Phenergan was originally prescribed for IBS. She said the Phenergan Syrup was dispensed in a pharmacy bottle, and didn't have a NDC, Lot, and Expiration Date. She said the Phenergan prescription label only had a printed barcode. Zofran 4mg tablet, as needed, three times a day. On an unspecified date in Feb2021, the patient experienced her hair has been falling out / Hair loss. She reported that her symptoms while a little better she is still tired all of the time, her hair is still falling out reporting, "If I roll it up in a clump its the size of a golf ball". She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. Hair Loss Treatment: She said the first thing she started taking was 1 Vitafusion Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support. She stated she also took 2 Vitafusion Vitamin C 282mg Gummies a day. She said the product label said to take 3 Vitafusion Vitamin C 282mg Gummies per day, but she only takes 2 Gummies; Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. She said her Fingers were frozen in a half closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to unstick; Couldn't eat and was barely hydrated. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed; Pain she had in her fingers/ Her toes hurt when she walks, she never hand been like this before. She said every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were sore. Treatment: Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6 day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and is to take 1 Prednisone 50mg tablet a day for 6 days; It was hard for her to cook, ash clothes, and do anything. She said she was just laying bed with an ice pack, or a heat pack, and taking pain pills. She said she told her doctor she had called the Health Department, and the CDC. She said the Health Department didn't want to tell her anything, and the CDC will only talk with someone who has had an anaphylactic reaction to the COVID-19 Vaccine. She said she asked her doctor how long she was going to have the side effects. She said her doctor said that all of her patients who had any reaction to the COVID-19 Vaccine, had mostly had called into her office to ask about the COVID-19 Vaccine side effects, and most of the patients COVID-19 Vaccine side effects resolved in a week. She said her doctor said not one of her other patients had ever told her about the kind of side effects she was having. She said her doctor told her she must be in the 2% group and to call Pfizer to report her side effects. She asked how long the events would last and what can she take. The patient underwent lab tests and procedures which included cardiac stress test: all was good right now (unspecified date). Therapeutic measures were taken as a result of her hair has been falling out/hair loss, like she had arthritis, nausea, vomiting, joint pain (arthralgia). Events did not require visit to emergency room. Outcome of the event hair loss was not recovered; outcome of feeling unwell, severe fatigue/exhausted, joint pain was recovering; nausea and vomiting was recovered on an unspecified date; and outcome of all other events was unknown. The patient considered the events as related. The reporter considered the events as serious - medically significant.; Sender's Comments: Based on a temporal association and known drug safety profile, the causal association between the events and the suspect drug BNT162B2 cannot be totally excluded. Possible contribution from patient's underlying medical condition is also considered. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
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| 65 | 2021-04-01 | hair loss |
Nausea; Vomiting; Feeling unwell; severe pain in all my joints, toes, ankles, knees and my arms shou...
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Nausea; Vomiting; Feeling unwell; severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers; didn't feel good; her fingers were frozen in a half closed position when she woke up in the morning; her body ached like she had arthritis; she couldn't eat and was barely hydrated; Hair loss; she couldn't eat and was barely hydrated; Tiredness/Fatigue extreme; Backache; "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning; sick; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: el9262, Expiration Date: Unknown) via intramuscular route of administration in left deltoid on 29Jan2021 (at the age of 65-year-old) at 13:15 as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown, Expiration date: Unknown) via an unspecified route of administration on 23Feb2021 as a single dose, both the doses for COVID-19 immunization. The patient medical history included Irritable bowel syndrome diagnosed 15 years ago (ongoing), ongoing Blood pressure high from an unknown date in 2000, high cholesterol for about 4-5 years or longer, depression (diagnosed in her 30s after a car accident), Type 2 diabetes mellitus (she couldn't take the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now), post-traumatic stress, she was bedridden for 2 weeks on an unknown date in feb2021 (only able to get up to go to the bathroom), it was hard for her to cook, wash clothes, and do anything on an unknown date in Feb2021. The patient underwent stress tests, and all was good right now. The patient did not receive any additional vaccines administered on same date of the Pfizer Suspect was none. The concomitant medication was not reported. The patient previously took historical vaccine, flu vaccine on an unknown date for immunisation and felt bad for 3-4 days. It was reported that after first dose patient has been so sick. The patient experienced back pain on 29Jan2021. She reports that starting the next day that was on 30Jan2021, she has experienced severe fatigue extreme and tiredness. She reports that her symptoms while a little better she is still tired all of the time. She reports "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning on an unknown date in Jan2021. Caller also reports, my joints are in severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers on an unknown date in Feb2021. My fingers are closed, and I can't straighten them out when I wake up". The patient put ice on her back and took pain pills and stuff. It was reported that patient had undergone back tests and result was not reported. The patient reported that she took she took Norco, or Hydrocodone/Acetaminophen 10mg/325mg. said her Norco 10mg/325mg prescription was for 1 Norco 10mg/325mg tablet every 6 hours, as needed, for pain. She said she normally would take 1 Norco 10mg/325mg tablet during the day, and another Norco 10mg/325mg tablet at bedtime. She said after her first COVID-19 Vaccine dose, she had been taking a Norco 10mg/325mg tablet every 6 hours. She said she also took a muscle relaxer, Tizanidine 4mg tablet. She said she took 1 Tizanidine 4mg tablet with the Norco 10mg/325mg tablet, three times a day. She said her backache felt like a belt across her lower back. She said when she has a backache, she gets off her feet, and puts her legs up on a pillow to take pressure off of her back. She said she rested, as well, but tried to do stuff around her house. She said she did have some tests on her back, and she had a fractured facet in her lower spine around the L1 vertebrae. She said she had to have some more tests done on her back. She said the backache she experienced after getting her COVID-19 Vaccine was not normal backache pain. It was Reported about 5-6 days after getting her first COVID-19 Vaccine, that was on an unknown date in Feb2021, her hair started falling out and the severity was explained by patient as "If I roll it up in a clump it's the size of a golf ball". She clarified she would brush her hair and would end up having hair everywhere (in her brush, on the counter, and floor). She said the day after she first noticed her hair falling out, she had even more hair fall out than normal. She said she was worried about her hair falling out and took Biotin and vitamins. She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. The patient took 1 vitamin Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support (UPC Number: 2791700026, Lot Number: WA01802798, Expiration Date: Dec2021). She stated she also took 2 Vitamin C 282mg Gummies (UPC Number: 2791702071, Lot Number: WAO1887038, Expiration Date: Jan2022) a day. She said the product label said to take 3 Vitamin C 282mg Gummies. She stated she also takes 2 Calcium (UPC Number: 2791701951, Lot Number: YY01548358, Expiration Date: Jun2022) 500mg per day. Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. Reported she was still tired. She clarified after she got her first COVID-19 Vaccine, she had felt tired for a few days with her back bothering her. She said she would get up and take her pain medicine, go to the bathroom, and get something to drink and go back to bed. She said she had felt a little better but wanted to take a nap every day. She said after she got her second COVID-19 Vaccine shot her tiredness was worse. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She clarified when she got home from her second COVID-19 Vaccine she was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad, she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she was exhausted from just going to a doctor's appointment. Reported every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were frozen in a half-closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to "unstick." Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and was to take 1 Prednisone 50mg tablet a day for 6 days. Reported she had severe nausea and vomiting on 25Feb2021 and clarified that the nausea and vomiting lasted 2 weeks. She said she took Phenergan and Zofran around the clock. She said she couldn't eat and was barely hydrated. Zofran 4mg tablet (NDC Number: 65862-187-30, Lot Number: OND420010-A, Expiration Date: Jun2024), as needed, three times a day. She said the Zofran was dispensed in a white manufacturer's bottle. Reported she needed to have some regular blood work done. The seriousness of the events Backache, Tiredness/Fatigue extreme, Hair loss, Feeling unwell, Joint pain, Nausea and Vomiting were reported as serious (medically significant) by the reporter. The final outcome of the events Backache, Tiredness/Fatigue extreme, Hair loss was not recovered; Feeling unwell, severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers, Nausea, Vomiting was recovering; didn't feel good, her fingers were frozen in a half-closed position when she woke up in the morning, her body ached like she had arthritis, she couldn't eat and was barely hydrated, sick and "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product to the development of reported events cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-04-24 | skin irritation |
Drug eruption; Severe inflammatory skin reaction / Inflammatory infiltrate; Interface dermatitis; Ph...
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Drug eruption; Severe inflammatory skin reaction / Inflammatory infiltrate; Interface dermatitis; Photodermatitis; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration in the left arm on 27Jan2021 12:00 (Batch/Lot Number: EL9262) at the age of 65 years old, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Concomitant medications was reported as none. No other medications were received within 2 weeks of the BNT162B2 vaccination. On 30Jan2021, the patient experienced severe inflammatory skin reaction eventually covering about 1/3rd of the body and was still active as of 07Apr2021. Lab data included "interface dermatitis with eosinophils, drug eruption and photodermatitis, dermoepidermal junction, inflammatory infiltrate". The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment included high-dose prednisone. The patient was currently in the 2nd round of treatment. The outcome of events drug eruption, severe inflammatory skin reaction, inflammatory infiltrate, interface dermatitis and photodermatitis was not recovered. No follow-up attempts are needed. No further information is expected.
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| 65 | 2021-04-26 | vaccination site pain |
I can't smell or taste today; Sniffles lots of mucus in throat; couldn't catch my breath; fever; Sor...
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I can't smell or taste today; Sniffles lots of mucus in throat; couldn't catch my breath; fever; Sore arm at the injection site; sore throat, felt like pins in throat; burning eyes; cough; achy; tired; chills; This is a spontaneous report from a contactable consumer (patient). This 65-year-old non pregnant female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on left arm on 11Feb2021 10:30 (Batch/Lot Number: EL 9269) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient not received other vaccine in four weeks. patient had Sore arm at the injection site the following 2 days in 20Feb2021. 18Feb2021 achy, tired, chills. 19Feb2021 burning eyes, achy, chills, cough. 20Feb2021 aches in lower back mild cough sniffles, chills, sore throat, felt like pins in throat, tired. At 20Feb2021 16:30 fever of 100.9. 21Feb2021 sore throat felt like pins poking them and also in ears. Sniffles lots of mucus in throat. Felt like I couldn't catch my breath to clear it. It's was a drowning feeling. 22Feb2021 sore throat sore ears, lots of mucus, chills. Temp of 100.1. Still stuffed up the pain in the throat and ears were better but no energy. 23Feb2021 still a lot of mucus, stuffy nose, Slight chills. 2.24 still stuffed up but better. Now I can't smell or taste today. Please get back with me as I want to know if this is just vaccine symptoms. Because if this is the case people need to know. The patient not received any treatment. patient not having covid prior vaccination; patient not tested covid post vaccination; The outcome of the events was recovering.
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| 65 | 2021-04-26 | vaccination site pain |
Mild pain at injection site; Slight headache; Mild fatigue; This is a spontaneous report from a cont...
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Mild pain at injection site; Slight headache; Mild fatigue; This is a spontaneous report from a contactable consumer(patient). A 65-year-old female non-pregnant patient received BNT162B2((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly in the left arm on 17Feb2021 11:00 (Lot Number: EL9266) at single dose for Covid-19 immunization. Medical history included asthma, mitral valve prolapses, gastroenteritis and leiomyoma. (Two weeks after receiving BNT162B2) the patient's concomitant medications included Calcium, Vitamin D3, Cranberry capsules and Turmeric. The past medications included Penicillin, Vancomycin, Levaquin, Ceftin and experienced known allergies to Penicillin, Vancomycin, Levaquin, Ceftin. Prior vaccination with BNT162B2 the patient had not experienced any covid symptoms. The patient reported that she was not on any other vaccine till four weeks after receiving BNT162B2. No Covid test were conducted post BNT162B2 vaccination. On 17Feb2021 19:00, the patient experienced mild pain at injection site, slight headache, mild fatigue. At the time of report, the outcome of the events mild pain at injection site, slight headache and mild fatigue was recovered on an unspecified date of 2021. The patient had not taken any treatment medications for the experienced events.
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| 65 | 2021-05-03 | skin warm |
cold sweats (skin very hot, I assume I had a fever, though was too sick to check it) sleeplessness a...
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cold sweats (skin very hot, I assume I had a fever, though was too sick to check it) sleeplessness aches all over body, pain not quellable with Tylenol headache sensitive glands all lasting about 12 hours this was my 2nd dose, first dose had no effects except for site soreness
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| 65 | 2021-05-04 | shingles |
Second vaccine not in list, COVID Pfizer done on 2/3/21 and 2/24/21 all info in my descriptions. Sh...
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Second vaccine not in list, COVID Pfizer done on 2/3/21 and 2/24/21 all info in my descriptions. Shingles shot at pharmacy given above and in my description. 4/5/21
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| 65 | 2021-05-04 | itchy skin |
it sounded like a form of Bell's Palsy; left cheek tingle; my left forehead, cheek, side of lip and ...
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it sounded like a form of Bell's Palsy; left cheek tingle; my left forehead, cheek, side of lip and chin felt like I had razor burn.; My head itched; left eye felt dry; salivate more than usual from the left side of my mouth; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; feel pain in my left ear; My lymph nodes on the left side of my face became swollen; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 12:45 (Batch/Lot Number: EN6202), at the age of 65-years-old, as single dose for COVID-19 immunization. Medical history included allergy to Sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included calcium; magnesium; colecalciferol, menadione (VITAMIN K+D); glutathione; all taken for an unspecified indication, start and stop date were not reported. Within 45 mins (also reported as 20-25 minutes) of receiving the shot, she began to feel her left cheek tingle. In the intervening days, her left forehead, cheek, side of lip and chin felt like she had razor burn. Her head itched. Her left eye felt dry, but that went away. She began to salivate more than usual from the left side of her mouth. The left side of her face began to feel heavy, sometimes also my sinuses, but more often my lower jaw. Sometimes, she would feel pain in her left ear. Her lymph nodes on the left side of my face became swollen. Her doctor on Zoom said it sounded like a form of Bell's Palsy (medically significant), though she does not have the drooping eye or mouth. She had an MRI of her left lymph node that did not reveal any issues. Her symptoms, while they have abated, are still present five weeks after the shot. The events started on 26Feb2021 13:30. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event left eye felt dry was recovered while other events was not recovered.
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| 65 | 2021-05-04 | redness, rash |
kidneys were inflamed; grade IIIa kidney failure; got a flight or fight response; lower lip was full...
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kidneys were inflamed; grade IIIa kidney failure; got a flight or fight response; lower lip was full tingling; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; mucoid eruption on her lower lip/ mucoid eruptions in her mouth, on her palate and down her throat; rash to her face, neck, chest, back, shoulders and thighs; has bright red palms and sole of her feet are bright red; it looked like Kawasaki disease; voice change; had joint pain in her left arm and could not use her left arm and her whole entire arm and hand; had left clavicle pain under the clavicle; spontaneous cough where her heart races; spontaneous cough where her heart races; felt she couldn't catch her breath; issues in her throat and neck area had something pressing around her throat; she was so tired; chest flutters; tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly; may be body inflammatory response to being vaccinated; This is a spontaneous report from a contactable Nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Mar2021 09:40 (Lot Number: EN6199) (at the age of 65 years old) as single dose (dose 1) for COVID-19 immunisation; and methylprednisolone (MEDROL), via an unspecified route of administration from an unspecified date to an unspecified date at short term increase of the Medrol dose (as reported), from unspecified date to an unspecified date at 2 mg (for four years, as reported), then from unspecified date to 10Mar2021 at 6 mg, then from 11Mar2021 to 13Mar2021 at 8 mg, then from 14Mar2021 to unspecified date at 6 mg, for Lupus. Medical history included diagnosed with asthma initially exercised induced and now it is seasonal and was diagnosed years ago (states she has not had to use her Albuterol inhaler that much now because it is seasonal but she is doing more outside and is allergic to outside things so she tends to use the inhaler more if needed), right leg paresthesia (she did have a right leg paresthesia and had that before the vaccine), autoimmune disorder, thyroid disorder and patient stated that she has lost height. Concomitant medications included salbutamol (ALBUTEROL HFA) taken for asthma; levothyroxine sodium (SYNTHROID) taken for thyroid disorder; paracetamol (TYLENOL); and diphenhydramine hydrochloride (BENADRYL). The patient had a history of Lupus and is on maintenance Medrol 2mg for four years and before that she had a short-term increase of the Medrol dose with flares of her Lupus. She had the Pfizer COVID Vaccine 1st dose and then three days later on 10Mar2021 at 16:00, she thought what is going on and had her tongue tip so irritated and a strange feeling that it was a tiny bit edematous, her lower lip was full tingling. She had mucoid eruption on her lower lip and saw then that the next day thought it was swollen but it wasn't swollen. She had eruption on her tongue, had a rash to her face, neck, chest, back, shoulders and thighs. The rash was dispersed and there is a red raised rash with Lupus called Livedo reticularis and that is usually on the thighs but this rash on her was below her thighs and came up and dispersed between all the same rash elsewhere on her body. The healthcare professionals were closed so she took increased Medrol steroids and her Albuterol inhaler and Benadryl; the Benadryl was thrown out and discarded so she has no lot number to provide for it, stated that the Benadryl was the pediatric dye free bubblegum free. The Albuterol Sulfate HFA inhaler is 90mcg per puff and she does two puffs every 6 hours as needed; she had not taken the inhaler but she has trouble with asthma and took the Albuterol inhaler now as preventative and needs to use the inhaler as of yesterday (lot Y23B with expiry date Dec2021). Patient stated that she has the tools of her Albuterol inhaler, the steroid Medrol and the Benadryl and the knowledge so she prevented the symptoms she was reporting from being life threatening but stated the reported events were a little disabling and medically significant.She had joint pain in her left arm and could not use her left arm and her whole entire arm and hand. She had left clavicle pain under the clavicle and knows this did occur in the random trials but for her it went away after two days and is now back regarding the pain. She has bright red palms and sole of her feet are bright red. The next morning on 11Mar2021, her upper lip was tingling and she did go see her healthcare professional in town and sent photos to her Rheumatologist. As time went on she had tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly and her soles and palms were bright red; it looked like Kawasaki disease and she used to take care of children with Kawasaki disease. On Saturday which was the 3rd day she was on the Medrol 8mg and had the fight or flight cardiac symptom and she cut herself down on the Medrol on the next Sunday to 6mg which seemed to make her better. The redness was gone until she had the Pfizer COVID Vaccine 2nd dose yesterday and the healthcare professional initially said after her 1st dose of the vaccine to wait and see her rheumatologist do decided to do the increased Medrol dose of steroids and she stated she has got to get the 2nd dose of the Pfizer COVID Vaccine; the healthcare professional checked her lungs that were clear and her pulse ox was fine and she was not wheezing and she then went on increased steroids from Medrol 6mg to 8mg right away. She did have a right leg paresthesia and had that before the vaccine so she knows what it is like because she has issues with her spine but had not had the paresthesia in a long time. She increased to Medrol 8mg for the three days after the 1st dose of the Pfizer COVID Vaccine and got a flight or fight response. She had to increase the Medrol dose from 6mg and popped it up to 8mg and she had mucoid eruptions in her mouth, on her palate and down her throat and had a voice change. She has a laryngoscopy on Thursday (25Mar2021) with her ENT. She has pediatric doses of everything because she reacts to almost everything. The 2nd dose of the Pfizer COVID Vaccine was administered to her on 29Mar2021 09:45 with lot ER8732. Patient stated that anyone else would have gone to the emergency room but she took care of herself at home and knows the risk factors related to the vaccine. She absolutely felt the reported events were related to the Pfizer COVID Vaccine in terms of causality and she never had these issues before. The rheumatologist had experience with patients with autoimmune diseases and stated people with autoimmune disease have a heightened immune reaction to the vaccine no matter which vaccine they get and are overly active and then a vaccine is thrown in there and we are charting new territory. The next Thursday or Friday over a week now after the Pfizer COVID Vaccine she had a multisystem type of thing and on 18th and 19th of March she started having episodes and was not doing anything but quietly doing something and had chest flutters and spontaneous cough where her heart races and felt she couldn't catch her breath and is now on a 30 day event monitor. She was not sure this is due to the Medrol steroids or the Pfizer COVID Vaccine. She got her thyroid TSH level done because sometimes when the Synthroid dose needs to be lowered because it is too high for your body and you can have atrial flutter which she has had before in the past from her Synthroid dose being too high; states her Synthroid is 50mcg and takes it once per day by mouth and it is in a prescription bottle with no lot, expiry date or NDC. Patient saw her primary care physician again last Tuesday on 23Mar2021 and all the issues in her throat and neck area had something pressing around her throat and thought it was lymph nodes and woke up with a voice change and physician said he would take a look and he said it was not thrush and she would have to be scoped because he couldn't see in her throat. She had a referral for a CBC and Chemistry lab to be done on 25Mar2021 and TSH was in the usual range for her, the results from Thursday (25Mar2021) night had her BUN and creatinine and GSR (Glomerular filtration rate) abnormal. The rheumatologist called her that night and talked to the physician and said he considered this may be body inflammatory response to being vaccinated and could be that her kidneys were inflamed and she does not know as this is all new territory. For the kidney issues, the information was sent off to the rheumatologist who did orders and called the physician back the next day and she told him she thought she needed a nephrology consult and had urine chemistry, a urinalysis and looked for protein and did a blood draw for a chemistry screen with the following results on 25Mar2021: BUN 22.3, grade IIIa kidney failure, creatinine 1.28, eGSR-NAA 42ml/min, normal is over 60 and she usually runs 70 something. She went to the hospital over the years to have her chemistry lab done because she has Lupus and over the last two years she has never been below 60 for the eGSR-NAA. On 26Mar2021, she repeated the blood work and sent everything to her physician and the CMP had her BUN still elevated at 19.5, the creatinine was down to 0.97 and the eGSR-NAA was up to 58mL/min which is still abnormal; the urinalysis was all fine with no white cells and no leukocytes and no protein; the urine chemistry had the creatine of 8.5, the protein in the urine LVL was less than 0.4mg. Her CBC had her lymphs and monos down and she would expect having this response to the vaccine. Both physician called her on the weekend and they were concerned this came out of nowhere and now are monitoring her again in a month; her physician and rheumatologist both were entertaining this could be related to the Pfizer COVID Vaccine. She does not take vaccines because of what they do to the body and did take the flu vaccine in Oct2020. She was covid negative (unspecified date) and stated had to be screened on Friday 26Mar2021 before her laryngoscopy and did the PCR test and only does the PCR. States she was doing research and had conflicting information from her physician and rheumatologist who she first saw her physician, after her 1st dose of the vaccine and the rheumatologist talked about increasing her steroids and she told him she was so tired and how with increased steroids, do steroids impact the effectiveness of the covid vaccine being blunt immune suppressants. Physician said long term chronic steroids have no effect on the effectiveness of the vaccine. She has no had headaches, shaky chills like everybody else has because she is on immune suppressants and has an article that says some evidence for steroids diminishing efficacy in Pfizer COVID Vaccine. No prior vaccinations within 4 weeks. No additional Vaccines administered on same date of the Pfizer suspect. Events required a visit to physician office (No visit to the ER but did see her physician). The last action taken in response to the events for methylprednisolone was unknown. The outcome of the event had left clavicle pain under the clavicle was recovered on 12Mar2021; event has bright red palms and sole of her feet are bright red was recovered in Mar2021; outcome for the other events was unknown.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but possible contributory effects from patient's medical history and concomitant medications cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-05-04 | bruising |
leg was bruised; heart spasms; Diarrhea; inflammation along the major vein in her leg; heart palpita...
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leg was bruised; heart spasms; Diarrhea; inflammation along the major vein in her leg; heart palpitation; light headed/dizzy; severe muscle pain; tenderness and soreness in her inner thigh of the left leg/throbbing pain; Chills; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6208), via an unspecified route of administration in unspecified arm on 09Mar2021 (12:00) at single dose for Covid-19 immunization. The patient's medical history included ongoing hypothyroidism. Concomitant medication included levothyroxine been taking for 10-11 years for hypothyroidism. On 17Mar2021, Wednesday, the patient received the vaccine and had chills. On 18Mar2021, the patient had tenderness and soreness in her inner thigh of the left leg. On 19Mar2021, the patient had severe muscle pain on her calf of leg to inner thigh and it was throbbing so bad behind her knee on her left leg that she called her physician, and a sonogram was performed on 23Mar2021 which had found there was not a blood clot but there was severe inflammation along the major vein in her leg. On 20Mar2021, the patient had heart palpitation, her doctor told her to drink water and propel, she had heart spasms for 6 hours and felt lightheaded and dizzy. she thought she would go to the hospital, but she lives in a rural community and felt it did not make sense to go to the hospital. Palpitations and tenderness recovering. Her doctor and she was put on a heart monitor for her heart palpitations. She had heart palpitations with her hypothyroid but, this was totally different when she has had heart palpitations in the past. On an unknown date in Apr2021, the patient had diarrhea for 6 days. Patient had not been back to the doctor, but the nurse thought it was ok for her to take the second vaccine, but the patient was not comfortable with it. No prior vaccinations within the week. The patient never taken the flu shot. She had never received the flu vaccine or pneumonia nothing, so this was new for her getting the COVID vaccine. Caller clarified the chills started the week after she received the vaccine on Wednesday 17Mar2021. Severe muscle pain: Caller stated this happened on the 19, 20, 21, and 22 as well as the throbbing pain and then the next day on Monday 22Mar2021 she went to call her doctor and had a sonogram that next day on Tuesday (23Mar2021). Caller stated she still had the muscle pain in her left leg on the inner thigh but it was more so when she was active and once in a while she felt like her leg was bruised for a day or two but then it went away and she did not have a blood clot. Left leg throbbing: Caller stated this continually got worse and then on Sunday she felt so bad she laid in bed with her knee up and it throbbed like crazy. Caller stated this stopped about 2 days after she got the sonogram and it was not that severe it was just really tender and sore. Heart palpitation: Caller clarified that the heart murmurs she referred to earlier was actually heart palpitations. Caller stated this started at 8 in the morning and then at 10 in the morning she started getting light-headed and thought about going to the emergency room and figured no she will get through this. Caller stated she called her physician for the heart palpitations on Monday and she saw her doctor the following Tuesday and that is when her doctor had given her the heart monitor. Caller stated for 6 hours she felt horrible on Saturday since she knows the difference from her normal heart palpitations from her thyroid. Diarrhea: Caller stated this last for 6 days and was last week or so. Treatment: Caller stated no she is not a medicine taker she does not even take Tylenol or Advil unless it is a necessity. Outcome of the event chills recovered on 18Mar2021, tenderness and soreness in her inner thigh of the left leg/throbbing pain was resolving, severe muscle pain and inflammation along the major vein in her leg was not resolved, heart palpitation was resolving, light headed/dizzy was resolved on 20Mar2021, diarrhea was resolved on Apr2021, leg was bruised was resolved, heart spasms was unknown. No follow-up attempts are needed. No further information is expected. follow up(20Apr2021): New information was reported from a contactable consumer (patient) included: new events (coronary spasm, pain in extremity, phlebitis lower limb and bruising of leg) and event details. Case is upgraded to serious upon this follow up. No follow-up attempts are needed. No further information is expected.
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| 65 | 2021-05-07 | skin burning sensation |
skin its burning like there was fire in her leg; Right leg was so swollen; can't walk; pain was excr...
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skin its burning like there was fire in her leg; Right leg was so swollen; can't walk; pain was excruciating; Knee problem; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right on 01Mar2021 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. The first dose was received on 08Feb2021 at age 65 years old. Medical history included diabetes and heart condition; both from unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After the vaccination, patient was in the hospital. They can't find nothing wrong with her, patient's right leg was so swollen and the skin its burning like there was fire in her leg and she believe that this was.. (statement incomplete). Patient had been in bed can't walk, her skin burns and the pain was excruciating. It was reported that three weeks ago, like 01April, she started getting the symptoms. Patient started having knee problem like a week, it got out worse and worse and then on 01Apr2021, it started really highly worse that she had to go back to the doctor and then can do X-ray. The things were worse and worse that she ended up in the hospital (reason not clarified) that she couldn't work, couldn't walk and it was burning achy and unbearable. Patient was still on bed, still can't work and was still have the burning feeling in her leg. She was hospitalized on 01Apr2021 but had problems prior to it but got worse on 01Apr2021. Date of discharge was reported was 18Apr2021. Outcome of the events was unknown.
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| 66 | 2020-12-31 | injection site pain | Pain, soreness at injection site, flushed feeling. |
| 66 | 2020-12-31 | rash papular |
patient developed red papules on arm. no itching, swelling or respiratory symptoms. instructed to mo...
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patient developed red papules on arm. no itching, swelling or respiratory symptoms. instructed to monitor and take benadryl 25mg prn. (Patient left vac clinic with no reaction and came back next day to report rash.)
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| 66 | 2021-01-03 | itchy skin, blister, hives | Patient developed painful hives, blisters, burning, itching |
| 66 | 2021-01-04 | itchy skin |
Patient was experiencing headache, lightheadedness, generalized itching, shortness of breath, wheezi...
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Patient was experiencing headache, lightheadedness, generalized itching, shortness of breath, wheezing, and nausea after 8-10 minutes of COVID-19 vaccine administration. Vital signs were stable RR 22 and SpO2 96% on RA. She was speaking in full sentence, no acute distress, with expiratory wheezing. No central cyanosis or new rash. After 15 minutes, she reports improvement on her symptoms. She was given Benadryl po and Albuterol 2 puffs in the clinic with improvement on her symptoms. Lungs have more air movement and less wheezing after the albuterol treatment. She was send home and educated in ED precautions.
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| 66 | 2021-01-05 | injection site pain |
Significantly sore left shoulder (injection arm) with pain now radiating up into neck & downward aro...
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Significantly sore left shoulder (injection arm) with pain now radiating up into neck & downward around shoulder blade, severe headaches, nausea (no vomiting), sore throat, FATIGUE, chills/cold sweat, general body aches.
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| 66 | 2021-01-06 | rash |
The patient states on 12/18/2020 at approximately 1430 a rash on both arms appeared. The rash has l...
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The patient states on 12/18/2020 at approximately 1430 a rash on both arms appeared. The rash has lasted several weeks. The rash continues to be present on 01/06/2020. No itchiness. Patient also states on 12/18/2020 at approximately 1700, she started with chills which got progressively worse throughout the evening, fever (99.8 F), patient states this temperature is 'high' for her, body aches, shortness of breath and a cough. All these symptoms got worse enough where she thought she had to call 911. However, the symptoms eventually subsided that night and she did not need to call 911. The body aches, chills and "fever" lasted for about 2 days.
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| 66 | 2021-01-06 | rash |
WENT TO SLEEP ON 1/6/21 WITHOUT ANY ADVERSE EVENTS. WHEN AWOKE ON 1/7/21 AT 07:00AM, HAD A RASH ON A...
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WENT TO SLEEP ON 1/6/21 WITHOUT ANY ADVERSE EVENTS. WHEN AWOKE ON 1/7/21 AT 07:00AM, HAD A RASH ON ARMS AND BELLY. RASH IS NOT ITCHY.
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| 66 | 2021-01-08 | skin swelling, itchy skin |
45 minutes after vaccination, I had swelling of my upper lip, mouth, face cheeks, eyes, forehead, sc...
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45 minutes after vaccination, I had swelling of my upper lip, mouth, face cheeks, eyes, forehead, scalp. At home I began taking antihistamines to reduce the swelling and itching. Symptoms continued for 8 days, reducing in severity each day.
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| 66 | 2021-01-08 | hives, rash |
SkinRash & Diarrhea Narrative: Hives general systemic, head, palms,right eye lid, back, abdomen. Hi...
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SkinRash & Diarrhea Narrative: Hives general systemic, head, palms,right eye lid, back, abdomen. Hives continued to pop up for the next four days.
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| 66 | 2021-01-09 | injection site pain, injection site swelling, injection site reaction, injection site pruritus, injection site redness |
After the first shot I had a very sore shoulder/deltoid area that started about 6 hours after the sh...
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After the first shot I had a very sore shoulder/deltoid area that started about 6 hours after the shot and lasted 3 days. After the second shot, I had mild soreness in my shoulder/deltoid that started about 3 hours after the shot and lasted 1 day. I also had a reaction on my skin in the L shoulder area - red with mild swelling and some itching. The size of the redness was about 2 in diameter.
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| 66 | 2021-01-10 | injection site pain |
1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 9...
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1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 99.3, muscle pain arms and legs worse Uncomfortable during the entire night (tossing and turning) 1/10/21- 07:30-General malaise(flu like symptoms)- muscle pain-feeling weak T-99 started feeling better during the late afternoon, still with muscle pain , T-98.7
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| 66 | 2021-01-10 | injection site pruritus, injection site pain, injection site hardening | Itchy and painful area around injection site; indurated area around injection site |
| 66 | 2021-01-10 | injection site redness, rash papular |
Low grade fever which lasted 24 hours. Raised, reddened area at site of injection also as well as si...
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Low grade fever which lasted 24 hours. Raised, reddened area at site of injection also as well as significant left axillary lymph node enlargement which both persist.
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| 66 | 2021-01-10 | shingles |
Shingles breakout about a week after 1st vaccine. Dermatology confirmed; medication given and treatm...
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Shingles breakout about a week after 1st vaccine. Dermatology confirmed; medication given and treatment plan started.
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| 66 | 2021-01-11 | injection site pain |
Felt very much like I was going to faint. Had nausea and without proper breathing and fighting thro...
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Felt very much like I was going to faint. Had nausea and without proper breathing and fighting through it, I would have passed out. And I was driving. The pain during the injection was one of the most severe I've ever had. It was injected in the top part of my shoulder where there is nothing but bone.
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| 66 | 2021-01-11 | injection site pain | Injection site pain, chills, fever, headache, muscle pain, nausea 12 hours after second vaccine |
| 66 | 2021-01-11 | injection site swelling, injection site rash |
PATIENT HAD A SORE ARM ON THURSDAY. ON SATURDAY MORNING SHE WOKE UP WITH A SWOLLEN, RASH AREA AROUN...
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PATIENT HAD A SORE ARM ON THURSDAY. ON SATURDAY MORNING SHE WOKE UP WITH A SWOLLEN, RASH AREA AROUND THE SITE OF THE INJECTION. ON SUNDAY THE AREA WAS LESS SWOLLEN. ON MONDAY SHE CAME IN TO SHOW ME THE RASH. IT WAS A STRAIGHT HORIZONTAL LINE WITH RED PETECHIAE AROUND THE LINE, EXTENDING TO THE REAR ARM PIT AREA.
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| 66 | 2021-01-13 | injection site pain, redness |
6:30 am 1/13/21: swelling in right axilla, headache, body aches, soreness at injection site 4:pm 1/1...
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6:30 am 1/13/21: swelling in right axilla, headache, body aches, soreness at injection site 4:pm 1/13/21: temp 99.8, chills, selling and redness in right axilla extending to right breast, body aches, severe headache 6:30 am 1/14/21: afebrile, moderate body aches and headache, increased swelling and redness in right axilla extending to right breast Called PCP office. Told to continue Tylenol and use ice packs
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| 66 | 2021-01-13 | injection site pain, redness |
Note: Took Tylenol 1000 mg before injection and every 4-6 hrs since injection 1/11/21 9:00 pm, sor...
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Note: Took Tylenol 1000 mg before injection and every 4-6 hrs since injection 1/11/21 9:00 pm, soreness at injection site 1/12/21 6:30 am, soreness at injection site, slight swelling in right axilla 1/13/21:6:30 am, soreness at injection site, moderate swelling in right axilla, headache, body aches 1/13/21 4:00 pm, temp 99.8, soreness at injection site, increased swelling and redness in right axilla extending to right breast, severe headache. body aches, fatigue 1/14/21 6:30 am, afebrile, increased swelling and redness right axilla extending to right breast, headache, body aches. 1/14/21 10:00 am, Called PCP office. Told to take Tylenol and use ice at axilla, and report to CDC
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| 66 | 2021-01-14 | injection site rash |
Patient received 1st dose of vaccine on 12/31/20 @ 1332. On 1/14/21 @ 0800, patient reported to Emp...
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Patient received 1st dose of vaccine on 12/31/20 @ 1332. On 1/14/21 @ 0800, patient reported to Employee Health Nurse that she awoke with a rash around the injection site. She described the rash as a circular rash around the injection site, with a smaller circle nearly on the injection site.
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| 66 | 2021-01-18 | hives |
Chills; Malaise; Hives; Other vaccine same date details: [{other vaccine same date product= Pfizer/B...
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Chills; Malaise; Hives; Other vaccine same date details: [{other vaccine same date product= Pfizer/Bio, other vaccine same date vaccine date= 08Jan2021}]; Other vaccine same date details: [{other vaccine same date product= Pfizer/Bio, other vaccine same date vaccine date= 08Jan2021}]; This is a spontaneous report from a contactable other hcp. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, intramuscular on 08Jan2021 11:30 at a SINGLE DOSE and via an unspecified route of administration on 08Jan2021 at a SINGLE DOSE for covid-19 immunisation. Other vaccine same date details: [{other vaccine same date product= Pfizer/Bio, other vaccine same date vaccine date= 08Jan2021}]. Medical history included drug hypersensitivity to Penicillin from an unknown date and unknown if ongoing. Concomitant medication included lisinopril (LISINOPRIL) and atorvastatin (ATORVASTATIN). The patient previously took clindamycin and experienced drug hypersensitivity. The patient experienced Hives, Chills, Malaise on 08Jan2021 18:00. The outcome of the event was unknown. Information on the lot/batch number has been requested.
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| 66 | 2021-01-19 | redness |
Patient received first dose of COVID-19 vaccine and within 15 minutes felt tongue swelling and lip s...
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Patient received first dose of COVID-19 vaccine and within 15 minutes felt tongue swelling and lip swelling and felt heart was racing like she has been exercising. Feels lightheaded and dizzy. No trouble breathing. Patient was immediately assessed. Benadryl 50 mg given in clinic. Minimal improvement in lip and tongue swelling. Patient feeling more lightheaded. Vitals: BP 120/70, Pulse 69-72 O2 saturation 98-99%. PE: CV: normal rate: Respiratory: CTAB. HEENT: swollen upper and lower lip and tongue swelling (angioedema) Skin: mild redness in left hand, no hives noted Patient has had hx of anaphylaxis in the past to compazine and phenergan. Recommend ER Evaluation and monitoring.
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| 66 | 2021-01-19 | redness |
Received vaccination @ 11:19 am 11:32 am noted red blotchiness on (L) neck by observer, pt denied SO...
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Received vaccination @ 11:19 am 11:32 am noted red blotchiness on (L) neck by observer, pt denied SOB itchiness, lightedheadeness, nausea given Claritin 10mg tab orally observation extended to 30 min blotchiness resolved, no further symptoms
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| 66 | 2021-01-20 | itchy skin |
1530-Pt in observation area in vehicle, started to honk horn for signal of distress. Pt reported ton...
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1530-Pt in observation area in vehicle, started to honk horn for signal of distress. Pt reported tongue swelling and itching 1551-EPI pen device deployed, EMS activated 1554-2 puffs Albuterol inhaler, 4L O2 via nasal canula applied. 1603-EMS arrive. Vital signs: HR: 102, BP: 140/70, O2 SAT now at 96% on Room Air 1608-Transport to local hospital ED by EMS
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| 66 | 2021-01-20 | injection site swelling, injection site inflammation, injection site pruritus |
I am an RN at this hospital, I received second injection 1/13/2021. On 1/15/2020 felt sick enough to...
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I am an RN at this hospital, I received second injection 1/13/2021. On 1/15/2020 felt sick enough to just lay down all day, then left arm below injection site became moderately swollen, itchy and inflamed. This has lasted until today 1/20/2021 swelling, inflammation and itching has subsided 50 %. It was most of my upper arm an extensive area.
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| 66 | 2021-01-20 | vaccination site pain |
Injection site pain; chills; fever; headache; muscle pain; nausea; This is a spontaneous report from...
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Injection site pain; chills; fever; headache; muscle pain; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 66-year-old female patient received the second dose of BNT162B2 (Pfizer, lot number: EL3246), intramuscularly in left arm on 08Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included known allergies: sulfa drugs. Concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (lot number: EK5730), intramuscularly in left arm on 21Dec2020 17:00 for COVID-19 immunization. Patient experienced injection site pain, chills, fever, headache, muscle pain, and nausea 12 hours after second vaccine on 08Jan2021 22:00. No treatment was received. Patient was recovered from these events. No follow-up attempts are possible; no information is expected.
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| 66 | 2021-01-21 | redness |
At about 4:15 pm which is 3.5 hours after receiving vaccine, I experienced tightness, swelling in my...
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At about 4:15 pm which is 3.5 hours after receiving vaccine, I experienced tightness, swelling in my throat, tingling, numbness of my face in around my mouth, red flushing of the skin in my upper chest and throat. I took 2 Benedryl tablets and experienced symptoms for the next hour. They subsided by 5:30 pm . I was able to breathe and swallow during the whole episode. I had very similar reactions several times in June when I was for unknown reasons experiencing hives and had same response when prescribed Bactrim, and then Keflex because of a UTI. I had no further incidents with the chest, throat, mouth reaction since mid June until yesterday. I had no adverse reaction to the vaccine until 3.5 hrs after receiving it. I feel this is because my body has some sensitivity, not that anything was done incorrectly in administration of the vaccine. All personnel were very attentive and careful that I observed.
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| 66 | 2021-01-21 | skin warm |
At the time of the injection was painful, hurt from that point forward and kept on hurting all day. ...
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At the time of the injection was painful, hurt from that point forward and kept on hurting all day. Yesterday started hurting in the shoulder and arm continued, still hurts today 1/22/21. Warm to touch, still warm to touch today, knot underneath armpit.
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| 66 | 2021-01-21 | redness, skin mass, pain of skin |
Developed an erythematous tender subdermal nodule directly over the L5/S1 area, 2 cm to the right of...
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Developed an erythematous tender subdermal nodule directly over the L5/S1 area, 2 cm to the right of posterior midline (low back). First noted a painful, firm, pea-sized pink area exactly 24 hours after receiving dose #1 of the Pfizer vaccine (1/15/21, 6:15PM). Within 24 hours this enlarged to ~ 4cm, remaining firm, red, tender, subdermal. It is gradually reducing in size as of 1/22/2021 (1-week post-vaccine), now ~2.5 cm, but still very red and painful. No fluctuance or break in the skin. No other symptoms (fever, rash, etc). Concern for immune-mediated granulomatous reaction.
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| 66 | 2021-01-21 | injection site pain |
Hurt bad when injecting. Hurt afterwards. Still hurts 2 days later. Shoulder started hurting yesterd...
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Hurt bad when injecting. Hurt afterwards. Still hurts 2 days later. Shoulder started hurting yesterday. Today I have a big knot under armpit.
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| 66 | 2021-01-22 | injection site pain | Dry mouth, pain/tenderness at injection site |
| 66 | 2021-01-22 | itchy skin | burning and itching on neck, began less than 1 day of COVID vaccination |
| 66 | 2021-01-23 | shingles, rash |
Shingles developed at 14 days after vaccine..I have never received shingles vaccine...burning sensat...
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Shingles developed at 14 days after vaccine..I have never received shingles vaccine...burning sensation on 1/20/2021 follow by rash in next 24hrs. Confirmed by Doctor on 1/22. Started Valtrex 1/22.
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| 66 | 2021-01-24 | redness |
A 66 YEAR OLD FEMALE RECEIVED FIRST DOSE OF PFIZER COVID-19 VACCINE ON 01/23/21 AND EXPERIENCED WHAT...
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A 66 YEAR OLD FEMALE RECEIVED FIRST DOSE OF PFIZER COVID-19 VACCINE ON 01/23/21 AND EXPERIENCED WHAT SHE THOUGHT TO BE A REACTION TO THE VACCINE. THESE REACTIONS HAPPENED 3 MINUTES AFTER RECEIVING THE VACCINE. SHE REPORTED FEELING HOT, HAD TINGLING SENSATION AND WAS FLUSHING. REPORTED SHE HAD RED EARS, FACE, AND NECK AND FELT THE FLUSH ALL OVER HER BODY. PATIENT REPORTED THAT SHE TOOK BENADRYL 25 MG PRIOR TO RECEIVING THE VACCINE. SHE ALSO REPORTED THAT SHE TOOK ANOTHER BENADRYL 25 MG WHEN SYMPTOMS SHOWED UP. EMS PERSONNEL OFFERED TO TRANSFER HER TO THE ER BUT SHE STATED SHE REFUSED THIS AND SHE SIGNED AN AMA FORM. PATIENT ALSO REPORTED THAT THE SIGNS AND SYMPTOMS DIDN'T PROGRESS AND SHE BELIEVED THIS WAS DUE TO THE EFFECT OF BENADRY. PATIENT REPORTED THAT SHE STAYED ON THE VACCINATION SITE UNDER OBSERVATION FOR 45 MINUTES AND BY THE TIME SHE LEFT THE SITE, THE SIGNS AND SYMPTOMS WERE GONE. PATIENT STATED SHE WILL CONTACT HER NEW PCP FOR FURTHER ADVISE WHETHER OR NOT SHE CAN GET THE SECOND PFIZER VACCINE. PATIENT DENIES ANY PROBLEM TODAY 01/25/21. WILL CONTINUE TO MONITOR.
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| 66 | 2021-01-25 | injection site pain |
Shot site on arm began hurting a lot around 1am the next day Jan 26. I began to feel nauseous the ne...
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Shot site on arm began hurting a lot around 1am the next day Jan 26. I began to feel nauseous the next day at 11 am. Also had some chills. Took Advil soon after and helped alleviate the chills right away. Received Pfizer-BioNTech COVID-19 Vaccine EUA
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| 66 | 2021-01-26 | itchy skin |
Eczema lesion on upper right inner thigh was resolving using Eucrisa. Received the Pfizer vaccine on...
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Eczema lesion on upper right inner thigh was resolving using Eucrisa. Received the Pfizer vaccine on 01/20/2021 & within a few days the lesion became very excoriated & itchy. No weeping noted. Have discontinued using Eucrisa & applied OTC topical HC to area.
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| 66 | 2021-01-26 | skin warm, redness, dry skin |
Patient Complained of feeling lightheaded 1 minute after vaccine administered. She bent over forward...
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Patient Complained of feeling lightheaded 1 minute after vaccine administered. She bent over forward in chair. Observation nurse called over and BP cuff applied. 0957=BP 97/58; radial pulse 60; skin warm dry and pink; 1002=complained of nausea, patient lowered to floor with legs bent; BP 96/60; 1005 nausea gone; epi pen administered in lateral left thigh; 1006 BP 104/70 radial pulse 68; 1008 BP 102/70 radial pulse 80; skin warm dry pink; EMS called and responded; transfer of care occurred at 1020am; patient refused to go to hospital; remained in our recovery area for 30 minutes post epinephrine injection. left with husband at 1040am. Vitals within normal limits.
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| 66 | 2021-01-27 | redness | noted redness to entire face and left deltoid, redness subsided |
| 66 | 2021-01-29 | injection site pain |
Pfizer-BioNTech COVID-19 Vaccine EUA Side Effects: Injection site pain, tiredness, headaches, join...
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Pfizer-BioNTech COVID-19 Vaccine EUA Side Effects: Injection site pain, tiredness, headaches, joint pain, feeling unwell, swollen lymph nodes, rough-feeling throat lasting just over 24 hours
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| 66 | 2021-01-30 | injection site reaction, injection site pain |
Muscle pain started with heaviness and stiffness around the injection site in left arm in the evenin...
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Muscle pain started with heaviness and stiffness around the injection site in left arm in the evening of being injected. By day two muscle pain had spread to the top of the deltoid and around shoulder joint. Through the sixth day it centralized in two knots at the topmost trapezius/supraspinatus and semispinalis capitis. The worst was day seven when the pain began to extend up and down the left side of the spine. On days eight and nine, the pain left the spine and started migrating back toward the shoulder and the knots of pain diminished. By the tenth day (today) it has localized again in the deltoid/shoulder joint and injection location. Note: No fever at any time. It appears I am recovering.
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| 66 | 2021-01-30 | shingles, rash, itchy skin |
Quarter size Herpes zoster rash on left buttock. Itchy, pain, bumpy. Have had shingles many times i...
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Quarter size Herpes zoster rash on left buttock. Itchy, pain, bumpy. Have had shingles many times in the past. Received Zostavax vaccine in 2017. Started Acyclovir 400 mg 5 times a day
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| 66 | 2021-01-31 | skin tightness |
Second vaccine Lot Number - EL3248 . 1/19/2021. Twitches in the left calf on the back. Then went t...
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Second vaccine Lot Number - EL3248 . 1/19/2021. Twitches in the left calf on the back. Then went to the upper leg. Short pains then they would come and go. Then the pain went to the right leg. Numbness under the left knee. Feel like her calf is full. Going to see a neurologist.
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| 66 | 2021-02-01 | itchy skin, hives |
Patient reports a week after dose she experienced on opposite side of where dose was administered, s...
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Patient reports a week after dose she experienced on opposite side of where dose was administered, scalp itchy, her face broke out (hives). If she doesn't take Benadryl her face itches and hives. Patient says she developed allergies after HepB shot and influenza vaccine caused he to have vertigo.
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| 66 | 2021-02-01 | redness |
This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm on 15Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included diabetic, allergies, asthma and allergies to mold, pollen and iodine. Concomitant medications included metformin, glimepiride, simvastatin, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and amitriptyline. The patient previously took cefaclor (CECLOR) and experienced allergies. On 15Jan2021 at 15:15, the patient's face, chin and chest turned bright red. The patient also experienced hot sensation all over and tightness when breathing. No treatment was received. The outcome of the events was recovered on an unspecified date. Information on Lot/Batch number has been requested.
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| 66 | 2021-02-01 | injection site pain, rash |
pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched ne...
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pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched nerve in my neck and blood pressure went up to 182/98; arm where she got the shot hurt like it was very tender; left breat hurt/then right breast hurt; having a little bit of trouble with asthma; congested and sneezing; congested and sneezing; bumpy rash on her chest and arms; puffiness/swelling in the neck; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration on 14Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing asthma and high blood pressure unknown if ongoing; both from unknown dates. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) for asthma, unspecified vitamins and an inhaler for asthma. On 14Jan2021, the patient received the vaccination. She had a reaction to the vaccine almost immediately within 15 minutes of receiving vaccine. First, she had a pinched nerve in her neck and blood pressure went up to 182/98. Then about an hour later, the arm where she got the shot hurt like it was very tender. Then, her left breast hurt, followed by her right breast hurt. A few days later on 17Jan2021, she had breast pain and also pain under her arm. In Jan2021, she was also have some trouble with her asthma, was congested and sneezing. She had bumpy rash on her chest and arms. It was like tiny little bumps but it was not painful. She also had puffiness/swelling in the neck. The clinical outcomes of the pinched nerve in her neck, blood pressure went up to 182/98, arm where she got the shot was tender, breast pain, pain under arm, trouble with her asthma, congested and sneezing, bumpy rash, and puffiness/swelling in the neck were unknown.
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| 66 | 2021-02-01 | blister, skin discolouration, bruising |
soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going...
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soreness; tiredness/Tired; looked bruised/Looked like a bruise and then in the afternoon I was going to take my late night showers I looked at it and it had blister on it; blister; didn't sleep well/Didn't sleep well; sore arm; Around the skin it is discolored; This is a spontaneous report from a contactable consumer A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 08:15 at a single dose for COVID-19 immunization. Medical history included covid-19 around 15Jun or 16Jun2020 and did the quarantine. The patient's concomitant medications were not reported. Patient had soreness and tiredness the next day after vaccination on 16Jan2021 and took TYLENOL every 4 hours. She was concerned because on 16Jan2021, when she was going to take shower, it looked bruised, and blister on it. Patient didn't know what to do. Patient applied ice packs. The patient had patches, blister on top of that and it was not at the injection site. It's where she applied the ice. That was on 15Jan2021. She also didn't sleep well on 15Jan2021. She took ibuprofen but was not running a fever with no itching. Around the skin it was discolored on Jan2021. Patient was scheduled to get the 2nd dose in 3 weeks. Patient took her Pfizer Vaccine (Covid Vaccine) on Friday morning the 15th approximately 8:15 in the morning. Other than a sore arm on Friday she was okay. They told her to put ice pack on it for soreness. So she did that afternoon. On 16Jan2021, she looked at it in the morning It looked like bruise on the arm, not where she gave patient the injection but down a little below her arm and it looked like a bruise and then in the afternoon she was going to take my late night showers I looked at it and it had blister on it. She took Ibuprofen. She didn't have fever. She felt herself today. On 16Jan2021, in the morning she did feel tired and she did take afternoon nap for about 2-3 hours because before that she didn't sleep well. She already knew that she need at least 8 hours. Patient height was reported as about 5'3.Outcome of the event soreness was not recovered while for the remaining events was unknown. The reporter considered the events as non-serious. Information on lot number/batch number was requested. Follow-up (17Jan2021): New information received from a contactable consumer included: new event (sore arm), patient weight, and event details.
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| 66 | 2021-02-02 | rash, itchy skin, rash with redness |
Message from patietn: Due to other vaccine reactions I had to wait for 30 minutes after my shot. A...
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Message from patietn: Due to other vaccine reactions I had to wait for 30 minutes after my shot. All was okay, until I got in the car to drive home. My tongue began to tingle and headaches began. I immediately took an antihistamine as a tingly tongue for me is a sign of an allergic reaction. I then had a band like pain across my upper back, and then the chills, tiredness, nausea, sore throat, sore arm which are all normal reactions from the printed information - well except for the tingly tongue and a red rash across my nose, cheeks and chin. Tingling and rash subsided about an hour after taking the antihistamine, but all of the other symptoms remained. My shot was at 1:50 PM and just before 11 PM I had instant onset of pain in my chest wall with breathing. It went across the top of both breasts in the center where my ribs meet my sternum. This has lessoned with laying down, but when I am up and about it increases although not as bad as last night. I am also experiencing bursts of itchy spots all over. As I have an EpiPen I did not go to hospital but am wondering about what to do for the 2nd shot. I think it will be best if I take an antihistamine prior to the shot and I will continue taking them for this one until my symptoms go away.
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| 66 | 2021-02-04 | vaccination site pain, vaccination site swelling |
Chills/rigors; wheezing; shortness of breath; cough; myalgias; local vaccination site swelling as we...
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Chills/rigors; wheezing; shortness of breath; cough; myalgias; local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); This is a spontaneous report from a contactable physician (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3283), via an unspecified route of administration on 20Jan2021 at a single dose on Right deltoid for COVID-19 immunization. Medical history included Chronic lymphocytic leukemia with 65% of cells lymph's, low WBC count (13500) otherwise; DM2, A1C usually close to 6.1; HTN. Unspecified concomitant medication taken. The patient previously took nickel and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9331), intramuscular on 31Dec2020 12:15 PM at a single dose on left arm for COVID-19 immunization. The patient experienced chills, rigors, wheezing, shortness of breath, local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop), cough, myalgias on 20Jan2021 23:30. Therapeutic measures were taken as a result of the events which included Benadryl, Aleve, Nebulizer treatment, change in local temperature to help stop rigors. The outcome of the events was recovering. No other vaccine in four weeks. The patient was not pregnant. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
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| 66 | 2021-02-04 | rash |
Developed runny nose, sneezing, muscle aches/joint pain, nausea, scratchy throat, sinus pressure, ra...
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Developed runny nose, sneezing, muscle aches/joint pain, nausea, scratchy throat, sinus pressure, rash on chest/neck, fatigue. Saw medical provider on 2/02/2021 who suspected above due to receiving 1st dose of covid-19 vaccine.
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| 66 | 2021-02-04 | redness |
Noticed pt had a red face while waiting in the post vaccination area I asked if this her normal She ...
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Noticed pt had a red face while waiting in the post vaccination area I asked if this her normal She said no She reported , nausea, dizzy. I brought to the EMT area They assessed her Hr 75 oxygen sat 95% BP 179/93 epi administered Iv insertion attempted by EMT x2 no results Glucose 91 by EMT Pt sent to ED 955
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| 66 | 2021-02-04 | skin reaction, redness |
Raised, red vaccine site - 2 inches noted on Feb 5. Felt faint, short time - for approximately 10 mi...
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Raised, red vaccine site - 2 inches noted on Feb 5. Felt faint, short time - for approximately 10 minutes on Feb 4.
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| 66 | 2021-02-04 | vaccination site pain |
She had a tiny bit of soreness if she touched the vaccine injection site, but did not experience any...
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She had a tiny bit of soreness if she touched the vaccine injection site, but did not experience any soreness if she moved or lifted her arm; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 16Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had her first dose of the Pfizer COVID-19 Vaccine on Saturday, 16Jan2021, with no side effects. The patient stated that she had read in the past that taking 1 ibuprofen before and after the flu vaccine was recommended. She said she also had medical people tell her the same. She recently read a study where it is recommended a person shouldn't take ibuprofen before or after receiving the COVID-19 Vaccine because the ibuprofen might interfere with the vaccine's effectiveness. She said she is now in a bit of a quandary moving forward, as to if she should take any kind of analgesic, or Ibuprofen, or anything of that nature before getting her second COVID-19 Vaccine dose. She took 1 Advil prior to receiving her first dose of the COVID-19 Vaccine. She wanted to know if she should not take any ibuprofen before her second COVID-19 Vaccine dose. The patient reported further that on 16Jan2021, she had a tiny bit of soreness in her arm, only if she touched the COVID-19 Vaccine injection site. She does not experience any soreness if she moved or lift her arm. Outcome of the event was unknown. Information on the batch/lot number has been requested.
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| 66 | 2021-02-04 | vaccination site pain |
Sore at injection site; This is a spontaneous report from a contactable consumer (patient herself). ...
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Sore at injection site; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the left arm on 06Jan2021 15:30 at a single dose for COVID-19 immunization. The patient was vaccinated in a doctor's office/urgent care. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient is not pregnant at the time of vaccination. On 06Jan2021 16:00, the patient experienced sore at injection site with outcome of recovered on unspecified date in Jan2021. The patient did not receive treatment for the reported event. The case was considered non-serious. Information on the lot/batch number has been requested.
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| 66 | 2021-02-04 | vaccination site pain |
left arm discrete soreness; This is a spontaneous report from a contactable Other HCP. A 66-years-o...
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left arm discrete soreness; This is a spontaneous report from a contactable Other HCP. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL1283, via an unspecified route of administration on 15Jan2021 18:45 at SINGLE DOSE Vaccine location: Left arm, dose number: 1 for covid-19 immunisation. Medical history is none. Concomitant medication included bisoprolol (BISOPROLOL), rosuvastatin (ROSUVASTATIN), asa (ASA). The patient experienced left arm discrete soreness on 15Jan2021 21:30 with outcome of recovered in Jan2021. The action taken was not applicable.
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| 66 | 2021-02-06 | itchy skin, redness, skin hardening, skin warm |
9th day after injection, once again have 1.5 inch diameter redness, hardness, itching, warm to touch...
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9th day after injection, once again have 1.5 inch diameter redness, hardness, itching, warm to touch. Arm again moderate sore. Same reaction after initial shot which cleared up around 5th day. No other symptoms.
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| 66 | 2021-02-06 | injection site rash, injection site pruritus, injection site redness | Redness, tash, itching at injection site |
| 66 | 2021-02-06 | injection site redness | Tiredness (no energy) Headache Chills Fever 107 Injection site redness Nausea |
| 66 | 2021-02-07 | itchy skin, redness |
1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Bena...
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1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Benadryl given with good effect. C/O nausea and decreased appetite 1/30 received PRN Zofran with good effect. No further complaints 2/1
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| 66 | 2021-02-07 | hives, rash |
Rash started then turned into hives on the neck the rash moved to her hands, then her feet. now it ...
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Rash started then turned into hives on the neck the rash moved to her hands, then her feet. now it is on her back rash is on fire
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| 66 | 2021-02-07 | injection site pain |
pain in injection site, up shoulder, down elbow on rt arm, small of back pain, left quad pain up hi...
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pain in injection site, up shoulder, down elbow on rt arm, small of back pain, left quad pain up hip, shooting pain up spine, torso pain
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| 66 | 2021-02-08 | rash, rash papular, itchy skin |
I started having itching on my lower back, almost like a rash. When I scratch it does come up. My he...
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I started having itching on my lower back, almost like a rash. When I scratch it does come up. My head and left ear and some spots on my hands, continue to itch. As soon as I start scratching little bumps come up. My scalp continues to become really itchy, I never had this before, the itch is constant. As soon as I scratch it starts to itch even more. I used some cream for my hands every once in a while. I started having pressure in my chest from my anxiety but felt a little more. She referred my to the Cardiologist to get a work up, but she believes it's due to my anxiety not the vaccine.
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| 66 | 2021-02-08 | itchy skin, redness | Itching to chest, neck, back and head within 10 minutes of vaccine administration |
| 66 | 2021-02-08 | itchy skin |
Patient reports tingling in the mouth and sudden pruritis appnx. 15 minutes after the vaccination. V...
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Patient reports tingling in the mouth and sudden pruritis appnx. 15 minutes after the vaccination. VS taken, (WNL) 113/62, HR of 94 and O2 sat of 97%. Patient states she will self medicate when she gets home w/Benadryl. Patient stated feelings have subsided and has been discharged 11:10am.
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| 66 | 2021-02-08 | rash macular |
left eye pain and redness, red patches and swelling under left eye started out slight and has swolle...
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left eye pain and redness, red patches and swelling under left eye started out slight and has swollen bag under eye, itchy eyes, redness and tingling in the area has also moved to my upper eyelid and eyebrow/temple area. Left cheek and left side of head are tingling.
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| 66 | 2021-02-09 | shingles, blister |
48 hrs after vaccination developed severe abd/low back pain. Worked up for diverticulitis but all te...
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48 hrs after vaccination developed severe abd/low back pain. Worked up for diverticulitis but all tests were WNL. 8 days after vaccination she develop blisters on left lower back and abd area and was then dx with shingles and started on acyclovir.
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| 66 | 2021-02-09 | rash, redness |
Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2...
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Pt was brought by wheelchair from Covid Vaccine clinic where rapid response was called; pt reports 2nd dose pfizer vaccine given; after obtaining chart pt reports "feeling flushed, and then redness/rash on chest, and blood pressure go up". Pt given epi during rapid response; Pt reported a headache at this time. Pt denies dizziness, nausea, diarrhea, sob, no facial swelling, no lip swelling; no dysphagia; RR equal non-labored; Alert and orientated x4;
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| 66 | 2021-02-09 | vaccination site itchiness, vaccination site rash |
Rash more like itchy area above the injection site; Rash more like itchy area above the injection si...
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Rash more like itchy area above the injection site; Rash more like itchy area above the injection site; Sore arm; reconstitution problem / 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS; patient received approximately "double strength dose"/ 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS, the recommended 0.3ml dose was then administered to the patient; medical history included rheumatoid arthritis; medical history included rheumatoid arthritis; This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, exp. date May2021) via unspecified route of administration on 25Jan2021 at 11:45am at 0.3 mL single dose in right deltoid for COVID-19 immunization. The patient's medical history included ongoing rheumatoid arthritis. The patient's concomitant medications included ongoing hydroxychloroquine for rheumatoid arthritis. The patient experienced sore arm on 26Jan2021, rash more like itchy area above the injection site on 27Jan2021. The patient had no treatment. Pharmacist stated is was a reconstitution problem. He did not have a syringe bigger than 1 ml so he put 0.8 ml, got distracted and forgot to put the rest of the diluent. 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS. The recommended 0.3ml dose was then administered to the patient. The patient received approximately "double strength dose". After applying the vaccine, he remembered that he did finish the preparation of the vaccine. The patient is a co-worker and they have been checking on her to see if she developed any adverse effect. The event was reported as non-serious. The patient recovered from sore arm. The patient was covering from rash more like itchy area above the injection site.
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| 66 | 2021-02-09 | hives, rash |
allergic reaction; Rash kind of hives in upper chest and neck area; Rash kind of hives in upper ches...
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allergic reaction; Rash kind of hives in upper chest and neck area; Rash kind of hives in upper chest and neck area; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL1284) , via an unspecified route of administration on 06Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included blood pressure abnormal, cholesterol abnormal. Concomitant medication included atorvastatin for cholesterol abnormal, warfarin sodium (COUMADIN). The patient stated that, " I got very bad rash it kind of looks like hives in my upper chest and in my neck area but that was like maybe 11 days later (17Jan2021) and I went to urgent care and they gave me prescription for prednisone, which is cleared it up but then I saw my primary doctor on Monday the 18th and my primary doctor recommends that I should not get the second vaccine, which I have an appointment for on Thursday and I am very confused, I don't know this is the reaction from the Covid vaccine. I just I am very confused and I would like feedback if I could get some, did anybody recorded any kind of allergic reaction like 11 days later, I got the first one I am due for the second one. I went to urgent care and they prescribed me Prednisone and Zyrtec for 5 days." Therapeutic measures were taken as a result of the events. The outcome of the events was resolved on an unspecified date.
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| 66 | 2021-02-10 | rash, rash macular |
3rd day I could barely move my limbs. Rash all over my upper torso. Tiny red dots in my skin Extr...
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3rd day I could barely move my limbs. Rash all over my upper torso. Tiny red dots in my skin Extremely tired. Hard time opening my eyes. Moving limbs. Slept 30 hrs.
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| 66 | 2021-02-10 | injection site pain, injection site swelling |
Injection site pain, Tiredness, Muscle pain in L arm, injection site swelling, Nausea, feeling unwel...
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Injection site pain, Tiredness, Muscle pain in L arm, injection site swelling, Nausea, feeling unwell, weakness, brain fog, lasted 40 hours.
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| 66 | 2021-02-10 | injection site redness | Site: Redness at Injection Site-Mild |
| 66 | 2021-02-10 | itchy rash, skin laceration |
Small rash on hind that itched for a couple of hours. Once it stopped itching the rash turned in to ...
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Small rash on hind that itched for a couple of hours. Once it stopped itching the rash turned in to what looked like a burn mark and the skin starting tearing and bleeding. I?ve been wearing a bandaid and I still have the mark today (1 week later), although it is slowly going away.
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| 66 | 2021-02-10 | skin peeling | The skin on my hands and feet deeply peeled. |
| 66 | 2021-02-10 | hives |
Within fifteen-minutes of vaccination, the patient reported that her lips; tongue; and throat became...
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Within fifteen-minutes of vaccination, the patient reported that her lips; tongue; and throat became "tingly and itchy". She also reported feeling lightheaded. She denied difficulty breathing or pain. EMS assessed patient and found urticaria present on face. Lung sounds were clear with normal respirations. Patient was hypertensive (185/92). Patient remained hypertensive (177/96), but stated the tingling and itching sensations had subsided. They refused transportation to a hospital for evaluation.
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| 66 | 2021-02-10 | redness |
on the fourth day following the second dose A red area painful appeared on my right breast with a lu...
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on the fourth day following the second dose A red area painful appeared on my right breast with a lump about size of cashew nut just above nipple area. It is still there on 6th day although not as sore. I have not received treatment or gone to doctor, waiting to see if it goes away in a few days.
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| 66 | 2021-02-14 | hives, itchy rash |
Had first shot at 1:30pm no probs all day and night....Sunday morning no probs....then approximately...
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Had first shot at 1:30pm no probs all day and night....Sunday morning no probs....then approximately 11pm at night start feeing a little itchy on upper torso down to groin.....but not bad.....approximately 3am...I was really itchy....got up looked at my torso and it was bright red and had hives(welts) on torso, breasts, stomach and groin areas.....No problem with breathing or swallowing.....Took 2 benedryl pills and within 30 minutes itching subsided ...redness starting to tone down....welts getting smaller. All is clear as of now.
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| 66 | 2021-02-14 | itchy skin, redness |
PATIENT DEVELOPED ITCHING, REDDNESS,SWELLING AND JOINT PAIN OF LEFT LOWER EXTREMITY THE DAY AFTER RE...
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PATIENT DEVELOPED ITCHING, REDDNESS,SWELLING AND JOINT PAIN OF LEFT LOWER EXTREMITY THE DAY AFTER RECEIVING COVID 19 VACCINE. SHE WAS SEEN BY HER PCP ON 2/8/21 AND VENOUS DOPPLER WAS ORDERED.
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| 66 | 2021-02-15 | injection site warmth, injection site pruritus, injection site discolouration |
An area about 2" high X 4" long and about 2" below the shot site became slightly pink, itchy , warm...
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An area about 2" high X 4" long and about 2" below the shot site became slightly pink, itchy , warm and sensitive to the touch. It gradually went away after 2 to 3 days. All is quiet since then....
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| 66 | 2021-02-15 | injection site bruising |
Significant bruising at injection site approximately 2 inches in diameter lasting approximately 10 d...
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Significant bruising at injection site approximately 2 inches in diameter lasting approximately 10 days to 2 weeks. No treatment and bruise eventually dissipated. Never had this happen with any other vaccine and the injection was uneventful.
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| 66 | 2021-02-15 | skin warm, redness |
pain, swelling and redness of arm; redness and numbness of face, redness and burning sensation of fa...
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pain, swelling and redness of arm; redness and numbness of face, redness and burning sensation of face persists.
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| 66 | 2021-02-16 | injection site pain |
Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days ...
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Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days Upper arm still sore after 12 days. Pain on movement and unable to sleep on that side, as the arm pain awakens me. Also, the injection seemed to be placed extremely high on the arm, about an inch from top of shoulder and in the center/front or arm where it more bone/less muscle
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| 66 | 2021-02-17 | itchy skin |
Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest...
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Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest pain; body ache; high fever; fatigue; profuse sweating; belabored breathing; hot; butterfly rash of face; This is a spontaneous report from a contactable physician (patient). A 66-year-old female (Not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 11Feb2021 14:30 at single dose for covid-19 immunization. Medical history included hypothyroidism, hypertension, hypercholesterolemia, breast cancer, osteoporosis, ligamentous RA, degenerative joint disease (DJD). The patient had known allergies to cilantro, cephalosporins, all morphine and morphine derivatives, Herceptin, astralogous mushrooms, gadolinium dye, fentanyl. The patient's concomitant medications reported as other medications in two weeks was yes.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, eye pain, earache on side of shot, itching both arms, severe jaw pain, severe chest pain, body ache and high fever &fatigue - profuse sweating, belabored breathing hot butterfly rash of face on 12Feb2021 at time of 06:00 AM. AEs resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient received Prednisone 80 mg and Benadryl 50 mg as treatment. Prior to vaccination, the patient was diagnosed with COVID-19. Covid was tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab and PCR test: negative on 09Feb2021. The outcome of events was recovering. Information on Lot/Batch has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-02-18 | rash |
2/11/21:sore arm 2/12/21: swollen lymph glands in neck, slight sore throat, in evening fever 100.6 F...
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2/11/21:sore arm 2/12/21: swollen lymph glands in neck, slight sore throat, in evening fever 100.6 F maximum 2/13/21: swollen lymph glands in neck, slight sore throat, afebrile, generalized rash over trunk and anticubital area 2/14/21: swollen lymph glands in neck, slight sore throat, afebrile, rash mostly faded 2/15/21 to 2/18/21 swollen glands in neck, slight sore throat, afebrile, no rash 2/19/21 (today): swollen lymph glands in neck, slight sore throat (improving), afebrile, no rash
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| 66 | 2021-02-18 | injection site swelling |
Patient received her first dose of Pfizer COVID. Lot # EN2600 Site: RD Patient started to develop ...
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Patient received her first dose of Pfizer COVID. Lot # EN2600 Site: RD Patient started to develop swelling to her right shoulder at the injection site where she had a COVID-19 vaccinate. Patient was referred by the vaccinator staff to go to the ER for evaluation. During the examination, patient denied any itching, redness, or new rash. Patient also denied any sensation of tongue, throat, or neck swelling. Patient also denied SOB or palpitation during visit. She denied history of allergy to eggs. For the swelling at the injection area, she said it was mildly sore but not particularly painful.
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| 66 | 2021-02-18 | injection site pain | Pfizer, dizzyness, sore injection site, fast heart rate |
| 66 | 2021-02-21 | rash, itchy skin |
Rash started 2 days after, continued to spread daily through sunday on bilateral arms, hips, thighs...
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Rash started 2 days after, continued to spread daily through sunday on bilateral arms, hips, thighs, ankles lower legs Itchy, sent pics to portal endocrinologist and office visit to dermatologiston monday . after trying benedryl and hydrocortisone cream derm ordered steroid prescription cream and endocrinologist ordered oral steroid pac, will wait till friday before start oral to see if gets better
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| 66 | 2021-02-22 | skin warm |
2 days after vaccination right thighs and right leg started to have pain similar to pain I got with ...
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2 days after vaccination right thighs and right leg started to have pain similar to pain I got with polymyalgia rheumatica that I have had in past and I though it was a flare up. A couple of days after that right leg started to swell and was warm. Went to ER on 1/29/2021 and had doppler which showed blood clots from groin area to below the knee. I was placed on Xarelto at that time. Got 2nd dose and about 24 hours latter back of thighs started to hurt again. Called doctor and applied heat and elevation and had no new swelling but I remain on Xeralto. Not sure if it was related but I have had no history of blood clots. 2 years previously broke my right patella and was with brace and no weight bearing for about 8 weeks and brace for 12 weeks without clot issues. Traveled by car a couple thousand miles last year and no issues.
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| 66 | 2021-02-22 | rash |
Exactly a week after receiving the Pfizer vaccine I noticed a red rash on both of my ankles. Mostly ...
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Exactly a week after receiving the Pfizer vaccine I noticed a red rash on both of my ankles. Mostly the interior area of the ankle. There is also some mild swelling. No pain or itching. I have had no other symptoms since receiving this vaccine, not even a sore arm at the injection site.
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| 66 | 2021-02-22 | hives | Hives, urticaria within 5 minutes of administration. Treated with antihistamines. Good results. |
| 66 | 2021-02-22 | injection site pain, itchy rash |
Injection site pain, tiredness, headache, muscle pain up and down Rt side of body from neck to feet...
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Injection site pain, tiredness, headache, muscle pain up and down Rt side of body from neck to feet, itchy rash all over torso, heart palpitations and pain.
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| 66 | 2021-02-22 | itchy skin, blister, rash |
Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itchi...
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Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Scarring; This is a spontaneous report from a contactable nurse (patient herself). A 66-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EK4176), via an unspecified route of administration in the left arm on 19Jan2021 at 10:00 as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not have any other vaccine in four weeks, did not have other medications in two weeks, did not have COVID prior to vaccination, has no known allergies, and was not pregnant. There were no concomitant medications. On 24Jan2021 at 08:00, the patient experienced pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on the vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm erupted after 4 more days. Scarring and itching up for two weeks. The patient was not tested for COVID after vaccination. As treatment, Permethrin cream was used to see if it was scabies to "no eff". The adverse events resulted in a doctor or other healthcare professional office/clinic visit and disability or permanent damage. Outcome of the events was recovering.; Sender's Comments: Based on temporal association and/or known drug profile a contributory role of BNT162B2 to the reported events cannot be totally excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-02-22 | rash | Rash on trunk. 13 and still profuse |
| 66 | 2021-02-22 | itchy skin |
She received her 2nd shot on 2/20/2021. Within minutes she noticed that she could not see, due to l...
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She received her 2nd shot on 2/20/2021. Within minutes she noticed that she could not see, due to localized swelling around her eyes. She began to feel itchy and her tongue felt swollen. She was taken to ED and was given Benadryl and Solu-Medrol, her symptoms continued and she was administered epinephrine about an hour later which immediately cleared up her symptoms. She has some residual generalized itching and has been taking Benadryl 50 mg every 6 hours until 9:00 p.m. yesterday. She also takes Zyrtec 10 mg daily starting yesterday. She denies having any dizziness or lightheadedness, hives urticaria, nasal congestion, weepy eyes, diarrhea or abdominal cramping. She does endorse nausea and was administered Phenergan in the emergency department. She also endorses that her eyes felt itchy. She also endorses that she was able to swallow. Takes celebrex but paused this prior to the vaccine to prevent possible anti-inflammatory interrupting vaccine efficacy. Her ED record is available for review. Exam findings endorse she is tolerating secretions, speaking in full sentences and her tongue was not enlarge. No labs were drawn during her visit. She denies historical reactions to vaccines. She does get itching with some medications. Historical angioedema/urticaria post pistachio and bran muffin were singular events and have not recurred. She had a normal tryptase in 2014
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| 66 | 2021-02-22 | redness, itchy skin |
Two days after vaccine: extreme fatigue and chills. Symptoms lasted just that one day. Four-five...
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Two days after vaccine: extreme fatigue and chills. Symptoms lasted just that one day. Four-five days after vaccine, full-body itching. Just thought it was my eczema flaring up (it's worse in the winter). After about 2 weeks, developed red areas on my body (torso, arms, legs and feet) - self-monitored - but got progressively worse. Dermatologist believes it is eczema aggravated by the vaccine. Provided a cortisone injection (right arm). Will monitor for two weeks to determine improvement or lack of improvement.
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| 66 | 2021-02-23 | hives |
Approximately 10 hours after the injection, she experienced one hive on her right cheekbone. She had...
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Approximately 10 hours after the injection, she experienced one hive on her right cheekbone. She had bilateral ocular swelling the next morning. She used topical benadryl 1-2 times that day and her symptoms resolved completely within 3 days
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| 66 | 2021-02-23 | itchy skin, hives, rash |
She started itching on 2/18/21 and bumps started on her legs, itching. It then spread to her knees, ...
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She started itching on 2/18/21 and bumps started on her legs, itching. It then spread to her knees, legs, side, arm and her back. It came and then it went away, then it came back again twice that day. Each day it would come and go and would leave hives on her body. She took Benadryl and then started having ankle issues, and then a ball formed on the bottom of both feet, which lasted for several hours and went away. She went to the hospital yesterday 2/23/21 and broke out into hives again and then went to the hospital as her PCP did not have an opening. They told her that they had had some report of people breaking out with hives, and told her to not to get hot, keep the house on a cool temperature. He prescribed Prednisone and Pepcid and to continue with the Benadryl and suggested to not to take the 2nd shot. She called the help desk to see if it was okay to take the Prednisone and answered her questions and told her there was no indication that she could not take it. The symptoms still come and go with the hives and itching.
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| 66 | 2021-02-23 | injection site bruising, injection site redness |
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injec...
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Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: PATIENT PRESENTED FOR SECOND SHOT, STATING SHE STILL HAS MUSCLE PAIN FROM 1ST SHOT 21 DAYS AGO. IN ADDITION THERE WAS STILL BRUISING, AND SOME UNIDENTIFIED RED SPOTS. I INSTRUCTED HER TO CONSULT HER DOCTORE, WHICH SHE HAD NOT YET, AS THIS COULD BE A SIGN OF SOMETHING THAT REQUIRES MEDICAL TREATMENT
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| 66 | 2021-02-23 | rash with redness |
The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to tha...
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The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to that dose. (Had arm pain and mild chills and fatigue). The day after dose two above noted fullness and discomfort in feet, On the second day after, had early erythematous (non-puritic) rash, mild multi-joint discomfort, 100 deg fever, and shaking chills. Doctor on call said to use judgment on starting Prednisone, since hope that this would stabilize. However, progressed and at 9am on the third day after vaccine started prednisone 40mg. At the worst, had to be dressed by husband due to pain and stiffness in upper extremities, widespread erythematous rash, fullness of skin, joint swelling.
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| 66 | 2021-02-23 | skin tightness |
Tongue feels thick 8:05 slight headache 0819 headache better. Lungs clear b/p 122/78 pulse 68 respi...
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Tongue feels thick 8:05 slight headache 0819 headache better. Lungs clear b/p 122/78 pulse 68 respirations 18. Patient cheerful and talkative, color pink. 0821 Swelling in tongue better. Denies shortness of breath. 0824 left arm feels tight. 0831 patient denies further care. States she going to have a work up for MS. Her sister has MS. Patient refuses further medical care here and states she is feeling ok. Tongue is feeling less thick and arm is less heavy. Patient states she would like to leave with her husband to go home. Patient is talkative and cheerful at this time. Speech is clear(husband states she had anxiety about getting the vaccine) Advised to call MD or 911 if needed.
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| 66 | 2021-02-23 | itchy skin, hives |
Was diagnosed WITH Covid first symptom on 2/18/2021. Day 1: felt slight fever; Day 2: Extreme headac...
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Was diagnosed WITH Covid first symptom on 2/18/2021. Day 1: felt slight fever; Day 2: Extreme headache (which I never get) low grade fever; Day 3:Hives and itche sin addition to dry cough; Day 4 - Hives deep red, full torso and back, top of legs and pubic areas. Deep and extreme.Chills Steady, Night Hard vomiting, Hives, Soaking Night sweats (never had before), Temp 101.5. Day 5 Morning - rapid test negative, fever 99.9. Started Ibuprofen Day 6 - Hives same - extremely dark and red. itchy. # day swab test was POSITIVE. Put on Prednisone. Day 7 - Fever normal, Hives going down but still ugly. Not sure whether this was really an adverse event as it was a positive test result AFTER the vaccine. I am an allergig person whose eosinophils report for duty quickly and obviously too much! I will assume that they were the result of the virus and NOT the drug as the drug does not have an active virus included. Your call.
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| 66 | 2021-02-23 | skin discolouration, rash macular, itchy skin, redness |
Within 5 minutes of receiving vaccine, patient developed purplish hands, red blotches on her arms, g...
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Within 5 minutes of receiving vaccine, patient developed purplish hands, red blotches on her arms, generalized itching. She felt thirsty, dry throat and a little bit of fullness in her throat. Throat did not actually close. She felt like she was looking through a fog. She was given oral zyrtec and IM benadryl. Symptoms resolved.
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| 66 | 2021-02-23 | rash |
fever, aching, spasmodic stabbing pains, teeth hurt, localized tooth pain, underwent emergency root ...
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fever, aching, spasmodic stabbing pains, teeth hurt, localized tooth pain, underwent emergency root canal on day 4 with "dying nerve", butterfly (lupus like) rash on face day 4, "covid arm" day 4 with tennis ball size red knot around injection site that extended down arm over next several days, winded for several days, fatigue and shortness of breath.
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| 66 | 2021-02-24 | injection site pain |
muscle soreness/mild pain at injection site (deltoid muscle) fo 24-36 hours after injection. Resolve...
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muscle soreness/mild pain at injection site (deltoid muscle) fo 24-36 hours after injection. Resolved spontaneously without requiring analgesics. No other adverse events noted.
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| 66 | 2021-02-25 | injection site bruising, injection site vesicles, redness |
About 38 hours after receiving the vaccine (2-20-21 - 1:00 am) I realized there was a blister locate...
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About 38 hours after receiving the vaccine (2-20-21 - 1:00 am) I realized there was a blister located on my shoulder about 1.5? to the right of the shot area (which was bruised). I don't know exactly when the blister started. I put 2-18-21 on this form since I didn't know. The size of the blister was approx. 1/4 x 3/8. I realized I had taken my blood pressure using the shot arm (3 times about 3 hours after receiving the shot and again the next day) and worried the tightness of the BP cuff had affected the shot and pushed the vaccine to cause the blister. I spoke to a couple of medical people at medical center and they didn't think so and said it was probably ok and to report it. The blister has gone away but the skin is a reddish pink.
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| 66 | 2021-02-25 | rash, itchy rash, rash with redness |
One day 4 after injection itchy, red rash was noted on abdomen. By day 7 the rash covered arms, legs...
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One day 4 after injection itchy, red rash was noted on abdomen. By day 7 the rash covered arms, legs, and trunk. As of today, day 9, the rash remains unchanged.
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| 66 | 2021-02-25 | itchy skin | Patient experienced increase heart rate with mild itching on right hand and right ear. |
| 66 | 2021-02-25 | shingles |
Shingles. My doctor said he has had a number of patients getting Shingles 2-4 days after getting sho...
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Shingles. My doctor said he has had a number of patients getting Shingles 2-4 days after getting shot. Some first shot some second shot.
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| 66 | 2021-02-26 | itchy skin |
147/67 BP 67 HR 18 RR 99% Pso2 on Room Air After receiving the first first doze of Pfizer vaccine...
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147/67 BP 67 HR 18 RR 99% Pso2 on Room Air After receiving the first first doze of Pfizer vaccine. Patient started developing pruritus around her face. Patient was taken to the assessment area where she now admits to a generalized itchiness. MD was informed. There is no rash, hives on the patient skin. Patient denies Shortness of breath at this time. Decision to give patient 25 milligrams of benadryl PO was consulted with MD and given to the patient. 11:20 patient states she feels much better at this time and her pruritus is gone. We will continue to assess and monitor patient. 11:30 patient was D/C per MD. Patient walked with a steady gait. No distress noted. Patient denies any dizziness, SOB, Patient will follow up with PCP
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| 66 | 2021-02-26 | rash | Rash under both arm pits snd now rash across chest and under arm pits. |
| 66 | 2021-02-26 | bruising |
Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank...
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Woke up at midnight with fever, chills, thirst. Tossed and turned all night, cold and thirsty. Drank about 20 oz of Crystal Light Peach Tea over night. Got up at 5am to get more to drink and find another place to rest. went into my kitchen to fill container and passed out. Woke a few seconds later. Left side of my forehead was bruised and swollen above left eye. Over the last 4 days both eyes an cheeks are bruised. All day felt like I had the flu without the fever. I did not go to the hospital.
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| 66 | 2021-02-27 | injection site rash, itchy skin, hives |
Day 5 after vaccine, developed 2 inch itchy rash below injection site. Rash progressed over 24 hours...
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Day 5 after vaccine, developed 2 inch itchy rash below injection site. Rash progressed over 24 hours to a large 5inch area. Itchy urticaria rash progressed to entire torso, front and back, pubic areas, both upper arms daily up to day 10 (today) when began to move up neck. Benadryl at night helped itch, topical Benadryl and topical hydrocortisone not helpful. Seen in Urgent Care clinic today by NP. Prescribed methylprednisolone dose pak 4mg for 6 days. Started dose at 4pm today (2/28/2021).
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| 66 | 2021-02-27 | itchy skin |
Insomnia, sleeplessness and brain fog starting one week after vaccine and lasting for one week. Sle...
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Insomnia, sleeplessness and brain fog starting one week after vaccine and lasting for one week. Sleeplessness was worse each night, with inablilty to sleep even with 50 mg of Benadryl and Valium. Did sleep about two hours a night with those meds but continued to be wide awake all day also. My body felt like it hadn't slept but was unable to do so. These symptoms left me suddenly with a severe chill and the brain fog litarally lifted and was gone. The next week following developed mild red itchy skin that comes and goes on hands and torso and that symptom persists. I am now able to sleep.
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| 66 | 2021-02-27 | injection site redness, injection site pruritus |
Spike in blood pressure occurred 3-4 hours after injection (controlled by additional medication) and...
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Spike in blood pressure occurred 3-4 hours after injection (controlled by additional medication) and again the day after. Injection site became red and itchy within an hour of injection; redness has spread down the arm and continues to itch on day 3. This did not occur with first jab. Loss of appetite, fatigue, and brain fog, the day of and next day.
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| 66 | 2021-02-27 | itchy skin, rash |
pt had vaccine friday afternoon was fine until Saturday around 1 pm she started to get a rash on h...
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pt had vaccine friday afternoon was fine until Saturday around 1 pm she started to get a rash on her face oNLy. NO wheR eLse. Saw MD who then predcribed prednisone & hydoxizine. Resolved in two days.
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| 66 | 2021-02-28 | redness, injection site pain |
2/25/2021 9:30am minor pain at injection site upper left arm 2/26/2021 1:30pm dull headache, backsid...
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2/25/2021 9:30am minor pain at injection site upper left arm 2/26/2021 1:30pm dull headache, backside of head and very tired 2/26/2021 5:30pm minor tongue swelling, minor throat and nasal passage constriction 2/27/2021 9:30am increased tongue swelling, increased throat and nasal passage constriction, minor difficulty swallowing, minor facial swelling 2/27/2021 6:30pm treatment at ER/Urgent Care with oral Prednisone tongue swelling started to decrease, released with Rx for Benadryl, Pepcid, Prednisone and EpiPen 2/27/2021 8:00pm started Benadryl + Pepcid. Tongue swelling decreased more, throat and nasal constriction starts to alleviate 3/1/2021 9:00am facial swelling continues with added redness to left side face and spot under right eye socket 3/1/2021 11:20am family doctor visit
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| 66 | 2021-02-28 | injection site pain, skin warm |
Loss use of right arm, Vaccine was given high up on arm near shoulder to the inside. Had trouble tak...
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Loss use of right arm, Vaccine was given high up on arm near shoulder to the inside. Had trouble taking off t-shirt in the evening, Arm had been very sore around injection site for days but by the 24th could barely raise right arm to remove shirt. Felt like two torn muscles. Since then, barely any use of arm, stays limp by my side. Painful and very warm. Have been resting and icing arm, very little improvement so far (total 12 days since vaccine)
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| 66 | 2021-02-28 | injection site pruritus |
Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room....
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Patient presented for COVID vaccine Pfizer dose 1 today. After injection and walked to waiting room. While she was sitting down patient started to complain of itchiness at injection site and felt like needed to scratch arm about 3 times, lasted only a minute. Started to feel lightheaded about 5 minutes after sitting down in waitng arae and notified observer. Felt weak and lighthed. Offered a wheelchair but refused and able to walk back to examination room. Taking Topamax this am for headaches, no other medications. Has COPD. Caring for adult daughter who is disabled and her husband left for a trip last Wednesday and back tonight. Patient often has interrupted sleep and up every couple hours with daughter. She has another daughter who will come and help at times but no one else around due to COVID concerns. Ate granola, blueberries, yogurt for breakfast this am Offered water in exam room, crackers and apple juice but patient refused. States has IBS and not want to eat other things In exam room feeling anxious, but the lightedness disappeared within 10 minutes. B/P decreased to 128/72. No nausea, abdominal pain, SOB. Denies any new illness. Has chronic cough with COPD Patient alert and oriented during entire visit and pleasant in conversation.
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| 66 | 2021-02-28 | vaccination site itchiness, vaccination site swelling, vaccination site warmth |
Took benadryl for injection site inflammation; Swelling; Itching; heat at injection site occurring o...
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Took benadryl for injection site inflammation; Swelling; Itching; heat at injection site occurring over the week post-injection; Knot; diarrhea which is like I had when I had Covid last fall.; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), on 01Feb2021 at 15:00 (at the age of 66-years-old) at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Doctor's office/urgent care. No other vaccine was given within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Other medical history included irritable bowel syndrome (IBS), and high blood pressure. Concomitant medications included linsinopril, estradiol, naproxen sodium (ALEVE), tocopherol (VIT. E), colecalciferol (VITAMIN D), multivitamin. On 03Feb2021 the patient experienced swelling, itching, knot, heat at injection site occurring over the week post-injection, injection site inflammation, as well as diarrhea which is like she had when had Covid last fall. The events resulted in emergency room/department or urgent care. As treatment received it was reported the patient took Benadryl for injection site inflammation. The events were resolving. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-02-28 | vaccination site pain |
veins in her hands are still swollen in the arms, its like the veins popped up; Numbness in arms and...
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veins in her hands are still swollen in the arms, its like the veins popped up; Numbness in arms and Hands; Tingling in Arm and Hands; some pain in the injection arm; muscles pain in the hands; a freezing cold sensation in her hands/her hands were frozen for 3-4 seconds; I would wake up with one hand completely numb; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included osteopenia and osteoporosis. She was shrinking, her height was about 5 feet 5 inches, she used to be 5 feet 7 inches. Concomitant medication included calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D3 [CALCIUM CARBONATE;COLECALCIFEROL]), fish oil, vitamin e nos (OMEGA 3 [FISH OIL;VITAMIN E NOS]), vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]), and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). It was reported that on 09Jan2021, she received the first dose of the vaccine. She started to feel tingling and numbness in both hands the same day after the vaccine was administered. She states she also had some pain in the injection arm and that the numbness/tingling was off and on and traveled to her arms occasionally. She states, "I would wake up with one hand completely numb and it was worse the first 15 days but is getting better and is a little less than before." She states she would have a freezing cold sensation in her hands occasionally and she states her veins were more prominent and visible in her hands/arms around the 13th day after getting the vaccine. She further reported that when she received the vaccine, that same afternoon she started feeling a tingling sensation in the hands and arms, also a sensation of numbness like electrical accompanied with muscle pain. The Numbness and Tingling was on and off and well as the muscles pain in the hands. It was more noticeable 13-14 days later now. She would be sleeping at night and would wake up because of the sensation in the left hand or on the other right hand. The hands would wake her up. She provides an example of its like when your foot is asleep with the pins and needles, because you had your foot squished under for a while, like the foot falling asleep but in this case she wasn't doing anything and would have that feeling. Once or Twice when having breakfast she noticed that her hands were frozen for 3-4 seconds. After the 13 or 14 days, things are milder but now she still has the sensation, its not so often but milder. She also notices the veins in her hands are still swollen in the arms, its like the veins popped up. She is still having this. She is concerned since she is suppose to get second injection on 30Jan2021, she is concerned if she should still it. She is nervous. She clarifies that the first dose was on 09Jan2021 at 10 or 10:15 AM. On the same day is when she started noticing the Numbness and tingling in the Hands and arms on 09Jan2021. She noticed the Veins popping on 22Jan2021. Caller clarifies that she has no side effects in the legs, she was just providing that comment as an example. The outcome numbness in arms and hands, tingling in arm and hands, wake up with one hand completely numb, was recovering; pain in the injection arm, muscles pain in the hands, freezing cold sensation in her hands was unknown; and veins in her hands are still swollen in the arms was not recovered. The reporter assessed the events as non-serious.
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| 66 | 2021-03-01 | pain of skin |
1/19/2021 vaccination *continued symptoms from 1st vaccine. Twitching in legs, can see the twitches ...
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1/19/2021 vaccination *continued symptoms from 1st vaccine. Twitching in legs, can see the twitches in both legs. Weird strange pains that last 3-5 seconds on skin; come and go. Internist, Neurologist referrals; no diagnosis as of yet. Ongoing symptoms.
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| 66 | 2021-03-01 | redness | 2/25/21 swelling and redden around arm. On 2/26/21 headache, body aches, chills and fever - 102. |
| 66 | 2021-03-01 | hives |
Twenty minutes post 1st vaccine dose on her left arm, patient began feeling light headed, tingling, ...
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Twenty minutes post 1st vaccine dose on her left arm, patient began feeling light headed, tingling, and warmth in her bilateral forearms. She then developed tingling at the tip of her tongue and had facial flushing. She developed rashes (hives in bilateral UE). She was brought for evaluation. Benadryl 50mg was given, Vitals taken and water was provided as well. She denies any SOB, CP, swelling or numbness. Physical exam: S1,S2, CTA, hives positive in bilateral UE, facial flushing, and neuro exam WNL. She reports her daughter had the Moderna vaccine a few weeks ago and developed full blown anaphylaxis. Her second daughter also had an allergic reaction to the MMR vaccine. She denies any history of allergic reaction to vaccines herself but does report allergies to several medications. About 10 mins post Benadryl administration, facial flushing resolved and the rashes in her forearms began to improve as well. Patient was recommended transport to the hospital/ER but she declined. She was instructed to contact her PCP for further evaluation. She was informed her second vaccine will have to be administered at an ER or facility that provides higher level of care. She was escorted to her vehicle to meet her husband.
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| 66 | 2021-03-01 | itchy skin |
With the first shot hands started itching and continued for about a week and half. Did'nt go to Doct...
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With the first shot hands started itching and continued for about a week and half. Did'nt go to Doctor just took otc Bendryl.Arm was a little sore. The second shot about 35 minutes later hands started itching but not as bad as the first shot and I did'nt take any otc Bendryl this time .shot was in same arm (left) it was more sore than the first shot and next day mild headache and sore throat by 3rd day felt better.
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| 66 | 2021-03-01 | rash with redness |
Within 3-5 Minutes, I got severe shooting pains in my left temple that went across my forehead with ...
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Within 3-5 Minutes, I got severe shooting pains in my left temple that went across my forehead with headache, Felt extremely hot and Red rash appeared on my face on both cheeks and when I got up to leave I had weakness in my legs and was dizzy. Was given benedryl by the pharmacist who stated it look liked I had a reaction. Still had pain in left temple, headache, rash and dizzyness the next day along with scratchy throat. Headache and pain in temple mild after 3 days. I am concerned about second dose only because of shooting pains in my left temple.
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| 66 | 2021-03-02 | injection site pruritus, injection site swelling, injection site redness, injection site rash | 9 days after vaccination, redness, swelling and severe itching near injection site |
| 66 | 2021-03-02 | rash papular, itchy skin |
On 2/19 @ 8:03pm, Red raised rash (bumps) across top of right breast. Burnt and itched. I took Bena...
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On 2/19 @ 8:03pm, Red raised rash (bumps) across top of right breast. Burnt and itched. I took Benadryl as soon as this happened. I Stopped itching and was getting better by 2/22/2021. (Bumps were not itchy, red at top, and stopped raising)
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| 66 | 2021-03-02 | redness, itchy skin |
Pt developed redness and itchiness on chest post-vaccination. Pt reports hx of allergic reactions af...
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Pt developed redness and itchiness on chest post-vaccination. Pt reports hx of allergic reactions after having surgeries in the past. Denies chest pain, palpitations, SOB, or trouble breathing. SpO2 99% on RA, un-labored breathing, lungs CTA bilaterally. Pt discharged under stable condition with Claritin 10mg x 1, ER precautions given.
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| 66 | 2021-03-02 | vaccination site swelling, vaccination site pain, vaccination site redness |
Raised, redness, swelling, tender at injection site; Raised, redness, swelling, tender at injection ...
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Raised, redness, swelling, tender at injection site; Raised, redness, swelling, tender at injection site; Raised, redness, swelling, tender at injection site; This is a spontaneous report from a contactable consumer (patient) reported that a 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on the left arm on 22Jan2021 11:45 at a single dose for Covid-19 immunization. The vaccine was administered at the workplace clinic. The patient medical history included allergic asthma, and had known allergies with penicillin both from an unknown date. Patient was not pregnant at the time of vaccination. Concomitant medication included melatonin taken from an unspecified date for an unspecified indication. On 30Jan2021 08:00, the patient experienced raised, redness, swelling, tender at injection site. As treatment, patient took Tylenol capsules. The outcome of the events was not recovered.
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| 66 | 2021-03-02 | hives, redness |
Yesterday, the day following my shot, I had a red welt bigger than the size of a quarter. Today, it ...
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Yesterday, the day following my shot, I had a red welt bigger than the size of a quarter. Today, it measures 3" x 1.75". Marginal dizziness a couple times tonight. No itching or breathing issue. I took a second claritin and put cortisone ointment on the welt. Also took an ibuprofen.
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| 66 | 2021-03-02 | vaccination site pain |
burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left...
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burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; charlie horse like cramps in left arm, hand and shoulder.; left breast swelled up; left armpit swelled up; This is a spontaneous report from a contactable consumer (patient). A 66 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263), via an unspecified route of administration (on left arm) on 27Jan2021 10:00 (at the age of 66 -years-old), single dose for COVID-19 immunization. Medical history included back surgery, knee surgery both on 2018. The patient's concomitant medications were not reported. Caller received 27Jan2021: 15 min after injection burning down her left arm, left breast and axillary swollen painful, charlie horse like cramps in left arm, hand and shoulder. She is drinking water, taking Tylenol, and using a heating pad but symptoms are persisting. Consumer states she is getting some interesting side effects from the vaccine. Adds she received the vaccine on 27Jan2021 10:00AM. Reports within the first 15 minutes she noticed just some burning down her left arm but then her left armpit swelled up; her left breast swelled up and she started to experience charlie horses in her arm. Adds now the pain has come down a little. She has been drinking water, taking Tylenol, and using a heating pad and that has helped a little. The pain comes and goes. It is worse at night when she lies down. Now it is in her hand, charlie horsing in her hand. She thinks maybe the shot got into her lymph nodes. Mentions the swelling her left armpit and breast has gone down some but the pain is still there. Clarifies patient received the first dose of the Pfizer COVID 19 vaccine on 27Jan2021 at 10:00AM on the left arm. She is scheduled for the second dose 24Feb2021. The outcome of the event Swelling arm, Breast swelling, Axillary pain, Axillary lymph nodes enlarged was recovering, other events was not recovered.
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| 66 | 2021-03-02 | vaccination site pain, vaccination site swelling |
large knot right above the injection site/size of a half dollar/size of a silver dollar and where th...
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large knot right above the injection site/size of a half dollar/size of a silver dollar and where the needle went in was right at the base of that knot/like egg under the skin or clot; felt like she got a flu shot and could tell her arm was very sore; swelling started almost immediately after the shot/swelling was exactly underneath the injection site, just in the pronounced area/about 4 inches wide and about 2 inches high; thought maybe someone has hit a vein because it did bleed and ran down her arm; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EN6201, unknown expiration), via an unspecified route of administration on 18Feb2021 at 04:30 at a single dose for COVID-19 immunization. Medical history reported as none. Concomitant medications included tolterodine and adalimumab (HUMIRA). The patient reported that she received the COVID vaccine on 18Feb2021 at around 4:30. Firstly it was fine, she felt like she got a flu shot and could tell her arm was very sore. What concerned her was the swelling started almost immediately after the shot on 18Feb2021. She knew that was one of the symptoms. This morning and yesterday though (18Feb2021), she noticed some of the symptoms. She got a large knot that was right above the injection site. Yesterday, it was about the size of a half dollar, today it is about the size of a silver dollar and where the needle went in was right at the base of that knot. It feels like an egg under the skin or a clot. Like a knot (a hard spot underneath the skin). The patient was wondering if it was something she should be concerned about because the swelling was exactly underneath the injection site, just in the pronounced area. It was a rectangle and is about 4 inches wide and about 2 inches high and then right above that was where the needle went in. The large circle or knot was right above that and she was thinking possibly when she was given the injection she has never really bleed before. So, she thought maybe someone has hit a vein because it did bleed and ran down her arm. She got no problem. That happens at times, but she started thinking if this was a clot or it was something that is right above there because it is so pronounced, and it really hurts. The patient stated that she took some Aspirin last night and is going to take an ibuprofen in a little while. She mentioned that she takes this one pill and it has nothing to do with anything. The patient had lab work done (unknown results) that was about 3 weeks ago (2021). She also stated that she also take Humira which is a shot every 2 weeks and it said in the fact sheet that she should be concerned or be sure that she did not take any medicine that affects the immune system and Humira does weaken the immune system but she was not ask that prior to. The patient wanted to know if is that something she should be concerned about. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-03-03 | injection site warmth, rash with redness, rash papular, injection site pruritus, injection site reaction |
I developed a raised red rash, warm to the touch, itchy area on my right arm in the vicinity of wher...
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I developed a raised red rash, warm to the touch, itchy area on my right arm in the vicinity of where the shot was given. It was small, roundish and approximately 2" across.
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| 66 | 2021-03-03 | rash | Rash on face, neck, various locations of body and in throat |
| 66 | 2021-03-03 | bruising, blister |
bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt h...
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bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt hot; her arm was hurting; water bubble appear on my arm with fever; fever; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EN6200), via an unspecified route of administration on 16Feb2021 at 09:15 (at the age of 66-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines four weeks prior to the vaccination. The patient was not tested for COVID-19 post vaccination. On 16Feb2021 at 22:00 the patient experienced bled at the injection site; arm is bruised, states there are little fever blisters on the arm, the arm was hurting and the arm felt hot (clarified the whole arm) on 16Feb2021; and water bubble appeared on the arm with fever "later on" on an unknown date in Feb2021. The patient was treated for the bled at injection site, arm felt hot and pain in arm which included cold ice pack and ibuprofen. The events did not require a physician visit or hospitalization. The clinical outcome of the event bled at injection site was recovered on 16Feb2021, the bruising and fever blisters at injection site was recovering, feeling hot and pain in arm was not recovered, water bubble and fever was unknown.
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| 66 | 2021-03-03 | itchy skin, rash |
today 3/4/2021 the day after my shot....at 11:30 am 3/4/2021....I noticed small red dots (rash) not ...
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today 3/4/2021 the day after my shot....at 11:30 am 3/4/2021....I noticed small red dots (rash) not many though. only on my legs at this point. They itch but didn't know if I should take benardly ? I am waiting on my primary doctor to call me back....out to lunch unt 2 pm CT.
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| 66 | 2021-03-04 | injection site rash, rash |
At 9pm the day of the vaccine the patients experienced rash with bumps from injection site up throug...
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At 9pm the day of the vaccine the patients experienced rash with bumps from injection site up through neck and back on shoulder blade. Pt took Benadryl and saw PCP the next day who called pharmacy, nurse reported that rash was still present and pt was instructed to continue Benadryl. They called agency who instructed the patient to not received the 2nd dose.
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| 66 | 2021-03-04 | itchy skin | Itch on her right side |
| 66 | 2021-03-04 | redness |
Sore arm 1st two days Afterwards severe ache and could not lift arm for 3 days Reddish sore on my f...
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Sore arm 1st two days Afterwards severe ache and could not lift arm for 3 days Reddish sore on my foot. Very painful. Cannot put weight on it
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| 66 | 2021-03-05 | hardening, redness, skin warm, itchy skin | Redness in upper right arm Hot - warm to the touch Hard Tender to touch Itchy |
| 66 | 2021-03-06 | redness, itchy skin | Achy, redness down my arm, swelling, burning itchy feeling. |
| 66 | 2021-03-06 | rash |
I received my shot Thursday and was in bed with severe headache and extreme fatigue for 3 days. On S...
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I received my shot Thursday and was in bed with severe headache and extreme fatigue for 3 days. On Sunday I ate some eggs for lunch and then took a hot shower at about 1:00 p.m. After the shower, I had a moderate/severe rash inside both arms by arm pits, left and right breast, stomach, lower back and above and below my knees. It lessened but by 4:00 p.m. the rash was still not gone.
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| 66 | 2021-03-06 | injection site swelling, injection site redness, injection site pruritus | Injection site is red and itchy with a small knot the morning after the injection |
| 66 | 2021-03-07 | itchy skin |
24 hours after the injection I started to flush on my face neck and ears. I itched all over especial...
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24 hours after the injection I started to flush on my face neck and ears. I itched all over especially my eyes and throat. I was very agitated and shaking. I took an allergy Med at 2 pm and again at 7pm. The 2 Nd dose calmed me enough to get to sleep around 11pm. I was very close to going to the ER. In the morning I had a stomach ache like I have experienced before with and allergic reaction. Cramping pain , it lasted all day there was no nausea. The 3 day a headache that seemed appropriate for the vaccine.
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| 66 | 2021-03-07 | redness, skin warm, dry skin |
9:25 am Returned to facility light headed, dry mouth and mouth tingling. Blood pressure 170/88 ,puls...
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9:25 am Returned to facility light headed, dry mouth and mouth tingling. Blood pressure 170/88 ,pulse70 ,pso2 99%. Respirations even and unlabored. Skin pink, warm and dry. Sat a while reported mouth tingling better. 9:44 reported dizziness increased took her pepcid and atavert as she said her allergist suggested. 9:48 Client reported difficulty swallowing taken to the ER
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| 66 | 2021-03-07 | itchy skin |
After observation period, patient went to POV and experienced diffuse pruritic (no hives or rash), c...
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After observation period, patient went to POV and experienced diffuse pruritic (no hives or rash), cough and shortness of breath, hoarseness and feeling of throat closing. Pt. used 5 puffs of albuterol. Pt. was transported via ATV to ED after administration of EpiPen. Pt. given Decadron in ED. Pt. has just started Prednisone taper and was instructed to complete it. Prescribed hydroxyzine and EpiPen. Discharged stable.
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| 66 | 2021-03-07 | vaccination site pain |
Arm soreness at vaccination site; This is a spontaneous report received from a non-contactable consu...
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Arm soreness at vaccination site; This is a spontaneous report received from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201, expiry date unknown), via an unspecified route of administration, on 19Feb2021 09:15, at single dose, for COVID-19 immunization. Medical history included asthma and penicillin allergy. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 19Feb2021 at 11:00, the patient experienced arm soreness at vaccination site. Treatment included Aspirin. The outcome of the event was unknown. The reporter assessed the event as non-serious. No follow-up attempts are needed. No further information is expected.
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| 66 | 2021-03-07 | injection site pain, rash |
Nausea immediately with injection, injection site pain, tiredness, headache, body aches, dizziness, ...
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Nausea immediately with injection, injection site pain, tiredness, headache, body aches, dizziness, blurred vision, poor appetite, unable to taste food, feeling unwell. day later rash on chest, next day heart racing, breathing shallow and fast, chest hurting. roads were iced over, to unsafe to drive.
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| 66 | 2021-03-07 | itchy skin, rash | Rash itching over body worse second dose and continues at present |
| 66 | 2021-03-07 | injection site pain |
Sore at injection site, 2chrs after shot slept 3 hrs than 2 hrs later another 2 hrs, light headednes...
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Sore at injection site, 2chrs after shot slept 3 hrs than 2 hrs later another 2 hrs, light headednes,
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| 66 | 2021-03-07 | vaccination site pain |
Sore at injection site; numbness to elbow; This is a spontaneous report from a contactable consumer....
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Sore at injection site; numbness to elbow; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: 10T EL 9262), via an unspecified route of administration on 05Feb2021 13:30 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included hypersensitivity allergies: Yes. Concomitant medications included ashwagandha, ascorbic acid (VIT C). On 06Feb2021 04:00, the patient experienced Sore at injection site and numbness to elbow. The patient did not receive treatment for the events. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.
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| 66 | 2021-03-08 | injection site redness, injection site swelling |
12 hours after 2nd shot, for the next 48 hours, fever continuously @ 99.9, severe muscle pain from h...
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12 hours after 2nd shot, for the next 48 hours, fever continuously @ 99.9, severe muscle pain from head to toe, that was not effected by motrin. fever and severe muscle pain had me rolling in bed with pain. Also simultaneously, My left arm, site of injection swelled twice its size, red, and had trouble moving it. Also noticed a swelling in left arm pit, which has improved but a slight swelling is still present . after exactly 48 hours , fever left, muscle pain stopped. Fatigue continued for 5 days. I have had many vaccines in my life, including flu vaccine every year and never experienced such severe symptoms. When I reported this to my PCP, he said it just means your immune system is doing its job no worries
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| 66 | 2021-03-08 | injection site pain, injection site swelling |
I had the normal, mild arm soreness after administration, Then two weeks and 2 days later, I had sev...
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I had the normal, mild arm soreness after administration, Then two weeks and 2 days later, I had severe pain , swelling and pain at the injection site, and unable to move arm to the arm away to the side or forward of the body.
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| 66 | 2021-03-08 | itchy rash, rash |
Initial reaction of splotchy, itchy rash over body which diminished but returned on 3/4/21 with seve...
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Initial reaction of splotchy, itchy rash over body which diminished but returned on 3/4/21 with severe pain and swelling in legs and rash from feet to buttocks/back area. Patient went to hospital on 3/7/21; negative for blood clots, lab work was normal; Prescribed Hydroxyzine, PCN-(for mild sore throat), Multi V, Areds 2
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| 66 | 2021-03-08 | hives | My tongue tip had welts and swelling. It was painful. |
| 66 | 2021-03-08 | itchy skin |
Skin Itching on back abdomen arms legs neck and chest. Initially Atarax one every 6 hours plus anti...
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Skin Itching on back abdomen arms legs neck and chest. Initially Atarax one every 6 hours plus anti itch creams (Sarna - Gold Bond) then Zyrtec for three days . I discontinued all anti itch lotion and applying only aloe vera gel. Warm showers help. Itching seems to have decreased only slightly. Strangely it flares up after a meal. I drink a lot of water and feel very thirsty.
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| 66 | 2021-03-08 | rash vesicular | vesicular rash right mid-back |
| 66 | 2021-03-09 | itchy rash, rash, blister |
Approximately two weeks after my first vaccine I developed small very itchy blisters. Just a few on ...
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Approximately two weeks after my first vaccine I developed small very itchy blisters. Just a few on my chest and inner thigh . They blistered , oozed and itched and now on March 10 are healing . I have had the shingles vaccine but this is all I could think it could be .. a small shingles breakout . The person administering my second dose thought I should report it . My husband developed the worse cold sore I have ever seen .. also approximately two weeks after his first dose. It is taking forever to heal . We are thrilled to get the vaccine and these side effects would not give us any reason not to do it . I was just told to report it .
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| 66 | 2021-03-09 | injection site pain, injection site swelling, injection site hardening |
My bicep where I was injected was swollen and hard and hurt very badly. I could not elevate my arm, ...
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My bicep where I was injected was swollen and hard and hurt very badly. I could not elevate my arm, I had to keep it my side. I also had a headache. 9 days after the injection I had extreme fatigue and wasn't myself. During the night My right arm/shoulder started throbbing and hurting again. I was cold and lightheaded. When I woke up I was fine!
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| 66 | 2021-03-09 | rash | Patient stated her chin and lips felt "tingly" she had a rash developing on her chin. |
| 66 | 2021-03-09 | injection site redness, injection site swelling | Swelling and redness at the injection site |
| 66 | 2021-03-09 | vaccination site redness, vaccination site pain, vaccination site swelling |
injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection si...
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injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection site pain, redness, and swelling; headache; chills; muscle and joint pain; muscle and joint pain; nausea; dizziness; weakness; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9809), via an unspecified route of administration in the left arm on 06Feb2021 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included slightly elevated blood pressure, not taking medication, and COVID prior to vaccination, on an unspecified date. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included paracetamol (TYLENOL) and vitamin supplements. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Feb2021 16:00, the patient experienced injection site pain, redness, and swelling; headache, chills, muscle and joint pain, nausea, dizziness and weakness. No treatment was received for the events. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 66 | 2021-03-10 | injection site pain |
About 10 minutes after receiving the vaccine, my left arm started burning. This lasted maybe 15 min...
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About 10 minutes after receiving the vaccine, my left arm started burning. This lasted maybe 15 minutes. I did not have this with the first vaccine. Around 7pm I started to develop chills which over a few hours I started to have shaking from the chills. I also developed a headache, Temperature 101.1, muscle weakness, pain at insertion site and diarrhea. I used Tylenol and Advil. Around 0500 no longer experienced a temperature and chills had lessened. Continued on day two to have slight chills and headache along with weakness. Day 3 minimal weakness
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| 66 | 2021-03-10 | redness, itchy skin |
About ten minutes after vaccine administration, patient noticed small erythema on lower left arm . A...
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About ten minutes after vaccine administration, patient noticed small erythema on lower left arm . Area also had minimal pruritis and erythema on left shoulder. No difficulty breathing, tightness in chest, dizziness or other symptoms. Given 25mg of bendaryl PO at 1435. Patient waited additional 30 minutes and all symptoms resolved before leaving.
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| 66 | 2021-03-10 | injection site pain |
Fever for 3 days. 101.2-101.6, chills, body aches, sore arm at injection Severe migraine type headac...
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Fever for 3 days. 101.2-101.6, chills, body aches, sore arm at injection Severe migraine type headache lasted for 4 days Severe exhaustion 4 days No appetite 4 days Day 5 just wiped out!
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| 66 | 2021-03-10 | rash |
Progress Notes Family Medicine COVID VACCINE CLINIC, 3/3/2021 Patient: Patient a 66 y.o...
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Progress Notes Family Medicine COVID VACCINE CLINIC, 3/3/2021 Patient: Patient a 66 y.o. female who was seen at a COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. Past Medical History: Diagnosis Date ? Depression ? GERD (gastroesophageal reflux disease) ? Hyperlipidemia ? Hypertension ? Obstructive sleep apnea (adult) (pediatric) ? Osteoarthritis She does have a way to monitor her blood pressure. She last ate around 9:30 am ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 03/03/21 1315 03/03/21 1326 03/03/21 1340 BP: (!) 167/81 (!) 167/81 (!) 163/63 Pulse: (!) 103 (!) 103 80 Resp: 18 18 16 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait abnormal (has her own wheelchair that she uses for long distances. ). Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) HTN Overall well appearing, not in distress. Pt observed in the bay for approx 25 minutes. Bp slowly improving. She is here with husband who will take her home. She feels better after water and snacks. Pt encouraged to monitor her bp at home. Follow up with pcp if continues to be elevated. Pt and husband voices understanding and denies any other questions or concerns. Electronically Signed 3/3/2021 1:27 PM
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| 66 | 2021-03-10 | rash macular, itchy skin |
Pt received vaccine and stated she felt light headed. She rolled up her sleeves and demonstrated blo...
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Pt received vaccine and stated she felt light headed. She rolled up her sleeves and demonstrated blotchy and itchy arms. Pt also reporting blotchiness on stomach. Pt did not report dizziness, light headedness, SOB. Vital taken: 1225 166/81, 98%, 62 and 1231 148/79, 98%, 62 and 1241 143/78, 98%, 62. Pt left ambulatory.
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| 66 | 2021-03-10 | rash with redness, skin warm, rash |
Vaginal bleeding at 3:30 am, bloodied underwear and sheets. Gynecologist gave me an internal ultras...
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Vaginal bleeding at 3:30 am, bloodied underwear and sheets. Gynecologist gave me an internal ultrasound of uterus, ovaries etc. were perfect. Had fatigue and aches for 24 hr. after vaccine. Also had a very bright pink, red rash covering the underside of my right arm and right chest, hot to the touch, some swelling, primary Doctor put me on antihistamines and antibiotics. Bleeding stopped. Rash and swelling is improving, still slight swelling on the underside of right arm 8 days later.
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| 66 | 2021-03-10 | injection site pain, injection site warmth, rash papular, injection site redness |
site of shot got red, warm, painful, and raised in 3" x 3" area 9 days after vaccine. This took 3-4...
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site of shot got red, warm, painful, and raised in 3" x 3" area 9 days after vaccine. This took 3-4 days to go away. Also, I experienced severe fatigue and feelings of arthritis in my hands which both lasted about 24-30 hours.
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| 66 | 2021-03-11 | itchy rash, rash |
Developed a rash between breast about 36 hours after receiving COVID 19 vaccine. Rash has spread to ...
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Developed a rash between breast about 36 hours after receiving COVID 19 vaccine. Rash has spread to entire front of torso to the waist. Very itchy but no secretions coming from rash. Went to the Dr. on 3/12/2021 and he determined it may be allergic reaction to the COVID-19 shot. Was prescribed medication for itch but was told a steroid shot would counteract the purpose of the COVID shot.
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| 66 | 2021-03-11 | hives | Hives |
| 66 | 2021-03-11 | itchy skin |
Itchiness of scalp, face, neck, upper chest without hives or rash. Feeling of itchiness of ear cana...
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Itchiness of scalp, face, neck, upper chest without hives or rash. Feeling of itchiness of ear canals and a sense of a little tightening of the throat.
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| 66 | 2021-03-11 | itchy rash, injection site rash | Itchy rash near injection site. |
| 66 | 2021-03-11 | hives | Severe hives on right leg |
| 66 | 2021-03-11 | hives | Swelling, Hives all over body |
| 66 | 2021-03-11 | skin tightness |
c/o facial and tongue swelling, tongue tingling, flushed cheeks, Hypertensive at 207/93, HR 50s, O2s...
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c/o facial and tongue swelling, tongue tingling, flushed cheeks, Hypertensive at 207/93, HR 50s, O2sat 98. Recommended EMS transport, patient/SO declined transport. Signed AMA and EMS form. Significant other drove patient to ED for further evaluation. Received normal saline fluids, famotidine 40 mg PO x 1, hydroxyzine 25 mg IM X1, and Methylprednisolone 125 mg IM X1 in the ED. Discharged from ED 3/8/2021. Patient contacted on 3/11/2021 and states feeling a little better since visit to the ED on 3/8/2021. Still feels like throat and face are a little "tight" but improving.
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| 66 | 2021-03-11 | rash |
pink rash started on upper, both arms, the left has more than the right arm & the rash has spread do...
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pink rash started on upper, both arms, the left has more than the right arm & the rash has spread down the arms to my wrists; pink rash on upper back shoulders & neck
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| 66 | 2021-03-12 | injection site pruritus, injection site pain, injection site redness |
4-5 days post-vaccination: Continued soreness at injection site, itchiness at injection site, and on...
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4-5 days post-vaccination: Continued soreness at injection site, itchiness at injection site, and on day 5 a visible red patch on arm at injection site (Reporting this on day 5 since most information indicates this is more common with Moderna than Pfizer and more common after dose 1 than dose 2.) (Earlier reaction had included 24 hours post-vaccination of chills, fever, fatigue lasting 8-10 hours)
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| 66 | 2021-03-12 | redness, injection site hardening, injection site pruritus, injection site swelling |
7days after receiving vaccine hard itchy swelling appeared at injection site. Next morning two inc...
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7days after receiving vaccine hard itchy swelling appeared at injection site. Next morning two inch round spot appeared. Like sunburn not rash.
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| 66 | 2021-03-12 | injection site pain | Chills, Fever, Fatigue, Aches, Headache, Nausea, Very Sore Arm at shot site, stuffy nose |
| 66 | 2021-03-13 | rash, itchy rash, hives |
Covered in itchy rash and hives. It started as rash and hives on chest and abdomen then spread to b...
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Covered in itchy rash and hives. It started as rash and hives on chest and abdomen then spread to back, arms, legs neck and eyelids.
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| 66 | 2021-03-13 | injection site pruritus, injection site redness |
Pfizer-BioNTech COVID-19 Vaccine EUA: nine days after vaccination patient presents to clinic with pr...
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Pfizer-BioNTech COVID-19 Vaccine EUA: nine days after vaccination patient presents to clinic with pruritic erythematous plaques on right proximal lateral arm near injection site. Symptoms started eight days after vaccination. No signs or symptoms of cellulitis. Vital signs all within normal ranges. Prescribed topical steroid ointment and able to manage at home.
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| 66 | 2021-03-13 | injection site pain |
Second day: soreness at the site. Fatigue and nausea. Third, fourth and fifth day fatigue and head a...
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Second day: soreness at the site. Fatigue and nausea. Third, fourth and fifth day fatigue and head ache
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| 66 | 2021-03-14 | skin warm, redness | Arm is swollen, red area more than 5 inches wide and three inches high, hot to the touch |
| 66 | 2021-03-14 | redness |
Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; ...
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Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and Neck red, swollen and hot to the touch.; Face and neck red, swollen and hot to the touch.; Similar to a Cortisone flush.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female non-pregnant patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration in the left arm on 29Jan2021 at 16:00 (at the age of 66-years-old) as a single dose for covid-19 immunisation. Medical history included diabetes mellitus, renal disorder fibromyalgia and hypersensitivity (allergies to medications, food, or other products). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received multiple concomitant medication (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jan2021 at 14:00 the patient expereinced face and neck red, swollen and hot to the touch, similar to a cortisone flush. On 31Jan2021 the patient underwent lab tests and procedures which included blood pressure measurement: normal and body temperature: 97.3 (normal). The patient was treated for face and neck red, face and neck red, swollen and hot to the touch similar to a cortisone flush with 50mg of benadryl (MANUFACTURER UNKNOWN). The outcome of the events was recovering. No follow-up attempts are possible. No further information was expected.
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| 66 | 2021-03-14 | injection site redness, injection site swelling |
No adverse reaction until March 1st 2021 Rytuxin Infusion plus (Bendadryl Decadron Zofran) Tues Marc...
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No adverse reaction until March 1st 2021 Rytuxin Infusion plus (Bendadryl Decadron Zofran) Tues March 2nd 2021 Redness Swelling @injection site Wed March 3rd 2021 Prevagen Infusion plus (Benadryl Zofran) Vitamin B12 injection Thursday March 4th 2021 Nerve Block with local anesthesia Saturday March 6th 2021 Headache Cough Sweats Chills Body Aches Monday March 8th Internal Medicine Telehealth Appointment NP Covid Test Rapid & PCR Negative results given for both March 10th Telehealth Appointment with Internal Medicine Dr. cough medicine & antibiotics given at this time
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| 66 | 2021-03-14 | rash with redness |
Red rash like on surface of left arm between elbow and wrist. When I rub my hand across the area, ...
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Red rash like on surface of left arm between elbow and wrist. When I rub my hand across the area, I feel 5 bumps just below the skin. the pain is very mild. One bump is larger than the others about the size of a pea. that one is a mild pain.
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| 66 | 2021-03-14 | itchy skin | itching, |
| 66 | 2021-03-15 | injection site swelling |
1. Baseball size swelling in arm pit on arm where shot was given. 2. Numbness of left foot that last...
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1. Baseball size swelling in arm pit on arm where shot was given. 2. Numbness of left foot that lasted for 4 hours on day of shot and intermittently since Saturday but able to walk without issues.
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| 66 | 2021-03-15 | cellulitis |
3/12/2021 Presented to the ED with left wrist pain and cat bite. Admitted for IV antibiotics for lef...
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3/12/2021 Presented to the ED with left wrist pain and cat bite. Admitted for IV antibiotics for left wrist cellulitis.
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| 66 | 2021-03-15 | hives |
I had no reaction after the 1st dose administered on January 26, 2021 other than a slightly sore arm...
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I had no reaction after the 1st dose administered on January 26, 2021 other than a slightly sore arm. After the second dose on Febrary 16, 2021, I expereinced the following in the following order. I did not feel better/normal until March 12. 101 fever for 24 hours, headache for days, chills, slight nausea, pain and aches all over and in joint areas, pain under shot arm in gland areas, black eyes and eye aches, divertiulitus event, brain fog - not being able to have sharp recall, and hives last 7 days.
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| 66 | 2021-03-16 | injection site pain | 2 weeks sore at injection site and limited shoulder movement. |
| 66 | 2021-03-16 | injection site pain |
Approx 5 hours follow Pfizer vac,, developed localized stiffness in the muscle. No redness or swel...
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Approx 5 hours follow Pfizer vac,, developed localized stiffness in the muscle. No redness or swelling. The following morning her arm was very sore from shoulder to elbow. On the 3rd day her arm hurt from shoulder to elbow when she raised it, and has not resolved at this time. The discomfort improves with use, but is sore/stiff again after a period of nonuse of that arm.
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| 66 | 2021-03-16 | injection site pain |
I received the vaccination at the clinic. About 24 hours after receiving the vaccination, my urine ...
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I received the vaccination at the clinic. About 24 hours after receiving the vaccination, my urine became very dark (amber) and stayed this way for 9 days. I was not dehydrated. Five days after the vaccination, my stool became very pale (clay color) and stayed this way for 6 days. Both conditions resolved on their own. I was very tired for a couple of days after the vaccination, had some soreness in the vaccination site and my appetite was off a little for a few days. These were the only other symptoms.
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| 66 | 2021-03-16 | injection site pain, injection site swelling, injection site redness, injection site hardening |
Injection was apparently given in the bicep area as opposed to the deltoid. Patient complained of s...
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Injection was apparently given in the bicep area as opposed to the deltoid. Patient complained of soreness and swelling thereafter (which is improving by the time she comes in for her second vaccination,) but she still has some limitations in range of motion which inhibits her work as a sign language interpreter. She has had no distal paresthesias or weakness, just soreness surrounding the site which she indicates to be the left inferolateral bicep area where there is a minute reddish (presumed) puncture site and underlying induration.
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| 66 | 2021-03-16 | itchy skin |
Patient and husband at drive thru vaccination clinic on 3/12/21. Vaccination given at 1519. EMS call...
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Patient and husband at drive thru vaccination clinic on 3/12/21. Vaccination given at 1519. EMS called to vehicle at 1527. RN arrived a few minutes later. Per EMS report: Patient complained of itching all over, trouble swallowing, throat tightness, legs hurting, and raspy voice. No hives present and injection site normal. Per EMS report VS- BP:165/81 P:100 O2: 98% on RA End Tidal CO2: WNL EMS administered 50mg Benadryl IM at 1541 and IV started. Departed in ambulance.
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| 66 | 2021-03-16 | itchy skin, rash |
Patient was being observed for 30 minutes, did not complain of any symptoms during this time. When o...
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Patient was being observed for 30 minutes, did not complain of any symptoms during this time. When observation nurse was checking on patient to allow the to leave, resident complained of light headed. Patient brought to triage for evaluation. Patient reported they had a Vasovagal response 6 years ago. Vital signs were taken, all within normal limits. Ice pack was applied to back of neck, as patient felt flushed and juice was given. Patient said she did not eat breakfast when asked. Patient was observed being very restless and rubbing/scratching her arms, scalp and upper back. Rash was noted on upper back left side, NO hives. Benedryl 50 mg IM was given. Called patients friend, patient did not want emergency contact called for pickup. Patient's friend was willing to come and pick her up. Patient observed with diminished restlessness and itching. Patient reported a "tightness" in her neck muscles, almost like she had swollen glands. Patient was able to talk well, no c/o of SOB or difficulty breathing or itchiness of her throat. Patients friends arrived, informed of the incident. Patient was sleepy, rash was gone, patient denied any more itching, patient appeared more peaceful. Advised if she had any worsening symptoms or signs of a severe allergic reaction to call 911. Patient stayed in total for 90 minutes. Patient was assisted by nurse to her friends car.
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| 66 | 2021-03-16 | rash, itchy rash, hives |
Started getting little tiny bumps in random places on my body that would itch extremely and then loo...
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Started getting little tiny bumps in random places on my body that would itch extremely and then look like a hive but it went away in about 20 minutes. Then it might be on my foot or back and do the same thing. Had a low grade fever and started getting fever sores on my lip and took Valtrex.
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| 66 | 2021-03-16 | hives, injection site hives |
The evening after patient received vaccine, she started to develop low grade fever and urticarial ra...
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The evening after patient received vaccine, she started to develop low grade fever and urticarial rash at the vaccine site. The urticaria improved the following day, as did the fevers. Then 3/5, the fevers started again, several times per day, as high as 102 at home. In association with the fever she has had some mild nausea, x1 non-bloody emesis last night, as well as rigors/night sweats. She went to urgent care and eventually was admitted to the hospital for the following 9 days. During this admission, she continued to have fevers intermittently as high as ~103. She also developed more generalized urticarial rash (worst on trunk), and lab abnormalities including low platelets and elevated liver function tests. She had extensive testing, ultimately determined likely vaccine reaction, started on prednisone 40 daily and improved for discharge to home on 3/17 without fevers x48 hours and with improving labs.
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| 66 | 2021-03-16 | itchy rash, rash with redness, rash papular |
Very itchy, fine, papular red rash on left ventral side, just proximal to the crook of the elbow. 2 ...
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Very itchy, fine, papular red rash on left ventral side, just proximal to the crook of the elbow. 2 in. diameter
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| 66 | 2021-03-16 | itchy rash, rash with redness, rash |
red rash on both forearms, red rash and itchy/tingly feeling on both cheeks. started about 20 minute...
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red rash on both forearms, red rash and itchy/tingly feeling on both cheeks. started about 20 minutes after administration, lasted about half an hour
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| 66 | 2021-03-17 | redness, skin warm, itchy skin |
An hour after receiving the vaccine my chin became red, hot and itchy. It has continued to be warm ...
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An hour after receiving the vaccine my chin became red, hot and itchy. It has continued to be warm and itchy for the 16 days since I had the shot.
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| 66 | 2021-03-17 | vaccination site mass, vaccination site itchiness |
I got the first shot on 24Jan2021 and I got the second dose on 31Jan2021; I got the first shot on 24...
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I got the first shot on 24Jan2021 and I got the second dose on 31Jan2021; I got the first shot on 24Jan2021 and I got the second dose on 31Jan2021; Have a lump on my arm and it's very itchy/lump where they give me the shot; Have a lump on my arm and it's very itchy/lump where they give me the shot; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 31Jan2021 at a single dose on arm for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 for COVID-19 immunisation on 24Jan2021. Consumer stated, "I took my second Covid shot on Sunday (31Jan2021) and I have a lump where they give me the shot. I have a lump on my arm and it's very itchy. So that's what I wanted to know that is why I have been hold for an hour to find out how you can assist me. I am asking you what you can do for me. I don't think you understand me. I have been holding an hour because my arm has a lump where I got the shot. Are they supposed to give the first shot and second shot in the same arm?" Event start date was reported as "Yesterday, 01Feb2021." The patient did not receive treatment for the events. The outcome of the events was not recovered.
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| 66 | 2021-03-17 | redness |
Patient is a 66 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 3...
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Patient is a 66 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/18/2021. The patient experienced the following reaction(s) during the immediate of observation: 10:35am Patient c/o redness to bilateral hands. Denies numbness and tingling to hands or difficulty breathing. Patient reports feeling fine. Patient was treated/managed as follows: VS BP 116/78 HR 63, RR 16, O2 sat 98% on room air. Redness to hands subsided. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 10:43am Patient escorted to door.
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| 66 | 2021-03-18 | injection site pain |
Extreme pain at injection site, then left arm became paralyzed, unable to move unless assisted by ri...
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Extreme pain at injection site, then left arm became paralyzed, unable to move unless assisted by right hand/arm. Pain spread to left side of head, neck, upper, then lower back. Extreme pain in lower back. General feeling of un-wellness, and wanting to die. Insomnia, and extreme tiredness. Thursday pm pain in left arm subsided, still very tired, severe pain in low back, slept better. Friday, as I write, no more pain in left arm, paralysis subsided, as well as head, neck pain. Low back pain still exists. Did not seek medical help. Took Hydrocodone and Tylenol, iced areas of pain. Not looking forward to next shot. Will contact my allergy doctor regarding if I should get second shot.
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| 66 | 2021-03-18 | hives |
she broke out in hives from her hands to the arches of her feet, it was progressive; This is a spon...
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she broke out in hives from her hands to the arches of her feet, it was progressive; This is a spontaneous report from a contactable Other Health care professional reported that: A 66-years-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EM9809; Expiration Date: 30Jun2021), via intramuscular, administered in Arm Left on 06Feb2021 as single dose for covid-19 immunisation. Medical history included chronic idiopathic urticaria, scrombid poisoning. There were no concomitant medications. Vaccination Facility Type: Hospital. The caller states she is a long-time retired nurse. The caller wishes to report an adverse event 74 hours after receiving the first Pfizer COVID-19 vaccine. The caller mentions she would appreciate some follow-up. Caller declined to include a healthcare professional for the report at this time. Today, 09Feb2021, at 11am, she broke out in hives from her hands to the arches of her feet, it was progressive. She took one Benadryl at that time and she had to take a second Benadryl over-the-counter dosage an hour later because the hives had not subsided. Right now, the hives are resolved but of course she is still covered by the second Benadryl she last took which was at noon. When probed for UPC, Lot number or expiry date for the Benadryl, the caller states it's over the counter, and she doesn't have that. Caller explains 2 years ago, she experienced hives, but it was diagnosed quite after when she returned (she was traveling at the time). She was diagnosed with "scrombid poisoning", 35 people had the same fish she and she was the one who was hypersensitive to it. It's basically a fish that was about to turn bad, but it isn't. She got hives and ended up in ER. She was tested for multiple food allergies and all were negative. Through the process of elimination, she was given a preliminary diagnosis of chronic idiopathic urticaria which was diagnosed over 2 years ago. The caller explains she thought of the vaccine after 5pm so she will call her physician tomorrow regarding this reaction. Of course, she had her paperwork, so she wanted to get it on Pfizer's records. Of course, if there is a other that have had hive experiences, she would be greatly appreciative if someone followed up with her about it. She is hoping this is just a strange little hive breakout and not a true reaction to the vaccine. She also would like to know if there is any guidance on second dosage. She is scheduled to receive her second dose on 27Feb2021. Outcome of the event was recovered. No further details were provided or obtained.
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| 66 | 2021-03-19 | rash |
About 5 hours after receiving vaccine, a rash appeared on my torso and upper arms, prickly skin sens...
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About 5 hours after receiving vaccine, a rash appeared on my torso and upper arms, prickly skin sensation, thready pulse 80/min, felt occasional palpitations, Couldn't get accurate BP because it was faint and hard to hear pulse. I took Benedyl 25mg orally at 10 pm.
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| 66 | 2021-03-19 | injection site pain |
After second vaccine, felt severe injection site pain/pain moving arm. Lasted for 3-4 days then got...
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After second vaccine, felt severe injection site pain/pain moving arm. Lasted for 3-4 days then got better. Then, about 4 days after this, pain increased. Couldn't sleep on that side, interfered with sleep, painful to move. This pain is still there and it's been 5 weeks. VERY slowly getting better. I recently started using CBD ointment and husband massaging upper arm. Reported to my doctor on Feb. 22 and he said it should get better in 7-10 days. (I'm unable to take steroids or ibuprofen due to medical reasons.) I also had a one-time milky discharge from nipple in breast after this second injection on side of injection. GYN Dr. said not to worry /return unless it happened again. It didn't. But I can't find anything about this type of long-lasting arm pain I'm having.
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| 66 | 2021-03-19 | injection site nodule |
My right arm has been knotting up at injection site. It also goes to sleep from the shoulder to the ...
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My right arm has been knotting up at injection site. It also goes to sleep from the shoulder to the elbow. This has been going on for over a week.
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| 66 | 2021-03-20 | injection site redness, injection site pruritus, injection site rash | Large flat red lesion surrounding the injection site, occasionally itchy |
| 66 | 2021-03-20 | injection site pain |
Symptoms/reactions started one week after I received the vaccine. I stated having severe pains in m...
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Symptoms/reactions started one week after I received the vaccine. I stated having severe pains in my left arm from the elbow up to my shoulder and left side of neck, with the site of the shot/vaccine being very tender and extremely painful. I can't hold my hand down, it is very sensitive, I can't turn my head around or even tilt my head back to gargle my throat.. I have to hold my hand in a certain way because it hurts terribly.
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| 66 | 2021-03-20 | itchy skin |
itching when I wake up, when I move a certain way, itching a lot of the time but no rash. Relative ...
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itching when I wake up, when I move a certain way, itching a lot of the time but no rash. Relative who is a nurse told me it should be reported and I should check with my doctor before getting second dose.
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| 66 | 2021-03-21 | injection site pain |
Day of injection, no adverse affects. That evening after I went to bed, I was woken up by extreme pa...
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Day of injection, no adverse affects. That evening after I went to bed, I was woken up by extreme pain and soreness at the injection site. I had a terrible time sleeping. It radiated into my shoulder and lasted for four days. I didn't sleep well at all the entire time and I was affected by the pain during the day as well. I also had extreme fatigue the next day after the vaccination but that only lasted for that day.
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| 66 | 2021-03-21 | shingles |
I started getting chapped lips and the 13th and I applied Chapstick - within two days, they became w...
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I started getting chapped lips and the 13th and I applied Chapstick - within two days, they became water blisters (like what you get with a sunburn) on both top and bottom of lips. On inside of lips there were more blisters. It started affected eating. My mouth was on fire. I realized it was another shingles outbreak - I have a standing prescription for shingles since I've had shingles before - Valacyclovir HCL - 1 gram tablet - I took two pills a day - 12 hours apart. Taking these: inflammation went down first and then blisters started going away - it took about two weeks. The herpes stays in my system but the outbreak is gone.
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| 66 | 2021-03-21 | injection site rash, injection site swelling, injection site pain |
Injection site swelled, with rash, and knot. Severe pain, hard to raise arm, throbbing, shooting pa...
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Injection site swelled, with rash, and knot. Severe pain, hard to raise arm, throbbing, shooting pain down arm. It?s been 9 days and I?m still having pain and it?s hard to use my arm.
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| 66 | 2021-03-21 | injection site rash, rash with redness | Red rash at vaccination site. |
| 66 | 2021-03-22 | itchy skin |
Approximately 3-4 hours after receiving the vaccination the patient developed itching in the "V" are...
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Approximately 3-4 hours after receiving the vaccination the patient developed itching in the "V" are of the neck. There was no visible discoloration, rash, or hive-like eruption according to the patient or her husband. No other symptoms. Because of this we were reluctant to give the second dose of the vaccine and she was advised to seek J&J when available. She is to report this occurrence to her PMD as well.
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| 66 | 2021-03-22 | injection site pain |
Low grade fever, widespread muscle pain (#8 on pain chart) severe headache, mild nausea, fatigue, sw...
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Low grade fever, widespread muscle pain (#8 on pain chart) severe headache, mild nausea, fatigue, swollen , painfull glands in neck, soreness at site of injection that traveled into armpit,
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| 66 | 2021-03-22 | rash with redness, rash, itchy skin |
On the 5th day after the vaccination, I noticed a rash on my right side on my waistline about the si...
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On the 5th day after the vaccination, I noticed a rash on my right side on my waistline about the size of the palm of my hand in two locations. It is red, a little itchy, under skin (not raised), but doesn't hurt. My right lower arm has a little redness, a little roughness again under skin. I called my doctor's office. They said Benadryl would be OK to take. I have no idea if this is a possible side affect of the vaccine. The nurse at the office did not know...The rash may be a little less red today.
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| 66 | 2021-03-22 | skin warm |
Racing heart, fatigue, headache, felt like fire bursts under my skin mostly in arms and legs. Had t...
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Racing heart, fatigue, headache, felt like fire bursts under my skin mostly in arms and legs. Had these adverse effects on and off for over a week. The second week after the shot felt numbness in my face. After about one month these events are mostly gone. Still have occasional fire bursts under my skin but only one or two not my entire arms or legs.
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| 66 | 2021-03-23 | injection site pain |
Started overnight (after 9:30pm on 3/23/21: Injection site pain,Tiredness,- The following occurred a...
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Started overnight (after 9:30pm on 3/23/21: Injection site pain,Tiredness,- The following occurred around 8am on 3/24/21: Headache,Muscle pain, Chills, Joint pain, Fever, Nausea, Feeling unwell, Dizziness, Fainting
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| 66 | 2021-03-23 | itchy skin |
Today at about 11: 30 AM, I took an Amoxicillin for gingival irritation. I have taken this medicine ...
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Today at about 11: 30 AM, I took an Amoxicillin for gingival irritation. I have taken this medicine before , but this was the first time since getting my Covid Vaccine. About one hour later, I began having intense itching of both hands, followed by diffuse flushing and pruritus and slight swelling around my face and eyes and a little feeling of throat irritation, but without SOB, wheezing or tongue swelling. My vital signs stayed stable, including a normal oximeter reading. I took a 180 mg Fexofenidine and used some OTC Hydrocortisone Cream on my hands when the first symptoms started. When the other symptoms progressed , I took 24 mg Methylprednisolone oral tablets and 25 mg liquid Diphenhydramine and my husband drove me to the ER, to be close in case I developed difficulty breathing. After about 30 minutes the symptoms stopped worsening and gradually resolved. I didn't go to ER
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| 66 | 2021-03-24 | injection site pain | Mild soreness at injection site |
| 66 | 2021-03-24 | rash with redness, vaccination site pain |
Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and s...
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Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and swollen; raised red itchy rash on neck, chest and abdomen; swollen lymph glands in throat; diarrhea; sore throat; site soreness; achy joints; headache; nausea; fatigue; Racing heartbeat; throat felt lujeir was closing; tongue felt tingly and swollen; This is a spontaneous report from a contactable healthcare professional (the patient). A 66-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6205), via an unknown route of administration in the left arm on 06Mar2021 at 16:30 (at the age of 66-years-old) as a single dose for Covid-19 immunization. Medical history was included celiac sprue, Crohns, chronic pancreatitis, psoriasis, osteoporosis, and ulcerative colitis, all from an unknown date and unknown if ongoing. The patient was allergic to penicillin and codeine. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269) on 13Feb2021 at 11:30 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported however it was reported the patient had other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 16:30, within 5 minutes of injection, the patient experienced Racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands. The patient also experienced the typical side effects of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat, and raised red itchy rash on neck, chest and abdomen. Treatment of Benadryl was given for the events as recommended by paramedic which was still being taken on day 4. The clinical outcome of the events racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands was recovered on 06Mar2021 (reported as 'last about 10 minutes'); outcome of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat and raised red itchy rash on neck, chest and abdomen was not recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-03-24 | itchy skin, hives | headache, fatigue, chills, vomitting, Extremely itchy hives, |
| 66 | 2021-03-25 | rash |
Experience a rash on the left torso . The rash look like insect bites. The rash appear about 12 day...
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Experience a rash on the left torso . The rash look like insect bites. The rash appear about 12 days after the vaccination. The only appeared on the left side of the body . The vaccine was given in the left arm.
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| 66 | 2021-03-25 | injection site pain |
Same day as vaccine administered 3/15/2021 Headache. Tiredness. During the early morning hours on 3...
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Same day as vaccine administered 3/15/2021 Headache. Tiredness. During the early morning hours on 3/16 Big Toe throbbing woke me up. Throbbing stopped in big toe and then moved to right wrist, then stopped at wrist and went to left leg. Throughout the next 24 hours their would be sharp pains in right ankle. Left arm at injection sight very painful. Pains would occur in different body parts next 24 hours. Extreme tiredness to the point of ongoing sleep well passed the 6 hours of regular sleep for me. It took 4 days for me to start to feel I was returning to normal function, the fifth day I felt normal. I thought this was a long time to recover from shot in comparison to what I did hear.
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| 66 | 2021-03-25 | pain of skin, injection site pain |
has been feverish, weak, temperature of 99.8 on 3/25 10:33 PM PDT, neck, and throat hurts, sore musc...
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has been feverish, weak, temperature of 99.8 on 3/25 10:33 PM PDT, neck, and throat hurts, sore muscles, very sore at the injection site, diarrhea, nausea, headache, tender scalp These symptoms are unchanged after 24 hours (started approx 10 pm 3/24 is is now after 10pm 3/25.
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| 66 | 2021-03-26 | bruising |
Had expected body aches and chills during the night. Very lightheaded when I got up and some nausea....
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Had expected body aches and chills during the night. Very lightheaded when I got up and some nausea. Thought to ?sit down before you fall down? then ?came to? next to toilet. Head resting on toilet seat. Had some bruising on cheek but don?t remember going to floor. Rest of day was okay with just the most common side effects. Never fainted before but not uncommon for me to be lightheaded with nausea. Most embarrassing...passed some stool.
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| 66 | 2021-03-26 | rash | Headache, chills, nausea, rash |
| 66 | 2021-03-27 | itchy skin, sensitive skin |
Entire body itching including face, lips, upper palate , throat and tongue. Skin slightly flushed b...
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Entire body itching including face, lips, upper palate , throat and tongue. Skin slightly flushed but NOT a raised rash. Took Benadryl within 15 minutes and slept for 5 hours. 24hours later body still feels hyper sensitive /itchy but tongue and lips not so much.
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| 66 | 2021-03-27 | hives, rash with redness |
Received vaccine, within 10 minutes developed a red rash on neck with small hive. Given benadryl, im...
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Received vaccine, within 10 minutes developed a red rash on neck with small hive. Given benadryl, improved within 30 minutes.
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| 66 | 2021-03-27 | rash with redness, rash | Red rash bilateral lower legs above ankle |
| 66 | 2021-03-28 | injection site warmth | warmth at site w fever 39 next day |
| 66 | 2021-03-29 | hives, itchy skin, redness |
itchy on my upper torso to groin area; skin was red, hives(welts) itchy; skin was red, hives(welts) ...
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itchy on my upper torso to groin area; skin was red, hives(welts) itchy; skin was red, hives(welts) itchy; skin was red, hives(welts) itchy; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9266), via an unspecified route of administration, in the left arm on 13Feb2021 13:30 (at the age of 66-years-old) as single dose for COVID-19 immunisation. Medical history included was reported as none. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included benazepril (BENAZEPRIL); ergocalciferol (VIT D); pitavastatin calcium (ALIPZA) and ezetimibe (EZETIMIBE). The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that no probs after shot. On 14Feb2021 after 36 hours became itchy on my upper torso to groin area. Skin was red, hives(welts) itchy. No trouble breathing or swallowing. Took Benedryl and all subsided within 2 hours. Outcome of the events were recovered on an unspecified date.
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| 66 | 2021-03-30 | cellulitis |
I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fev...
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I woke up the following morning (March 5) having chills, vomiting, and very very weak-----but no fever. On Saturday I was better but still weak and that is when cellulitis started in my left leg. On March 7, 2021, I was seen in the ER. I was given a shot and antibiotics and told to return if not better. So on Monday, March 8, I returned to ER and then was admitted to the hospital. I was allowed to go home on Saturday, March 13. Since then I had two sores to develop on my left leg. I had to have wound surgery on them on March 25. I am a lot better but still not completely well.
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| 66 | 2021-03-30 | skin burning sensation |
drop in blood pressure; swelling of the face and throat; swelling of the face and throat; fast heart...
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drop in blood pressure; swelling of the face and throat; swelling of the face and throat; fast heart beat; no appetite; exacerbation of existing neuropathy; Palpitations; being lightheaded; sweating; burning mouth syndrome; burning mouth syndrome; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire.; especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire.; Some of my reactions look like an allergic reaction; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 66-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL3302, expiry date not reported) via an unspecified route of administration, administered in left arm on 11Mar2021 14:00 at a single dose for COVID-19 immunisation. Medical history included neuropathy from 2006 and ongoing, since she had chemotherapy in 2006 for breast cancer in 2006 and burning mouth syndrome. The patient had no covid prior vaccination. The patient had no known allergies. The patient had other medications in two weeks which included unspecified dietary supplements. The patient had no other vaccine in four weeks. The patient previously took doxycycline from 2010 to an unknown date for Lyme's diseaseand experienced burning mouth syndrome. On 11Mar2021 at 02:00 PM, patient had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. These symptoms still continue. Patient stated that people were talking about the second dose being worse. Patient stated that some of the reactions in Mar2021 look like an allergic reaction. They (HCP) only have cautioned the patient about difficulty breathing in Mar2021. They were saying there wasn't anything they can do for it. Patient asked how long the side effects will last and how to go about changing the appointment. If they are going to continue, patient was very concerned about following up with the second shot and asked if they can have that second shot be postponed until patient was not experiencing these side effects to the effect that she was. She completed the self-reporting on Monday (15Mar2021), but because her side effects were not going away she wanted to reach out to someone. She has reached out to her practitioner and had an appointment yesterday. Doctors didn't really know because it was all very new. She had the first vaccination shot on 11Mar2021, almost a week ago. In the 15 minutes that she waited afterwards she definitely experienced palpitations and a feeling of lightheadedness. She has an underlying condition of burning and pain called neuropathy. She has had neuropathy since she had chemotherapy in 2006 for breast cancer. This exacerbated that. She had been very concerned about that prior. Everyone said and the CDC recommends even with neuropathy to go ahead with the vaccine. It also triggered another underlying condition. She had a reaction to a course of Doxycycline in 2010 for Lyme's disease that caused burning mouth syndrome. Both of these things were really acute now, the neuropathy and burning mouth syndrome. Monday (15Mar2021) was a particularly bad day because the symptoms of an allergy which were swelling of the face and throat, fast heart beat, and dizziness were with the burning mouth syndrome. She didn't have difficulty breathing. It was the nerve endings of the tongue that go all the way to the back of her throat and gave the sensation of the whole mouth being involved. Monday was difficult. It was 8 hours of an acute episode then it eased off a little that evening. She had no appetite on Monday and barely ate anything. Yesterday was ok and much better although she was being triggered by environmental thing such as food and toothpaste. Things she normally uses were setting it off. She had an acute reaction this morning to a protein shake she has had every day for 14 years. The reaction this morning, 17Mar2021, was a drop in blood pressure and palpitations. It passed. She has been documenting this and made her provider aware of what she was experiencing. She was participating in the V-Safe through the CDC that checks up on her everyday and asks about symptoms. She didn't know if she was supposed to report this to the vaccine adverse event system or not. Obviously, she didn't want to get COVID. She was struggling with the recommendation to get second shot because she was extremely concerned. She wanted to know how long will the side effects will last and if she can postpone getting the second shot until she gets reasonably well. No practitioner can recommend whether to do it or not to do it. She reported this information online to Pfizer on 15Mar2021. She provided the lot number when she reported it online. The patient was not tested for COVID post vaccination. No treatments received from the events had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. The patient recovered with lasting effects from the events had palpitations, being lightheaded, sweating, exacerbation of existing neuropathy and especially burning mouth syndrome - nerve endings in tongue, lips and cheeks were all on fire. The outcome of the other reported events was unknown.
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| 66 | 2021-04-01 | shingles |
Had 2 seizures; Had 2 seizures; Tongue hurts; it was an allergic reaction; Patient reported that nex...
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Had 2 seizures; Had 2 seizures; Tongue hurts; it was an allergic reaction; Patient reported that next the day her arm was so hot that she could have roasted a weenie over her arm and it was very swollen; Patient reported that next the day her arm was so hot; got shingles again after receiving the vaccination; got shingles again after receiving the vaccination; This is a spontaneous report from a contactable consumer (patient's husband). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6202), via an unspecified route of administration, administered in left arm on 12Mar2021 10:30 (at the age of 66-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a health clinic. The vaccine was not administered at a facility. The patient had no additional administered vaccines. No prior vaccinations (within 4 weeks). Medical history included ongoing seizures from 1982 (began shortly after she had the surgery for her brain aneurysm (in 1982 to 1982). The patient had not had any seizure activity for 20 years before the seizures that occurred on 13Mar2021. Sometimes electrical activity in the brain hits the metal clamp used to treat the brain aneurysm and that triggers the seizures); migraines (suffered from migraines when she was younger but hasn't had one in umpteen years. The patient gets tension headaches like most people but not very often); shingles (patient had shingles three times. Patient's first case of shingles was in the early 1990's and that patient had recurrences in the mid 1990's and the early 2000's. The first incidence was the worst and that the second and third occurrences weren't nearly as bad as the first); blood pressure high; ongoing cholesterol; ongoing headache (tension headaches) and was adopted. Family history included migraines with grandkids, a couple of them had migraines and had MRI's she'd had a sister that was 6 years older than her that had died of a brain aneurysm. Concomitant medications included levetiracetam (KEPPRA) for seizures from an unspecified date (in the late 90's) to an unspecified date then from Mar2021 and ongoing; nadolol for headache from 2001 and ongoing; lovastatin for cholesterol from an unspecified date (been on it for a long time) and ongoing and on a low dose of medication for high blood. The patient had the Pfizer vaccine first shot on Friday (12Mar2021). The husband stated his wife (patient) had a possible side effect to the vaccine shot and was concerned with getting the second dose of Pfizer's COVID vaccine. She had 2 seizures the next morning after the shot (on 13Mar2021) which she hasn't had in 20 years. The patient experienced her first seizure about 11:00 on 13Mar2021. It took the patient about 45 minutes to come out of the first one completely, until she was conscious again. The second seizure occurred about 13:00 on 13Mar2021, about an hour and a half after the patient recovered from the first seizure. fter the second seizure, the fire department was called and she was transported to the Emergency Room. The doctor told the husband that it was up to them if they wanted to receive the second dose. The husband stated, "I know there is something out there that I heard about where you can disqualify yourself from getting the vaccine for medical reasons." Also on 13Mar2021, the patient's tongue hurts in the Emergency Room, no one was willing to give her a new tongue after she bit it. The patient's tongue was what hurt's the most, but that it was slowly healing. The patient seemed to be fine since Saturday. he patient's father was really persistent about them getting the Covid-19 vaccinations. A CT scan and blood work were performed while she was in the Emergency Room on 13Mar2021 and reported that everything was fine. The patient went to the emergency room on 13Mar2021 and physician office on 17Mar2021 as a result of the seizure activity on 13Mar2021. On 17Mar2021, the patient's blood pressure was 130/82 with blood work with result of everything was fine. The patient went to her physician on 17Mar2021 due to concern about getting the second dose of the Covid-19 vaccine. When asked about prior vaccinations within 4 weeks of the Covid-19 vaccine, the patient stated that she didn't want to get the first dose of the Covid-19 vaccine because she's never even had the flu shot. The patient stated that back in 1977 when they first came out with the flu shot, she was unable to receive the vaccine as she was pregnant and she has never gotten the flu. The patient reported that she was unable to get MRIs due to the metal clamp in her. Patient reported that the clamp in her head was metal, not surgical metal, and that she has to be very careful because getting an MRI could kill her. The patient reported that next the day (in Mar2021) her arm was so hot that she could have roasted a weenie over her arm and it was very swollen. The patient reported that she went to urgent care and was told that it was an allergic reaction. The patient also reported that she got shingles again after receiving the vaccination. The husband considered the case as non-serious. The patient recovered from seizure with associated disease recurrence on 13Mar2021; for tongue pain was recovering while for the remaining events was unknown.
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| 66 | 2021-04-01 | rash |
Shortness of breath; allergic reaction; Rash on arms, neck, chest, hands.; This is a spontaneous rep...
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Shortness of breath; allergic reaction; Rash on arms, neck, chest, hands.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (Lot number: EL3249; solution for injection), via an unspecified route of administration in left arm on 21Jan2021 at 11:30 AM at a single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in left arm on 09Feb2021 at 01:45 PM at a single dose, for COVID-19 immunisation. The patient's medical history included asthma and hypertension. Concomitant medication included montelukast sodium (SINGULAIR), ammonium chloride, diphenhydramine hydrochloride, menthol, sodium citrate, sulfogaiacol (BENACOL EXPECTORANT), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). The patient was not diagnosed with COVID-19 prior to vaccination. On 12Feb2021 at 06:30 PM (52 hours after second dose of bnt162b2), the patient experienced allergic reaction, rash on arms, neck, chest, hands and shortness of breath. The patient received diphenhydramine (BENADRYL) and albuterol as treatment for the events. The outcome of the events was recovered on an unspecified date. It was also reported that post vaccination, the patient had not been tested for COVID-19.
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| 66 | 2021-04-17 | redness |
Bells Palsy; Numbness on the left side of the face; Left side of face hot, red, and a mild burning s...
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Bells Palsy; Numbness on the left side of the face; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; BP 183/90; This is a spontaneous report from two contactable consumers (one is the patient). A 66-year-old female patient (no pregnant) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), in left arm on 09Mar2021 at 13:00 (at the age of 66-years-old) at single dose for COVID-19 immunization. Medical history included known allergies at lemon, lime, green peppers, mushrooms, walnuts, sleep apnea, asthma, obesity, anxiety/antidepressants for 35 years from 1986. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), tiotropium bromide (SPIRIVA), albuterol (salbutamol), duloxetine hydrochloride (CYMBALTA), colecalciferol (D3), ascorbic acid (C), antidepressants. The patient previously took furosemide and theophylline and experienced allergies. The patient experienced numbness on the left side of the face, started 25 minutes after the injection, on 09Mar2021 at 13:30 and resolved fully within 30 hours. ER visit immediately. MRI showed nothing. Blood pressure (BP) 183/90. Left side of face hot, red, and a mild burning sensation on 09Mar2021 at 13:30. Diagnosis bells palsy probably. Follow up visit to the doctor concurred. The events resulted in emergency room/department or urgent care; no treatment was received for the events; no Covid prior vaccination; no Covid tested post vaccination. No other vaccine in four weeks. The patient had recovered from the events on 10Mar2021.
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| 66 | 2021-04-17 | pain of skin |
her pain is worse constantly and she can hardly use the opposite arm; even to touch the skin is extr...
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her pain is worse constantly and she can hardly use the opposite arm; even to touch the skin is extremely painful; her cubicular lymph node was swollen; the area between her neck and armpit has swelled up more and more; pain in between neck and armpit; pain goes into back; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 2 parenteral (reported as "injection") at the age of 66-years-old on 19Mar2021 (Batch/Lot number was not reported) as single dose in Arm Left for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2), dose 1 on an unspecified date for COVID-19 immunization. The patient received the first vaccine with no problem. She received the second vaccine on Friday 19Mar2021 and the next day, 20Mar2021 it felt like her cubicular lymph node was swollen. Every day since then, the area between her neck and armpit has swelled up more and more. Her pain is worse constantly and she can hardly use the opposite arm and even to touch the skin is extremely painful. This is on the opposite side from where she received the shot. The event "area between neck and armpit swelled up" started 20Mar2021 and is ongoing. It increases constantly and it is almost disabling it is in between medically significant and disabling. It has worsened. The event "pain in between neck and armpit" started the past Friday (Mar2021) and is ongoing. It is medically significant but almost disabling as she cannot use her right arm. This has worsened. The event "pain goes into back" started 2 days ago and is ongoing. This is medically significant and has worsened. Treatment was received for the events. The doctor gave her Toradol injection intramuscular and it did not effect anything and she has also taken Tramadol and Flexeril, a muscle relaxer, which did not effect anything. Her doctor has never seen anything like the symptoms she is experiencing. She had an X-ray done but she does not have the results yet as it was done yesterday (29Mar2021). The outcome of the events "her cubicular lymph node was swollen" and "even to touch the skin is extremely painful" was unknown while for the rest of the events was not recovered. Relatedness to COVID 19 vaccine: area between neck and armpit swelled up, pain in between neck and armpit, pain goes into back - Related. Information on the batch/lot number was requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-04-17 | rash, hives |
seizures; muscle fatigue; hives; rash from head to toe; sore muscles; wrap around headache; This is ...
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seizures; muscle fatigue; hives; rash from head to toe; sore muscles; wrap around headache; This is a spontaneous report received from a contactable healthcare professional (patient herself). A 66 -year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EN6208; Expiration Date: 30Jun2021) as a single dose for COVID-19 immunisation. She provided a brief history from 2017. She was walking her dog and she fell and suffered a concussion, she had a seizure, then she developed bipolar disorder. She's been taking sodium valproate (DEPAKOTE) for her seizures since 2017. She reports she's very active. She's not an old lady. She can run circles around some 22 year old's. In September of 2017, she had a concussion and had seizures. She's been on sodium valproate (DEPAKOTE) since that time. She's not mentally ill, the concussion she got in 2017 caused her brain to turn bipolar. It's hard for people to understand that. Sodium valproate (DEPAKOTE) was 500mg. She takes 1 tablet in the morning and 2 tablets at night because it can make you sleepy. She reports she was recently hospitalized in Feb2021 for atrial fibrillation with rapid ventricular rate (RVR). Her heartrate was 181 beats per minute, her blood pressure was dropping, she tested positive for rhinovirus and the doctor thinks the atrial fibrillation with RVR was caused from the rhinovirus. She was allergic to bee venom and carries an EPI PEN. Medical history also included ongoing high blood pressure from an unspecified date (controlled with medication). Concomitant medications included ongoing metoprolol tartrate (LOPRESSOR) taken for blood pressure; ongoing lisinopril; ongoing valproate semisodium (DEPAKOTE) taken for seizure from 2017; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for blood pressure; paracetamol (TYLENOL) from an unspecified date in 2021. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EM9810; Expiration Date: 30Jun2021). The patient did not receive any recent vaccines for any other conditions or any recent vaccines for any other conditions prior to the event being reported; or any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient reported that with the second Covid 19 vaccine she had two seizures on 27Mar2021. The seizures were back to back. The seizures resolved within 2 minutes. She had fatigue from an unspecified date, sore muscles and a wrap around headache on 26Mar2021. The wrap around headache felt like she was going to have a stroke even though her blood pressure was fine. She monitored her blood pressure at her home. She feels it's weird that they publish that the second Covid 19 vaccine is going to be worse. She thought she'd have muscle soreness and fatigue but not seizures. She looked it up and the wrap around headache and seizure are the rarest things that can happen after receiving the Covid 19 vaccine. She stayed in bed from Friday afternoon after she received the second Covid 19 vaccine on 26Mar2021 and started to feel better Sunday afternoon, 28Mar2021. Her blood pressure and pulse were both fine with her wrap around headache. She had fatigue with both Covid 19 vaccines. She also developed hives, which she still has. She has a rash from her head to her toes. It looked like she rolled around in an ant bed. The hives were clearing up. She was using an anti-itch cream. The hives and the rash started midday on Saturday, 27Mar2021. She only has around 5 hives now on her chest. She hasn't taken Benadryl. She doesn't like to take it. Her doctor didn't want her to open the hives and cause impetigo. She never had any soreness in her arm. She doesn't think the headache was serious because she had a blood pressure cuff at home. She just knew the hives and the rash were a reaction to the Covid 19 vaccine. She didn't go to the hospital for her seizures. She was not seen in the Emergency Department, hospitalized, or admitted to an Intensive Care Unit. She tries to do holistic medicines and treatments. She doesn't run to the hospital every time something happens. She tries to stay out of the hospital. She's fine now and she loves Pfizer. If she can get a medicine she needs that Pfizer makes she tries to get it. She tries to see every side of things. Outcome of seizures was recovered on 27Mar2021 and sore muscles was recovered on 28Mar2021; of remaining events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and seizure cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 66 | 2021-04-24 | rash |
Erythema multiforme; asthma attack/shortness of breath/cough; Rash started on legs on the 03Apr2021 ...
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Erythema multiforme; asthma attack/shortness of breath/cough; Rash started on legs on the 03Apr2021 late morning buy next day (04Apr2021) full body rash from shoulders to top of feet; extreme exhaustion; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER 8730), via an unspecified route of administration, administered in left arm on 02Apr2021 09:15 as single dose for covid-19 immunisation. Medical history included heart disease, high blood pressure, asthma, drug hypersensitivity and wasp stings. Concomitant medication(s) included amlodipine; aspirin and atorvastatin. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 09:45 late morning, the patient experienced rash started on legs by next day (04Apr2021) full body rash from shoulders to top of feet. Later on 03Apr2021, extreme exhaustion and dry cough that went into shortness of breath and asthma attack. Visit to ER and later sent to dermatologist. Possible Erythema multiforme. As of 09Apr2021 still have rash and exhaustion and dry cough. It was unknown whether patient received any treatment. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-04-24 | rash, blister |
Rash started on r forearm and spread to left arm am currently spreading to chest and legs; Blisters,...
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Rash started on r forearm and spread to left arm am currently spreading to chest and legs; Blisters, what looks like calcium splinters and skin peeling; Peeling skin with pain in joints; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, via an unspecified route of administration, administered in the left arm on 29Mar2021 at 13:00 (Lot Number: LAB-1451-0.7), at the age of 66 years, as a single dose for COVID-19 immunization. Medical history included myasthenia gravis, mixed auto immune diseases, allergies to Valium and Zofran. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included omeprazole, alprazolam, levothyroxine, rivaroxaban (XARELTO), losartan potassium (LOSARTIN), atorvastatin, amlodipine, fluticasone, albuterol (SALBUTAMOL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, at 12:00 am, the patient developed rash started on (R) forearm and spread to left arm and currently spreading to chest and legs. Blisters, what looks like calcium splinters and skin peeling, peeling skin with pain in joints. The events were reported as non-serious. The events required a physician office visit. No treatment was given for the events. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 66 | 2021-04-24 | shingles |
swells right under her finger; pain in the center of the palms of her hands and bottom of her feet/ ...
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swells right under her finger; pain in the center of the palms of her hands and bottom of her feet/ achy pain; She couldn't straighten it out or bend it all the way down, it was like it was locked; joint went stiff and the pain; joint went stiff and the pain; Center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like; Center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) via an unspecified route of administration at left upper arm 10Mar2021 at 12:30 (66-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included thyroid, and "had stem cells put in her hip". Concomitant medications included ongoing thyroid (ARMOUR THYROID) for thyroid. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) via an unspecified route of administration at left upper arm 17Feb2021 at 14:00 (65-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient previously received the second dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for shingles and felt like we were getting the flu and the next morning was fine. Patient states she had stem cells put in her hip and was (medical office name) for an x-ray to see how it's doing. She showed a nurse practitioner her hand and nurse practitioner said patient needs to report that. Patient states it swells right under her finger, swelling under her middle and ring finger. The joint went stiff and the pain. She can't bend her fingers, it is mostly her ring finger. She couldn't straighten it out or bend it all the way down, it was like it was locked. Following her second vaccine dose she has had pain in the center of the palms of her hands and bottom of her feet. The pain is inconsistent as it comes and goes. The feet pain come and go not bad like the hands. The middle of the palm pain comes and goes and the joint on 1 finger never did get better, it is worse at night and a teeny bit better in the morning. She felt pain in 1 of her feet for a moment yesterday and not continuous like her hand. The left hand is not swelling, the center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like, it is an achy pain. States she kept telling her husband she has pain in the center of her hands and on the bottoms of her feet and feels like she is about to have a break out and didn't. Patient states it has been a month since she had the 2nd vaccine. States the symptoms all started within 24 hours of the 2nd vaccine. On 07Apr2021, nurse practitioner put a lubricant injection (name unknown) into her hand where the swelling was. Patient was told it was a lubricant that might help, and it has helped some. It is moving a little better today after the injection but she still has pain. Adverse events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the event "swells right under her finger" and included lubricant injection. The outcome of swells right under her finger, joint stiffness, and joint lock was recovering; other events were not recovered. No follow-up attempts are needed. No further information is expected.
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| 66 | 2021-04-26 | blister |
developed two watery like blisters in the palm of Right hand; This is a spontaneous report from a co...
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developed two watery like blisters in the palm of Right hand; This is a spontaneous report from a contactable consumer(patient). A 66-years-old non pregnant female patient received bnt162b2 (COVID 19, Formulation: solution for injection), dose 2 via an unspecified route of administration in Arm Right on 22Feb2021 at 15:45 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included historical vaccine received bnt162b2 (COVID 19, Lot number= EL9264), dose 1 via an unspecified route of administration in Arm Right on 29Jan2021 at 11:45 AM, hypertension from an unknown date and unknown if ongoing, hyperlipidaemia from an unknown date and unknown if ongoing. Concomitant medications included sertraline hydrochloride taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported; hctz taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. There was no COVID prior vaccination and no COVID tested post vaccination. On 23Feb2021 at 17:00, The patient experienced developed two watery like blisters in the palm of right hand. The event was considered as non-serious. The outcome of the event was reported as Not recovered. No follow up attempts are needed. No further information is expected.
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| 66 | 2021-04-26 | vaccination site pain |
nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels li...
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nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Constipated; Doesn't sleep through the night; Headache lasted for days and days; No appetite, lost 6 pounds in a week; No appetite, lost 6 pounds in a week; Tired; Diarrhea; Nausea; felt like Dumping Syndrome; Stiff neck, like an iron claw; Anxiety reared up; Blacked out; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 17Mar2021 at 11:30 AM (at the age of 66 years old) (Lot Number: EN6205, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included ongoing anxiety (40 years or more), ongoing depression (46 years ago, at the age of 20), ongoing acid reflux (maybe 25 years), ongoing GERD (maybe 25 years), ongoing Barrett's esophagus (for 12 years), mild to moderate COPD since 2011, gastric bypass (a year and a half ago), and lost 120 pounds. Concomitant medications included bupropion for anxiety depression and omeprazole for acid reflux, both ongoing. The patient previously received flu and tetanus on unspecified dates for immunization and both experienced hard red welt on arm (welt was hard and lasted for 5-7 days). The patient reported no side effects for 12 hours, but a little soreness at injection site on 17Mar2021 at 20:00 (8:00 PM). Her arm wasn't heavy, but she had an awareness of the soreness. She has had life-long anxiety and depression. Several weeks ago (on 26Mar2021), her anxiety reared up, and it could have been due to a family situation. On the 9th day after the first shot, she was having a therapy appointment on the phone and talking about her anxiety, and she got a stiff neck, like an iron claw (26Mar2021 at 10:00 am). It lasted for a couple of 5 minutes and she laid down on the couch then on the floor. Her therapist said to call 911. Emergency medical technicians came to her house and they said all of her numbers looked good. She went to the hospital, and was in the emergency room for several hours, but she only remembers one hour of it. She also had diarrhea and nausea on 26Mar2021 at 11:30, and it felt like Dumping Syndrome, that one can have from a gastric bypass. She was only aware for one hour at that point and blacked out (on 26Mar2021). With regards to nausea, she mostly saw bile in the bag, all she had that day was a protein drink. She was back home and the next day, she did not remember how she got home. She hasn't had blackouts anymore but feels it may be from heightened anxiety. On 27Mar2021 at 09:00, she had no appetite, lost 6 pounds in a week, and was tired. She had headache lasted for days and days on 29Mar2021 at 09:00 AM. She is slowly improving but she still doesn't sleep through the night on 29Mar2021 at 16:00. It was like a feeling like she was resetting her surgery, like she didn't care about eating. The also experienced back pain, butt and legs hurt, feels like sciatica on 31Mar2021 at 16:00 and was constipated. She is using a stool softener and is back in her routine. She called her primary doctor and could not tell her what happened, and she went in a loop trying to get information and authorizations for her to make a determination of what had happened. Her doctor felt like she should have an MRI. Her heart and all of her numbers looked good, as the emergency medical technicians said. Her primary doctor recommended her to get the second shot. She had cancelled the second shot for this week, and she has rescheduled it for another date. She was afraid that she will black out again, after the next vaccine, and is not sure if that is how her anxiety manifested. The main reasons she is calling is that she had no concerns of side effects prior to the vaccine, and a couple of her neighbors said they had read about side effects of the vaccine, but she was not worried. When the patient started to read about side effects of the vaccine, she understood that on the 10th day, the vaccine starts to be in a person's system and that maybe is why she didn't have initial side effects, but then she had side effects several days later because the vaccine was in her body. By day 10, the vaccine is in effect in the body and she is nervous. Her second vaccine is scheduled on 26Apr2021. The patient would like to know if there is any information on people that have had a gastric bypass. The patient has no prior vaccinations within 4 weeks. The events resulted in emergency room visit (except nervous). The patient recovered from soreness at injection site on 18Mar2021; recovered from diarrhea, nausea, felt like Dumping Syndrome on 26Mar2021; recovered from stiff neck on 26Mar2021 at 10:05am; recovered from constipation on 02Apr2021; and recovered from no appetite and lost 6 pounds on unspecified dates. The patient also recovered from headache with sequelae on unspecified date; and recovered from blacked out on 27Mar2021 with sequelae. The patient had not yet recovered from anxiety reared up; tired; doesn't sleep through the night; back pain, butt and legs hurt, feels like sciatica. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-04-27 | vaccination site pain |
swelling starting 8 days later and continuing two weeks; Lymph nodes under arm and near breast, swel...
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swelling starting 8 days later and continuing two weeks; Lymph nodes under arm and near breast, swelling starting; burning in arm immediately after injection; This is a spontaneous report from a contactable consumer (patient). A 66-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9263), via unspecified route of administration on 28Jan2021 at 1:00 PM (at the age of 66-years-old) in left arm at a single dose for covid-19 immunisation. No Other Vaccination within 4 weeks. The patient medical history included hashimoto's disease. The patient had known allergies with morphin based drugs. Concomitant medication patient had in two weeks included thyroid medication. The patient experienced burning in arm immediately after injection. Lymph nodes under arm and near breast, swelling starting 8 days later and continuing two weeks on 04Feb2021 at 08:00 AM. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the events was not recovered. .
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| 66 | 2021-05-04 | dry skin, rash |
Caller reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the ...
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Caller reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the neck, describes as dry skin.; Caller reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the neck, describes as dry skin.; Heart palpitations, heart fluttering; Heart palpitations, heart fluttering; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8730), single dose, dose 1 via an unspecified route of administration, administered in the right arm on 31Mar2021 at 09:30 (at the age of 66 ears-old) for COVID-19 vaccination. Medical history included hip arthroplasty from 21Nov2020 to an unknown date. Historical vaccine included felt like she had the flu and was down for a few days after she got the flu vaccine. Family Medical History Relevant to the adverse events included her aunt passed away from taking penicillin years ago but does not specify that she has an allergy herself. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On There were no additional vaccines administered on the same date of the Pfizer suspect. The patient experienced heart palpitations, heart fluttering on 31Mar2021, reclarifies rash as on the back of her neck, shoulder, face, under the neck and front of the neck, describes as dry skin on 04Apr2021. She felt was down for a few daysThe events did not require an emergency room or physician's office visit. The patient used moisturizer and Vitamin E oil for the rash. The clinical outcome of heart palpitations and heart fluttering was not recovered and recovering for rash and dry skin. . .
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| 66 | 2021-05-04 | vaccination site rash |
Dose number-2 Administration date:17-Feb-2021 Dose number-1 administration date:31-Jan-2021; had a r...
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Dose number-2 Administration date:17-Feb-2021 Dose number-1 administration date:31-Jan-2021; had a rash near the injection site; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EL9296 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Feb2021 17:00 (at the age of 66-year-old) as single dose for COVID-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200), via an unspecified route of administration on left arm on 31Jan2021 16:00 at single dose for COVID-19 immunization. Medical history included, hypertension, hypercholesterolemia, coronary artery disease, neoplasm malignant. The patient's concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and received other vaccine within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 5 days after receiving the second dose. On 22Feb2021, the patient had a rash near the injection site and an area lower on that arm where she had basal cells removed that was swollen and itchy. The patient did not receive any treatment. Outcome of the events was not recovered. No follow-up attempts are needed. No further Information is expected.
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| 66 | 2021-05-10 | rash |
Developed left sided neck swelling 1 day after vaccination. Left sided neck swelling was associated ...
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Developed left sided neck swelling 1 day after vaccination. Left sided neck swelling was associated with lymphadenopathy. Persisted for 3 weeks before spontaneously improving. Patient also developed a rash (biopsy confirmed leukocytoclastic vasculitis) about 2 weeks after vaccination, which persisted 5 days before resolving.
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| 67 | 2021-01-03 | injection site bruising |
Beginning the day after, pt had mild bruising over injection site. Over the next several days, bruis...
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Beginning the day after, pt had mild bruising over injection site. Over the next several days, bruising darkened and extended from superior L shoulder to elbow.
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| 67 | 2021-01-03 | skin laceration |
disoriented; hit her head and cut herself; hit her head and cut herself; Passed out at night; This i...
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disoriented; hit her head and cut herself; hit her head and cut herself; Passed out at night; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose at left arm for COVID-19 immunization. Medical history included Atrial fibrillation/heart problems diagnosed prior to the vaccine, got the COVID virus on 18Nov2020, disoriented in Nov2020. Concomitant medications included her heart medication every day and vitamins, nothing out of the normal. Caller stated she had heart problems. The heart problems were diagnosed prior to the vaccine. Caller also stated that she got the COVID virus this year before the vaccine as well and she was off, of work for like a month. On 23Dec2020 she got the vaccine. Then on Thursday 24Dec2020 and Friday 25Dec2020 she had a reaction. She had passed out in the night, hit her head and cut herself, she was then disoriented for 1 full day. Caller stated that the last time she was disoriented like this was when she had the COVID Virus, because she had heart problems. Caller stated that she was fine now. Caller stated that she had been off, of work so much. The heart problem she had was Atrial Fibrillation. Caller clarified that she had the COVID virus this year in Nov2020, it was before thanksgiving, on 18Nov2020 she had the virus, then on 19Nov2020 she got tested and it was positive. She got the vaccine on the 23Dec2020 Wednesday then on 24Dec2020 at night she passed out and on 25Dec2020 she was disoriented all day. Investigation Assessment: No. On 24Dec2020 she was going to bathroom, and found herself on the floor, then the following day 25Dec2020 was when she was disoriented. She knew this because when she had the actual COVID virus previous in Nov2020 this happened previously. When queried outcome of being disoriented she stated that she still felt a little weird but if getting better very, very slow. The Second dose was schedule for 13Jan2021. Caller confirmed that she did have a Positive Test for Covid Previously. Her treatment at the time was in the Emergency Room, they gave her an Antibody infusion, she had to schedule it because it was actually a clinical trial. Caller was asked if she knew the name of covid test, she stated that she does not know, she only recalled that she opened her mouth and they test her that way. The outcome of the event "disoriented" was recovering, of the other events was unknown.
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| 67 | 2021-01-05 | injection site pain |
severe headache, fever, nausea, frequent bowels, injection site pain, chills, joint pain - it felt l...
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severe headache, fever, nausea, frequent bowels, injection site pain, chills, joint pain - it felt like 36 hours of bad flu
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| 67 | 2021-01-06 | itchy skin, hives |
UrticariaPruritus Tingling of upper lip and under eyes Narrative: 12:45 stated upper lip felt fingly...
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UrticariaPruritus Tingling of upper lip and under eyes Narrative: 12:45 stated upper lip felt fingly and under eyes; VS 73, r 16, BP 1589/90, sat 98%. ambulated to MD office Evaluated by Dr. Benadryl ordered (25mg PO x 1 dose) and given at 1305). Ambulated back to personal office, called friend to pick up after work. 1330, 72, 16, 96%, 135/82, denies worsening of symptoms, no rash or hives noted. No symptoms of difficulty breathing, swelling of face or tongue, increased heart rate, rash or dizziness or head ache. Assessment and follow up by M.D.
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| 67 | 2021-01-07 | vaccination site pain |
sore at injection site; This is a spontaneous report from a contactable Other HCP. This 67-year-old ...
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sore at injection site; This is a spontaneous report from a contactable Other HCP. This 67-year-old female nurse (patient) received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported) on 30Dec2020 09:00 (at the age of 67-years) as single dose, unspecified route into left arm for immunization. Medical history included hypertension, depression, and hyperlipidemia. Known allergies: crestor, ANSAIDS, red dye, lavendar. Concomitant medications include hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), amlodipine (AMLODIPINE), bupropion hydrochloride (WELLBUTRIN), and atorvastatin calcium (ATORVASTATIN CALCIUM). Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 31Dec2020 at 6 AM the patient experienced 'sore at injection site'. No treatment was received as a result of the event. The outcome of event 'sore at injection site' was recovered on an unspecified date.
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| 67 | 2021-01-08 | cellulitis | Vaccine allergic reaction with cellulitis |
| 67 | 2021-01-08 | itchy skin, hives, rash |
welty rash appeared Friday night. very uncomfortable and itchy, clothing swapped, was gone by mornin...
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welty rash appeared Friday night. very uncomfortable and itchy, clothing swapped, was gone by morning. Later in the morning, reappeared, mainly on back of thighs and rear end. took 2 tablets of 25mg Benadryl. took a n ap, and rash is gone again.
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| 67 | 2021-01-12 | hives, itchy skin |
Within 10 minutes started itching on arms, within 45 minutes hives started first on arms, then trunk...
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Within 10 minutes started itching on arms, within 45 minutes hives started first on arms, then trunk, neck and ears. During this time throat began to get scratchy. Took two 50mg of benadryl then 1 hour later took one more 50mg of benadryl. Within 3 hours hives and scratchy throat was gone.
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| 67 | 2021-01-13 | rash |
Rash to chest and neck area started around 6pm on 12/19/20 and it is current today 1/14/21 but fadi...
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Rash to chest and neck area started around 6pm on 12/19/20 and it is current today 1/14/21 but fading
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| 67 | 2021-01-14 | injection site tingling |
INJECTION WAS ADMINISTERED IN THE CLAVICULAR SECTION OF THE L DELTOID: TINGLING AND HEAVINESS AT SIT...
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INJECTION WAS ADMINISTERED IN THE CLAVICULAR SECTION OF THE L DELTOID: TINGLING AND HEAVINESS AT SITE RADIATING DOWN THE ARM TO HAND AND INTO THE L SHOULDER (I BELIEVE IT WAS GIVEN TOO CLOSE TO THE NERVE: THIS RXN R/T VACCINE DELIVERY TECHNIQUE; RXN TO VACCINE ITSELF: 32 HOURS AFTER ADMIN, CHILLS, SEVERE ARTHRALGIAS THAT LASTED 12 HOURS AS WELL AS SUSTAINED HEADACHE AND SACRUM ACHE FOR 4 DAYS
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| 67 | 2021-01-14 | rash with redness |
Pt verbalized feeling flush on the face (red cheeks), she was evaluated by paramedics and released h...
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Pt verbalized feeling flush on the face (red cheeks), she was evaluated by paramedics and released home at 1:20 pm feeling better.
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| 67 | 2021-01-14 | injection site redness |
received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to hersel...
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received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to herself out of bed, needed to wake husband for assistance due to employee being unable to use Right arm. Developed headache, chills, sweats, joint pain Stated "it felt like I was hit by a bus" felt like I got beat up. Wednesday Headache was gone, R arm swollen, lymph nodes at axilla and R neck large as grapes, painful. No appetite, effort to move .Arm was swollen and reddened at injection site.
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| 67 | 2021-01-15 | itchy skin |
About 15 minutes after injection, my scalp began to itch all over. Have basically felt unwell for t...
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About 15 minutes after injection, my scalp began to itch all over. Have basically felt unwell for the last three days.
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| 67 | 2021-01-16 | injection site redness | sore arm redness at the site chills and fever-101.3 fatigue |
| 67 | 2021-01-17 | dry skin, rash with redness, itchy rash, rash papular, skin warm |
Eczematous dermatitis of forearm papular erythematous pruritic rash warm to touch rough in touch ro...
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Eczematous dermatitis of forearm papular erythematous pruritic rash warm to touch rough in touch rough in texture occurred within 24 hours of first dose rash persistent at one month SIMILAR REACTION FTER 2 ND DOSE given in opposite arm
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| 67 | 2021-01-18 | rash |
Verbalize red rash on neck and chest. Was evaluated by Fire Rescue and MD on site and released home...
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Verbalize red rash on neck and chest. Was evaluated by Fire Rescue and MD on site and released home at 11:37 am feeling better.
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| 67 | 2021-01-19 | rash macular, hives, rash, itchy skin, redness |
4 days after the vaccination (96+ hours after the vaccination) on 1/3/2021 pt noticed a rash with hi...
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4 days after the vaccination (96+ hours after the vaccination) on 1/3/2021 pt noticed a rash with hives ("red, splotchy, very itchy") on the back of both hands and around both wrists. By that evening (5 pm on 1/3/2021), she noticed that the rash was on her neck, chest, upper and lower back, and both legs (lower and upper legs). At 6:30 pm on 1/3/2021 she took 1 Benadryl (25 mg) and fell asleep. The next morning (1/4/2021) at around 7 am, the rash had lessened all over her body, but was still the same on her wrists and hands as the prior night. She took 1 more Benadryl (25 mg) and within 2-3 hours the rash had disappeared.
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| 67 | 2021-01-19 | itchy skin, rash |
I developed a rash in my torso, back, elbows. It itches very much. Seven days after the applicatio...
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I developed a rash in my torso, back, elbows. It itches very much. Seven days after the application of the vaccine, the itch, or rash, is still active.
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| 67 | 2021-01-19 | itchy skin, rash vesicular, rash |
Pt presented to COVID vaccine clinic today and developed a mild reaction after receiving the second ...
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Pt presented to COVID vaccine clinic today and developed a mild reaction after receiving the second Pfizer vaccination. Pt reported a blister like rash on her chest after receiving the first dose. Hx of hives with adhesives and latex, occasional rash with tylenol. Pt reported a flushing sensation and swollen lymph nodes in neck 30 minutes after administration. Pt reported tingling in her hands shortly after. BP: 135/73 HR: 72 O2: 100% Pt denied SOB, swelling of face/tongue/throat, difficulty swallowing, nausea, itchiness, dizziness. No visible swelling. Paged Allergy (Itchy). Advised to give Zyrtec 10 mg and observe to see if there is any improvement. Symptoms improved 15 minutes after administration of Zyrtec 10 mg. Pt sent home and advised to continue to take antihistamines as needed
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| 67 | 2021-01-20 | itchy skin | Itchiness to both hands, sensation of scratchiness in throat |
| 67 | 2021-01-20 | vaccination site pain |
Slight tenderness at injection site; This is a spontaneous report from a contactable consumer (patie...
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Slight tenderness at injection site; This is a spontaneous report from a contactable consumer (patient) and a contactable other health professional. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at arm left on 11Jan2021 at 11:15 for COVID-19 immunization. The patient medical history included known allergies to adhesive from an unknown date and unknown if ongoing. The patient concomitant medication included metronidazole (METROGEL), vitamin c, cholecalciferol (VITAMIN D), krill oil (MEGARED OMEGA 3 KRILL OIL), cyanocobalamin (B12). On an unspecified date, the patient previously took triple antibiotic ointment and experienced allergy. The patient experienced slight tenderness at injection site on 11Jan2021 at 17:00. The patient outcome of the event was recovering. The information on the batch number has been requested.
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| 67 | 2021-01-20 | vaccination site pain |
Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pa...
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Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pain; This is a spontaneous report from a contactable nurse (patient). A 67-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration on 07Jan2021 09:45 at single dose for covid-19 immunization. Vaccine location was left arm. Patient received the first dose on 17Dec2020 08:45 AM (lot number EK5730) at right arm for covid-19 immunization. Patient is not pregnant. The facility type vaccine was hospital. Medical history included hypertension, elevated cholesterol. Known allergies included Sulfa. Concomitant medication included losartan, hctz, atorvastatin, zinc, ergocalciferol (VIT D). Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore muscle at injection site, fatigue, joint pain on 07Jan2021 10:00 AM. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in Jan2021.
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| 67 | 2021-01-21 | itchy skin |
Developed Itching 20 minutes post-vaccination. Administered 50mg PO Diphenhydramine Capsule. Observ...
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Developed Itching 20 minutes post-vaccination. Administered 50mg PO Diphenhydramine Capsule. Observed for additional 30 minutes. Symptoms improved.
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| 67 | 2021-01-21 | shingles, rash macular, blister, rash |
Developed what looked like a spider bite on right shoulder; painful for two days, additional red spo...
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Developed what looked like a spider bite on right shoulder; painful for two days, additional red spots appeared over the next 4 days with rash extending now down upper arm. Some spots starting to blister. Very painful. Suspect shingles. There is some literature that suggests the COVID 19 vaccine and shingles may be related.
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| 67 | 2021-01-22 | redness, skin warm |
Left Arm reddness and hot to touch, red circle 5 inches wide - Approx 4 hr following injection (5:30...
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Left Arm reddness and hot to touch, red circle 5 inches wide - Approx 4 hr following injection (5:30PM 1/21/21) Fever 102 at 10PM : Aleve 2 gelcaps for fever and arm discomfort , also used heating pad on Left arm discomfort Woke at 5 AM TEMP 102.2 , arm much better, vertigo significant, took mezcalin anti vertigo RX (had from from weeks virus) took 1 Aleve gelcap Temp assessed at 2PM - 99.2 Temp assessed at 5PM - 98 No anti pyretic taken after5am
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| 67 | 2021-01-23 | injection site pain |
In the middle of night started feeling dizzy and developed soreness in arm at injection site.. Over ...
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In the middle of night started feeling dizzy and developed soreness in arm at injection site.. Over the next few days, I developed symptoms: slight fever of 99.4 F, diarrhea, unable to eat much, malaise, still dizzy and sort of "blanking out" at times. Arm pain lessened in 2 1/2 days.
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| 67 | 2021-01-24 | hives | Allergic dermatitis (L23.9). Broke out in hives 01/23/2021 (not due to anything by mouth). |
| 67 | 2021-01-24 | cellulitis, redness |
The first 3 days i had chills weakness headache and small pimples on my tongue. My arm was soar .aft...
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The first 3 days i had chills weakness headache and small pimples on my tongue. My arm was soar .after the 3 days i went back to normal on Jan 22 i wake up with pain in left arm i thought it was due to my neck issue Sunday the 24 th noticed that my Arm is swollen and red check with a primary care provider and been told that i hv cellulitis that he thinks it is from the injection . The Physician prescribed immediately doxycycline 100 mg twice a day for 10 days .. on the 25 i informed my care provider . I started the Antibiotics Jan 24th at 8:00 pm.
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| 67 | 2021-01-25 | rash, hives |
Within 15-minutes of vaccination, patient developed urticaria on their chest, which developed into a...
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Within 15-minutes of vaccination, patient developed urticaria on their chest, which developed into a rash and hives. No throat/tongue swelling or shortness of breath noted by EMS. EMS transported patient to hospital and administered Benadryl (IV) in-route.
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| 67 | 2021-01-26 | itchy skin |
Generalized pruritus associated with itchy throat and sensation of throat tightening. Epinephrine 0...
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Generalized pruritus associated with itchy throat and sensation of throat tightening. Epinephrine 0.3mg IM and Benedryl 50mg. Symptoms resolved. Refused transport to ED
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| 67 | 2021-01-26 | hives |
Urticaria within 5-10 minutes of receiving vaccine. No other symptoms. Solumedrol adminstered IV. S...
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Urticaria within 5-10 minutes of receiving vaccine. No other symptoms. Solumedrol adminstered IV. Symptoms resolved about 20 minutes later.
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| 67 | 2021-01-27 | itchy rash, rash |
10 minutes post-vaccine, patient developed itchy rash on right cheek. Symptoms include itching, burn...
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10 minutes post-vaccine, patient developed itchy rash on right cheek. Symptoms include itching, burning, tingling at rash site. Patient also felt thirsty (was then given water). Benadryl oral was given, but symptoms did not resolve and patient began to feel feverish and dizzy. Itch worsened and spread throughout body. Dexamethasone oral was given 15 minutes later. Itching started in mouth. EpiPen was administered intramuscularly to left vastus lateralis. Hypertension was noted post administration. Itching in mouth subsided, but patient began to feel shaky and still felt dizzy. Monitored for additional 20 minutes. After, patient was stable, walked out via wheelchair enroute home.
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| 67 | 2021-01-27 | injection site hives, injection site pruritus |
Itchy hives around the injection site that has been resolving over the last 3 days, no respiratory d...
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Itchy hives around the injection site that has been resolving over the last 3 days, no respiratory distress experienced.
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| 67 | 2021-01-27 | itchy skin | Within 15-minutes of vaccination, the patient reported pruritus on their neck and chest. |
| 67 | 2021-01-28 | redness |
7:07 Started coughing then became nauseated proceeded to vomit. Nurse suggest after about 10 mins t...
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7:07 Started coughing then became nauseated proceeded to vomit. Nurse suggest after about 10 mins that she should take me to ED for Zofran. Upon getting to ED I was wheezing badly and trying to find inhaler in purse; wheezing and unable to catch a breath I was placed in a room, by then my body was turning red and wheezing worse. I was given epinephrine and prednisone immediately for anaphylaxis. They reacted immediately upon my arrival. Time I unsure. I just say thank God for them. Meds Given- Tylenol Duoneb, Decadron, Benadryl, Epinephrine, Pepcid, Nss
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| 67 | 2021-01-28 | injection site pain |
Almost immediately after taking the vaccine for covid19, I felt extreme dizziness (vertigo). The nu...
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Almost immediately after taking the vaccine for covid19, I felt extreme dizziness (vertigo). The nurse had me drink some water and eat some nuts. I had drunk some glucerna that morning for breakfast with my medication. The RN had me wait for about an hour. I then called my primary care doctor who told me to go home and rest. He said that I did not need to go see him or go to a clinic or Emergency Room unless I felt worse. (I have progressively felt better). I left his number and contact information under the contact information above. However, I had received the shot from the Hospital site. I am providing this as you were a little vague in your question about contact address. Anyway, my husband took my temperature about 6 pm. I had a temperature of about 93.8. I normally have a temperature of 98.6 F. He used a digital thermometer. However, I did not feel as if I had asthma. I did have a slight headache then and my arm was a little bit sore. Today (the 29th) my temperature is about normal. I do not have any breathing problems, but my arm is a little bit sore where I got the shot. I still have a slight headache, but it's not too bad. I don't need to take medication for it. There is no redness at the site of the injection. I should mention that one of the RN's did look at my fingernails and the color was normal which I assume means no problems with oxygen levels. I am only reporting this because of the extreme dizziness! I felt a lot better after about an hour after taking the shot, drinking the bottle of unflavored (still) water and eating the nuts. My A1C is back to normal today. (and remember I am not currently needing or taking any form of insulin but my doctor has my blood checked regularly and has for many years). I am only putting no on the item number 20 below because I still have a slight headache and a little bit of soreness in the injection site. Today the site of the injection is not red either.
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| 67 | 2021-01-28 | injection site pain |
Injection site pain, mild, 1day; Fatigue 2 days, mild; pain to the touch and lifting arm, in right a...
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Injection site pain, mild, 1day; Fatigue 2 days, mild; pain to the touch and lifting arm, in right armpit, started 24 hrs post vaccine, still occurring; no treatment for anything
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| 67 | 2021-01-28 | vaccination site redness, vaccination site swelling |
redness and swelling at injection site; redness and swelling at injection site; muscle pain; muscle ...
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redness and swelling at injection site; redness and swelling at injection site; muscle pain; muscle and joint pain; not feeling well; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) at the 1st dose on 22Dec2020, at the 2nd dose on 12Jan2021; both via an unspecified route of administration at left arm at single dose for covid-19 immunization. Medical history included diabetic and allergies to sulfur drugs. Concomitant medications included other medications in two weeks. The patient was not pregnant. The patient had no other vaccine in four weeks. The patient experienced redness and swelling at injection site, muscle pain, muscle and joint pain, and not feeling well on 24Dec2020. No treatment was received for events. The patient had no COVID prior vaccination. The patient had Covid test post vaccination by Nasal Swab on 11Jan2021 with negative result. Outcome of the events was unknown.
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| 67 | 2021-01-28 | redness | shaking chills body aches headache fatigue red sore arm |
| 67 | 2021-01-28 | shingles |
shingles pain flair up. right mid riff and left arm, and left neck, cheek, and foot. A burning pain ...
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shingles pain flair up. right mid riff and left arm, and left neck, cheek, and foot. A burning pain and dizziness. the pain is very intense causing me to lay down and close my eyes. This has happened everyday for two weeks now. everyday is the same and has not gotten better.
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| 67 | 2021-01-29 | hives, rash |
No problem with injection site. Developed what appears to be a rash (hives?) on my right side at my...
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No problem with injection site. Developed what appears to be a rash (hives?) on my right side at my waistline. Noticed two spots and at first thought it was bug bites. Since Wednesday, several more spots have appeared in same area around waist from navel area around to back. Spots are not large or itchy but have an occasional mild sensation like a twinge (mostly from the new spots). Been self-treating with witch hazel, hydrocortisone cream, fexofenadine and acetaminophen. Note: I am assuming this is a side effect from Covid vaccine because I have never before had hives. I had a senior flu shot in October with no side effects.
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| 67 | 2021-01-30 | injection site pain, injection site swelling, injection site pruritus, injection site redness |
Swelling, redness x 3cm, itching, mild tenderness at injection site. Recommend Zyrtec 10mg. daily, t...
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Swelling, redness x 3cm, itching, mild tenderness at injection site. Recommend Zyrtec 10mg. daily, take medrol dose pak if symptoms worsen in 24-48hrs.
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| 67 | 2021-01-31 | injection site redness, injection site pruritus |
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion...
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Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion-Severe, Systemic: Other- mild chest pain, dizziness, feeling like she was going to pass out or fall asleep-Medium
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| 67 | 2021-01-31 | shingles | herpes zoster left scapular area |
| 67 | 2021-02-01 | rash, shingles |
During the evening of the day that the vaccine was given, patient had pain in right flank. Pain les...
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During the evening of the day that the vaccine was given, patient had pain in right flank. Pain lessened the next day. That second night at about 3:00 AM, she was awakened by severe pain in the same area. The next day, she went to her physician. By that time, she had a rash in the right flank area. Her physician diagnosed shingles and prescribed Valtrex. The Valtrex , along with ice, subdued her pain. and after 2 weeks, her symptoms resolved.
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| 67 | 2021-02-01 | itchy skin, injection site pruritus |
Itching at injection site within 3 minutes or less from time of injection, After two to three minute...
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Itching at injection site within 3 minutes or less from time of injection, After two to three minutes of the itching episode, heart racing followed by palpitations. Followed by chest tightness over heart area. Followed by shaking in upper torso and arms and hands. Became nauseous followed by weakness and a need of a wheel chair to get to my car. A few hours after arriving at home, itching started all over my body and nausea persisted through the night. Itching became stronger. The morning after the shot explosive diarrhea. Fatigue, chills and hot and cold feelings the following day as well as itching persisted. Now, two days later, itching remains with intermittent mild chest tightness which is abating and taking zytrec for the itching
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| 67 | 2021-02-01 | injection site pain |
Pinched nerve, pain on injection site, numbness of fingers. Describes pain as shooting pain in finge...
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Pinched nerve, pain on injection site, numbness of fingers. Describes pain as shooting pain in fingers. Stabilized - discharged to home. BP/pulse: 154/70, 81; 154/76, 82. O2 sat 100%.
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| 67 | 2021-02-01 | vaccination site pain |
She is being told that one of the nurses at the outpatient clinic where she works was positive for C...
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She is being told that one of the nurses at the outpatient clinic where she works was positive for COVID.; right arm soreness at the injection site with the first dose; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female nurse received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) via intramuscular in right arm on 28Dec2020 09:52 at single dose for COVID -19 immunisation. Medical history and concomitant medications were not reported. She does not have any health issues or chronic health conditions. Patient was calling about the COVID-19 vaccine. She is a Registered Nurse. She reported right arm soreness at the injection site with the first dose at the first day (28Dec2020). Nurse declined any treatment. Nurse provided seriousness assessment for right arm soreness at the injection site with the first dose: Not serious. She tested negative for coronavirus that Monday prior to the surgery (11Jan2021). She is being told that one of the nurses at the outpatient clinic where she works was positive for COVID. Patient just had rotator cuff repair surgery last Thursday (14Jan2021). She is on pain medicine from her surgery. She is taking hydrocodone acetaminophen 10/325mg and a muscle relaxer called methocarbamol but she does know the dose. She is not having pain at her site of her surgery. She had the second dose on 19Jan2021 11:03. Patient did not have additional vaccines administered on same date of the Pfizer vaccine. Patient did not visit emergency room nor physician office. No prior vaccinations within 4 weeks. Outcome of the events was unknown.
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| 67 | 2021-02-01 | redness, itchy skin, rash, hives | rash on stomach itchy red hives |
| 67 | 2021-02-02 | vaccination site swelling, vaccination site warmth, vaccination site itchiness, vaccination site redness |
itching around noon on 16Jan2021 to her right arm/injection site; the area was red, swollen, warm, a...
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itching around noon on 16Jan2021 to her right arm/injection site; the area was red, swollen, warm, and measured about 5 inches in diameter; the area was red, swollen, warm, and measured about 5 inches in diameter; the area was red, swollen, warm, and measured about 5 inches in diameter; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) via an unspecified route of administration on right arm on 07Jan2021 at single dose for COVID-19 immunization. Medical history included Low Thyroid Function, High Blood Pressure, IBS, High cholesterol. Concomitant medication included simvastatin for high cholesterol, metoprolol tartrate (METOPROLOL) for high blood pressure, levothyroxine sodium (SYNTHROID) for thyroid. Patient received the first dose of the bnt162b2 on 07Jan2021 on her right arm. She started to experience itching around noon on 16Jan2021 to her right arm/injection site and reported the area was red, swollen, warm, and measured about 5 inches in diameter. Also reported as starting 16Jan2021 she started to experience in the same injection site area warmth, redness, swelling, itching and she reported that it was measured about 5 inches in diameter around the injection site. She reported taking Benadryl and icing the affected area and stated it felt a little better as of 17Jan2021. The outcome of the events was recovering.
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| 67 | 2021-02-03 | redness, skin discolouration |
3 days following vaccine, experienced tenderness and discoloration in left hand. With it was tendern...
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3 days following vaccine, experienced tenderness and discoloration in left hand. With it was tenderness in my hand and wrist, by the 3rd day, I woke with throbbing pain in my knuckle joint with swelling and redness. Since then, the swelling and pain has progressed to additional knuckles in my left hand and into my right hand. There has also been joint pain in my left shoulder that resolved. Yesterday my right knee began to hurt. I've used ice packs and alternated between ibuprofen and acetaminophen for the pain. The swelling has somewhat improved but has not resolved. The pain is still present. I've had occasional join pain before but nothing like this and it has always resolved. Not sure if this has anything to do with the vaccine, but since joint pain was listed as a side effect, I thought I should report it. Have not contacted my physician yet.
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| 67 | 2021-02-03 | itchy skin, rash macular, rash, injection site pain |
After leaving the site after over 15 minutes, noticed splotchy area on neck. It went away on the 2-h...
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After leaving the site after over 15 minutes, noticed splotchy area on neck. It went away on the 2-hour drive home. Today I am feeling some itchiness in random areas. The mild pain at the injection site is gone.
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| 67 | 2021-02-03 | redness |
Do not believe he gave it IM, I believe he gave it subQ; Redness; Swelling; heat coming out; Skin le...
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Do not believe he gave it IM, I believe he gave it subQ; Redness; Swelling; heat coming out; Skin lesions 4.5 to 7cms/Red spot on my arm; Low grade temperature elevation; Fatigue; This is a spontaneous report from a contactable physician (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899, reported as "SARS-COV-2 then it says Pfizer EH9899", expiry date: Unknown), subcutaneous on 05Jan2021 at single dose for COVID-19 immunization (reported as "To not get COVID 19"). Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) 25mcg, once a day for hypothyroidism. The patient got the vaccine last Tuesday (05Jan2021). When she got the vaccine, the gentleman was from military who gave the vaccine. The patient does not believe that he gave it intramuscular (IM), she believed that he gave it "subQ" because she had no muscle tenderness and "skin a 4.5 by 7cm skin reaction", and it was nowhere near the deltoid muscle. The patient had a high degree of suspicion that he gave it "subQ" (subcutaneous). When asked for the anatomical location of administration, the patient stated that "He gave it on my right arm but it was not into the deltoid, I think he gave it subcutaneously. I am not positive of that but missed the deltoid, it was lower, it was below the deltoid, it was in between the deltoid and the bicep and I am assuming it was subQ because none of my muscles were sore at all after getting the vaccine, accept that big red spot on my arm". Patient asked "Now my question to you is because I looked through all your literature and I can't find anything about this". Since then the skin lesion within a couple of days it was up to about 4.5 to 7cms. It was still about that size however the redness has gone way down, "the not redness", just pink, the swelling was almost gone. The heat coming out of it was almost gone. The patient mentioned that the actual skin region was much better, it was still about the same size though. Patient was not too worried about that and stated "what am concerned about is what I've also have is a low grade temperature elevation and some fatigue. If I got it on 3 O'clock on Tuesday the 5th that would be day 9. Is the 9 days post injection for dose 1 to still have a low grade temperature elevation and some fatigue. Is that acceptable or does that indicate a problem?". Patient stated the she went to her internist and he had a look at it and he said "I had no idea, he said that they just don't have experience like this. Do you have a phone number that I can talk to somebody?". The patient was about 5' 7" (height) and about 175 pounds (weight) approximately. The patient stated that fatigue and temperature elevation started one or two days after the vaccine (Jan2021). Patient reported that she still have it. The fatigue was much less but it was there and low grade temperature elevation was still there. There was no investigation assessment. The patient assessed that the events swelling, redness, skin lesions, temperature and fatigue were related to COVID-19 vaccine, also reported as "Yes, because I never had that before and I am not taking anything now. So, it is like yes. It is definitely because that. The two main symptoms I am asking about are the fatigue and the low grade temperature elevation". Outcome of the events fatigue and skin lesion, redness, swelling and heat coming out was recovering, for low grade temperature elevation was not recovered.
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| 67 | 2021-02-03 | hives |
hive in the middle of her chest, it is swollen and raised; This is a spontaneous report from a conta...
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hive in the middle of her chest, it is swollen and raised; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9231), via an unspecified route of administration (left upper arm) on 14Jan2021 (15:30) at single dose for Covid-19 immunization. The patient's medical history included blood cholesterol abnormal, anxiety, high blood pressure, sleep disorder, and obesity. Concomitant medication included amlodipine besilate (NORVASC) for high blood pressure been on it for years and ongoing, hydroxyzine for anxiety been on this medication for 10 years and ongoing, trazodone for sleep taking for 10 years and ongoing, pravastatin sodium (PRAVACHOL) for cholesterol taking for 12 years and ongoing, and colecalciferol (VITAMIN D) from 2019 and ongoing. In November, she received her shingle shot and croup shot. The patient reported that got she the vaccine yesterday (14Jan2021S). She woke up with a hive on 15Jan2021 (8:30 am). She has a hive in the middle of her chest, it is in between her boobs. She added that it is swollen. There is nothing else anywhere. She is going to take Benadryl. She didn't have a prescribing doctor. Her boss set up the appointment for them. The hive has stayed, it is swollen and raised. Her second dose is scheduled on 04Feb2021. The outcome of event was not recovered.
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| 67 | 2021-02-03 | itchy skin |
itching in hand on arm that she got shot in; swelling in her hand; This is a spontaneous report from...
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itching in hand on arm that she got shot in; swelling in her hand; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3246, expiration date unknown), via an unknown route of administration (reported as "through a needle") in the left arm, on 18Jan2021 (at the age of 67-years-old) at an unspecified dose for COVID-19 vaccination. The patient's medical history was not reported. The patient was administered the vaccine in the Health Department. The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 19Jan2021 (reported as "last night") the patient experienced itching in hand on the arm that she got the shot in. She stated that she is experiencing swelling in her left hand as well. The patient described further that it is not itching as bad and stated that after the itching it swelled up. Treatment was reported as having taken Benadryl for the itching. The clinical outcomes of itching in hand was reported as recovering and the clinical outcome of swelling in hand was reported as not recovered.
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| 67 | 2021-02-03 | injection site pain |
one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she start...
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one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she started feeling a little warm; Low grade fever; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302), intramuscularly on 19Jan2021 11:03 on right arm at single dose for COVID-19 immunization. Vaccination Facility Type was at Clinic. Medical history included just had rotator cuff repair surgery last Thursday (11Jan2021), pain, muscle relaxer. Concomitant medications included acetaminophen; hydrocodone as pain medicine, methocarbamol as muscle relaxer. Historical Vaccine included first dose of BNT162B2 (Lot number: EK9231) intramuscularly on 28Dec2020 at 9:52 am for COVID-19 immunization on right arm and experienced right arm soreness at the injection site. It was reported that last night (19Jan2021) she had a low grade fever and chills, then it went away, she was not having the chills earlier today and the fever went away. The fever had come back and she was chilled even though it was hot. She tested negative for coronavirus that Monday (08Jan2021) prior to the surgery. She was being told that one of the nurses at the outpatient clinic where she worked was positive for covid. She clarified that the fever and the chills go together and started last night. The fever did get better and she was not feeling feverish or chilled during the day. About 2 or 3 hours ago (20Jan2021) she started feeling a little warm, nauseated and she checked her temperature 30 minutes ago and it was 99.4. She always run low and did not have a fever. No treatment received for all events. The outcome of event low grade fever was resolving, outcome of events chills and nauseated were not resolved, outcome of other events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events low grade fever, chills and nausea cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-02-04 | skin warm, redness |
Face got red and warm and a burning sensation in her throat. Gave Benadryl PO. Continued to monitor ...
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Face got red and warm and a burning sensation in her throat. Gave Benadryl PO. Continued to monitor for 30mins and patient still complained of burning and tightness in throat. Called her family and they drove her to the ER. I have spoken with patient and she has had to go to the ER a total of 3 times.
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| 67 | 2021-02-04 | injection site warmth, injection site redness |
received both shots): first - 1/9; second 1/30 normal arm soreness at first which went away; then ye...
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received both shots): first - 1/9; second 1/30 normal arm soreness at first which went away; then yesterday woke up and the arm is very warm to the touch and red about 4in by 3in at the injection site; no symptoms at all after the first reaction
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| 67 | 2021-02-05 | rash, redness, skin warm |
I received vaccine subcutaneous in left arm and below the deltoid muscle- rash five to six inches be...
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I received vaccine subcutaneous in left arm and below the deltoid muscle- rash five to six inches below injection site from gravity - wondering if vaccine will be effective- have pictures.
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| 67 | 2021-02-07 | vaccination site pain, itchy skin |
face got even hotter/her face felt warm; mild allergic reaction; scalp itchiness moved to the back o...
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face got even hotter/her face felt warm; mild allergic reaction; scalp itchiness moved to the back of her neck down the middle of her back; eyes started to itch; arm soreness/it felt like a bruise; arm soreness/it felt like a bruise; This is a spontaneous report from a contactable consumer(patient). The 67-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246), via an unspecified route of administration in the right arm on 20Jan2021 14:05 at single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), hot flashes, Cholesterol, clear her lungs, eyes(disorder), hair(disorder), high cholesterol, heart(disorder), arthritis in hip and knee, face felt warm from 2015, quit smoking, back pain. In 2015 she had a reaction to a cortisone shot in her knee and experienced her face felt warm. She got a spinal epidural last Jan2020, she had gone to an allergist prior to the spinal epidural to take a five hour test for allergy to dexamethasone and had a very mild reaction with face warming so she did get the spinal. When she got a flu shot her arm would be sore when she moved it. Her last flu shot(Infs Fluarix Quadrivalent) was on 24Sep2020 at his 67-year-old. she usually didn't have issues with vaccines but she was going to make herself wait the 30 minutes due to her weird reactions. She had a lot of weird reactions to medications and always had to wait 30 minutes for Penicillin and sulfa. Penicillin put her in a coma for two days when she was 7 years old. She has never had penicillin since then. with Sulfa she got an immediate rash and itching but that was 20 years ago. She couldn't take pain killers and lots of other medications including clindamycin; Neurontin; gabapentin; carbamazepine; endocet; metoprolol; tamalor. The pain medication issue happened in 2003 and the metoprolol issue happened in 2008. Ongoing concomitant medication included aloe vera for hot flashes and GERD, acetylsalicylic acid (ASPIRIN) for high cholesterol and heart, biotin for hair, cod liver oil to clear her lungs(like a heart supplement), famotidine for GERD, chondroitin sulfate sodium/glucosamine (GLUCOSAMINE AND CHONDROITIN) for arthritis in hip and knee, lansoprazole for GERD, latanoprost for eyes, lovastatin for blood cholesterol, xantofyl (LUTEIN) for eyes , zeaxanthin from 21Jan2021 for eyes and multivitamins(women over 50) for supplement. On 20Jan2021, the patient experienced a mild allergic reaction to the vaccine, only had a mild reaction, she had a mask on and when she got in the car and took off the mask, her face felt warm; Her reaction(face getting warm) was similar to what she experiences with a cortisone shot and dexamethasone before. The face feeling warm happened about 35 minutes after the vaccine(20Jan2021 14:40), then she got home and her face got even hotter; her scalp started to itch, it was really itchy; her eyes started to itch and then the scalp itchiness moved to the back of her neck down the middle of her back for about 2 hours. All of the itchiness went away after about three hours or 17:00PM on 20Jan2021; then a little bit of the scalp itching came back for about 45 minutes and then went away. All of the itching has been gone since evening on 20Jan2021. Later that night on 20Jan2021, she noticed she had a little bit of arm soreness; it felt like a bruise; when she laid on it hurt. 21Jan2021 it had gone away, too. The arm soreness wasn't even as bad as the flu shot. She was scheduled to receive the second dose of the Pfizer COVID 19 vaccine 10Feb2021. Outcome of arm soreness/it felt like a bruise was recovered in 21Jan2021, of other events was recovered on 20Jan2021.
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| 67 | 2021-02-08 | rash, pain of skin |
Day 2 - Had a bad headache but that went away by day 3. Day 4 I started to notice a tenderness in m...
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Day 2 - Had a bad headache but that went away by day 3. Day 4 I started to notice a tenderness in my right thigh and a rash started to appear. The entire front of my thigh is very tender. Plus my body just seems to feel achy.
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| 67 | 2021-02-08 | injection site pruritus, injection site redness, itchy skin, injection site pain, injection site swelling |
Nausea, a bit of headache immediately after receiving vaccine. The next day extreme fatigue, some pe...
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Nausea, a bit of headache immediately after receiving vaccine. The next day extreme fatigue, some periods of weakness, muscle ache, joint ache, a bit of nausea and headache; soreness, swelling, and redness at injection site; intermittent itching at injection site and upper body
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| 67 | 2021-02-08 | rash macular, itchy skin |
Pt. received her 2nd dose of the Pfizer vaccine today at 9:00 a.m. to left deltoid. Almost immediat...
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Pt. received her 2nd dose of the Pfizer vaccine today at 9:00 a.m. to left deltoid. Almost immediately, noticed blotches of redness to left arm . VS stable. Also mentioned being itchy to her right foot and inner thigh. Was relieved by a cold compress. Will also take Benadryl at home if worsens. Patient was released to home with no other symptoms.
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| 67 | 2021-02-08 | injection site pain, skin laceration, rash |
Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unw...
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Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation. Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3. Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills. Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-02-08 | itchy rash, rash with redness | red itchy rash and bulge on left arm |
| 67 | 2021-02-09 | itchy skin |
1120 started with itching on the back. Given Benadryl 25 mg PO at 1130 per standing orders. 1140 ...
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1120 started with itching on the back. Given Benadryl 25 mg PO at 1130 per standing orders. 1140 Itching a little better. 1145 Itching progressed to legs - given another dose of Benadryl 25 mg PO per standing orders. 1215 Itching decreased on back and legs. Advised to call doctor if worsens and take Benadryl as needed. Allowed to go home.
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| 67 | 2021-02-09 | itchy rash |
Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb a...
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Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb and go numb a bit; arm began to hurt then throb and go numb a bit; The patient was cold; clammy; the first blood pressure was 90 over something/second blood pressure was 70 over 40 something; diarrhea; tired; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 3247), via an unspecified route of administration in the left arm on 18Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 18Jan2021 10:10, the patient's arm began to hurt then throb and go numb a bit. On 18Jan2021 10:15, the patient started sweating. She stood up to try and feel better. The patient's husband called the nurse over and they called the paramedics because they said the patient was cold, clammy, and still sweating. The patient sat down again and they put leads on me to check her heart rate, blood pressure (BP), and oxygen on 18Jan2021. Her heart rate and oxygen were fine but the first BP was 90 over something. A few minutes later, she closed her eyes and could have fallen asleep right there. Her second BP was 70 over 40 something. She opened up her eyes and tried to stand up again. After a few more minutes, her BP came up and was OK. They refused an ambulance and went home. She had diarrhea at home on 18Jan2021. She ate, walked and felt better. She just experienced the normal tired and hurt arm in the afternoon on 18Jan2021. She rested the balance of the day. On Wednesday (20Jan2021), she got a bumpy itchy rash on both legs which is still present but with cream, it was OK. No treatment was received for the adverse events. Outcome of the "the first blood pressure was 90 over something/second blood pressure was 70 over 40 something" was recovered on 18Jan2021 and of the remaining events was recovered on Jan2021.
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| 67 | 2021-02-09 | itchy rash, rash with redness, rash |
Red, itchy rash over body, numbness in face and lips, red, itchy eyes this lasted for about 20 minut...
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Red, itchy rash over body, numbness in face and lips, red, itchy eyes this lasted for about 20 minutes, then began to subside - the swelling and numbness in face and lips first and then the itching of rash - rash went away and also itching and redness in eyes
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| 67 | 2021-02-09 | vaccination site pain |
Very bad arm pain on injection arm; tiredness; mild headache; chills; feeling unwell; This is a spon...
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Very bad arm pain on injection arm; tiredness; mild headache; chills; feeling unwell; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient received bnt162b2 (BNT162B2 also reported as COVID 19 vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration in arm on 16Jan2021 10:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included allergy to latex, iodine, motrin. No other vaccine in four weeks. There were no concomitant medications. On 16Jan2021 15:00, the patient experienced very bad arm pain on injection arm, tiredness, mild headache, chills, feeling unwell overall for 4 solid days. No treatment was given. The outcome of events was recovered on 20Jan2021. Information about lot and batch number was requested.
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| 67 | 2021-02-09 | vaccination site pain |
after 1st immunization mild injection site pain; This is a spontaneous report from a contactable nur...
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after 1st immunization mild injection site pain; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EJ1686, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 30Dec2020 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included hypothyroidism, arthritis, chronic neck R shoulder pain, migraines, submaxillary gland removal, and tubal ligation. The patient had COVID prior vaccination. The patient was not pregnant at the time of reporting. Concomitant medications/other medications within two weeks included levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN), ibuprofen, amitriptyline hydrochloride (AMITRIP) and vitamin D3. There was no other vaccine within four weeks of vaccination. The patient previously took amoxicillin, cefadroxil (DURICEF), meloxicam (MOBIC), and esomeprazole magnesium (NEXIUM) and experienced allergies to all. On an unspecified date, after 1st immunization, the patient experienced mild injection site pain. Reported labs performed included chest xray, CT head neck, and EKG with unknown results on an unspecified date. The patient was not Covid tested post vaccination. The outcome of event was recovering.
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| 67 | 2021-02-10 | itchy skin, rash with redness |
After Dose #2, I had no side effects until the morning of the 5th day after. At 3 a.m. I woke sudden...
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After Dose #2, I had no side effects until the morning of the 5th day after. At 3 a.m. I woke suddenly to a very severe itching in the front of my left forearm about an inch below the crook of my elbow. I went in the bathroom to examine it and had a slightly red rash that was about an inch in diameter. As I looked at it, it appeared to be spreading. At that point I applied topical Benedryl gel and the itching and redness went away almost immediately! I was able to go back to sleep and so far have had no further reactions.
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| 67 | 2021-02-10 | injection site swelling, injection site pain, skin infection at injection site |
Cellulitis from covid vaccine injection site; I developed injection site pain and swelling post 6 da...
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Cellulitis from covid vaccine injection site; I developed injection site pain and swelling post 6 days of vaccination; I developed injection site pain and swelling post 6 days of vaccination; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (COVID 19, Pfizer Covid Vaccine, Solution for injection, Lot number: EL9263), via an unspecified route of administration on left arm on 22Jan2021 09:45 at single dose for covid-19 immunisation. Medical history included hypertension. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine, aspirin [acetylsalicylic acid], pregabalin (LYRICA), gelatine hydrolysate (GENACOL), collagen, ginkgo biloba, vitamin D3, vitamin b complex, vit C [ascorbic acid], vit E [tocopherol], fish oil, zinc (Tablet), magnesium (Tablet). On 28Jan2021 at 20:00, the patient developed injection site pain and swelling post 6 days of vaccination and her PCP put her on Keflex for Cellulitis from covid vaccine injection site. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of cellulitis from covid vaccine injection site and Keflex was prescribed. Prior to vaccination the patient was not diagnosed with COVID-19. Outcome of the events was recovering. No follow-up attempts possible. No further information expected.
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| 67 | 2021-02-10 | injection site pain |
Symptoms: soreness at injection site, headache, tiredness Timing: came on by 6pm on day of injection...
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Symptoms: soreness at injection site, headache, tiredness Timing: came on by 6pm on day of injection, gone by 10am following day
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| 67 | 2021-02-11 | hives, rash | Diarrhea, vomiting, rash, mild hives, chills, episode of delirium |
| 67 | 2021-02-14 | hardening |
At 8pm arm started to swell up to shoulder; at 11:30 pm neck became numb up to jaw top of chest, arm...
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At 8pm arm started to swell up to shoulder; at 11:30 pm neck became numb up to jaw top of chest, arm was hard and soar to wrist. couldn't make fist. joints throbbing. foot swollen and couldn't lift up arm. Feeling like getting flu. Most symptoms lasted 1 week- last reported 2/11/2021.
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| 67 | 2021-02-14 | rash, skin warm, itchy rash, rash with redness, hives |
I had no adverse reactions the first three days after receiving the Pfizer COVID-19 vaccination (fir...
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I had no adverse reactions the first three days after receiving the Pfizer COVID-19 vaccination (first dose), except for a sore arm. On day four at 3pm in the afternoon I broke out in a rash in between and under my breasts, which I treated with Clobetasol cream, and the rash got better. At 3 am in the morning I broke out in severe hives (welts) on both sides of my abdomen (more pronounced on my left side), under my abdomen and in my groin area. Those areas were very red, raised, itchy and warm to touch. I did not experience any shortness of breath, swelling of face or throat, or fast heart rate. There were no changes in my diet, medications, laundry detergent, or bath soap. I took Benadryl (25 mg) at 3 am and again at 4 am because there was not much improvement. At 9 am that morning the hives were still present but less red and raised, and not itchy. I took another Benadryl (25 mg) in the afternoon because the hives had not completely vanished.
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| 67 | 2021-02-14 | bruising | Myalgias, fatigue, headache, weakness, nausea, chills, decreased appetite and easy bruising. |
| 67 | 2021-02-14 | itchy skin | Patient experienced mild itching and peri-orbital swelling of right eye. |
| 67 | 2021-02-14 | injection site pain |
Saturday, 2/13/21 7;00 am. chills, fatigue, nausea 11:00 am-3:00pm, vomiting 3 times, fever of 10...
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Saturday, 2/13/21 7;00 am. chills, fatigue, nausea 11:00 am-3:00pm, vomiting 3 times, fever of 100 degrees ( normal temperature is 97.5) 6pm - 6:00 am. Fever spiking to 102.7 throughout night Sunday, 2/14/21 Fatigue and weakness. Increased pain at injection sight.
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| 67 | 2021-02-14 | injection site pain |
Sore left arm from elbow to shoulder lasted 24 hours. Could not lift my left arm straight up above m...
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Sore left arm from elbow to shoulder lasted 24 hours. Could not lift my left arm straight up above my head. Difficult time carryiing any weight in my left arm.
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| 67 | 2021-02-14 | itchy rash, rash |
The 2nd dose was received on 06-02-21. The next day I had muscle pain and intense cold. Two days lat...
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The 2nd dose was received on 06-02-21. The next day I had muscle pain and intense cold. Two days later I got a rash on my vaccinated arm. Five days later, my body gradually filled with a rash and itching that appeared first on the chest, then neck and face, then on the back and abdomen and went down to the thighs and finally on the feet and soles of the hands. Yesterday 02-14-21 I went to the emergency service at Hospital, after being examined, the diagnosis was an allergic reaction to the vaccine I was prescribed a steroid and anti-allergy. Today is the ninth day after receiving the 2nd dose of the vaccine and I still get the rash and itchy
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| 67 | 2021-02-14 | hives | hives 15 minutes after vaccine |
| 67 | 2021-02-15 | injection site pain | High heart rate, hard to breath, shivers, sore at injection site and general weak feeling |
| 67 | 2021-02-15 | injection site pain |
I received the shot on Feb. 13, 2021. My side effects started on February 14 before bedtime and cont...
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I received the shot on Feb. 13, 2021. My side effects started on February 14 before bedtime and continued through the day on February 15. I felt much better on Tuesday, symptom free. Pain at shot site and in muscles beginning about 1 hour after the shot and got worse for the next several hours. I began to be very tired before bedtime and started a headache, a fever of about 99.6, and chills. Chills throughout the night on Feb. 14 until morning the 15th. Felt achy in back and general aches all day the 15th and headache. Fever Feb. 15 when I got up in the morning was 100.2. Just sat around very tired and achy throughout the day on Feb. 15. Still a slight fever that night (99.3), but I began to start feeling better close to bedtime on Feb. 15. Feb. 16- I feel fine, just a bit tired, but doing my normal activiites.
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| 67 | 2021-02-15 | itchy rash, rash with redness | Itchiness large red rash started 3 days after shot |
| 67 | 2021-02-15 | redness, skin warm |
On the 4th day after getting my second COVID dose (4 weeks after my first COVID dose) I got a very ...
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On the 4th day after getting my second COVID dose (4 weeks after my first COVID dose) I got a very swollen lump (lymph node) on my neck /shoulder area the same side I got the shot on. Node is noticeably swollen, red, and hot to the touch.
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| 67 | 2021-02-15 | hives, itchy skin |
minor lip swelling, hives and itching 20 minutes after 1st shot; minor lip swelling and worse hives...
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minor lip swelling, hives and itching 20 minutes after 1st shot; minor lip swelling and worse hives and itching, worse than 1st vaccine, which have continued 10 days later.
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| 67 | 2021-02-16 | itchy skin |
Face was swollen; Eyes and then my mouth and lips started swelling; Eyes and then my mouth and lips ...
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Face was swollen; Eyes and then my mouth and lips started swelling; Eyes and then my mouth and lips started swelling; Eyes and then my mouth and lips started swelling; Itching around my neck ears and eyes; Itching around my neck ears and eyes; Itching around my neck ears and eyes; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 28Jan2021 14:00 at a single dose in the left arm for COVID-19 immunisation. Medical history included multiple sclerosis and environmental allerges. Concomitant medications included ascorbic acid (VIT C), colecalciferol (VIT D3), zinc, acetylcysteine (NAC), montelukast, and other unspecified medications. Patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of bnt162b2 (brand: Pfizer, lot number: EL3246) on 07Jan2021 11:00 on the left arm. After the first dose, the patient formed a sty on her right eye and it is still there three weeks later. After second dose, the patient started itching around her neck, ears, and eyes on the day after injection, on 29Jan2021 10:00. By the third day, on 30Jan2021, when she woke up, her face was swollen, especially eyes and then her mouth and lips started swelling and the itching worsened. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient recovered from the events on an unspecified date. Treatment received for the adverse events was Depo-Medrol Injection. The events were reported as non-serious.
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| 67 | 2021-02-16 | itchy skin, redness, hardening | Red swollen indurated tender arm.. itches |
| 67 | 2021-02-16 | itchy skin |
Within 15-minutes of vaccination, the patient reported nausea, pruritus on bilateral feet, her throa...
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Within 15-minutes of vaccination, the patient reported nausea, pruritus on bilateral feet, her throat "feeling itchy and weird", and that it was hard to swallow. EMS evaluated patient on-site and was found to be hypertensive (182/133). Administered 4mg Ondansetron PO and 50mg Benadryl IV. Patient was transported to ED for evaluation. In the ED, patient was hypertensive (191/85) but noted feeling better after Benadryl IV. No evidence of worsening allergic reaction or respiratory distress. Patient was discharged from ED with instructions to follow-up with PCP.
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| 67 | 2021-02-21 | itchy skin, vaccination site mass, rash macular |
About one week post-vaccination, I noticed itching and when I scratched, I noted a lump where it itc...
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About one week post-vaccination, I noticed itching and when I scratched, I noted a lump where it itched. This was Feb. 11th at about 2pm. When I got home, I removed my shirt and noticed I had a red blotch and lump at the vaccination site. It no longer itches, but I still have the red splotches and a slight lump under the skin. I want to know if it is safe to get the second vaccine. I already plan to get it in the opposite arm.
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| 67 | 2021-02-21 | itchy skin |
Blurred vision, benign vertigo, immediately after vaccine given. Corrected itself over the next hou...
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Blurred vision, benign vertigo, immediately after vaccine given. Corrected itself over the next hour. But at 4:30 am 2/22/2021 I was awakened by intense itching on my left arm and hand. Over the next 2 hours the itching increased in intensity and progressed to my right arm and hand, over my upper back and shoulders, and along the back of my thighs and buttocks. I took 2 Benadryl allergy tablets (25mg) and used Benadryl GEL extra strength on the affected areas. This resulted in my sleepiness for the remainder of the day. Contacted my physicians office for an appointment to resolve the issue.
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| 67 | 2021-02-22 | rash papular | Rash with raised bumps. No itch however if I scratch them they bleed. |
| 67 | 2021-02-22 | injection site pain |
mild arm soreness at the injection site (none with 1st shot) small unformed/ soft bowel movements fo...
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mild arm soreness at the injection site (none with 1st shot) small unformed/ soft bowel movements for several days at end of second week after 2nd shot (similar but shorter/ day plus symptom after 1st shot)
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| 67 | 2021-02-23 | rash papular, injection site warmth |
2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like fee...
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2/7: By 7:00 pm, I had fever which rose to 102+ before midnight. 2/8: Low-grade fever, flu-like feeling, "heavy head", lethargic 2/9-2/10: Pretty much back to normal with the addition of an injection site "hot spot"- raised, rashy and feverish 2/11: Began feeling general malaise in the afternoon. Low grade fever, pain behind collarbone on both sides. By 7pm, severe chills. 2/12: Called PCP and advised of symptoms. Went and got a Covid19 PCR test just in case. Negative 2/13-2/15: Still had low-grade fever (usually around 100*) which often didn't present until 2pm and then stayed until bedtime. Glands became swollen, bad night sweats. Pain behind collarbone worse when sneezing, coughing, yawning, burping, etc. Additional information for Item 18: Almost like a "catch" rather than constant pain. 2/16: Went to local medical center for drive-thru rapid Covid 19 and flu test. Both came back negative as did the PCR Covid test they also ran. 2/17-2/20: Symptoms pretty much the same....no fever in the am and thought I was finally getting better, then it would spike again around 1:00-2:00. Never over 101*. On the morning of 2/21, the "catch" around the collarbone had moved down to the bottom of my ribcage. 2/22: Contacted PCP again and made appointment for bloodwork, chest x-ray, and further tests. "Sick and tired of feeling sick and tired!"
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| 67 | 2021-02-23 | redness, injection site pain |
Bitter taste in mouth immediately after shot. A few hours later bad headache, nausea, injection sit...
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Bitter taste in mouth immediately after shot. A few hours later bad headache, nausea, injection site pain and redness and swelling , tiredness, muscle and joint pain, slight fever, feeling unwell. Lasted 5 days.
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| 67 | 2021-02-23 | redness, rash macular |
Blotchy redness mostly face. Denies respiratory distress,chest pain. b/p 140/82 pulse62 respirations...
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Blotchy redness mostly face. Denies respiratory distress,chest pain. b/p 140/82 pulse62 respirations 18. Denies feeling warm. Denies need for further medical care. 1316 Patient she feels fine and would like to leave. Advised to call MD or 911 is shortness of breath or chest pain. 1259 returned to clinic with reddish blotches on face. None else where. 1316 b/p 122/72 pulse 62 respirations 16 Patient denies any other signs or symptoms of reaction to vaccine. Lungs sounds are clear. Denies itching or pain.
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| 67 | 2021-02-23 | rash | Developed Rash on Lower Back, on 2/23 since rash is still on back. |
| 67 | 2021-02-23 | itchy skin, vaccination site pain, rash papular, rash with redness |
nausea; felt tired; Rash is red and she can feel bumps; rash is red and she can feel bumps; pain at ...
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nausea; felt tired; Rash is red and she can feel bumps; rash is red and she can feel bumps; pain at the injection site; itching going on in my face, my left arm, in the elbow / stomach about 2 inches to the left where they made the incision for the cancer removal; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL9269), via an unspecified route of administration into left arm on 06Feb2021 (at the age of 67-years) as a single dose for COVID-19 immunization. Medical history included allergic to peanuts, allergic to Penicillin, cancer and hysterectomy. There were no concomitant medications. The patient previously took vancomycin, cefalexin (KEFLEX) and zelnorm and was allergic. On 06Feb2021, the patient had pain at the injection site, but that was gone now. She also experienced rash, which was elaborated as an itch, like a rash that started since she got the shot. She had the itching rash going on into her face, left arm, the elbow, and also 2 inches from naval on the left side where she had incision from cancer removal, hysterectomy. The rash was started in the area of the hysterectomy. The patient elaborated that the rash was red and she can feel bumps. The patient was taking diphenhydramine hydrochloride (BENADRYL) which usually stop the itching. Last night 06Feb2021, the back of her left elbow and her face started itching as well and at 23:30 the patient experienced nausea and felt tired. The patient is scheduled for second dose on 27Feb2021. The clinical outcome of event rash is red and she can feel bumps was not recovered. The outcome of pain at the injection site was recovered in Feb2021. The clinical outcome of other events was unknown.
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| 67 | 2021-02-24 | redness |
Because of all of my allergies I took 25 milligrams of benadryl 30 minutes prior to the vaccine in...
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Because of all of my allergies I took 25 milligrams of benadryl 30 minutes prior to the vaccine injection. Just a few minutes less than an hour after vaccine injection, my face turned beet red and got flaming hot. After 40 minutes of a red, hot face I took another 25 milligrams of benadryl. Now two hours and 40 minutes later my face is much less red and much less hot.
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| 67 | 2021-02-24 | itchy skin | Itching to face/ eyes- Given oral Benadryl and monitored in office |
| 67 | 2021-02-24 | itchy skin, rash |
Raah appeared in my right breast and between both breast. same side as injected arm. Very itchy. La...
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Raah appeared in my right breast and between both breast. same side as injected arm. Very itchy. Lasted about 3 hours or so, then stopped itching out of nowhere. Called nurse: Took Zyrtec on advice of an advice nurse. Rash still presenting 4 hours later. Not getting worse and is not itchy.
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| 67 | 2021-02-25 | injection site pruritus, itchy skin |
Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patien...
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Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed 3rd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine 2nd Attempt to call patient for follow up via phone. No answer. Progress Notes (Nurse Practitioner) ? ? Family Medicine Attempt to call patient for follow up via phone. No answer. Progress Notes: (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand All Collapse All 2/24/2021 Patient Date: 2/24/2021 Subjective is a 67 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, drooling, hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH includes none. She does not take any medications but is on Vyvanse.none. She denies any medial hx. Not on any medications. She did drink a protein shake this am. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills, chest tightness and itching of skin (to R shoulder/injection site area) Patient denies fever, malaise/fatigue, nasal sores, sneezing, sore throat, frequent throat clearing, cough, shortness of breath, wheezing, rash, hives, eczema, abdominal pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 1024 02/24/21 1029 BP: (!) 180/73 (!) 150/90 Pulse: 71 SpO2: 97% Blood Sugar 108 collected at 1050 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Findings: No rash. Comments: Injection site and R arm without erythema or swelling. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) PT monitored and improving. Pt ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Pt aware of what to monitor and when to go to ED. Pt voiced understanding and appreciated. Pt able to ambulate out of the facility with ease. APRN Electronically Signed 2/24/2021 12:27 PM
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| 67 | 2021-02-25 | itchy skin, redness |
Red small itchy area on rt forearm after her vaccine. The reddened area was itchy but not spreading....
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Red small itchy area on rt forearm after her vaccine. The reddened area was itchy but not spreading. Pt placed an ice pack over the area and the reddened area went away. Pt felt better after 15 min the she signed a release to the observation area and checked herself out.
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| 67 | 2021-02-25 | itchy skin |
itching on the skin of the back; Headache; malaise; This is a spontaneous report from a contactable ...
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itching on the skin of the back; Headache; malaise; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 04Feb2021 at 09:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date in Jan2021 (age at vaccination: 67 years) at 09:00 on the left arm for COVID-19 immunization. Prior to vaccination, was the patient has not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced itching on the skin of the back, headache and malaise on 05Feb2021 at 07:00. It was unknown if the patient received treatment for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 67 | 2021-02-25 | vaccination site pain |
sore arm; diarrhea; bad taste in her mouth/can taste vaccine in her mouth and throat; This is a spon...
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sore arm; diarrhea; bad taste in her mouth/can taste vaccine in her mouth and throat; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL1283), via an unspecified route of administration on 26Jan2021 09:55 at single dose in the left arm for COVID-19 vaccination. Medical history and concomitant medications were none. Patient got her first injection of the COVID-19 vaccine on 26Jan2021 at 09:55AM in her left arm. Patient said that the diarrhea just started on 26Jan2021, she had tried calling earlier and had to hang up because of it, maybe because she was nervous. Patient said that she tasted the vaccine constantly, she has been experiencing a bad taste in her mouth, she couldn't stand the taste. Patient couldn't get rid of the taste. She said beforehand she was scared of anaphylactic shock, but she was having the taste in her mouth and diarrhea. She said she had the taste of the vaccine in her mouth and throat on 26Jan2021. She said that everything that she eats she is trying to get taste out of her throat. Patient has done no treatment yet for the diarrhea or the taste in her mouth. She said that her arm didn't hurt afterwards and she didn't feel the shot, and now she can't touch her arm without it hurting though she has been moving her arm a lot. She said she knew that from the flu shot, but that never hurt her, this thing was sore (sore arm) on 26Jan2021. She said she wasn't worried about that though, she just wanted to know if the taste would go away, and if it was normal. She said that there was nothing that said anything about diarrhea either, and she was not sick, she didn't feel sick, there was just the taste. Outcome of the events was unknown.
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| 67 | 2021-02-25 | skin peeling | tingling hands/fingers, loss of sensation and then peeling skin on palm /in between fingers |
| 67 | 2021-02-26 | injection site pain |
Dose was injected at 9:30 am and around 1 pm, my neck started to stiffen up and get sore on both sid...
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Dose was injected at 9:30 am and around 1 pm, my neck started to stiffen up and get sore on both sides and up into occipital region. It was very painful and difficult to turn my head in either direction. It started to ease after 5 or 6 hours but my neck still feels somewhat sore now which is 3 days later. My injection site was throbbing and painful from elbow to shoulder from about 1 pm until about noon the next day. I did not experience any fever but felt tired.
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| 67 | 2021-02-26 | itchy skin |
Within 5 minutes of administration pt began to experience difficulty breathing and vigorously shake,...
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Within 5 minutes of administration pt began to experience difficulty breathing and vigorously shake, transported to gurney and obtained vitals, pt with O2 Sat 70%, HR 88, administered one dose of epinephrine, placed 10L of O2 via facemask, pt began speaking, was alert and oriented to name and place, continued to report tightness of the chest and itching, called EMS, continued to monitor vitals, and patient transferred to ER without incident.
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| 67 | 2021-02-27 | hives | Hives on face, ears and itching eyes |
| 67 | 2021-02-27 | redness | erythema-face, angioedema-hands, lips, nausea |
| 67 | 2021-02-28 | vaccination site pain |
Achy right arm (site of injection) about 12 hours after injection; achy muscles all over body; This ...
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Achy right arm (site of injection) about 12 hours after injection; achy muscles all over body; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809), via an unspecified route of administration on 13Feb2021 10:00 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant at the time of vaccination. The facility type vaccine was Pharmacy or Drug Store. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. None medical history. Concomitant medication included omeprazole, fexofenadine hydrochloride (ALLEGRA). The patient experienced achy right arm (site of injection) about 12 hours after injection on 13Feb2021 21:30; achy muscles all over body about 16 hours after injection on 13Feb2021. Pain was relieved by taking two naproxen tablets. The outcome of events was recovered in Feb2021. The events were reported as non-serious.
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| 67 | 2021-02-28 | redness, hives, itchy skin, rash |
Extreme hive spots beginning at scalp and spreading to knees between 6-12 midnight. Area between hiv...
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Extreme hive spots beginning at scalp and spreading to knees between 6-12 midnight. Area between hive welts filling in with rash or redness. Following day, began to spread again around 5 PM - went to ER - prednisone and benedryl administered. Hives intensified over night disallowing sleep. Next two days hives continued to welt up especially late in the day (having spread to face and neck). Sunday night seeing the redness between welts start to subside in some areas completely. Itching continues into Monday morning but not as intense.
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| 67 | 2021-02-28 | redness, skin tightness, itchy skin |
I received the vaccine at approximately 1 p.m. in my left arm. I informed the technician that I ha...
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I received the vaccine at approximately 1 p.m. in my left arm. I informed the technician that I had allergies and had previously had anaphylaxtic reactions to foods and some medications. I had noticed that the Pharmacy was not requiring people to stay after receiving the vaccine, so I told the technician that I would stay until I was sure I did not have a reaction. No one came to check on me, and in about 15 minutes, I noticed that my scalp was starting to itch and my face felt hot. I decided to go home, which was only a 5 minute drive from the store. I took off my mask in the car and discovered that my face was very red and starting to feel tight. I got home and took 1 Benadryl pill. By the time I got home, around 1:25 my ears were itchy and my lips were starting to swell. I waited an hour and started to feel better, the color in my face was returning to normal, and I had no swelling of my throat, which I have experienced with food allergies. At hour 2 I took a second Benadryl and went to sleep for 2-3 hours. When I woke up, I felt better, my lips were still slightly swollen, but my face, scalp and ears were back to normal.
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| 67 | 2021-02-28 | itchy skin | Itching following injection - Given Benadryl and monitored - at home care |
| 67 | 2021-02-28 | pain of skin, rash | RASH ON FACE AND NECK WITH BURNING AND STINGING. SWELLING OF FACE AND EYES. |
| 67 | 2021-02-28 | hives |
Tongue and throat swelling; Tongue and throat swelling; not able to breathe; right and left sided fa...
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Tongue and throat swelling; Tongue and throat swelling; not able to breathe; right and left sided face swelling; hives from top of head to lower extremities; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tongue and throat swelling and took diphenhydramine (BENADRYL). Patient was also not able to breathe, had right and left sided face swelling, and hives from top of head to lower extremities. Patient reported that the doctor gave her an epi pen. Patient would like to know if she should get second dose. She is scheduled to receive second dose on 28Jan2021 also if she should get a pneumonia vaccine and was instructed to wait 14 days after the Pfizer Biotech Covid-19 vaccine administration. Outcome of the events was unknown.
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| 67 | 2021-02-28 | itchy skin |
about 45 mins after vaccine administration patient began to experience itching in hands. No fever, ...
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about 45 mins after vaccine administration patient began to experience itching in hands. No fever, chills, headaches, visual changes, lightheadness, or dizziness. No nasal discharge or sore throat. No neck or back pain. No difficulty breathing or swallowing. No throat swelling. No chest pain, shortness of breath, abdominal pain, nausea, vomiting or diarrhea. No numbness or tingling.
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| 67 | 2021-03-01 | hives, redness, dry skin | Hives; some redness; dry skin; BP 94/54; (pulse 66); stable; Benadryl 25 mg given. |
| 67 | 2021-03-01 | injection site pruritus, injection site mass | Very itchy at site and pea size lump. |
| 67 | 2021-03-02 | vaccination site pain |
Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the...
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Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the muscle goes jumping up and down; Not feeling well; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL9262 expiry date not reported, via an unspecified route of administration from 28Jan2021 at single dose for COVID-19 Immunization. Medical history included High blood pressure and Pre-diabetic. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) 12.5 mg, metformin (METFORMIN) 1000 mg, twice a day, lisinopril (LISINOPRIL) 20 mg at night, pravastatin (PRAVASTATIN) 20 mg, acetylsalicylic acid (BABY ASPIRIN) and atorvastatin calcium (ATROSTAT). The patient experienced joint pain, not feeling well and muscle stagnant; where they gave me the shot the muscle goes jumping up and down all on 29Jan2021 and chills, injection site pain, flu and cold all on unspecified date. Consumer stated, "I am having a joint pain and chills and not feeling well, I had it Thursday evening, I took it Thursday evening. I am not feeling well from that Friday night and last night I mean the joint pain, the muscle pain you know, it's just you have to deal with." Consumer added, "I have been taking pain medicines, Ibuprofen and Tramadol for pain and Mucinex for cold and flu." Therapeutic measures were taken as a result of joint pain, injection site pain, flu and cold. Outcome of the events was unknown.
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| 67 | 2021-03-02 | vaccination site pain |
Heart palpitations to the point where I could not sleep; Heart palpitations to the point where I cou...
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Heart palpitations to the point where I could not sleep; Heart palpitations to the point where I could not sleep; Extreme fatigue; Slight headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (brand=PFIZER), via an unspecified route of administration (vaccine location=right arm) on 28Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included breast cancer and mitral valve prolapse. She had no known allergies. Concomitant medications included celecoxib (CELEBREX). No other vaccine in four weeks. No covid prior vaccination. The patient experienced heart palpitations on 28Jan2021 10:00 PM to the point where she could not sleep - started 6-8 hours after receiving vaccine. Some better the next day but still having palpitations. Day 2 after vaccine about the same. Extreme fatigue, slight headache & sore arm but not too bad on an unspecified date in 2021. No treatment received for the events. No covid test post vaccination. The patient was recovering from heart palpitations to the point where I could not sleep while outcome of other events was unknown. Information on the lot/batch number has been requested.
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| 67 | 2021-03-02 | hives, rash | Hives/rash |
| 67 | 2021-03-02 | skin reaction, injection site swelling, injection site mass |
Immediate localized swelling at the injection site about the size of a small grape. Provided the pa...
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Immediate localized swelling at the injection site about the size of a small grape. Provided the patient diphenhydramine 50mg to treat the localized reaction. Monitored the patient for 30 minutes and she left in good health accompanied by her husband
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| 67 | 2021-03-02 | injection site swelling |
Patient had small bump around the injection site after patient received the vaccination. She iced it...
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Patient had small bump around the injection site after patient received the vaccination. She iced it and was observed in the waiting area. Swelling went down and patient went home. She had no other symptoms and was not under any distress.
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| 67 | 2021-03-02 | injection site warmth, injection site redness, injection site pruritus, injection site swelling, injection site hardening | Swollen redness at the site of vaccination. Hard and warm to touch and itchy. |
| 67 | 2021-03-02 | sensitive skin, rash macular, injection site pain, injection site discolouration |
Vaccine 5:30 pm 2/27, sensitive skin 10:30 am 2/28 - 1:30 pm 3/1, sore joints in hands and feet 3/1...
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Vaccine 5:30 pm 2/27, sensitive skin 10:30 am 2/28 - 1:30 pm 3/1, sore joints in hands and feet 3/1 and 3/2, sore armpit 3/1 to current (3/3), pain decreasing, sore and pink patch at and below injection area 3/1 to current.
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| 67 | 2021-03-02 | redness | heat and redness throughout entire face |
| 67 | 2021-03-02 | vaccination site pain |
injection site pain; headache; joint pain; nausea; feeling unwell; tiredness/tired; swollen lymph no...
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injection site pain; headache; joint pain; nausea; feeling unwell; tiredness/tired; swollen lymph nodes under left arm; achy; This is a spontaneous report from a contactable consumer reporting for herself. This 67-year-old non-pregnant female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Jan2021 at 09:30 AM, in left arm, for COVID-19 immunisation. Medical history included allergies to sulfa and COVID before vaccination. Concomitant medications included calcium, glucosamine/chondroitin and unspecified multivitamin. On 30Jan2021 at 16:00 the patient experienced injection site pain, headache, joint pain, nausea, feeling unwell, tiredness, swollen lymph nodes under left arm and achy. The events got progressively worse the following day. On 01Feb2021 the patient was too tired and achy to go to work. The events did not require any treatment and were resolving at the time of report. COVID was not tested post vaccination. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
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| 67 | 2021-03-03 | itchy rash, injection site reaction |
3/2 - sore arm, chills, low grade fever 3/3 - woke up with heart palpitations. Apple watch recorded...
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3/2 - sore arm, chills, low grade fever 3/3 - woke up with heart palpitations. Apple watch recorded range between 59 and 166. 3/4 - itchy rash near injection site ( have photo)
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| 67 | 2021-03-03 | itchy skin, hives |
Felt lightheaded after vaccination. Had pruritis over arms bilaterally. Had two urticarial lesions o...
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Felt lightheaded after vaccination. Had pruritis over arms bilaterally. Had two urticarial lesions over back. SBP 144. The patient was provided with water and asked to lie down. The patient felt better and able to ambulate. Pruritis resolved without intervention. Urticaria almost completely faded. No SOB, GI distress, mucosal involvement, difficulty swallowing.
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| 67 | 2021-03-03 | redness |
Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (t...
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Immediately after medicine went in my arm I felt a warm flush from my neck all the way to my toes (the same as when I have had radioactive dye), during my 15 minutes of observation my hands and feet were cold and sweaty and I felt a little shaky. I waited 20 minutes and went to the restroom and had diarrhea (very rare for me). I went to my car and looked in the mirror and my face was bright red and the whites of my eyes were red and my eyes were glassy. I went back in to the observation area and was given oral Benadryl. and monitored for 45 minutes. Right after I took the Benadryl my throat felt itchy (not sore - itchy). My blood pressure was 157/62 when I first sat down but came down to 130/ 60 by the time I was sent home. My bp is normally about 106/60. I was really tired at home for the rest of the day so went to be early. The next day I felt fine and my arm was only slightly sore. The doctor at the immunization clinic told me not to get the 2nd shot. I called my GP, and he too told me not to get the 2nd COVID shot and wait until more information has come out about adverse reactions to the vaccine. I did not have any difficulty breathing. I don 't know if the redness on my face went down my neck to my chest. I didn't look. I did not have a fever.
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| 67 | 2021-03-03 | redness |
Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; This is a ...
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Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; Left Arm Red, Hot and raised; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) via an unspecified route of administration on 21Jan2021 (at the age of 67-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included "thyroid," high blood pressure, depression, anxiety, and osteoporosis. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. It was unknown if the patient had any allergies to medications, food, or other products. The patient received unspecified concomitant medications. The patient did not receive any pother vaccines within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced left arm red, hot, and raised at first. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcome of left arm raised was recovered. The outcomes of left arm hot and red was not recovered; left arm was still red and hot and it was day 12. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-03-03 | rash |
Rash on neck and chest; This is a spontaneous report from a contactable consumer (patient). A non-p...
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Rash on neck and chest; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 67-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9262), via an unspecified route of administration in the left arm on 30Jan2021 at 08:00 at 67-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 09Jan2021 at 67-years-old (lot number=EL1284; vaccine location=Left arm; first dose; administration time: 08:00). On 31Jan2021 at 21:00, the patient experienced rash on neck and chest (non-serious). The clinical outcome of the event, rash on neck and chest, was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
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| 67 | 2021-03-03 | redness, cellulitis, skin warm, pain of skin |
Shot in left arm. No side effects until three days later began having nausea, fever, chills, aches....
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Shot in left arm. No side effects until three days later began having nausea, fever, chills, aches. Next day noticed heat, redness, increased swelling, tenderness of RIGHT arm that has Lymphedema. Called doctor today and was prescribed Keflex 500 4x a day for 7 days for suspected cellulitis.
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| 67 | 2021-03-03 | hives |
Yesterday I received my 2nd Pfizer vaccine at 9AM. My first dose was a non-event. About 50 minutes a...
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Yesterday I received my 2nd Pfizer vaccine at 9AM. My first dose was a non-event. About 50 minutes after the jab, I broke out in hives on my upper thigh and stomach. By 7 PM, I felt really sick, my arm felt as though the strongest person in the world punched me, and by 8, I was shivering and wrapped in a ton of blankets, by 10, every muscle in my body ached beyond its capacity and my fever was 101.8. It got to 102.1. My head was weighed down with an unrelenting headache. Finally, an hour ago, my fever broke. I have Systemic Lupus and CRPS and do not vaccinate because my body is always attacking itself. But this year I got my first ever flu vaccine. Same results. So sick.
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| 67 | 2021-03-04 | itchy skin, hives, injection site pain |
I STARTED ITCHING ALL OVER MY BODY. NOT JUST AT THE INJECTION SITE. THE INJECTION SITE WAS A LITTL...
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I STARTED ITCHING ALL OVER MY BODY. NOT JUST AT THE INJECTION SITE. THE INJECTION SITE WAS A LITTLE SORE, BUT DID NOT ITCH. ITCHING WAS EXTRMEMLY INTENSE. SEEMED TO BE SAME SPOTS BUT THERE WAS NO RASH OR REDNESS AT ALL, JUST THE ITCHING. I COULD NOT SIT STILL OR LAY DOWN. HAD TO FRANTICALLY SCRATCH THE SPOTS. MORE ON TORSO... BUT A FEW SPOTS ON UPPER THIGHS TOO. I HAD TO TAKE BENEDRYL TO FINALLY GET RELIEF. DID IT THE NEXT DAY TOO IN THE AFTERNOON OF 3/3/2021 AND THEN ANOTHER BOUT OF IT IN THE EVENING ON 3/4/2021. IT JUST COMES ON AND WILL NOT END. NOT DOING ANYTHING UNUSUAL AND NOT HAVING ANY OTHER REACTIONS.
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| 67 | 2021-03-04 | rash, injection site rash, rash papular |
Raised rash around injection site and across hips at lower back. Not red, no swelling, nor itching ...
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Raised rash around injection site and across hips at lower back. Not red, no swelling, nor itching other than the skin stretched over the raised area. Came on within 4 days of vaccine. Never have had this symptom before. Only telling CDC for info gathering. No real issue.
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| 67 | 2021-03-04 | rash, injection site redness |
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details:...
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Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: redness of injection arm
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| 67 | 2021-03-04 | injection site swelling, injection site pain |
Woke up feeling fine, a few hours later started with fatigue, extreme chills, achy, and my arm was v...
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Woke up feeling fine, a few hours later started with fatigue, extreme chills, achy, and my arm was very sore swollen some at injection site, however, I had swelling under my armpit that was very tender and sore to touch. These symptoms lasted for 2 days, the armpit tenderness lasted for 4 days. I could t keep my blood sugar levels low, as they remained high almost 400. I was taking additional insulin to try and bring it down and I wasn?t eating.
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| 67 | 2021-03-05 | injection site pain, injection site redness |
Within 3 hours - Fatigue, injection site pain Within 6 hours - Fatigue, injection site pain, chills ...
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Within 3 hours - Fatigue, injection site pain Within 6 hours - Fatigue, injection site pain, chills Within 24 hours - Fatigue, increased injection site pain Within 4 days - injection site redness
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| 67 | 2021-03-06 | injection site pain |
Pfizer, pain in arm around the injection site, down into left breast, nausea could not sleep on the ...
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Pfizer, pain in arm around the injection site, down into left breast, nausea could not sleep on the side of injection too painful
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| 67 | 2021-03-06 | injection site hives, injection site redness, injection site swelling |
Severe muscle and joint pain Severe body aches Skin pain Severe headache Nausea Vomiting Fever S...
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Severe muscle and joint pain Severe body aches Skin pain Severe headache Nausea Vomiting Fever Severe chills Left arm pain Injection site swelling, redness hives around left upper arm Left axillary lymph node swelling
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| 67 | 2021-03-07 | blister, shingles, itchy rash |
6 Days after shot massage therapist noticed rash on lower back. No pain but itched. Continually g...
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6 Days after shot massage therapist noticed rash on lower back. No pain but itched. Continually got worse and small blistering. 9 days after shot diagnosed with shingles. Never had an outbreak before. I am convinced it was from the vaccine. I had mild case of covid Nov. 2020. I only got shot because my son insisted I needed it before seeing his 6 month old daughter.
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| 67 | 2021-03-07 | vaccination site pain |
Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/...
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Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/labored breathing; tightness in the chest/chest felt tight there was a heaviness just like a feeling of discomfort; joint pain started in her right elbow, right thumb, right knee, left ankle and left instep; Feeling unwell; Muscle pain; Injection site pain; Headache; has not felt normal; Tiredness; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261), intramuscularly on 22Jan2021 09:35 at 0.3 ml single dose for COVID-19 immunization. Medical history included ongoing High cholesterol, allergies to penicillin and sulfanized antibiotics, allergies to latex, Shingles since 2007, post herpetic neuralgia, mild shingles pain from the neuralgia, changes in temperature, the temperature and the weather going up and down. No other condition was reported. Concomitant medication included rosuvastatin (strength: 10mg) from 18Jan2021 to 24Jan2021 at 10 mg for High cholesterol. Past drug event included doxycycline allergy (she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP and unable to sleep), Ibuprofen allergy, Levaquin allergy, Valium allergy and omeprazole allergy, took sulfanized (SULFA) antibiotics allergy (she had rapid heartbeat, sweating). Patient stated she said that she had received the first dose of the COVID-19 vaccine and did experience some side effects of the COVID-19 vaccine. She said she did not have an anaphylactic reaction but had difficulty in breathing 2 days after having the first dose. She said she experienced 30 hours of labored breathing. She wanted to know if there is "sulfa dioxide" in the lipid/mRNA portion of the COVID-19 vaccine. She said she is highly allergic to "sulfanized compounds". She is also allergic to all forms of penicillins. Caller wanted to know if the second dose of the vaccine has the same ingredients as the first dose. She wanted to know if the ingredients have the same amounts as the first dose or if the actives are stronger. She based this question from "most people having more reaction on the second dose of the vaccine" and also from what Pfizer second line told her "the first dose primes the system while the second dose strengthens the system". She wanted to know what ingredient causes the anaphylactic reactions for this vaccine and if it is penicillin. On 22Jan2021 she learned that there is a small amount of Sulfa Dioxide in the lipid portion of mRNA and she is highly allergic to sulfa compounds. With her side effects she would also like to add that she had a severe case of shingles in 2007 that was not diagnosed until the end of the 7th week. She had seen 8 doctors, her family doctor, she had 3 ER visits so prior to the vaccine she had post herpetic neuralgia and so a week and half before the vaccine there were changes in temperature, the temperature and the weather going up and down so she was having mild shingles pain from the neuralgia going into the vaccine which was given on 22Jan2021. The other thing is she had high cholesterol and her cardiologist put her on a statin she does not have high BP but she has high cholesterol so she was started on a statin, it was Crestor 10 mg, actually it says it is Rosuvastatin Calcium 10 mg and she took that 18Jan2021 and the 19Jan2021 and then on the 20Jan2021 her doctor told her to stop it before her vaccine so she did and she felt okay just had mild reactions so she took the Rosuvastatin that Friday night 22Jan2021 and she took it 23Jan2021 then she took her self-off of it on 24Jan2021. She called her doctor on 25Jan2021 and he said yes stop the Rosuvastatin and stay off it until after your second dose of the vaccine. So she was having an allergic reaction in Jan2021 she has had a lot of side effects from being post shingles and all the side effects from COVID vaccine and being post shingles and the statin all of the possible side effects mirror one another. As far as the reaction she got a headache about 35 minutes after she took the shot Friday morning at about 9:35 AM and she took Tylenol twice that day, once that morning and she took it also around 4:30 PM when she was having medium pain at the injection site and that is when she took her statin and she woke up on 23Jan2021 and until late in the afternoon she had tightness in the chest so she took one more Tylenol then that was mid-morning, so total she had 3 doses of 325 mg Tylenol. Then on 24Jan2021 at about 4:30 AM in the morning she woke up with labored breathing, it wasn't normal. She did not have a closed throat but her breathing was labored, her chest felt tight there was a heaviness just like a feeling of discomfort. Then around 5 pm that same day the joint pain started in her right elbow, right thumb, right knee, left ankle and left instep and the pain wasn't constant it was jumping to different parts of her body and she still felt the tightness in her chest and heaviness all day. Then around 4PM on 24Jan2021, Saturday the labored breathing dissipated around 8pm and she did not take the statin that night then on 25Jan2021 her breathing was normal but she still had tightness in her chest. She had injection site pain on the 22Jan2021, 23Jan2021 and the 24Jan2021 and it was almost totally gone on 25Jan2021. Tiredness began on the evening 22Jan2021 the day she had the shot and it comes and goes. Headache- she had mild headache and she had took Tylenol so it was mitigated a little but it started 22Jan2021 and she had a headache through the 23Jan2021, 24Jan2021 and the 27Jan2021 so around 3:25PM yesterday she took another Tylenol yesterday 27Jan2021. Muscle pain she has had since 23Jan2021 and it has been ongoing but less today, she doesn't know if it will come back or not. It is mainly in the in the rhomboids which is the shoulder wings. She had it on both sides. Chills she had 25Jan2021, 26Jan2021 and 27Jan2021 and they come on mid-day-late afternoon they go on up until early evening, a little past supper/dinner time. Joint pain was 23Jan2021, 24Jan2021, 27Jan2021 and pain in her rhomboid muscles. She has had no fever, no swelling or redness at the injection site, no nausea. Feeling unwell- she would say from 23Jan2021 to the present she has not felt normal on 22Jan2021, it comes and goes She has not had swollen lymph nodes. Difficulty breathing 24Jan2021 at 4:30 am it woke her up and she had labored breathing, no closed throat and she stopped the Statin that day, tightness in her chest started 24Jan2021 in the morning and she had that 25Jan2021 26Jan2021 and it has been present on and off mainly in her back discomfort. She says the tightness is not really in the front around the heart but it is like a total tightness in the chest area. Muscle pain on the 27Jan2021 mainly in her back, the rhomboids. Fast heartbeat- She was sound sleep this morning at about 12:45AM and it woke her up her heartrate was 87, her BP was 135/81 (2021) and she did an ice pack for 16 minutes on her head and then she went back to sleep at 4:45 AM she woke up again her BP 131/87 pulse was 80 temp was 97.8 (2021). She didn't take her temp the first time she woke up she just did an ice pack for 16 minutes and she as up for a while typing side effects at that point. Then she went back to sleep from 6:20-7:20 and then when she woke up again her BP was 122/75 and pulse was 64, temp 98.3 (2021). For someone look at at her BP they may say that's not high but for someone post shingles, the pain, the nerve endings are already on edge she can feel it working on her body. They say reactions are proof that the vaccine is working but her issue with the joint pain, it disappeared when she stopped the Statin and then there is the labored breathing, she has had 2 new drugs that went into her system at the same time and she doesn't know, one has the documented side effects and the other one it is so unknown at least the mRNA part she does not know if she is just having a reaction to Sulfa. She says that blood pressure doesn't seem high but for someone whose body is stressed and with her pulse to go up when she is sound asleep, normally when her body is sleeping and she wakes up she would be about 117/70 (2021), she would have low numbers she doesn't have high BP. She took the statin for 2-3 days and then stopped it her doctor told her she could start and stop it and her doctor told her to stay off of it but she started it because she felt okay she only had a headache and injection pain so she said she is going to take it and then things intensified so she decided to stay off it. She has a history of having delayed serious side effects. She is allergic also to Penicillin and that is probably in the records already because she called and asked when she was thinking about taking it. It dates way back with her allergies with her, it is extensive Doxycycline, Ibuprofen, Levaquin, all forms of Penicillin, sulfanized antibiotics, Valium, latex, Omeprazole. She had shingles so bad after about 7.5 weeks of it going undiagnosed she had the 2 worse reaction and they asked her they went through her history and asked what are the 2 worst things she had and that was with Doxycycline they gave her that because they thought she had a bacterial infection and didn't realize it was shingles and she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP she was unable to sleep literally she could feel the blood coursing through her veins. and then the other one she knows is Sulfa she has had that allergy since a child but she had rapid heart beat, sweating and there may have been other symptoms but she does not remember she was a child. She has been given Sulfa drugs since then and she is highly sensitive to Sulfa. Outcome of the event muscle pain was not recovered; injection site pain was recovered on 25Jan2021; labored breathing was recovered on 24Jan2021, while other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-03-07 | injection site pain |
Extreme chills, aches body and head, swollen lymph node in left arm. Very sore left arm and difficu...
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Extreme chills, aches body and head, swollen lymph node in left arm. Very sore left arm and difficulty lifting it. Fatigue. LARGE RED CIRCLE ON UPPER LEFT ARM NEXT TO INJECTION SITE. The red spot is warm and tender and has persisted for 3 days.
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| 67 | 2021-03-07 | injection site pruritus |
I am still experiencing excessive itching at the site of the injection and this is one month after t...
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I am still experiencing excessive itching at the site of the injection and this is one month after the 2nd dose. It is usually at night and wakes me up. The only relief that seems to work is an ice pack. Topical cortisone does not help. It seems to be happening less and less but I thought I should report it. There is no rash or swelling. I had a similar reaction to The Shingrix Vaccine after the 2nd dose. It lasted six months and was worse! I would like to know what might be causing this. I had no problem with the Flu Shot.
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| 67 | 2021-03-07 | injection site pain, rash | flu like symptoms for 48 hours, fatigue, sore arm at injection site, rash possibly related. |
| 67 | 2021-03-07 | redness | red legs 9 hours after getting shot. gone by morning |
| 67 | 2021-03-08 | rash, rash with redness |
Extreme tiredness 8 hours after the vaccine. Fever over 100 that evening continuing intermittently f...
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Extreme tiredness 8 hours after the vaccine. Fever over 100 that evening continuing intermittently for four days after vaccine. On the fourth day, I woke up with a reddish purple rash over most of my body. My doctor advised me not to take the second dose.
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| 67 | 2021-03-08 | injection site pain |
Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cra...
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Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cramps. Difficulty walking. Fatigue. Chills and Fever 102.2 degrees. Brain fog and off-balance could not sleep but no headache. Nausea —no appetite. Nasal congestion and mild cough. Symptoms woke me at 2 am with chills. Took 500 mg acetominophin at 10 am. Forgot to take medication resulted in high heart rate and blood glucose. Symptoms started to decrease after 2 pm 2/28/21. Took 500 mg acetominophin around 3 pm. Fever 100. 5 on 3/1. Fever 100 on 3.2 Felt better but cancelled morning appointment on 3/3. Went for short walk outside on 3/5/21. Did not seek medical care. Still have muscle pain fatigue and brain fog.
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| 67 | 2021-03-08 | pain of skin |
Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremi...
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Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremities started stinging, nose running & feeling feverish. My ears started ringing too & got vertigo. Also I started having trouble breathing with a slight ache/pain in my lungs. A noticible itch started in my nose & a tickle in my throat and I had extreme muscle pain, especially in extremities affected by previous carpal tunnel injuries & sciatica. Tuesday afternoon all symptoms were worsening so I used Zicam Gel swabs in my nose, made chicken garlic soup & tea with honey & went to bed. It took 3 days for the sinus, headache & respiratory symptoms to resolve. The neuropathy (skin stinging) pain in my arms, hands & lower legs persists and is very painful.
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| 67 | 2021-03-08 | rash |
The rash came on approx 30 min after vaccine. It was barely visible, not raised and was non-puriti...
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The rash came on approx 30 min after vaccine. It was barely visible, not raised and was non-puritic. Limited to forearms. She had no injection site findings. She stated she felt fine. She had no cp or sob or cough. No tongue or lip swelling. Bp 130/80 and HR 90/min. Lung cta and heart sounds normal. Benadryl givenand resolved within 10 min
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| 67 | 2021-03-08 | injection site pain |
migraine next 2 following days after shot. Tiredness the day of the shot and the following day. Col...
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migraine next 2 following days after shot. Tiredness the day of the shot and the following day. Cold/allergy symptoms including nasal sinus congestion and runny nose all the way up until today. Also paying on the side of injection on the day of the shot and following day
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| 67 | 2021-03-08 | rash |
vomiting, diarrhea, chills Thursday 9:00 PM to Friday 9:00 AM rash over entire body, pins and needle...
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vomiting, diarrhea, chills Thursday 9:00 PM to Friday 9:00 AM rash over entire body, pins and needles effects Friday 8:00 PM to Saturday 10:00 rash continues but not as severe to currently Tuesday at noon Jaundice, elevated liver enzymes, and elevated billirubin started Saturday to currently Tuesday at noon
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| 67 | 2021-03-09 | redness, itchy skin | Left arm pain itching, redness and swelling approx. 6cm/3cm. |
| 67 | 2021-03-09 | itchy rash, rash, rash with redness |
Rash on left arm . Red and circular about 2 inches. It's itching and seems to be getting larger. No ...
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Rash on left arm . Red and circular about 2 inches. It's itching and seems to be getting larger. No treatment other than observation.
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| 67 | 2021-03-09 | rash, hives, itchy skin | Rash that I did not witness, patient reports hives. pruritis on arms |
| 67 | 2021-03-09 | hives |
This is a spontaneous report from a contactable Consumer(patient). This consumer reported similar ev...
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This is a spontaneous report from a contactable Consumer(patient). This consumer reported similar events for the patient. This is the first of two reports. A 67-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at Arm Right on 14-JAN-2021 at the 67 years old at single dose for COVID-19 immunization. The medical history included breast cancer survivor, allergies to strawberries, bananas, lobster, mahi, whiting fish. The concomitant medications were cholecalciferol (VITAMIN D), ascorbic acid(VITAMIN C), collagen, curcuma longa(TURMERIC) , olive oil. The patient previously took VALIUM and experienced allergy. The patient got hives near her left eye with the first Pfizer shot in 2021 but wasn't sure if that was the cause as she did have food allergies. Her arm was a little stiff but not significantly and she did not have any other side effects in 2021. There was not treatment received for all the events. The patient had no Covid prior vaccination. There was no Covid tested post vaccination. The outcome of the events was recovered in 2021. The information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148988 same patient, same product( different dose), similar events
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| 67 | 2021-03-10 | pain of skin |
First effects looked like psoriasis after the first dose. More skin lesions appeared and after the s...
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First effects looked like psoriasis after the first dose. More skin lesions appeared and after the second dose my arms and legs were affected with various skin disorders. Dermatologist seen 3/2/21 indicated herpes and another bacteria. Was given Valacyclovir 1gm 2 x day, Cephalexin 500mg 2 x day, Prednisone packet and Mupirocin ointment. Festering lesions have continued to grow and now are painful. More lesions are appearing on extremities.
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| 67 | 2021-03-10 | hives | Headache, nausea, patch of hives on face. |
| 67 | 2021-03-10 | rash, itchy rash |
On Saturday-Sunday, March 6-7 I had diarrhea, nausea, chills and body aches. Beginning Wednesday, ...
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On Saturday-Sunday, March 6-7 I had diarrhea, nausea, chills and body aches. Beginning Wednesday, March 10 and continuing to the present, I have had an itchy rash over much of my body--arms, stomach, and back of legs.
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| 67 | 2021-03-10 | vaccination site pain |
syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills...
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syncope; feeling of heat rising into throat; feeling of heat rising into throat; lightheaded; chills; mild pain at injection site; This is a spontaneous report from a contactable pharmacist reported for self. This 67-year-old female patient (no pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 13:45 PM on Arm left via Intramuscular at single dose (Lot # EL9269) for covid-19 immunisation. Medical history included Osteoporosis, known allergies: Sulfa, flu vaccine for immunisation. No COVID prior vaccination. Concomitant medications included alendronate sodium (FOSAMAX), ergocalciferol (VITAMIN D), calcium, magnesium, biotin, bifidobacterium lactis (PROBIOTIC). No other vaccine in four weeks. Past similar reaction from Flu vaccine 8 years ago (2013) for immunisation and treated in ED, had no problems with any other vaccine such as HepB (Hepatitis B), DTAP, pneumococcal 23, Shingrix all for immunization. On 17Feb2021 14:15 PM, feeling of heat rising into throat, then lightheaded- EMT on-site monitored BP, heart, oxygen then administered IV Benadryl and zofran - signed out in 2hr, developed chills and syncope for next 4 days and mild pain at injection site. Self treated with Tylenol/ advised by MD to not get 2nd dose. Events resulted in emergency room/department or urgent care. Treatments were received for the events. Treatment included IV Benadryl and IV Zofran. Outcome of the events was recovering.; Sender's Comments: Based on a temporal association, a causal relationship between the events of feeling of heat rising into throat, lightheaded and syncope, and BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-03-11 | pain of skin, sensitive skin, rash with redness |
Approximately 18 to 20 hours after my injection, my left arm developed a red and swollen rash in a c...
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Approximately 18 to 20 hours after my injection, my left arm developed a red and swollen rash in a circular shape approximately 3.5 cm in diameter. The circular area was very sensitive and painful. My upper arm was also sore, although not severely. On day 3 or 4 post-injection, the red circular area remained the same in size but seemed less swollen. Although sensitive, it was no longer painful. However, it is now day 8 post-injection and the circle remains the same size and color.
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| 67 | 2021-03-11 | itchy skin |
Diffuse pruritis within minutes of receiving vaccine. Reported that she had experienced a feeling o...
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Diffuse pruritis within minutes of receiving vaccine. Reported that she had experienced a feeling of palpitations and throat swelling 2 weeks following her first dose of vaccine.
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| 67 | 2021-03-11 | injection site pain |
Had low grade fever 0n 3/11/2021 along with slight headache and slight body aches. Sore arm at injec...
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Had low grade fever 0n 3/11/2021 along with slight headache and slight body aches. Sore arm at injection site. Still felt tired on 3/12/2021 but fever gone.
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| 67 | 2021-03-11 | injection site pain |
Headache, sore injection site, pain all over my body Started @ 8 am and continued all day until abou...
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Headache, sore injection site, pain all over my body Started @ 8 am and continued all day until about noon the 2nd day
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| 67 | 2021-03-11 | itchy skin, rash, rash with redness, hives | hives to back and arms with itching, red rash to arms |
| 67 | 2021-03-12 | redness, itchy skin | 7 days after the shot, my right arm started getting itchy, swollen, sore and red. |
| 67 | 2021-03-12 | injection site pain |
Nausea, vomiting, diarrhea, dizziness, swelling, and soreness at the injection site, unable to raise...
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Nausea, vomiting, diarrhea, dizziness, swelling, and soreness at the injection site, unable to raise arm without pain
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| 67 | 2021-03-12 | itchy skin |
Patient developed generalized itching within hours of administration of the vaccine. She stated th...
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Patient developed generalized itching within hours of administration of the vaccine. She stated that her PMD and allergist said that she could have 2nd dose but 2 MDs , 1 PA and 1 RN at our public health facility did not feel safe in doing this. We declined to give the 2nd dose of Pfizer vaccine.
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| 67 | 2021-03-12 | rash macular, redness |
Suddden onset of feeling very hot in my face and neck.. I went to bathroom and looked at my face n...
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Suddden onset of feeling very hot in my face and neck.. I went to bathroom and looked at my face no swelling noted. My neck had a pouch of fluid accumulating with small redden areas on my neck and upper chest area. No other symptoms noted. My breathing was good.
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| 67 | 2021-03-12 | skin spots | developed petechiae on legs, feet, abdomen - first noticed 3 weeks after dose1 - has since had dose2 |
| 67 | 2021-03-12 | redness |
redness in the arm that spread after one day to the whole body and remained for more than a week as ...
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redness in the arm that spread after one day to the whole body and remained for more than a week as per patient, sensitive to the touch.
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| 67 | 2021-03-13 | itchy skin, rash |
3/9/21 PM headache, 3/10/21 AM fever, generalized achiness, 3/11/21 bilateral hand swelling and rash...
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3/9/21 PM headache, 3/10/21 AM fever, generalized achiness, 3/11/21 bilateral hand swelling and rash on hands, diffuse itching. 3/14/21AM swelling around eyes. continues itching. continued fever. swelling in hands improved.
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| 67 | 2021-03-13 | injection site pain |
Pain at injection site 12:44pm 4:25 pm high temperature of 102 took tylenol. Swelling and pain und...
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Pain at injection site 12:44pm 4:25 pm high temperature of 102 took tylenol. Swelling and pain under left armpit. Felt a lump in my left breast. Feels like someone punched me real hard in my armpit. Took Ibuprofen for swelling. Swelling and pain lasted 3-4 days then subsided and now there is no longer any pain. Don't feel the lump any longer in my left breast.
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| 67 | 2021-03-13 | rash | Rash appeared on back and across abdomen |
| 67 | 2021-03-13 | skin irritation, rash, skin reaction, redness |
Red rash on upper chest. It may not be related to the vaccine...I have had various skin reactions ...
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Red rash on upper chest. It may not be related to the vaccine...I have had various skin reactions over the past year. It is still red and inflamed five days after it appeared
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| 67 | 2021-03-14 | rash |
A rash on my forehead and that spread around the right eye for next two days; Developed pain on righ...
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A rash on my forehead and that spread around the right eye for next two days; Developed pain on right side of face; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231), via an unspecified route of administration on Right arm on 21Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included Allergies to Sulfa and Osteopenia/osteoarthritis. The patient's concomitant medications were not reported. The patient reported, On 28Jan2021, one week after receiving the Covid vaccine, I developed pain on right side of face. On 31Jan2021 I developed a rash on my forehead and that spread around the right eye for next two days. The Dr was contacted on 02Feb2021 and I started on Valtrex (Valacyclovir HCL, 1 Gm, 3 times a day on 28Jan2021 13:00 upon Doctor or other healthcare professional office/clinic visit). The patient received treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events recovering. Information on the lot/batch number has been requested.
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| 67 | 2021-03-14 | rash | All over body rash started day after, still prominent on Monday but not quite as intense. |
| 67 | 2021-03-14 | injection site pain, injection site redness |
This injection was not placed correctly in the deltoid muscle. She experienced some pain and some r...
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This injection was not placed correctly in the deltoid muscle. She experienced some pain and some redness.
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| 67 | 2021-03-14 | hives |
Three days after the second dose of the vaccine I started coughing, wheezing and having shortness of...
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Three days after the second dose of the vaccine I started coughing, wheezing and having shortness of breath on exertion. This symptoms did'nt alarm me at first since I have this asthma for couple years. Then after a week from receiving my second dose vaccine in 02/28/21, my symptoms got worst. In additon to having SOB, wheezing , coughing I developed generalized hives. I started taking steroids started 03/13/21 to ease my symptoms. Today I started feeling better and able to walk for 30 minutes without any problems. Hives also subsided. I had no asthma or hives attack for the last three years.
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| 67 | 2021-03-15 | redness |
2/23/21- Redness swelling to Rt side of face - Rt eye red and swollen and headache Rt entire arm swo...
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2/23/21- Redness swelling to Rt side of face - Rt eye red and swollen and headache Rt entire arm swollen and redness from shoulder to elbow w/a sting 2 weeks after 2nd dose
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| 67 | 2021-03-15 | shingles |
I developed Shingles (herpes zoster) approximately 10-12 days after receiving the first covid-19 va...
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I developed Shingles (herpes zoster) approximately 10-12 days after receiving the first covid-19 vaccine; This is a spontaneous report from a contactable Nurse (Patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL1284), via an unspecified route of administration, in right arm, on 31Dec2020 at 11:00 as SINGLE DOSE for covid-19 immunisation at Hospital. Age at vaccination was 67 years. The patient's medical history included asthma, osteoporosis. Allergies to medications, food, or other products included NSAIDS allergy. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included fluticasone propionate, salmeterol xinafoate (ADVAIR); montelukast sodium (SINGULAIR); omeprazole (PRILOSEC [OMEPRAZOLE]); ergocalciferol (VIT D); Multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated "I am a healthy active senior citizen. On 12Jan2021 at 04:00 after the first dose of vaccination the patient developed shingles (herpes zoster) approximately 10-12 days after receiving the first covid-19 vaccine. I did not have a weakened or compromised immune system prior to the first covid-19 vaccination." The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration, in left arm, on 21Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The patient received treatment included Valacyclovir 1 gm PO three times daily for 7 days. Since the vaccination, the patient hasn't been tested for COVID-19. Outcome of the events was not recovered. The events were considered non-serious by the reporter. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-03-15 | rash | Rash around face, night sweats. |
| 67 | 2021-03-15 | itchy skin |
nausea, dizziness and chest compression with in 15 minutes of shot. oxygen and laid supine flat. I...
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nausea, dizziness and chest compression with in 15 minutes of shot. oxygen and laid supine flat. Itchiness within 60 minutes. Benadryl 25 mg. Resolution post shot 3 hours, released home. At 3 PM I experienced chest compression again and used my rescue inhaler with resolution of sx, also took another benadryl Note: I was premedicated with zyrtec and 50 mg of diphenhydramine at the time of the second shot
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| 67 | 2021-03-16 | itchy skin |
67 year old female with PMH of HTN, HFpEF, history of DVT, obesity, migraines, gastroparesis, Sicca ...
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67 year old female with PMH of HTN, HFpEF, history of DVT, obesity, migraines, gastroparesis, Sicca symptoms, asthma, chronic bronchitis, and GERD who presents with anaphylactic reaction s/p COVID vaccine administration. Received COVID vaccine across the street (<1 minute EMS ride) C/o itching, cough, and wheezing shortly after No respiratory distress or hypoxia en route Received IM epi (2 weeks expired) and Benadryl PTA Symptoms improving now Has extensive allergy list Review of Systems 10 point ROS completed and negative except noted in HPI above Physical Exam/Objective Vitals & Measurements last 24 hours VITAL SIGNS Temp C: 36.3 DegC Heart Rate: 87 bpm Resp Rate: 16 br/min BP #1: 139 / 59 mmHg SpO2 (%): 99 % O2 Device: Room air Height CM: 152.4 cm Ideal Body Weight: 45.5 kg General: NAD, well-nourished Eyes: No scleral icterus, EOMI HENT: Normocephalic, atraumatic, no airway edema Neck: Supple, intact range of motion Respiratory: Lungs CTAB, symmetric chest wall expansion, no wheezes, speaking in full sentences Cardiovascular: RRR, no murmur, +2 peripheral pulses Abdomen: Soft, NTTP, non-distended Musculoskeletal: No gross deformity Integumentary: Intact, warm, dry, no rashes Neurologic: A&O x 3, no focal deficits Psychiatric: Cooperative, appropriate mood and affect Medical Decision Making 67 year old female with extensive PMH including asthma, chronic bronchitis, and GERD who presents with anaphylactic reaction s/p COVID vaccine administration. Has long list of allergies. On exam, airway intact, no respiratory distress, no wheezing, speaking in full sentences, C/o subjective itching and cough that is starting back up. IV methylprednisone IV famotidine Albuterol PRN Benadryl PRN Observe Rx EpiPen upon discharge Re-Assessment Observed for >4 hours Symptoms resolved Counseled patient on EpiPen use and gave strict return precautions Has albuterol and Benadryl in her purse Has had many reactions in the past and is very familiar with how to manage them Discharge home with daughter
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| 67 | 2021-03-16 | rash |
Day 2 diarrhea, fever and upset stomach Day 2 broke out all over my chest and stomach and just don't...
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Day 2 diarrhea, fever and upset stomach Day 2 broke out all over my chest and stomach and just don't feel good
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| 67 | 2021-03-16 | hives, redness |
One week after 2nd dose patient developed 1 1/2"x 3/4" welts on her cheekbones with redness to the t...
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One week after 2nd dose patient developed 1 1/2"x 3/4" welts on her cheekbones with redness to the tissue. She states it felt pliamble to the touch, thicker than fluid. Her dermatologist, saw her and she was treated with a steroid injection, in the left welt area under her right eye, unsure of name of medication she received. The dermatologist told her today during her visit that her reaction was due to her covid vaccine (Pfizer). Patient had fillers done 5 years ago (Juvederm). The smaller welt on the left side cheekbone area has gone down and is barely noticeable now so she did not get a steriod injection in that area. She is schedule to return to see her dermatologist in 6 weeks.
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| 67 | 2021-03-16 | shingles |
pt developed bad case of shingles on Left abdomen to left side of back. Went to Urgent care 3/12 an...
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pt developed bad case of shingles on Left abdomen to left side of back. Went to Urgent care 3/12 and was given acyclovir and cephalexin. pt is having stabbing pain on abdomen and back
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| 67 | 2021-03-17 | injection site pain, injection site swelling |
3/14/21: 10:00 pm violent hand tremors - 3 hours 3/14/21: 10:30 pm nausea 3/14/21: 11:00 pm vomiti...
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3/14/21: 10:00 pm violent hand tremors - 3 hours 3/14/21: 10:30 pm nausea 3/14/21: 11:00 pm vomiting every hour - 7 hours and off and on the next 48 hours 3/15/21: 10:00 am extreme joint pain 48 hours 3/15/21: 10:00 am headache off and on 72 hours 3/16/21: 3:00 am 102.4 temperature (couple of hours?)16 3/16/21: 12:00 pm sore throat 24 hours 3/16/21: Fatigue Continues 3/16/21: Very dizzy 3/17/21: 3:00 pm injection side tenderness and slight swelling 48 hours 3/18/21: 3:00 pm first time able to get out of bead and shower - slight light headedness
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| 67 | 2021-03-17 | injection site pain |
About 12hours after the vaccination I had a 101.3 fever (normally 98.1) Body aches; when I got up...
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About 12hours after the vaccination I had a 101.3 fever (normally 98.1) Body aches; when I got up about 9am the next morning I was dizzy and then fainted. The fever persisted until mid afternoon that day, as did the body aches, and a headache. I spent the day dozing or sleeping. I did eat some oatmeal and have a cup of black coffee about noon. That helped the headache. That evening I was more tired than usual, but no fever or aches. The next day I was also very tired, but I did go to work. The rest of the week I had no energy, but that was the only other side effect. After the first shot, I had only had an achy arm at the injection site that persisted for 2 or 3 days.
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| 67 | 2021-03-17 | redness, hardening |
Four days after, I noticed a soft "lump" right axilla. Cancer Institute did an ultrasound. "No enla...
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Four days after, I noticed a soft "lump" right axilla. Cancer Institute did an ultrasound. "No enlarged lymph nodes." No sign of cancer The lump in my axilla got very large. "Not as big as a baseball but larger than a golf ball." I could wrap my fingers around it. Hard as a rock. Within a week my whole entire chest wall on the right (from side to sternum) was scarlet red. And I was getting another "lump" in the fold of tissue where my upper chest meets my upper arm. I was put on Keflex 500 mg four times a day. The redness in my chest wall subsided. Five days after being on Keflex, the lump on my chest was hard, red, very painful, "angry." Fevers, feeling "pretty sick." (Very uncharacteristic of me. I didn't miss a day of work through months of multiple rounds of chemo, 5 weeks of radiation.) February 7 PCP requested I go the ER. Suspecting an abscess. They did an I&D. Expressed "lots of puss" and left a drain in. To be removed in 5 days. Placed on Bactrim twice a day for 5 days.
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| 67 | 2021-03-17 | injection site pain |
Initial minor pain at the injection site that became worse after the 3rd day. Pain radiating up the ...
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Initial minor pain at the injection site that became worse after the 3rd day. Pain radiating up the arm and shoulder into the neck area. Tingling in thumb and 3 fingers. Never have had any issues like this. Went to Orthopedic doctor who found arthritis in neck. Given Prednesone but did not help at all. Called doctor again and asked if tingling in hands was associated with arthritis and told not normally and what else I could do? Suggested an MRI which did not have yet. Pain is diminished today but tends to flare up. Pain is worse at night. Never had any symptoms like these before the 2nd Covid shot.
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| 67 | 2021-03-17 | injection site redness | Large bright red circle at injection site approximately 2 by 3 inches |
| 67 | 2021-03-17 | rash, skin peeling |
Severe rash covering entire lower back, severe sore throat and mouth with sores, cough, some shortne...
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Severe rash covering entire lower back, severe sore throat and mouth with sores, cough, some shortness of breath, low grade temp., extreme lethargy, nausea, bloating, peeling of the tips of my fingers on the palm side, loss of appetite.
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| 67 | 2021-03-17 | injection site pain |
Sore arm at injection site, bad headache, chills, fever, aches in joints, back pain, nausea, tiredne...
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Sore arm at injection site, bad headache, chills, fever, aches in joints, back pain, nausea, tiredness Treatment, sumatriptan for headaches, Advil for aches , pain and fever. I was in bed for 2 1/2 days because I felt so sick and was very tired Most of my symptoms were better after 3 days but the headaches and tiredness are still bothering me today 3/18/21.
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| 67 | 2021-03-18 | injection site pain, injection site discomfort |
9pm pressure at site; 1am pain in right arm at injection site; 3/19 7am pain in right scapula radia...
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9pm pressure at site; 1am pain in right arm at injection site; 3/19 7am pain in right scapula radiating up into neck; swelling to right side of neck; pain radiating down to hand with pain in first two knuckles; swelling noted to axillary area; pressure moving to 1st and second rib from shoulder; feeling of fullness in right arm and shoulder; difficulty move arm and hand grasp affected.
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| 67 | 2021-03-18 | hives |
Approximately 2 hours after receiving vaccine, patient states her back started burning and she broke...
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Approximately 2 hours after receiving vaccine, patient states her back started burning and she broke out in hive on back and both arms. She self-treated with benadryl for duration of hive (2 days).
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| 67 | 2021-03-18 | injection site warmth, hives, injection site rash, rash with redness, itchy rash |
Day 1 none noted Day 2 extreme overall body aches, headache, fever (101.2) chills. Took Tylenol o...
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Day 1 none noted Day 2 extreme overall body aches, headache, fever (101.2) chills. Took Tylenol one time -30 hrs. after injection Day3 fever and aches began subsiding *now noted itchy, red, hive-like rash, warm to touch- around upper and inner arm around injection site as well as sore and swollen lymph node in armpit of same arm. Took Tylenol 2 times Ice to arm Day 4 fever, aches, headache subsided. Red rash on arm larger, red, itchy, warm and node still sore (no fever) Ice to arm and took 10 mg Cetirizine
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| 67 | 2021-03-18 | skin warm |
Discussed vaccine ADE after first dose with patient. Pt reports having existing lung disease for whi...
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Discussed vaccine ADE after first dose with patient. Pt reports having existing lung disease for which she uses oxygen and CPAP overnight. She reports feeling fatigued and increased SOB on exertion and increased O2 requirement for 2d after receiving vaccine. She also reports intermittent sweating and feeling hot on her head and scalp but without chills or bodyaches for 3 weeks now. When she checked her temperature at home, she reports temps of 98 or 99. Based on discussion, her reaction is not likely to be an allergic reaction and more likely an immune response to vaccine. Patient agrees to proceed with 2nd dose and will continue to monitor symptoms.
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| 67 | 2021-03-18 | itchy skin, redness |
Patient received 2nd dose at 1226 on 3/19/2021. At approximately 1240, she felt itchiness on her thr...
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Patient received 2nd dose at 1226 on 3/19/2021. At approximately 1240, she felt itchiness on her throat both inside and outside. She then took 25mg of Benadryl. The itchiness didn't subside and she requested another 25mg of Benadryl at 1255. She took a total of 50mg of Benadryl. Her neck was visibly red and she was scratching it. After 5 minutes, she said she felt better. When she left at about 1315, she said she felt nearly 95% normal. She was with her husband, sister and daughter. She was given instructions to call 911 if her throat felt like it was closing. Compared to her first dose of the vaccine, this was a more mild reaction.
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| 67 | 2021-03-18 | rash | Rash on my torso that lasted 2 days. No itching. |
| 67 | 2021-03-18 | rash |
Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; F...
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Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; Freezing and chills; Felt like would pass out/felt so faint; Ate dinner but food came back up; Shortness of breath; Cheeks flushed; Achy; felt draggy/feeling tired; This is a spontaneous report from a contactable. A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: GL9266, via an unspecified route of administration, administered in left arm on 21Feb2021 as single dose for COVID-19 immunisation. Medical history included rheumatic fever (occurred age 7), vulvovaginal dryness and sore joints. The patient was negative on Covid test on an unspecified date. Historical vaccine included BNT162B2 on 28Jan2021 for COVID-19 immunisation and flu shot. Concomitant medications included estradiol (IMVEXXY) taken for vulvovaginal dryness; vitamin C [ascorbic acid] (VITAMIN C); colecalciferol (VITAMIN D); calcium. On Monday, 22Feb2021, the patient felt draggy, but did not think it was a big deal. She just thought it was from the shot and was feeling tired. The draggy feeling lasted a few days, but she was unable to clarify outcome further. On Tuesday, she started to feel achy and felt like that too was to be expected. The achiness went away on 25Feb2021. On Wednesday, 24Feb2021, she was really busy. She was still achy but was busy. She also did not drink much water for several hours. It dawned on her later when she was not feeling good. Late Wednesday afternoon it was like everything cratered and she felt horrible. She was feeling bad. She was freezing and had chills. It was a horrible feeling. She helps with her grandkids since she is retired. They were home from school and had to sit on the couch. She felt cold, yucky, and achy. It was a yucky feeling. She went home a couple of hours later. She told her husband she had to lie down on the couch because she felt horrible. She could not further describe horrible feeling. Her daughter had called her as well and was unable to describe how she felt to her daughter. She could only say she felt so sick but could not explain further. She felt awful and could not put her finger on it. She was laying down and when she got up, she felt like she would pass out. At that time, she had not eaten dinner yet. She ate dinner, took one bite and the food came back up. For a few moments she felt so faint, she felt shortness of breath, but it was only for a few seconds. After that, her and her and her husband took a drive to go to hospital. However, by the time she got to hospital she was feeling better. She was also talking to a friend at that time who said all of this was probably form the shot as well. Since she was feeling better decided not to go into the hospital and went back home. At the time she was thinking this was all from the shot and no big deal. On Wednesday night, things got crazy and worse. That evening Wednesday she was getting ready for bed and noticed her cheeks were flushed. On Thursday she got up and noticed rash. She was covered all over her body. It did not itchy really, but it was a rash. Not a bumpy rash, it reminds her of Roseola. Her joints and fingers were starting to swell. Her hands were swollen. It started with her knuckles, it went to her fingers, up to her hands, wrist. Her wrist was sore. Her joint swelling was worse. On Friday, she tried to see her doctor, but could not be seen by the doctor. However, she got in with the PA. When she saw the doctor, it could be seen her hands were swollen. However, the main reason she went to the doctor was due to the rash. However, her joints were sore and swollen. Treatment for rash included Hydroxyzine, for joints and fingers swollen/ wrist was soreincluded prednisone 10mg one tablet every day for five days. The patient recovered from the event felt like would pass out/felt so faint and shortness of breath on 24Feb2021. The outcome of the events joints and fingers swelling/hands were swollen, wrist was sore and cheeks flushed was not recovered.
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| 67 | 2021-03-18 | rash, itchy skin |
Severe rash on neck and some on torso developed 48 hours after the shot. Persistent itching for 2 da...
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Severe rash on neck and some on torso developed 48 hours after the shot. Persistent itching for 2 days thereafter.
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| 67 | 2021-03-18 | vaccination site pain |
sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 67...
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sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration (left arm) on 02Feb2021 11:45 AM at a single dose for COVID-19 immunisation. Medical history included known allergies to codeine. No concomitant medications. No other medications in two weeks. No other vaccine in four weeks. No COVID prior to vaccination. The patient experienced sore arm at injection site on Feb2021. No treatment received for the event. No COVID test post vaccination. The patient recovered from the event on Feb2021. Information of batch and lot number has been requested.
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| 67 | 2021-03-19 | injection site redness, injection site warmth | Covid vaccination arm - red, warm spot around injection site. (No pain, no itching.) |
| 67 | 2021-03-19 | injection site redness, rash with redness, injection site pain, injection site swelling | Expanded red spot at injection site. Scab covered, slightly sore. Continues to enlarge. |
| 67 | 2021-03-19 | itchy rash, rash |
Possible Pityriasis Rosea. Hd a "herald patch" first on left upper arm. First rash was on legs, w...
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Possible Pityriasis Rosea. Hd a "herald patch" first on left upper arm. First rash was on legs, which disappeared the following day. Currenlty have red measle like rash on torso, back, and belly. Slightly itchy, Have used hydrocortisone on it and taken Benedryl. See dermatologist on April 13th.
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| 67 | 2021-03-19 | injection site pruritus |
Pulsatile Tinnitus in left ear started 5 days after 2nd dose administered and is ongoing. Other eff...
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Pulsatile Tinnitus in left ear started 5 days after 2nd dose administered and is ongoing. Other effects post 2nd dose had resolved before tinnitus began. Other effects experienced were headache, nausea, itching at injection site, diarrhea, fatigue
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| 67 | 2021-03-19 | injection site pain | Severe chills, low grade fever, headache, body aches, sore arm at injection site |
| 67 | 2021-03-20 | rash | Change and rash in breasts |
| 67 | 2021-03-20 | redness, itchy skin, hives | Large red hives and itching , all over body except face. Took Benadryl caplets and Benadryl lotion |
| 67 | 2021-03-20 | vaccination site pain |
Slight injection site soreness; This is a spontaneous report from a contactable consumer (patient). ...
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Slight injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201) via unspecified route of administration on 11Feb2021 at 13:15 (at the age of 67-year-old) in left arm as a single dose for COVID-19 immunisation. The patient medical history included Crohn's disease, and asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included Allergy Antigen injs (as reported), Humira pen and metoprolol succinate. The patient didn't receive any other vaccine within four weeks prior to the vaccination. The patient experienced slight injection site soreness. On a scale of 1-10, with 10 being the highest. The soreness was maybe a 3. The outcome of the event was recovered on an unknown date in Feb2021.
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| 67 | 2021-03-21 | hives | Full body hives. Got worse after 2nd dose on 3/18/2021 |
| 67 | 2021-03-21 | injection site pain |
Pain in arm at the injection site. fever of 100 degrees, sweats and chills, extreme tiredness, tota...
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Pain in arm at the injection site. fever of 100 degrees, sweats and chills, extreme tiredness, total body aches for about 36 hours
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| 67 | 2021-03-21 | injection site pain |
Patient has pain that started after vaccine and is now ongoing. It is in the vaccinated arm and also...
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Patient has pain that started after vaccine and is now ongoing. It is in the vaccinated arm and also base of left neck. Describes pain as a burning nerve type pain. It is improving with time but not with gabapentin or tylenol. Hx of CRPS
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| 67 | 2021-03-21 | itchy rash | Systemic itchy rash appearing 8 days post vaccine. |
| 67 | 2021-03-21 | redness, injection site pruritus, skin warm |
Thursday day of vaccine no problems. Friday around 8 pm she was having itching at the vaccine site ...
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Thursday day of vaccine no problems. Friday around 8 pm she was having itching at the vaccine site and noticed the arm was swollen "about softball" size. Now, on Monday (22nd) she states her right arm from her elbow to her shoulder is swollen, red, and has some heat.
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| 67 | 2021-03-21 | injection site rash |
Woke up in middle of night with pain at the collar bone (same side as injection ) It was swollen and...
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Woke up in middle of night with pain at the collar bone (same side as injection ) It was swollen and felt a lump the size of a large marble . Went to the emergency room that morning. Seen by nurse practitioner and diagnosed with Inflammation of the lymph nodes. Could not confirm it was related to the vaccine. The next morning on 03/13 woke up with large very red patchy rash that covered the shoulder area and down to the elbow. Again same side as the injection. Took Benadryl for 5 days
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| 67 | 2021-03-21 | itchy skin, rash, redness |
right cheek redness; right cheek redness and rash with burning; right cheek redness and rash with bu...
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right cheek redness; right cheek redness and rash with burning; right cheek redness and rash with burning; itching; tingling sensations; felt hot; dizzy; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration, administered in the left arm on 28Jan2021 as a single dose for COVID-19 immunisation. Medical history included hypertension and hypothyroidism, both from an unknown date and unknown if ongoing. The patient had COVID prior vaccination (dates unspecified). The patient was not pregnant at the time of the vaccination and report. The patient's concomitant medications were not reported. The patient had known allergies to aspirin, codeine, metoclopramide, morphine, hydromorphone, tramadol, hydrocodone, and prochloperazine maleate (COMPAZINE). The vaccination was done in the hospital. In Jan2021 (also reported as 18Jan2021), patient experienced right cheek redness and rash with burning, itching, tingling sensations. The patient also felt hot and dizzy. The events caused hospitalization from an unspecified date in 2021. The patient was not tested for COVID post vaccination. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-03-22 | bruising | Bruising black and blue and swelling on arm with lump the size of a silver dollar |
| 67 | 2021-03-22 | injection site tingling, injection site numbness |
Client verbalized feeling tingling and numbness to right arm after receiving the vaccine. Assessment...
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Client verbalized feeling tingling and numbness to right arm after receiving the vaccine. Assessment done by Fire Rescue Paramedics. Client was released for home at 5:30 pm. Per paramedics no further evaluation needed. Symptoms resolved.
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| 67 | 2021-03-22 | rash | Fever, aches pains, rash brain fog sleep |
| 67 | 2021-03-22 | shingles | Shingles.......given Valtrex.......still having some fatigue......diagnosed on 02/09 |
| 67 | 2021-03-22 | itchy skin |
Temperature read 99 degrees upon arising. Elevated through out the day to a high of 100.2 at 9pm. Le...
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Temperature read 99 degrees upon arising. Elevated through out the day to a high of 100.2 at 9pm. Left armpit swollen & itchy. Dull headache all day. All joints in entire body ached entire day. Tired feeling all day and night. Slept 4-6:30 pm and 9:30 pm to 1:30 am the following morning. Temperature down to 99.2 degrees at 1:30 am. Difficulty raising left arm more than 45 degrees.
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| 67 | 2021-03-23 | rash | Bad headache Fever Fatigue Nausea Rash |
| 67 | 2021-03-23 | itchy skin, hives, rash |
Flushing, hives, rash, itching, lips swelling tingling, high BP dose 1 - 209/107 high BP dose 2 188/...
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Flushing, hives, rash, itching, lips swelling tingling, high BP dose 1 - 209/107 high BP dose 2 188/87. Symptoms began 30 -40 minutes after vaccines.
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| 67 | 2021-03-23 | vaccination site pain, vaccination site warmth, rash macular |
I had chills; feeling of being unwell; arm, it was swollen looked like Popeyes arm; warm to touch/ T...
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I had chills; feeling of being unwell; arm, it was swollen looked like Popeyes arm; warm to touch/ The arm she got the vaccine in; arm she got the vaccine in, left arm, really hurt; arm, it was swollen looked like Popeyes arm, blotches,; her adverse reaction turned out to be cellulitis/cellulitis from the injection.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration left arm on 03Mar2021 14:15 (Batch/Lot Number: EN6203),at the age of 67-years at vaccination, as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose on vaccine on 10Feb2021, LOT:EL9266 to Upper Left Arm. On 03Mar2021 at 2:15PM; patient received the second dose of the Pfizer covid vaccine, in her left arm; her adverse reaction turned out to be cellulitis, Patient states, it could have been happening two days or a day before she actually noticed it when she took off the Band-Aid, she had chills and didn't feel well on day 3 of the vaccine she still didn't feel well it was still hurting, she looked at the arm, it was swollen looked like Popeyes arm, blotches, warm to touch, she didn't have a temperature but she knew something was wrong. She got an antibiotic started from a doctor, and Famciclovir , that she took one day. She thought all of this stressed her out and she would end up with shingles. the medications are Doxycylcine, Hyclate, and Famciclovir, A doctor over the phone said that she had cellulitis, and told me to go into the ER, so early in the afternoon, she went to urgent care and they said she had cellulitis, and that's when she got the prescriptions. They wanted to see her on 07Mar2021 to check, and it is doing better. The patient was also asking, should she be somebody to get an antibody test, to see if it did it's job. Does she need to re-do the vaccine? The patient asked, was the bacteria in the vaccine or in the needle? She feel like there was something in the vaccine, maybe the bacteria was in the vaccine. LOT EN6203 - She has a Band-Aid from the site kept in a freezer at home. The vaccination Center. She stated she feel really fortunate, she was just scared to death of getting covid. For some reason, she got a bacterial infection that day, she have no way of knowing if it was the health care worker and bad technique, or bad vaccine. Psychologically, there's something about not knowing if the vaccine is protecting me because she took these medications, she was not sure I have the protection, and it creates a level of anxiety. Patient states that she believes she had an adverse reaction from her second dose on 03MAR2021. She states that three days later after the shot, she had already had chills and a feeling of being unwell. The arm she got the vaccine in, left arm, really hurt and she looked in the mirror and could see red blotches from her shoulder to the elbow and it was swollen and warm to touch. Patient states that she called around Saturday morning asking if this was typical or to be expected. She states at one point she called an ER and the doctor there said right away cellulitis and said that someone needed to see her. Patient states that she has no transportation so she had to wait until the afternoon and her son took her to Urgent care to be seen and she was diagnosed with cellulitis from the injection. The patient states she noticed when her arm felt unusual, thinks 6MAR2021. Treatment: Patient states that she was given an antibiotic, Doxycycline HYCLATE, 100mg twice a day for 7 days. She started taking it on Saturday 06Mar2021. Patient states the doctor asked her to come back the following day and looked at it again and thought it was improving and sent her home. Patient states that she also took a one day dose Samciclovir Sunday 07MAR2021. Patient clarifies that she had shingles in past and feels stress is going to cause this to occur again for her. She did take one day dose. She states that she does not have a shingles breakout nor did she have one. States that it prevents shingles breakouts and she took it as a preventative dose. Patient states the actual injection site is still warm and painful. Patient states, because she is on the antibiotic and also took the samsivocloir, a total of 2000mg, she is wondering does that make the vaccination ineffective, would she have to redo it? The outcome of the event was not recovered. Information on lot/batch is requested
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| 67 | 2021-03-23 | injection site swelling, injection site warmth, injection site pain, injection site redness |
I had some initial swelling and soreness at site, then about a week later injection site got red and...
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I had some initial swelling and soreness at site, then about a week later injection site got red and hot. The area was about the size of a 50 cent piece. This lasted 24 hours then subsided.
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| 67 | 2021-03-23 | injection site swelling | My arm continues to swell. it is now the size of a huge grape fruit. |
| 67 | 2021-03-23 | hives |
Scratchy throat, facial hives, increased work of breathing after second dose of Pfizer mRNA COVID-19...
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Scratchy throat, facial hives, increased work of breathing after second dose of Pfizer mRNA COVID-19 vaccine IM right arm. Took patient to ED for monitoring. Gave albuterol, prednisone 60 mg PO, and diphenhydramine 50 mg PO. Monitored until symptoms resolved and discharged from ED in stable conditions.
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| 67 | 2021-03-24 | itchy skin |
Couldn?t swallow good, itchy ears and throat, blood pressure 170/87 , elevated heart rate, numb lips...
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Couldn?t swallow good, itchy ears and throat, blood pressure 170/87 , elevated heart rate, numb lips, bad headache. I received a shot of benedryl and steroids.
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| 67 | 2021-03-24 | injection site pain |
Severe chills, migraine, some nausea, zero appetite, body muscle pain and joint ache, soreness at va...
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Severe chills, migraine, some nausea, zero appetite, body muscle pain and joint ache, soreness at vax site and extreme tiredness. Symptom onset was 12 hours after the shot.
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| 67 | 2021-03-25 | injection site pain |
A few hours after the shot, I experienced a mild bout of diarrhea. Then began to run a fever. The...
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A few hours after the shot, I experienced a mild bout of diarrhea. Then began to run a fever. The injection site and right arm became extremely heavy and painful. Overnight, I experienced fever, extreme muscle cramping and a burning sensation in all of my joints. Took a Tylenol at midnight which helped. Fever remained at 99.8 which is high for me. This lasted for the next 24 hours. Today, Friday the 26th, I am finally feeling better and fever is gone.
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| 67 | 2021-03-25 | itchy skin, hives | Hives , welts and severe itching all over my body |
| 67 | 2021-03-25 | itchy skin |
The patient reports a severe allergy to Corn/corn syrup. S: I feel itchy and nauseous. I feel like...
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The patient reports a severe allergy to Corn/corn syrup. S: I feel itchy and nauseous. I feel like my chest is heavy. Denies CP or SOB. Denies dizziness or lightheadedness. O: A&O x3. Skin is pink, warm, and dry. No rash. Resp: normal resp rate- no cough no stridor. Cards: RRR in the 80s. Radial pulse palp. A/P: 67 y/o female who reports severe Corn allergy and is having symptoms of s/p Pfizer vaccine that are similar to when she ingests corn or corn derivative. She takes Cetirizine when this happens but does not have any with her. Cetrizine 10 mg po x1 given Patient monitored for 30 min with a resolution of reported symptoms
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| 67 | 2021-03-25 | itchy skin, hives |
Urticaria. With pain , burning, itching....cortisone cream, oral steroids, aspercreme With 4% lido...
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Urticaria. With pain , burning, itching....cortisone cream, oral steroids, aspercreme With 4% lidocaine. Benedryl orally and famodine. 2 visits to clinic for this rash which continues to spread
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| 67 | 2021-03-25 | pain of skin |
Very rapid onset of severe nose congestion, slight runny nose and sneezing. Lasted about 12 hours. S...
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Very rapid onset of severe nose congestion, slight runny nose and sneezing. Lasted about 12 hours. Severe skin sensitivity ( pain when touched) on right side of back and eventually stomach area. Took two different over the counter allergy pills over 2 days (claritin was one) , two Advil cold and Sinus pills and eventually before bed a decongestant nasal spray. The spray was the most effective. By next day symptoms were better but not gone. By third day this had cleared up. I was also tired and a bit achy for two days.
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| 67 | 2021-03-25 | injection site redness |
fatigue, headache 6 hrs after vaccine (same as 1st dose), ~11 pm, severe chills, nausea, joint pai...
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fatigue, headache 6 hrs after vaccine (same as 1st dose), ~11 pm, severe chills, nausea, joint pain, short of breath ~ 2 am increased heart rate (112, usually in 80's) fever over next 3 days fever, joint pain, injection site redness and area on arm below -day - continued redness in arm
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| 67 | 2021-03-26 | hair loss |
I'm an RN, so I can say this with a basis of medical knowledge. I had my first Covid Pfizer dose on...
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I'm an RN, so I can say this with a basis of medical knowledge. I had my first Covid Pfizer dose on 2-12-2021 and my second dose on 3-5-2021. 1. I began having sharp, stabbing, intermittent pain along several dermatomes approximately two days after the second dose on 3-5-2021. It is now 3-27-2021, and the intermittent pain continues. 2. After the first dose on 2-12-2021, I began to lose more hair than I normally do on a daily basis. Since the second dose of the vaccine, I'm losing handfuls of hair everyday. I'm finding clumps of my hair on the floor and even in my bed. It's most disconcerting. I'm not sure what's causing either one of these symptoms, but I felt I should report it. I have NOT seen or talked to my internist about these symptoms. Being an RN, I'm trying to ride out the symptoms.
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| 67 | 2021-03-26 | redness, skin warm | woke up with red, swollen, warm to touch, painful (4 on 10 scale) (making neck tighten) |
| 67 | 2021-03-27 | rash | Rash on right foot and left arm, and lower legs |
| 67 | 2021-03-27 | injection site redness, injection site hardening, injection site pruritus | Red itchy indurated area to injection site approximately 4 cm diameter |
| 67 | 2021-03-28 | injection site pain |
Oddest thing, I know how bizarre this sounds. About 8 hours after my injection, I had moderate pain...
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Oddest thing, I know how bizarre this sounds. About 8 hours after my injection, I had moderate pain in my left (injection) arm. However, I also developed the same or greater level of pain in my right (non-injection) arm. The pain was located in my upper arm, exactly the same area where I experienced pain in my injection arm. The pain lasted about 18 hours, fading away after that. I had the same reaction to the second dose of the vaccine, given three weeks following the first. I had less pain after the second shot, and the "mirror" pain in the other arm was also less. This lasted between 12 and 18 hours, and then the pain in both arms faded away.
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| 67 | 2021-03-28 | rash with redness, rash papular |
something in her throat; rash/bumpy rash; nausea; vomiting; started having a taste in her mouth; tic...
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something in her throat; rash/bumpy rash; nausea; vomiting; started having a taste in her mouth; tickle in her throat, and she kept trying to clear her throat, and then her voice was gone; it felt like her throat was closing up.; rash/red rash; lost of voice; dizziness; headache; This is a spontaneous report from a contactable consumer. A 67 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200, expiration date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 67 -years-old), single dose for COVID-19 immunisation. Medical history included diagnosed in 1978 with Gestational Diabetes, and that went away, but it came in 1995 and has been active and progressing ever since; Diabetes, Type Two; allergies to various medications; food allergy. Caller had concomitant medicines of unspecified anxiety medicine, pain medicine,anti-inflammatory, diabetic, blood pressure medicines, the statins. After getting the first dose of the Pfizer BioNTech COVID-19 vaccine, caller had adverse events that made her become hospitalized. She said she had developed dizziness, light headedness, headache, something in her throat, lost of voice, rash nausea, and vomiting. She was in the hospital for 5.5 hours. She originally has the appointment for the second dose of the vaccine on 25Mar2021 but it got cancelled. Caller got the vaccine on 04Mar2021, and the guy gave her the shot, and then said the would check on her in 10 minutes, because of the caller's history of allergies to various medications and foods. Caller reports that she started having a taste in her mouth, and then she got lightheaded, she was dizzy, she got a headache, she felt sick to her stomach and that progressively got worse to where she ended up throwing up twice at the hospital. Caller was given a Bendaryl, and some anti-nausea pills under her tongue, but she did not know she was rashy, until she got home, there was a rash on her chest, arms, back, and legs that was all bumpy and red. Caller started to feel a tickle in her throat, and she kept trying to clear her throat, and then her voice was gone. An ambulance was called, but her husband took her to the hospital because it was right across the street, because her doctor had advised her to get the shot at a site near the hospital because of her history of allergies. Caller reports that she was in the ER for like five and a half hours, and when she started to feel better, she said she wanted to go home and lay in her own bed if she is just going to be puking her guts out. Caller states that she went home and crashed and burned for a few days, with no voice, and she was still coughing to try and clear her throat, it felt like her throat was closing up. Caller confirms she was not admitted to the hospital for this reaction. All events started 04Mar2021. Treatment was given for all events. The outcome of the events was unknown. Caller had no other vaccines on the same day.
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| 67 | 2021-03-29 | rash |
Hand swelling; Rash on face; lip swelling; received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ...
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Hand swelling; Rash on face; lip swelling; received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left leg; This is a spontaneous report from a contactable healthcare professional (patient herself). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left leg on 20Feb2021 12:45 as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation, chronic urticaria, and known allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC). The patient was not pregnant and did not receive any other vaccine in four weeks. She was not diagnosed with COVID prior to vaccination. On 20Feb2021 01.15 PM, the patient experienced hand swelling, rash on face, and lip swelling. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Hospitalization was also reported. Treatment included diphenhydramine (BENADRYL). Outcome of the events was recovering. Patient had not been COVID tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 67 | 2021-03-30 | injection site pain |
Injection site pain; Joint pain in both hands "mild" continuing; This is a spontaneous report from a...
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Injection site pain; Joint pain in both hands "mild" continuing; This is a spontaneous report from a contactable nurse (Patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL3249), via an unspecified route of administration, administered in Arm Left on 28Jan2021 14:00 as single dose for covid-19 immunisation. Medical history included hypertension and breast cancer from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole, losartan potassium (LOSARTIN), hydrochlorothiazide. On 29Jan2021, the patient experienced injection site pain and joint pain in both hands "mild" continuing. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered.
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| 67 | 2021-03-30 | skin discolouration, vaccination site pain |
passing out; she was 155 lbs before when she was in the hospital - and now 160 lbs; States that she ...
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passing out; she was 155 lbs before when she was in the hospital - and now 160 lbs; States that she was dehydrated in hospital and did not eat a thing; stayed dizzy; confused; She had felt disoriented; foggy; it was like the flu shot; sleeping a lot; her vision would get very narrow; thumb pink; erratic body temperature; horrible headache; bodyaches; dry heaves; slight fever/ body temperature 104.4; injection site sore; lymph nodes swollen; This is a spontaneous report from a contactable consumer (patient). The 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 04Feb2021 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer - stage 2 from Jan2008; 29Jan2008 surgery, breast cancer. First surgery for breast cancer removal and lymph node removal, then the cancer went around the first and second lymph nodes so they had to go back in because they had to take out a bunch more and she had to give them permission to take out more lymph nodes. Concomitant medication(s) included ongoing simvastatin for High cholesterol; ongoing bifidobacterium bifidum, bifidobacterium longum, lactobacillus gasseri (PHILLIPS COLON HEALTH) she has high pain tolerance, had stomach cramp did not know what it was and one a day vitamin. The patient previously took bnt162b2 (BNT162B2), dose 1 intramuscular administered in Arm Right on 14Jan2021 (Batch/Lot Number: EL8982) as SINGLE DOSE for covid-19 immunization and experienced Injection site sore. The patient experienced passing out on 28Feb2021, injection site sore, lymph nodes swollen on 04Feb2021, thumb pink on 26Feb2021, erratic body temperature, horrible headache, bodyaches, dry heaves on 05Feb2021, she was 155 lbs before when she was in the hospital - and now 160 lbs on an unspecified date. The patient was hospitalized for passing out from 01Mar2021 to 02Mar2021. The event passing out leaf to emergency room visit. The patient lab tests and procedures which included cat scan/ cat scan groin area with contrast: normal; EKG: normal; blood workup: normal; Blood culture:normal, all on 01Mar2021; cat scan head and neck with contrast: normal and cat scan head and neck without contrast:normal on 02Mar2021. The outcome of the event thumb pink was recovering, erratic body temperature was not recovered, horrible headache, bodyaches, dry heaves recovered on 26Feb2021, and was unknown for the rest events. Reported as: Caller states that on 04Feb2021 she received her 2nd vaccine at around 3:30 pm, and then around 10 pm she had injection site soreness. The morning after the second injection around 4 am, she had site on her arm soreness, erratic body temperature with slight fever, horrible headache, bodyaches, and dry heaves. Her lymph nodes also swelled up again. Caller clarifies that this also happened after her first injection of the Pfizer Covid19 vaccine and on a similar timeline. Caller clarifies that 2 weeks later on 26Feb2021 she had ended up with horrible headache, dry heaves, headache, body temperature 104.4. She states that this lasted Friday night and Saturday night and Sunday she was feeling better. Clarifies that was the week of 26Feb2021. Caller states that her events were on a similar timeline and that her first vaccine was 14Jan2021 at 3:30 pm on Thursday. States that by 10 o'clock that night, injection site was sore. At 4 am, injection site was very sore. A couple of days later, her lymph nodes were swollen in her left leg, groin area, right arm under armpit. Adds that area under armpit was the size of her thumb. Also, on the left underneath her chest wall. She states that she has had breast cancer in that left breast. She states that the swelling went away completely, but that the groin area swelling took 2 weeks to go away. Unable to verbalize exact dates. Confirms that this was after the first vaccine and also occurred after the second vaccine. Caller then adds that she was feeling better Sunday, 28Feb2021 but that her husband then found her on the floor Sunday night at 8:45 pm. She states that she passed out. Monday she passed out again and was taken to the hospital where she stayed until 02MAR2021. Healthcare Provider also provides information that her son ran her to emergency room, and she is not familiar with the doctors there. Also, a doctor that she does not remember the third physician but it was a neurologist. Caller states that she was 155 lbs before when she was in the hospital - and now 160 lbs. States that she was dehydrated in hospital and did not eat a thing. Normally she runs around 160 lbs. States she had breast cancer so left arm cannot be used, so they used her right arm for both vaccines. caller adds that she had a cruise she was going to go on but refused to go on in 2020. States that she heard you will need to have a vaccination passport to travel in the future so she wanted to get vaccine. States she did not want to get covid. States that so many people have died. Caller clarifies that she was admitted to (Hospital Name) on 01Mar2021. Caller adds that she went to the hospital 2 weeks after the second dose. She states that is what makes them wonder if it is from the Covid vaccine. Adds that she is not saying that is what caused all of this, but that it is just a coincidence that it was exactly 2 weeks after the vaccine, exactly 2 weeks out when this happened. She states that she has been thinking if she should be wasting Pfizers time reporting this but it could be a coincidence or maybe a reaction. Caller adds maybe it is because she had 34 radiations, 8 chemo treatments, 1 year of Herceptine, and breast cancer. States that maybe she can save somebody else, or if a possibility, people can be prepared two weeks early. She adds that she is lucky she did not break an arm, leg. or bone. States that she doesn't know if maybe she can save some other person by sharing this information. Injection site sore: States that this was after both first and second vaccine. It stayed sore for about a week, and was just tender after that. If she touched it, she noticed, but it didn't hurt her from doing anything. With the first vaccine, injection site soreness started 14Jan2021 around 10 pm and completely resolved after about a week. She adds that with the second vaccine she also noticed injection site soreness that same day on 04Feb2021 around 10 pm also. She adds that it lasted about six days or seven days or so. It was the same way, tender the first day and then at 4 am was when it got really bad. That Friday 05Feb2021 was when it hurt worse. Adds that she went into hospital on 01Mar2021 on Monday. States she was feeling okay, stayed dizzy and confused and thought she was getting Alzheimer's or dementia but it cleared. At 11 pm on Sunday felt completely different, like the old her. States she was fine yesterday 15Mar2021. She had felt disoriented but is now feeling better and back to normal. Eratic Body Temperature: States that she started watching and recording her body temperature on 09Mar2021. She states that it was 104.5 on Friday, and Saturday and Sunday night she used a wet washcloth to her forehead. States that her body temperature initially was variable starting on 26Feb2021. She adds that it continued until Sunday 28Feb2021. On 26Feb2021, her body temperature was 104.5. She states that it was then low on Sunday 28Feb2021 and was 98 or 99. Adds that it had been erratic but that once the fever broke it has been between her normal which is 98.6 to 98.7. Adds that her and her husband know for sure that when she passed out the three times, her temperature was 94.4. States that her husband gave her aspirin for the temperature. Adds that her temperature has been between 97.9 to 94.9 and dropped to its lowest on Saturday 13Mar2021 at 10:35 am. She states that it is still doing this erratic behavior and that this morning it was 96 at 1 am and then 96.8 at 8 am. While on phone today, it is 97.1. Lymph nodes swollen: States noticed swelling at 4 AM 16Jan2021. States this occurred 4 am after both first and second injection. Occurred to groin area, right arm, and left arm. It was there for a couple of days and then it would just remind her it was there. The arm lymph node swelling went away after a few days, maybe before a week or so. The one in the groin was there for about two weeks. On a scale of 1 to 10, it was a 1.5 and was not something that people need to take an Advil or something for. Clarifies it was in the armpit except in the left side because they took those lymph nodes out during surgery in 2008. Also, she noticed lymph node swelling in the chest area. Lymph Nodes at second vaccine she also noticed them starting at about 4 am after the vaccine and it started hurting again. Caller reiterates both shots were given at 3:30 pm and then at 10 pm injection site gets sore.Then 4 am injection site gets more sore. She's been telling everybody to get the vaccine in the morning. Her symptoms lasted two weeks and then she was fine. Caller adds that her husband never felt a thing from receiving the vaccine. She states that the injection site was tender on her husband but gone the next day. Investigations: stated they looked at her in the hospital and said she was fine. The girl came back up and did more cultures and nothing grew. They were confused and so was she and she has been debating whether to call and waste time reporting but thinks that Pfizer needs to know what happened to her. Simvastatin: Adds that asked doctor if this caused her symptoms and he said no. Phillips colon: doctor 6 to 9 months later did scan, the next day was in emergency surgery and it was her appendix. It enlarged and had grown into the other organs. Doctor said it was a mess and it was ready to rupture as a precaution they wanted to remove it. Bayer product Code above expiration date states 0C09C and expiration is Mar2023. Thumb pink: thumb nail to finger print past where you bend it was where she noticed it was pink. States it is now 98% better. Friday 26Feb2021 afternoon at 1 pm, right thumb turned pink. She took a pen and marked where it was vertical and horizontally pink to scarlet in color. She put herself on antibiotics. She was not sure if maybe she cutting chicken and cut it, or closed finger in drawer. It swelled up twice the size, turned purple. Went all around the finger and it was hot. She thought it was going to pop off. She kept wondering what she was going to do to her thumb. She did jam it and cut herself 2 months ago. Clarifies it was right hand thumb. Treatment: took antibiotics, which she states they kept her on in the hospital in IV form. She started the antibiotics on Friday 26Feb2021. Took it Friday afternoon, Friday night, and Saturday and Sunday. She thought it was doing better Sunday night before she passed out. Clarifies Cephalexin, 500 mg daily (Keppra) three times a day and by mouth. Adds that she keeps this medication on her because she travels the world and it is good to have on hand since it is broad-spectrum. Passing out: 28Feb2021 Sunday night noticed the volume on television was driving her crazy and it was irritating. Around a quarter to 9 she got up to brush her teeth and go to the bathroom. She went pee and then fell off toilet. She got really really dizzy, and her husband was standing over her yelling asking what happened. She saw the wall and she did not know what happened. States she was out cold and he was calling her name but she did not hear him. She heard him asking what happened but it was in the distance. He got her to bed and about 20 minutes later (husband reports 30 minutes later) she was so dizzy and passed out again. She adds that this may have happened Saturday also because she was sleeping a lot and it was like she was seeing words repeat themselves over and over again and her vision would get very narrow. Her husband was note sure if she passed out on Saturday also, but said both times Sunday she was out cold. Monday 01Mar2021 she called her husband's office and woke up to the nurse on the other line screaming. She dropped the phone and heard her name being screamed over and over on the phone and when she picked it up the nurse said that she must have passed out even though she thought she was sleeping. The nurse got ahold of her husband in his office. She believes she passed out again Monday morning and was then in the hospital Monday and Tuesday. Hospitalization: On 01Mar2021, her husband is a physician and suggested she go to the hospital. She was trying to get ahold of her son and daughter in law. She sent them a text and called and they did not answer. Her sons phone was charging and when he looked at it he was on his way to her. She states that when she came to all three times, she was extremely dizzy foggy and confused. Adds that the nurse at her husband's office alerted her husband and he told her to stay in bed and her son came to help her and then drove her to ER. States she was there Monday 01Mar2021, and discharged Tuesday night 02Mar2021 about 4:30 to 6 pm. Caller does not want to file a report for her husband regarding the injection site soreness. She states it was like the flu shot. She clarifies that it was not his arm, it was the injection side. She states that these people who are going on and on about their arm hurting, it is the injection site. She states it is the injection site and will not be the arm. States that it is like the flu shot. States she does not want to file a report regarding her husband because it was injection site soreness and went away. Provides no additional information. Adds that this is a new drug and new disease and we do not know what the future holds Caller adds that she keeps a diary and started a diary so that she has everything recorded in terms of medical history. States that it is important that everybody do so. Family Medical History Relevant to AE(s): callers dad passed out at age 85. He found out he was diabetic and had heart issues. Also had a stroke at age 87 and passed away. Adds that between ages 85 and 87 he passed out every few months, he would do one of his passing out things. Caller also had a brother who passed out sitting at table and went forward into table. She states at that time her brother didn't realize he had stage 4 lung cancer, and her brother passed away 1 and a half years later. Caller adds that he smoked from ages 15 to 64, and quit at age 63 because the doctor told him to. No follow-up attempts possible. No further information expected.
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| 67 | 2021-03-30 | hair loss |
pt states she started feeling very bad and everything hurt the day after getting the vax. She has a...
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pt states she started feeling very bad and everything hurt the day after getting the vax. She has a lot of hair loss. She had to stay in the bed for the next couple of days because she had fatigue and body aches. 5 weeks after taking the vax she has swollen lymph nodes in both arm pits and he developed sore knots under the skin on the outside of her thighs. Her BP has become uncontrollable. She was on 10mg of bp medicine and then it was upped to 20 mg. About 7 days ago a diuretic and her BP is still very high. on 3/20/2021 it was 180/89. she checked it again a couple of hours later and it was 165/92. She has had symptoms of GERD since 3/22/2021. Blood work she had on 3/18/21 shows way too much carbon monoxide in her CO2. Her anxiety has increased since she was vaccinated. She has an appt w/ her PCP on 4/9/21. She is very concerned that she is going to die from taking this vax.
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| 67 | 2021-03-31 | rash with redness, rash, skin irritation, dry skin |
inflammation; sometimes I get a reaction in my ears if it flares up and gets hot/first shot it was r...
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inflammation; sometimes I get a reaction in my ears if it flares up and gets hot/first shot it was really hot like a boil; sometimes I get a reaction in my ears if it flares up and gets hot/first shot it was really hot like a boil; skin is dry from being inflamed; skin is dry from being inflamed; skin reaction red rash under both armpits; skin reaction red rash under both armpits; swelling in arm; soreness in arm; This is a spontaneous report received from a contactable nurse (patient). A 67-year-old female nurse reported for herself that she had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EM9809), via an unspecified route of administration in left arm on 09feb2021 14:00 at single dose for prevent the covid virus. Medical history included female surgery. Concomitant medication included colecalciferol (D3) at 3000 iU, daily, macrogol 3350 (MIRALAX) at alternate day for female surgery. The patient's had a past drug included included Zyrtec for seasonal allergies like dust and stated that she took no Zyrtec at all for either shots. The patient stated that she takes macrogol regularly every other day for the last 5 years for a female surgery and her female surgeon says she needs it to stay out, but the ingredient is also in macrogol. The patient reported that she had both vaccinations and had the rosy arm pits red rash and sometimes she get a reaction in my ears if it flares up and gets hot. For 5 weeks she was taking children's Benadryl. The patient had a quicker reaction with the second dose and still had some lingering effects from the first dose when I got the second. On 09Feb2021 she had swelling in arm after shot and has been using a cool cloth on it and was better by the next day. The patient reported she still feels it though and it has been five weeks and she tries to turn arm and can still feel it but it is not bad. The patient stated a day later she had her first skin reaction which was a red rash under both armpits. The patient stated she waited because she wanted to see what reactions she would have with second dose. The reaction from first dose happened for three weeks. It was reported that she had been taking liquid Benadryl everyday sometimes during night and also cold wet compresses in armpits has helped with inflammation. The patient stated she called primary care doctor and talked to nurse to see if she should try some other medication before second shot and the nurse recommended, she should not get second shot that she should see an allergist. The patient stated she asked the nurse about the quality of first and second shot working together if she had waited and not got second shot and the nurse told her she would have to come back at least four days after the second shot was due or it would not work together. The patient stated she went ahead and got the vaccine and it has not been life threatening as of now. The patient stated she saw an allergist three days after second shot. The patient had rosy red inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly bilateral armpit and then sometimes ears would get hot. The patient then stated she would take Benadryl. The patient stated her primary care physician told her to try to take Allegra 24 hours but caller stated it did not work that it only worked for 12 hours and not the full 24 hours. The patient took the Allegra medication on Sunday morning and that it worked for her for about 12 hours and she knew she could not take any more Allegra but the Benadryl seemed to help. The patient reported her Allergist felt she made the right decision since her events are not life-threatening since it is not respiratory. It was reported that the Allergist saw her armpits agreed the children Benadryl was working and that she should stick with that. The patient then stated but it is not going away been like this the whole time since 02Mar2021 and still having a reaction in her armpits. The patient stated after the second shot the flare up was quicker because first shot was already in system still. The patient stated it is not a flare up like when someone cannot eat seafood and stuff like that. The patient stated she wanted to wait for second dose before contacting Pfizer to see what would happen. The patient stated she is really blossoming under the armpits and they are rosy, red but no blisters and her skin is dry from being inflamed all this time. The patient squeezes a rag under her armpits and that it is better during the day than at night, it is worse at night. The patient was only taking 20 mL of Benadryl in the morning and then evening before bed. It was reported that with the first shot right at the beginning she had to take Benadryl in the middle of the night as well but got to where she was taking it 12 hours apart before second dose. It was reported that she hopes she is not having to walk around with compresses in the summer as it is easier when it is cold and that she hopes this fazes. It was reported that she was noticing since she had not taken a shower or hot bath this morning that she had rosy red cheeks like a rosy red U on her face. The patient did not experience any swelling or soreness with second shot. The patient stated she experienced ears would get warm feeling very hot only six times and it was usually at night or in the morning from the second shot. The patient stated every once in a it while flare up from the first. The patient stated the hurt was always in the center of armpit not in the armpit. Caller stated thank goodness she can still shave. The patient stated past couple of days her skin has been dry. The patient stated she has used hand cream but is afraid to put anything else on it because of reaction. and she will probably put cream on it so it does not crack, it is very dry and it has not been dry like this. The patient stated she has been putting water on at night which could have dried it out. The patient stated soreness in arm happened right after first shot. The patient stated she did not want to double up on Allegra as she was not sure what the reaction would be. The patient stated the medical ingredient was Fexofenadine HCL 180 mg antihistamine and stated she only took one pill as it did not work. The patient was taking Children Benadryl 20mL and would take at least every 6 six hours and was trying to hold off to now taking it 12 hours and will use cold compress if she has to. The patient stated she had the Pneumonia shot and never had swelling. The patient was not recovered from soreness in arm, skin reaction red rash under both armpits, skin is dry from being inflamed and recovering from inflammation, outcome was unknown for sometimes I get a reaction in my ears if it flares up and gets hot/first shot it was really hot like a boil and swelling in arm. The reporter assessed events are related to drug. The outcome of the event inflammation was recovering, ear discomfort, Feeling hot, swelling in arm was unknown and rest of the events was not recovered.
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| 67 | 2021-04-01 | redness |
microemboli.; some splinter hemorrhages; erythema and tenderness progressively over weeks of all her...
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microemboli.; some splinter hemorrhages; erythema and tenderness progressively over weeks of all her finger pads; erythema and tenderness progressively over weeks of all her finger pads; crop is elevated; This is a spontaneous report from a contactable physician. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in left arm on 25Feb2021 12:00 (Lot number was not reported) as single dose for covid-19 immunization at age 67 years old. The vaccine was given in a Pharmacy or Drug Store. Medical history included APLA, hypothyroid, obesity, and allergies. The patient was not pregnant. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included warfarin sodium (COUMADIN); levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC); all taken for unspecified indications, start and stop date were not reported. No other vaccines administered in four weeks. The patient previously took erythromycin and PCP and experienced allergies to both. The patient previously received the first dose of bnt162b2 intramuscular in left arm on 04Feb2021 12:00 PM (at age 67 years old) for covid-19 immunisation. The patient with APLA on coumadin 1-2 days after receiving the vaccine developed erythema and tenderness progressively over weeks of all her finger pads, crop is elevated (as reported) and some splinter hemorrhages suspect microemboli. Just to left hand, systemically well. The adverse evemts occurred on 26Feb2021 12:00 PM. The AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment was given to patient for the events. The patient had not recovered from the events. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-04-03 | redness, skin irritation, rash, rash with redness, dry skin |
Skin reaction red rash under both armpits: Caller stated the event started the first day after the f...
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Skin reaction red rash under both armpits: Caller stated the event started the first day after the first shot then still having reaction from the second shot; Skin reaction red rash under both armpits; Ears would get warm feeling very hot; after the second shot the flare up was quicker; skin is dry from being inflamed; skin is dry from being inflamed; blossoming under the armpits and they are rosy red but no blisters; hurt was always in the center of armpit not in the armpit; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 02Mar2021 14:00 (Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 (lot number: EM9809) on 09Feb2021 in the bicep left arm upper muscle for COVID-19 immunization. Medical history included surgery from an unknown date and unknown if ongoing. Concomitant medication included vitamin D3 taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took Miralax. The patient previously had first dose of BNT162B2 (lot number: EM9809) on 09Feb2021 in the bicep left arm upper muscle for COVID-19 immunization and Pneumonia shot and never had swelling. The patient had rosy arm pits red rash and sometimes get a reaction in ears, if it flares up and gets hot. The patient stated, "For 5 weeks I've been taking children's Benadryl. I had a quicker reaction with the second dose than I did the first one but I still had some lingering effects from the first dose when I got the second. How long do these side effects usually last?" The patient had second COVID 19 vaccine and also had first one. The first dose was on 09Feb21 and she had swelling in arm after shot and has been using a cool cloth on it and was better by the next day. The patient still feels it though and it has been five weeks. The patient tries to turn arm and can still feel it but it was not bad. A day later she had her first skin reaction which was a red rash under both armpits. The patient waited because she wanted to see what reactions she would have with second dose. The reaction from first dose happened for three weeks. The patient has been taking liquid Benadryl everyday sometimes during night and also cold wet compresses in armpits has helped with inflammation. The primary care doctor and talked to the patient to see if she should try some other medication before second shot and the nurse recommended she should not get second shot that she should see an allergist. The patient got second shot and talked to nurse there. The nurse told the patient she would have to come back at least four days after the second shot was due or it would not work together. The patient went ahead and got the vaccine and it has not been life threatening as of now. The patient saw an allergist three days after second shot. The patient had rosy red inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly bilateral armpit and then sometimes ears would get hot. The patient would take Benadryl. The physician told the patient to try to take Allegra 24 hours but the patient stated it did not work that it only worked for 12 hours and not the full 24 hours. The patient took the Allegra medication on Sunday morning and that it worked for her for about 12 hours and she knew she could not take any more Allegra but the Benadryl seemed to help. The allergist felt she made the right decision since her events are not life-threatening since it is not respiratory. The allergist saw her armpits agreed the children Benadryl was working and that she should stick with that. The patient stated, it is not going away been like this the whole time since 02Mar2021 and still having a reaction in her armpits. The patient stated after the second shot the flare up was quicker because first shot was already in system still. It was not a flare up like when someone can not eat seafood and stuff like that. The patient still has a rosy armpit. The patient has not seen her doctor since last year when she had a physical. The patient would inform her doctor about these events. The patient stated she is really blossoming under the armpits and they are rosy red but no blisters and her skin is dry from being inflamed all this time. She squeezes a rag under her armpits and that it is better during the day than at night, it is worse at night. The patient was only taking 20 mL of Benadryl in the morning and then evening before bed. The patient stated, "the first shot right at the beginning she had to take Benadryl in the middle of the night as well but got to where she was taking it 12 hours apart before second dose." The patient hopes she is not having to walk around with compresses in the summer as it is easier when it is cold and that she hopes this fazes. The patient was noticing since she had not taken a shower or hot bath this morning that she had rosy red cheeks like a rosy red U on her face. The second shot she asked the nurse to give in her back upper part of bicep in arm muscle since it was a better location and it did not swell up and it did not hurt. Caller stated the nurse the first time gave the shot like when you see people getting shots on tv they put it really high up in muscle. The patient considered the event as medically significant and that it is ongoing and has worsened. The hurt was always in the center of armpit not in the armpit. The past couple of days her skin has been dry. She has used hand cream but is afraid to put anything else on it because of reaction. Just annoying. The patient will probably put cream on it so it does not crack, it is very dry and it has not been dry like this. The patient has been putting water on at night which could have dried it out. Some days is worse than others more red. This is persisting. Soreness in arm happened right after first shot. The shot was given in the proper way but seemed like more of a reaction. The second shot is much better and that she does not feel it at all. The patient can still feel where the vaccine went in left arm. It was annoying but it does not keep her from moving her arm and it has been five weeks. Since it is not going away it is serious. The patient was not taking Benadryl in middle of day like before but it is itchy so she is going to go out in the cold and work in yard. Before first week or two she would use cool compresses all day and take Benadryl during day and then at night it petered out. The patient was hoping it will fade out eventually. The patient did not want to double up on Allegra as she is not sure what the reaction would be. The medical ingredient was Fexofenadine HCL 180mg antihistamine. The patient only took one pill as it did not work. 24 hour Allegra, 180mg antihistamine 15 tablets per box. The patient was taking Children Benadryl 20mL and would take at least every 6 six hours and was trying to hold off to now taking it 12 hours and will use cold compress if she has to. The patient usually takes Zyrtec for seasonal allergies like dust. She took no Zyrtec at all for either shots. She felt the Benadryl worked better and quicker. The patient was at the Allergist she asked what is in this vaccine like what chemical. She looked up the ingredients but did not understand. Her friend told her Polyethylene glycol was in both the Pfizer and Moderna vaccine. The patient had rosy red, inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly her bilateral armpits and then sometimes ears would get hot. The patient stated her primary care physician told her to try to take Allegra 24 hours but caller stated it did not work that it only worked for 12 hours and not the full 24 hours. The patient stated she took the Allegra medication on Sunday morning and that it worked for about 12 hours and she knew she could not take any more Allegra. The patient stated the medical ingredient was Fexofenadine HCL 180mg antihistamine. The patient stated she only took one pill as it did not work. Sample of the product was available to be returned. The packaging was sealed and intact. The outcome of the event "Ears would get warm feeling very hot" and "after the second shot the flare up was quicker" was unknown. The outcome of the rest of the events was not recovered.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of events rash and erythematous rash (allergy context) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-04-06 | redness, itchy skin, rash, shingles, blister |
Rash in her mouth/break out on her lips and her ear; Rash in her mouth/break out on her lips and her...
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Rash in her mouth/break out on her lips and her ear; Rash in her mouth/break out on her lips and her ear; Shingles; Pain; Ramsay-Hunt syndrome; Loss of hearing; Itchy on the left side of the face; Blisters on face, temple, ear; Left side of her face is scorched bright red and painful; Left side of her face is scorched bright red and painful; Numbness; no feeling in her mouth on the left, cheek, temple; Numbness; no feeling in her mouth on the left, cheek, temple; Blisters in her mouth; Pain, teeth started hurting went to her temple; Pain, teeth started hurting went to her temple; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 20Feb2021 (09:30) as a single dose, with route of administration unspecified, for COVID -19 immunization at the pharmacy/drug store (not a military facility). Medical history included shoulder surgery in Aug2020; ongoing abnormal blood pressure; ongoing heart disorder; and was in a pacemaker and defibrillator. Concomitant medications included carvedilol for abnormal blood pressure from 2012 and ongoing; losartan for heart disorder from 2012 and ongoing; and furosemide from 2017 and ongoing. On 05Mar2021, the patient had Ramsay-Hunt syndrome and loss of hearing. On 21Feb2021, the patient had pain/teeth started hurting and went to her temple. On 22Feb2021, the patient had blisters in the mouth; left side of the face was scorched bright red and painful; and numbness/no feeling in the mouth on the left, cheek and temple. On 23Feb2021, the patient had blisters on face, temple and ear. On 25Feb2021, the patient was itchy on the left side of the face. On an unspecified date, the patient had rash in her mouth/broke out on her lips and ear; shingles; and pain. The events, 'pain/teeth started hurting and went to her temple', 'blisters in the mouth', 'blisters on face, temple and ear' and 'pain', had resulted into physician's office visit. The patient's ENT had the patient put on treatment with valaciclovir (VALTREX) and prednisolone for the 'blisters in the mouth', 'blisters on face, temple and ear'; treatment for 'pain/teeth started hurting and went to her temple', 'left side of the face was scorched bright red and painful', 'itchy on the left side of the face', 'rash in her mouth/broke out on her lips and ear', 'shingles' and 'pain'; and unspecified ear drops for 'loss of hearing'. The outcome of the events was not recovered for 'Ramsay-Hunt syndrome', 'loss of hearing', 'pain/teeth started hurting and went to her temple', 'left side of the face was scorched bright red and painful', 'numbness/no feeling in the mouth on the left, cheek and temple' and 'itchy on the left side of the face'; was recovered on 04Mar2021 for 'blisters in the mouth' and 'blisters on face, temple and ear'; and was unknown for 'rash in her mouth/broke out on her lips and ear' and 'pain'. The patient had received the second dose of vaccination on 20Mar2021. Information about batch/lot number has been requested.
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| 67 | 2021-04-06 | rash macular |
Red blotches/The blotches are golf ball sized. The blotches came and then went away and then came ba...
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Red blotches/The blotches are golf ball sized. The blotches came and then went away and then came back; This is a spontaneous report from a contactable consumer (patient's husband). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 24Feb2021 to 24Feb2021 (Lot Number: EN6198; Expiration Date: 30Jun2021, at the age of 67-years-old) as single dose and dose 2 via an unspecified route of administration on 16Mar2021 to 16Mar2021 (Lot Number: EN6204; Expiration Date: 30Jun2021) as single dose for preventative measure (COVID-19 immunisation). Medical history included ongoing blood pressure. Concomitant medications included losartan potassium at 25 mg twice a day (low dose) for blood pressure, centrum, Vitamin D and fish oil. The caller was calling about the covid vaccine. The caller was calling for his wife. The caller and his wife both had 2 shots. He states that she received her first dose of the Pfizer BioNTech COVID-19 vaccine on 24Feb2021 and afterwards reports finding two red large blotches the size of a golf ball, one on her throat and one on her forehead. The blotches went away and then came back before the patient received her second dose. Then after the patient had the second dose on 16Mar2021 and got a third red blotch the size of a golf ball under her ear. The blotches are golf ball sized. The blotches came and then went away and then came back. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained
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| 67 | 2021-04-17 | itchy rash |
Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell...
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Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; busted her lip and it was bleeding real bad; Weakness/ feeling weak; Feel weak in her arms and legs; Sweating profusely; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Foggy Brain; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) intramuscularly, administered in the left arm on 11Mar2021 (batch/lot number: EN6205) at 67 years old as a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Pharmacy/ drugstore. The patient's medical history included compromised immune status; respiratory illness, genetic /chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; asthma diagnosed since childhood; diagnosed allergies, allergies (seasonal and food); food allergies included gluten, dairy, artificial sweeteners including Sorbitol and Xylitol, broccoli, cauliflower, cabbage, brussel sprouts, asparagus, all "percifirous"/ cruciferous vegetables; she also has allergies to cats, pollen, trees, grass, ragweed, mold, mildew, and dust; and allergies to Codeine, Penicillin, Sulfa, Iodine, Epinephrine, Morphine, and Clindamycin (patient does not have a manufacturer, lot or expiration to any of these medications). The patient had no family medical history. Concomitant medications included unspecified prescription medications for years which she did not feel they were relevant. On 11Mar2021, the patient experienced "weakness/ feeling weak" (weakness), "feel weak in her arms and legs" (weakness of limbs), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (faint), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (fall), "busted her lip and it was bleeding real bad" (bleeding lips), sweating profusely (excess sweating), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Flu-like symptoms), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Joint pain), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (muscle pain), and foggy brain (foggy feeling in head). On 12Mar2021, the patient experienced headaches, chills, itching rash on arms, back, neck and chest (itchy rash). On13Mar2021, the patient experienced blurred vision. It was reported that after the first shot, on 11Mar2021, patient experienced weakness, then she got home and she fainted, fell, and busted her lip and it was bleeding real bad. Then she began sweating profusely. She started feeling weak 30 minutes after getting the shot. Someone took her there because she would not have been able to drive. They brought her home and she was in the kitchen. While over the sink, she started to feel weak in her arms and legs. Before she could tell her husband that she was feeling weak, she dropped to the floor and everything was turning black. She fell face first and busted her lip and it was bleeding real bad. The weakness gradually started getting a little better on 30Mar2021. She is having to walk with a cane now because of the weakness. She was not using a cane before. Two days later on 13Mar2021, she was in the kitchen again and she felt that feeling coming and her husband was able to grab her and sit her down and she did not faint but she could tell it was coming. Patient also reported that from 12Mar2021, she is getting headaches every day off and on and in different spots of the head. Sometimes it is in the forehead, top, side and back. For about a good week, she had chills and it tapered off after the first dose. Also, on 12Mar2021, she experienced itching rash on arms, back, neck and chest. They were fine bumps and they just itch. The patient was recovering from the events faint, fall, bleeding lips, excess sweating, and itchy rash; and has not recovered from the events weakness, weakness of limbs, flu-like symptoms, joint pain, muscle pain, foggy feeling in head, headache, chills, and blurred vision. Follow-up attempts are completed. No further information is expected.
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| 67 | 2021-04-17 | skin discolouration |
Bottom of heel hurt/she is not experiencing any arm pain. It is in her ankle and feet; discoloration...
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Bottom of heel hurt/she is not experiencing any arm pain. It is in her ankle and feet; discoloration inside of the left ankle and bottom of heel; she is not experiencing any arm pain. It is in her ankle and feet; Hallucinations; ankle swollen; This is a spontaneous report received from a contactable consumer (patient). This 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 25Mar2021 10:00 (Batch/Lot Number: EN6208; Expiration Date: Jun2021) as a single dose for COVID-19 immunization. Patient received the first dose on 04Mar2021 10:00 in the left arm (Batch/lot number: EN6200, Expiration Date: Jun2021) and she had headaches, arm ache, and hallucinations which would go and come. When she would try to sleep, the hallucinations would go and come but then the hallucinations stopped prior to getting the second dose. Headaches started a couple of days after the first dose probably started the next day and started coming and going. This stopped prior to the second dose probably a week or week in a half maybe two weeks before getting second dose. The headache only lasted about half a day, it wasn't that bad. She recovered completely. Arm sore, red only happened with the first dose as her arm did not hurt at all after the second. This started the next day or even the same day but she kept it comfortable and probably stopped within the first week and it did not come back either. She has recovered completely. Sharp pain through arm go and come. This started after the first dose so in that week or week in a half area and it stopped about at least a week before the second dose somewhere in that period of time. She has recovered completely. Hallucination: she was laying down at night and something would come across her head that she was not thinking. It started right after the first dose probably first, second, or third night but it stopped like all the rest of it in same period of time. She had recovered completely prior to getting the second dose. Medical history included arthritis and diabetic. The patient's concomitant medications were not reported. Patient had the flu vaccination for the first time in Oct2020 or Nov2020 and did have a headache and she has never taken the flu vaccine before. The patient had side effects from the vaccine she received on 25Mar2021. Her ankle was swollen on 28Mar2021 but that went down on 30Mar2021. This has left discoloration inside of her left ankle and bottom of her heel and it was sore from 30Mar2021 and ongoing. It was not red, tender, or bruised. The bottom of her heel hurt when she put pressure on it and walked on 31Mar2021. It was ongoing but was off and on and it has worsened. She had her feet up on the bed. As treatment, patient used heat, ice, and has been elevating her feet. She called her doctor and doctor told her to keep doing it since she has been doing it since Monday. With the second shot, she is not experiencing any arm pain. It is in her ankle and feet and then the hallucinations still go and come and she sees images that come still but do not stay they just go and come. After the second dose, she had this last night and the night before last, she would not be thinking it but it would appear in her mind and she was wondering why it was doing that but she thought maybe a week or two it will stop and come down. This started on 28Mar2021, Sunday after the second dose and is still going on. Outcome of the event ankle swollen was recovered on 30Mar2021, of the event arthralgia was unknown, and of the other events was not recovered.
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| 67 | 2021-04-18 | cellulitis, redness |
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to dialysis session two days after vaccinatio...
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Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to dialysis session two days after vaccination reporting right lower extremity pain and redness for one week. Admitted for management of cellulitis, received antimicrobials, and discharged to home improved and medically stable.
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| 67 | 2021-04-22 | injection site numbness | Numbness to right deltoid. B/P 126/72, HR 76, O2Sat 97%, BS 86. |
| 67 | 2021-04-24 | rash macular |
Losing voice, like Laryngitis; Chest was heavy; Red spots on arm; Losing voice, like Laryngitis; Har...
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Losing voice, like Laryngitis; Chest was heavy; Red spots on arm; Losing voice, like Laryngitis; Hard to swallow; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left, 2 inches below shoulder on 31Mar2021 14:45 at the age of 67-years-old (Lot Number: EP7533) as single dose for covid-19 immunisation. The patient medical history included Covid in January in an unspecified year and underlying health issues. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient had adverse reactions to some medications, she did not know the names of the medications. On 31Mar2021, the patient experienced hard to swallow after she had the shot about 15 minutes at 3 p.m.; losing voice 20 minutes after the shot, chest was heavy and red spots on arm about 20 minutes after the shot. The patient stated she went to the emergency room where the doctor gave her 50mg of diphenhydramine hydrochloride and she tought some type of stomach pill. The patient stated she fell asleep for an hour and when she woke up, her chest was not heavy and she could swallow better, reclarifies that, her voice, felt like she had some laryngitis. The patient stated she had an appointment on 28Apr2021. The patient stated that she talked to the provider about taking the second vaccine, and her doctor told her to take the diphenhydramine hydrochloride before the she got the vaccine. She would have had the second vaccine by the time of her next appointment. The events outcome was recovered on 31Mar2021. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-04-24 | vaccination site redness, vaccination site pain |
Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; inject...
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Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; injection site redness; severe allergic reactions; slight dizziness; severe headache; nausea; weak; tired; feverish; sweat; had pain at the Pfizer Covid 19 Vaccine injection site; right arm started to swell; chills; extreme muscle pain; certainly extreme and joint pain; Heart beat seemed to speed up; Has not been able to walk or move body in normal fashion; This is a spontaneous report from a contactable consumer (patient herself) A 67-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7533) a week ago via an unspecified route of administration on 02Apr2021 at 13:45 hrs on the right upper arm as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.When caller was 18 they required a booster for Small pox and caller received the small pox booster on the leg in the same site where it was given at age 5. Caller's leg swelled up to 5 times the normal size, at the time caller was 18 years old.Took a long time for swelling to go away, a couple weeks. Caller requires it hindered sports activities during this time. On 02Apr2021, the patient started reported slight dizziness, severe headache, Shakiness, nausea, weakness, tiredness, have been feverish, pain at the injection site and stated that her right arm started to swell. The patient stated that through out the night of 02Apr2021, she had extreme muscle pain, certainly extreme and joint pain that was also extreme and heart beat seemed to speed up within the first hour and by the end of the hour. On 03Apr2021, the patient stated that her muscles and nerves seemed to be locking up like almost paralyzed. The patient described the events she experienced slight dizziness and didn't worry because it wasn't major and caller was driving herself and with in an hour the dizziness got worse. Caller had severe headache and had to drive home a significant distance and the time the caller got home, she reports being shaky, dizzy, had headache, nausea, was weak and tired and must have been feverish. Caller reports she must have been feverish because she was drenched in sweat by the time she got home and it was a 2 hour drive home from the vaccine administering facility. Caller had pain at the Pfizer Covid 19 Vaccine injection site, and caller's right arm started to swell.Caller clarified that the injection site was in the right upper arm, doesn't know what the muscle is called. Caller says she couldn't see if her arm was getting red, caller has some discs out in her neck and is unable to look at the arm. Caller could feel the injection site on her right arm was swollen and swelling. Caller reports fever was gone and fever got replaced with chills later on. Caller reports there was progression of the symptoms after the first hour. Caller states the information provided thus far was the first hour of her experience and through the night a lot of other things changed and added.Through the night caller had extreme muscle pain, certainly extreme and joint pain that was also extreme. Muscles and nerves seemed to be locking up like almost paralyzed: By the next morning, after caller had the Pfizer Covid 19 Vaccination, states she was not a doctor but all of her muscles and nerves seemed to be locking up like caller was almost paralyzed. Caller reports she couldn't move, couldn't get out of bed. It took a long time to get caller's fingers and toes moving and the rest of the body, but fingers and toes were the first ones. Caller was able to kind of release from muscle cramping. Whatever was going on, caller says can't tell exactly what was going on, does not have a Doctor in the home. States the information given should cover that part of the experience. Through the night had extreme muscle pain, certainly extreme and joint pain that was also extreme: Reports since the morning after receiving the Pfizer Covid 19 Vaccine, caller has had continued muscle pain, although not as extreme, its pretty extreme, and join pain. The patient has not been able to walk or move body in normal fashion. The patient stated that she had every side effect listed on the fact sheet at the top minus the swollen lymph nodes and injection site redness and she had two of the side effects listed under the severe allergic reactions. The patient wanted to know whether it is safe to receive the second dose of the vaccine. The patient lives in an isolated area where all through COVID-19 she tried to get information from the local medical clinics and they did not seem to stay informed. Caller states she has a doctor's appointment, and she will let them know the side effects she experienced after the first dose but she is not confident in the recommendations they might provide. Patient was given a list of side effects to look for, ones they were assuming, doesn't know if the hand out was published by Pfizer or not.The hand out listed emergency kind of side effects people were experiencing.Caller reports they are over age 65 range and knew a lot of people before her who had the Pfizer Covid 19 Vaccine and said they only had injection site soreness. Caller was expecting the same reaction, caller was told by the Doctor she was in pretty good shape. Caller reports she had most all of the reactions except anaphylactic reaction of not breathing after receiving first dose Pfizer Covid 19 Vaccine. Caller is nervous about going for the second round of the Pfizer Covid Vaccine, is not sure how to proceed and would like that information. The case was assessed as serious medically significant for the event paralysis. It was reported that patient took Aspirin as treatment medication for pain. The outcome of the events was resolved for fever and nausea, resolving for swelling arm, unknown for swollen lymph nodes, Chills , Vaccination site pain, injection site redness, severe allergic reactions, sweat, shaky feelings, heartbeat increased, movement disorder and not resolved for all other events.
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| 67 | 2021-04-24 | hair loss |
cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in swe...
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cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in sweats; She is still cold/She is freezing cold; She is loosing her hair. clumps of hair falling out.; sinus headache; had issues with her thyroid; sinusitis like when she had COVID; palpitation; nausea; feeling achy like you have a flu/ aches and pain; fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2, via an unspecified route of administration, administered in arm left on 26Mar2021 15:00 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included atrial fibrillation on an unknown date. Caller added she takes medication for Atrial Fibrillation. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache since she was diagnosed with Covid. Caller had a funny sensation in her sinuses after the injection. It was a weird feeling, just like when she had Covid. She had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. She had a lot of allergies. The patient's concomitant medications were not reported. The patient experienced headache on 26Mar2021 with outcome of recovered with sequelae on 27Mar2021, achy, chills, fever, nausea on 27Mar2021 with outcome of recovered with sequelae on 29Mar2021, palpitation, sinusitis like when she had covid, cramps, stiff neck, couldn't move her neck, it was very painful, she was breaking out in sweats, still cold/ freezing cold, loosing her hair/ clumps of hair falling out, sinus headache and had issues with her thyroid on an unspecified date with outcome of unknown. The clinical course reported as follows: Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 26Mar2021 and scheduled to get the 2nd dose on 16Apr2021. Patient experienced headache, sinusitis like when she had COVID, nausea, feeling achy like you have a flu, fever chills, cramps ,aches and pain, palpitation. Patient had tested positive for COVID last 28Dec2020 that lasted for 6 weeks. Asking if 2nd dose will be more intense when it comes to reactions and if she can safely have the 2nd dose. She will see her cardiologist due to chest palpitations. She worked and had her first Pfizer Covid-19 vaccine 26Mar2021. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache on Friday immediately after her injection. Then was okay. On Saturday morning after waking up, she felt achy, nauseous, had a fever, chills, and a headache. On Sunday she was not feeling great. Even into Monday, she had fever and chills and felt the same as when she had Covid. Caller added she is not supposed to get sick. Caller states weighs 160 pounds, which she shouldn't be. After the shot she felt a sinus headache. Funny sensation in her sinus's just like it was when she had COVID. Once she had the shot, the original headache went away along with her stiff neck. She couldn't move her neck, it was very painful, it still happens. And she had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. Caller had lasting effects from Covid, but didn't know if these symptoms were related to the shot. She was breaking out in sweats. She was still cold. There was something going on. She was having her Vitamin D level and thyroid checked. She was loosing her hair, clumps of hair falling out. She had issues with her thyroid. Caller wondering if the vaccine was the cause. She was freezing cold. She hadheart palpitations and was seeing her Cardiologist next Thursday. Caller received the vaccine because she had Covid and didn't want to get it again. She was pretty sick. She worked around people and didn't want to be in a situation because not everyone wants to get the vaccination. Treatment of events included: She had not been to the doctor for this, she just jumped into bed and took Tylenol. The events didn't require a visit to emergency room or physician office. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-04-24 | redness |
face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinu...
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face swelled up, numbness and red on left side; face swelled up, numbness and red on left side; sinus infection; Shortness Of Breath; pounding in my chest/throbbing in her chest; ringing in ears; flared up some digestive issues / digestive disturbances; flared up some digestive issues / digestive disturbances; red on left side/face redness; exhausted all the time; This is spontaneous report received from contactable female consumer (patient) reported herself. A 67 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199) on 10Mar2021 17:30 at age of 67 years old at single dose in right upper arm for COVID-19 immunisation. Medical history included: last year February, she was really sick with bad sinus infection not knowing about COVID at the time. Sometime later she got these horrible digestive attacks, ended up in her stomach and esophagus, horrible attacks where she couldn't breath, she has had acid reflux in the past. digestive problems stayed with her a really long time, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. She tested in April last year, it was negative (not detectable). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). No adverse events (AE) following prior vaccinations. Patient had first Pfizer covid vaccine on 10MAR2021, approximately 10 days to 14 days after the vaccine her face swelled up, numbness and red on left side, went to see my doctor, he treated her with steroid and antibiotic for sinus infection, at the same time she had some shortness of breath and pounding in my chest, and had and still have ringing in ears since then, it kind of flared up some digestive issues she had last year. If she back up to last year February, she had a bad sinus infection, went to see allergist, family doctor and ENT, all treated her for sinus' before covid testing was even a thing, they didn't think of covid testing at the time. It ended up in her stomach and esophagus, horrible attacks where she couldn't breath, they did and endoscopy and put her on amitriptyline 10mg daily, continuing to take this medication for hypersensitivity. In March2020 her husband came home with covid, after that, talking to his doctor, she brought him meals outside of the door, it occurred to her that queried if this could have been covid. She tested in April last year, it was negative (not detectable), they were still not sure if it could have been covid. She was supposed to get the second vaccine, she postponed it, the numbness and swelling of face is gone, next shot was tomorrow. Since this was a delayed reaction, typically one to three days would be a reaction to the vaccine. she didn't associate it with the vaccine, asked if it could have been from the vaccine. She wanted to make sure that she was safe to get the second one. Response: Spoke from EUA factsheet for Recipients and Caregivers: LAB-1451-4.0 Revised: 06 April 2021: Sections: who should not get the PFIZER-BIONTECH COVID-19 VACCINE and what the risks of the PFIZER-BIONTECH COVID-19 VACCINE were. Spoke from attached VR Consumer- Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer BioNTech Covid 19 vaccine). Your doctor/healthcare provider is in the best position to assess and advise you as your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. Patient calling about the COVID vaccine. She states that she had the first vaccine 10MAR2021, and 10 days afterwards her face swelled up. She had numbness in it and redness. She went to the doctor and the doctor thought that maybe it was a sinus infection. So she was treated for that. She states that she did have a few other symptoms. To make a long story short, she was suppose to have the last vaccine last Friday. She postponed it for a week (postponed getting the second shot for a week). She wants to know what Pfizer thinks about her getting her second vaccine and her side effects. She says that somewhere between the 10th and 14th day, after receiving the vaccine the symptoms started and that was why she did not think she had a reaction to the vaccine. She has not had anything like that before, it was sort of a delayed reaction. She states she is better now. She had a few symptoms after the face things started and the only thing that she still has now is ringing in her ears. She states it all started around the same time as her face issues, or might have started a little after that. She confirms everything but ringing in her ears have completely resolved. She states that she did have some digestive disturbances, shortness of breath, and throbbing in her chest after receiving the vaccine. She asks if she can go back a little bit to explain. She states that last FEB2020 she was really sick with bad sinus infection not knowing about COVID at the time. She went to her allergist, then her family doctor, and then an ENT. She states that it was nothing like she has ever had, it was really bad. Sometime later she got these horrible digestive attacks, she has had acid reflux in the past but it was nothing like this. In March her husband had COVID and tested positive for COVID. She decided to get tested and she tested negative. She wonders if she had COVID earlier but at that time they were not testing for COVID. Her digestive problems stayed with her a really long time, and she was still on the medications her gastrointestinal doctor put her on. They are hypersensitive esophageal medication. She states that she has been exhausted all the time. The rest of the story she has told already. She states that after the face thing happened she started getting those digestive issues again. Her friend suggested that she call Pfizer, so she is doing that. She confirms that the vaccine card does not have an expiration date, NDC, or dosing information. She states it says 0.3 ml, but she cant see a point, so she doesn't know if its just 03. She states she got the vaccine to lessen her chances of getting a severe disease, in case she ends up in the hospital. Also, to keep herself safe from other people. She states she wants the second one because husbands works with the public and she wants to be protected when he comes home. She states that she has those gastrointestinal disturbances and is on amitriptyline 10 mgs for that. She states she also takes something for her thyroid but she has no major health issues. She states that she had a endoscopy and a colonoscopy as well as blood work done but she doesn't have any of the results because they are in her Beaumont chart where she actually got the vaccine. All of this was pre-vaccine so she doesn't know how relevant it is. The patient did not require a visit to Emergency Room, but visit to Physician Office. The only thing similar had a sister who reacted to a shingles vaccine, She has no information about her sisters reaction to the vaccine. Outcome of event ringing in ears was not recovered, for others was recovered. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-04-24 | vaccination site swelling, vaccination site redness, vaccination site warmth |
sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot,...
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sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; This is a spontaneous report from a contactable Nurse (patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:00 (Batch/Lot Number: ER8734) as SINGLE DOSE (at the age of 67 years) for covid-19 immunisation. The patient had the first dose of BNT162B2 for COVID-19 immunisation in the left arm lot number EP7534 and the patient experienced peripheral swelling in left leg and blood clot. Medical history included ongoing thalassaemia beta Caller stated she was diagnosed with this in her later 20s or early 30s. The patient's concomitant medications were not reported. The patient experienced fever (disability) on 06Apr2021 20:00 with outcome of recovered, real achy (disability) on 06Apr2021 with outcome of recovered, terrible headache (disability) on 06Apr2021 with outcome of recovered, weak (disability) on 07Apr2021 with outcome of recovering, really thirsty (medically significant) on 07Apr2021 with outcome of recovered, tired (disability) on 07Apr2021 with outcome of recovered, sleeping for 3 days on an unspecified date with outcome of unknown, left arm hot, red, and swollen at injection site on 06Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 102, body temperature: 101.9, body temperature: 106, body temperature: 101.6. Therapeutic measures were taken as a result of fever, real achy, terrible headache, weak. Treatment: Advil. The patient is not in a study or programme. No Additional vaccines administered within last 4 weeks. Events were considered related for real achy, terrible headache, weak, really thirsty, tired, and left arm hot, red, and swollen at injection site. Follow-up attempts completed: case closed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for fever and other reported events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-04-26 | injection site mass, skin peeling, injection site pruritus, injection site pain |
Small lump and mild soreness at injection site proceeded to larger lump at site and moderate full up...
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Small lump and mild soreness at injection site proceeded to larger lump at site and moderate full upper arm soreness for 3 days, then fully resolved. Itching and circular scaly patch approx. 1 inch diameter at injection site started on 03/01/2021 and continued to 03/14/2021 when fully resolved.
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| 67 | 2021-04-26 | bruising |
hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pr...
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hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pretty badly bruised / bruise has gone above her knee to her ankle; Weak and could not get out of bed; Sleeping a lot; Dizziness; Headache; Chills; Vomiting; Queasy; This is a spontaneous report from a contactable consumer reporting for herself. A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:05 (Batch/Lot Number: EP7534; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation . Medical history included hypersensitivity , immune system disorder , respiratory disorder , cytogenetic abnormality , endocrine disorder Endocrine abnormalities , diabetes mellitus , obesity , anxiety, hypersensitivity. Concomitant medication(s) included alprazolam (XANAX) at 5 mg daily, taken for anxiety, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) at 60 mg daily taken for anxiety, start and stop date were not reported. The patient experienced fall on 05Apr2021 with outcome of recovered with sequelae , pretty badly bruised / bruise has gone above her knee to her ankle on 05Apr2021 with outcome of unknown , headache on 16Mar2021 with outcome of recovering , chills on 16Mar2021 with outcome of not recovered , vomiting on 16Mar2021 with outcome of recovering , queasy on 16Mar2021 with outcome of not recovered , diarrhea on an unspecified date with outcome of recovering , weak and could not get out of bed on 17Mar2021 with outcome of recovering , dizziness on 16Mar2021 with outcome of not recovered , sleeping a lot on 17Mar2021 with outcome of not recovered , hot and cold on an unspecified date with outcome of unknown , very ill on an unspecified date with outcome of unknown , felt horrible on an unspecified date with outcome of unknown , clammy on an unspecified date with outcome of unknown , feeling odd, kind of wonky, woozy on an unspecified date with outcome of unknown. The events fall and contusion were considered Important Medical Events. The remaining events were non serious. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-04-27 | vaccination site pain |
Nausea; Dizzy; Face Hot; Trouble breathing/chest tightness; Trouble breathing/chest tightness; 1hr p...
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Nausea; Dizzy; Face Hot; Trouble breathing/chest tightness; Trouble breathing/chest tightness; 1hr pain to shot; administered in right leg; This is a spontaneous report received from a contactable hcp (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right leg on 15Mar2021 09:30 (Batch/Lot Number: EN6204) as single dose for COVID-19 immunization. Medical history included known allergy, asthma, atrial fibrillation, urticaria. Concomitant medications included cetirizine hydrochloride (ZYRTEC) as pre treated; diphenhydramine hydrochloride (BENADRYL) as pre treated. The patient previously received the first dose of BNT162B2 (Batch/Lot number: EN6200) on 20Feb2021 13:00 in left leg by injection for COVID-19 immunization. The patient experienced nausea, dizzy, face hot, trouble breathing/chest tightness, pain to shot, all on 15Mar2021. Clinical course: Pre treated u/ 50mg Benadryl and 1 Zyrtec. 1hr pain to shot. u/in 15 minutes of shot: Nausea, dizzy, face hot, trouble breathing/chest tightness, given oxygen +2 more Benadryl laid down u/ feet up, discharged 1200HR Sx resolved by next day (24hours). The outcome of the events was recovered on 16Mar2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: There is a reasonable possibility that the events nausea and vaccination site pain were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events "face hot, trouble breathing/chest tightness" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-04-28 | skin discolouration, skin peeling, bruising |
This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient re...
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This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:00 (Lot Number: ER2613) (age at vaccination: 67-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history was reported as no, and no known allergies. The patient was not pregnant. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). On 23Mar2021 13:00, the patient was tired and slept, 25Mar2021 through 31Mar2021, had Low grade fever and fatigue. On 31Mar2021, thumbs turned purple and looked bruised Went to emergency room. All fingers were turning purple and swelling, could not bend fingers. Hurt to touch anything, couldn't open containers. Spent 2 nights (31Mar2021-01Apr2021) at hospital. Infectious disease doctors both agreed it was a reaction to the Pfizer Covid shot. Also CT scan at hospital showed a small nodule in the right lung. There was no nodule in the CT scan from 09Feb2021. Saw pulmonary Dr 14Mar2021 she and her colleague also believe the nodule was from the vaccine and she need to have another CT scan early May to see if it is gone. Skin peeling off thumbs and first fingers. On 02Apr2021 fingers less purple and moving some. Saw Dr 05Apr2021 wanted pulmonary appointment as soon as possible. 03Apr2021 through 12Apr2021 afternoon the patient had fatigue. The events resulted in: Emergency room/department or urgent care. No treatment received for events. Covid test (Nasal Swab) on 31Mar2021 showed Negative result. The outcome of the events was not recovered.
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| 67 | 2021-04-28 | bruising |
collapsed, head hit the tile floor of bathroom; collapsed, head hit the tile floor of bathroom; righ...
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collapsed, head hit the tile floor of bathroom; collapsed, head hit the tile floor of bathroom; right arm was bruised; corner of her eye was purple/bruised; feeling nauseated; Headaches off and on; pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6208) intramuscular, administered in Arm Left, at the age of 67-year-old, on 19Mar2021 11:00, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma and Allergies. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203) single dose, at the age of 67-year-old, on 26Feb2021, for covid-19 immunisation and experienced slight ache in her left arm, headaches, and mitral valve disease. On 20Mar2021, the patient had headaches off and on and the patient mostly woke up with them. The patient doesn't know if the headaches were from pollen in the air since it is Spring time or mold. On 24Mar2021 at 4am, the patient got out of bed because she had to use the restroom. As soon as the patient took the first step into the tile floor of the bathroom, the patient collapsed. The patient didn't fall, the patient collapsed on the file floor. Her head hit the floor. Her head was killing her when she was laying there. The patient used the restroom and went back to bed. The patient got out of bed because her head was killing her. The patient guesses she threw her right arm out to brace herself, because she noticed her right arm was bruised the morning of 24Mar2021 when she went to shower. The patient took Equate 500MG for the events head hit the tile floor of bathroom, headache, and right arm was bruised and used a wash cloth with cold water as a cold compress and applied it by her eyebrow, the corner of her eye was purple/bruised. It looked like she had eyeshadow on. On 24Mar2021, she was feeling nauseated. Thankfully, she had the next 2 days off (Thursday and Friday) because she didn't feel so hot. On 26Mar2021, the patient called her PCP and was asked if she wanted to come in/ make an appointment. Since, the caller was planning to meet with the surgeon about her upcoming surgery on 29Mar2021, it didn't really fit into her schedule. She was undergoing all these tests, etc. It was determined her surgery was going to happen after receiving the second vaccine. The surgery is hopefully a mitral valve repair. The patient mentioned that her provider is aware of her experience with the COVID vaccine. The patient saw the surgeon on 29Mar2021, and she told him all about her experience. He advised the patient to call her PCP and schedule an appointment with them. She saw her PCP on 01Apr2021. She told her PCP what happened and her PCP asked why she didn't go to urgent care. The patient doesn't really know why she didn't, she just thought she was going to feel better. The patient thought she would work through the pain since Mar2021. Plus, she had everything going on with her surgery- like finding out she had to have the surgery and going under other tests. Her PCP wanted her to go to radiology to have a MRI of the head/brain done. She had the MRI done at 3:00PM on 06Apr2021 and the results were negative. Up until last weekend, she still felt "headachy". The patient has headaches too because of stress knowing her surgery was scheduled in a matter of 2 weeks, so she didn't know if the headaches she was experiencing was because of the COVID vaccine, stress, allergies, etc. The patient was certain the headache she experienced the day after she collapsed, was due to the collapse. The patient clarified that she knew it was more of a "collapse" instead of a fall because all the furniture leading to the bathroom, like the loveseat, lamp, cedar chest, etc, were all intact with no marks. It was like all of a sudden she collapsed. Her bruising is all gone, but there might be a slight mark that is like yellow and green (because the bruising changes colors) on her arm. Her eye was okay. The patient will have her planned surgery on 15Apr2021. The events required physician office visit. The patient underwent unspecified lab test and procedures relevant to her upcoming surgery but no other testing in regards to her symptoms after the COVID vaccine. Outcome of headache was not recovered, the events corner of her eye was purple/bruised and right arm was bruised recovered in 2021, while it was unknown for the other events.
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| 67 | 2021-04-28 | vaccination site pain |
slight ache in left arm; headaches; surgery is hopefully a mitral valve repair; This is a spontaneou...
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slight ache in left arm; headaches; surgery is hopefully a mitral valve repair; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203) intramuscular, on left arm, at the age of 67-year-old, on 26Feb2021 5:45pm, single dose, for covid-19 immunisation. Medical history included asthma and Allergies. Concomitant medications were not reported. On 27Feb2021, the next morning when she woke up, she had like a slight ache in her left arm and then everything was fine. She clarifies she was getting headaches after the first injection but she didn't know if it was from the vaccine or not. The headaches were not that severe. She took Tylenol and the headaches kind of went away. The patient found out that she had to have a surgery on 29Mar2021 and was subsequently moved on 15Apr2021. It was determined her surgery was going to happen after receiving the second vaccine. The surgery is hopefully a mitral valve repair. Outcome of headache and slight ache in her left arm was recovered in 2021 while it was unknown for mitral valve disease. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-04-30 | bruising, itchy skin, rash |
bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc...
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bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc mental health; arm pain; bleeding/bruising; localized rash; SOB (Shortness of breath); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); Visual/Neuro concerns; Visual/Neuro concerns; mechanical irritation; This is a spontaneous report from a non-contactable other HCP. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. During her 15-minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. Patient monitored and improving. Patient ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Patient aware of what to monitor and when to go to ED. Patient voiced understanding and appreciated. Patient able to ambulate out of the facility with ease. Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP (Cerebral palsy), SOB (Shortness of breath), NVD (Nausea, vomiting, and diarrhea), Visual/Neuro concerns). Outcome of pruritus was recovering, chest discomfort was recovered on an unspecified date. Outcome of rest of the events was unknown No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-05-04 | hives |
Hives appeared on both inner forearms, stomach, bilateral upper legs; This is a spontaneous report ...
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Hives appeared on both inner forearms, stomach, bilateral upper legs; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-years-old female (non pregnant) patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 08:15 (Batch/Lot Number was EL9262) as single dose (at the age of 67-years-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had not known allergies. Medical history included hypertension. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm right on 30Jan2021 08:30 AM (Batch/Lot Number was EL99265) as single dose for covid-19 immunisation. Concomitant medications (other medications in two weeks) included atenolol and chlorthalidone taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 21Feb2021 00:30, the patient experienced hives appeared on both inner forearms, stomach, bilateral upper legs. Patient stated that at 67 years of age, this was her first experience with hives. Therapeutic measures were taken a Benadryl cream for hives appeared on both inner forearms, stomach, bilateral upper legs. The outcome of event was recovered on an unspecified date in 2021..
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| 67 | 2021-05-04 | hives |
I felt hives on my forehead; With the 2nd shot my arm was definitely sore; I felt like I had a fever...
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I felt hives on my forehead; With the 2nd shot my arm was definitely sore; I felt like I had a fever but it did not show on the thermometer; This is a spontaneous report from a contactable consumer(patient). A 67-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration in Arm Right on 05Feb2021 at 08:00 as SINGLE DOSE for covid-19 immunization. Medical history included breast cancer survivor from an unknown date and unknown if ongoing, food allergy valium, strawberries, bananas, lobster, mahi, whiting fish from an unknown date and unknown if ongoing. The patient received other vaccines within 4 weeks prior to the COVID vaccine via right arm on 14Jan2021. There was no COVID prior vaccination. The patient was not tested post COVID-19 vaccination. Concomitant medications included turmeric [curcuma longa rhizome]; ergocalciferol (VIT D), vitamin c [ascorbic acid], collagen (collagen), olive oil (olive oil). The patient previously took bnt162b2, valium and experienced drug hypersensitivity. On 05Feb2021 at 15:00, The patient stated that, I got hives near my left eye with the first Pfizer shot but I wasn't sure if that was the cause as I do have food allergies. My arm was a little stiff but not significantly and I did not have any other side effects. On 5Feb21, With my second shot, I felt hives on my forehead which confirmed I did have a hive reaction from the first vaccine on 14Jan2021 shot, with the 2nd shot my arm was definitely sore, I wanted to just lay down and I felt like I had a fever but it did not show on the thermometer. However, it is a lot better 24 hours later. My hives have gone down and I feel fine. The patient underwent lab tests and procedures which included body temperature: fever but it did not show on the thermometer. Therapeutic measures were taken as a result of the 2nd shot my arm was definitely sore with Aleve to reduce the pain of the vaccine area on right arm. The events were considered as non-serious. The outcome of the events were reported as recovered. Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122958 same patient, same product( different dose), similar events
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| 67 | 2021-05-04 | dry skin, skin reaction, rash with redness |
skin reaction; skin reaction red rash under both armpits; soreness in arm; ears would get warm feeli...
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skin reaction; skin reaction red rash under both armpits; soreness in arm; ears would get warm feeling very hot; swelling in arm; ears would get warm feeling very hot; skin is dry from being inflamed; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203, expiration date not reported), on towards side of muscle in right arm via intramuscular on 02Mar2021 14:00 as single dose for COVID-19 immunisation. Medical history included female surgery (caller stated she takes Miralax regularly every other day for the last 5 years for a female surgery and her female surgeon says she needs it to stay out but the ingredient is also in Miralax. Caller then stated she knew it was not that ingredient causing the reaction), pneumonia (Caller stated she had the Pneumonia shot). Concomitant medications included colecalciferol (D3) at units everyday from an unspecified date and macrogol 3350 (MIRALAX) taken for female surgery. The patient previously took zyrtec [cetirizine hydrochloride] for seasonal allergies like dust (Caller stated she usually takes Zyrtec for seasonal allergies like dust. Caller stated she took no Zyrtec at all for either shots) and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9809), at the age of 67-years on bicep left arm upper muscle on 09Feb2021 14:00 for Covid-19 immunisation. On an unknown date the patient experienced skin reaction red rash under both armpits, soreness in arm, ears would get warm feeling very hot, swelling in arm, skin is dry from being inflamed. The report received as, Caller received the COVID vaccine and stated she had rosy red, inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly her bilateral armpits and then sometimes ears would get hot. She had second COVID 19 vaccine and also had first one. The first dose was on 09Feb2021 and she had swelling in arm after shot and has been using a cool cloth on it and was better by the next day. Caller then states she still feels it though and it has been five weeks. Caller states she tries to turn arm and can still feel it but it is not bad. Caller states a day later she had her first skin reaction which was a red rash under both armpits. She called primary care doctor and talked to nurse to see if she should try some other medication before second shot and the nurse recommended she should not get second shot that she should see an allergist. She got to building for second shot and talked to nurse there. She asked the nurse about the quality of first and second shot working together if she had waited and not got second shot. the nurse told her she would have to come back at least four days after the second shot was due or it would not work together. She went ahead and got the vaccine and it has not been life threatening as of now. She saw an allergist three days after second shot. She had rosy red inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly bilateral armpit and then sometimes ears would get hot. She would take Benadryl and her primary care physician told her to try to take Allegra 24 hours but caller stated it did not work that it only worked for 12 hours and not the full 24 hours. She took the Allegra medication on Sunday morning and that it worked for her for about 12 hours and she knew she could not take any more Allegra but the Benadryl seemed to help and her Allergist felt she made the right decision since her events are not life-threatening since it is not respiratory. The Allergist saw her armpits agreed the children Benadryl was working and that she should stick with that, but it is not going away been like this the whole time since 02Mar2021 and still having a reaction in her armpits, after the second shot the flare up was quicker because first shot was already in system still, it is not a flare up like when someone can not eat seafood and stuff like that. She still has a rosy armpit and probably will not see her HCP unless she gets bad but she will go to Allergist. She wanted to wait for second dose before contacting Pfizer to see what would happen. She is really blossoming under the armpits and they are rosy red but no blisters and her skin is dry from being inflamed all this time. She squeezes a rag under her armpits and that it is better during the day than at night, it is worse at night. She is only taking 20 mL of Benadryl in the morning and then evening before bed. The first shot right at the beginning she had to take Benadryl in the middle of the night as well but got to where she was taking it 12 hours apart before second dose. She hopes she is not having to walk around with compresses in the summer as it is easier when it is cold and that she hopes this fazes. Since she had not taken a shower or hot bath this morning that she had rosy red cheeks like a rosy red U on her face. Caller states her sister asked what did she did and she said nothing. Swelling in arm was from the first shot it was really hot like a boil but it was not red it just felt hot, she used a cold compress during the night like a washrag and by the next day it was fine. She got the shot on the left arm on purpose because she was left handed and could move it more but noticed the swelling stayed a while. When she got the second shot she asked the nurse to give in her back upper part of bicep in arm muscle since it was a better location and it did not swell up and it did not hurt. She can still feel exactly where she got the first shot. Swelling in arm was not terrible. her allergist felt she made the right decision since it is not life threating like respiratory related or closing of throat like food allergies just uncomfortable and annoying. Skin reaction red rash under both armpits was the event started the first day after the first shot then still having reaction from the second shot. She had the reaction a couple hours later and did wait half hour before leaving after getting the shot with the second shot she did not experience any swelling or soreness. The reason she went ahead and got the second shot at the medical building was she asked the nurse how many people had skin reaction before second shot. Ears would get warm feeling very hot, she only experienced it six times and it was usually at night or in the morning from the second shot. Every once in a it while flare up from the first. The hurt was always in the center of armpit not in the armpit. Skin was dry from being inflamed from past couple of days her skin has been dry. She has used hand cream but is afraid to put anything else on it because of reaction. The serious criteria is just annoying. She will probably put cream on it so it does not crack, it is very dry and it has not been dry like this. she has been putting water on at night which could have dried it out. Some days is worse than others more red and this was persisting. The second shot is much better and that she does not feel it at all. She can still feel where the vaccine went in left arm. It is annoying but it does not keep her from moving her arm and it has been five weeks. Since it is not going away it is serious. The soreness had not gone away before she got the second shot so double whammy. She guesses right now it is uncomfortable and that she has had better days. She is not taking Benadryl in middle of day like before but it is itchy so she is going to go out in the cold and work in yard, before first week or two she would use cool compresses all day and take Benadryl during day and then at night it petered out. She is hoping it will fade out eventually. Caller stated that the seriousness criteria is medically significant. She is taking Children Benadryl 20mL and would take at least every 6 six hours and was trying to hold off to now taking it 12 hours and will use cold compress if she has to. her primary care physician told her to try to take Allegra 24 hours but caller stated it did not work that it only worked for 12 hours and not the full 24 hours. She took the Allegra medication on Sunday morning and that it worked for about 12 hours and she knew she could not take any more Allegra. The medical ingredient was Fexofenadine HCL 180mg antihistamine. She only took one pill as it did not work. she had not had an an anaphylactic reaction yet. She is taking Children Benadryl 20mL and would take at least every 6 six hours and was trying to hold off to now taking it 12 hours and will use cold compress if she has to. Outcome of the events skin reaction red rash under both armpits, soreness in arm and skin is dry from being inflamed were not recovered and remaining events were unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events skin reaction, rash erythematosus and pain in extremity and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021307484 Same reporter/drug/AE, different patient;US-PFIZER INC-2021307485 Same reporter/drug/AE, different patient;US-PFIZER INC-2021307486 Same reporter/drug/AE, different patient;US-PFIZER INC-2021307487 Same reporter/drug/AE, different patient
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| 67 | 2021-05-07 | rash, itchy skin, dry skin |
cardiac enzymes were extremely elevated; Weight from 223 pounds to 211 pounds in 2 months; No appeti...
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cardiac enzymes were extremely elevated; Weight from 223 pounds to 211 pounds in 2 months; No appetite; Sleep pattern is bad/she cannot fall asleep until 0400 and then wakes right back up around 0800; Feels rough with fine bumps at times; Feels rough with fine bumps at times; Itches at times; Rash on outer aspect of arm; Tightness, uneasiness in chest; Palpitations, Fluttering in Chest; Palpitations, Fluttering in Chest; Easily Winded; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose on 16Mar2021 (Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), then the second dose on 07Apr2021 (Batch/Lot Number: ER8730; Expiration Date: 31Jul2021), both via an unspecified route of administration, at the age of 67-years-old, administered in arm left as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from 2002 and ongoing, ongoing diabetes mellitus, penicillin allergy from an unknown date and unknown if ongoing, became really sick, really fast, uncertain if was Covid 19 from Feb2020 to an unknown date and chest discomfort from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), glyceryl trinitrate (NITROGLYCERIN), both taken for chest discomfort; dulaglutide (TRULICITY) taken for an unspecified indication, all from an unspecified start date and ongoing. The patient previously took morphine and codeine and experienced drug allergy. The patient was at her eye doctor on 02Apr2021 and decided afterwards to have her grandson take her to the Emergency Room (ER) for some tightening and uneasiness she had been having in her chest over the preceding days. She also felt some palpitations, they were fast, then slowed down; did not feel labored. She went to the ER and was there for 8 hours. They told her that her cardiac enzymes were extremely elevated. After the cardiologist reviewed her results she was allowed to go home. She went to her regular cardiologist on 05Apr2021. That cardiologist went over her tests results and said that while it was not normal results for her he didn't find them too worrisome. He stated that just because her enzymes are elevated does not mean she is in trouble. He scheduled her for a Dobutamine Stress Test on 07Apr2021. She has been trying to get the results of this stress test from the doctor's office but has not been successful in doing so. Says that once she completed the Stress Test on 07Apr2021 she went to get her second dose of the Covid Vaccine. She was still having her symptoms when she got her second vaccine and they have continued since. She saw her endocrinologist who went over blood work with her. The endocrinologist told her that her blood glucose level was very good and her A1c was a 5.5. The endocrinologist was concerned because usually the A1c is between 6 and 7. Patient was 5 foot 6- and one-half inches. Tightness, Uneasiness in chest: Stated it is not pain, just an uneasy, uncomfortable, fluttering feeling. Palpitations, Fluttering in chest: Not a labored feeling, goes fast, then slows down, not constant. Rash on outer aspect of arm: Extends from her wrist to about 2-3 inches below her elbow. Outside of arm, not on the inner part of her arm. Feels rough with fine bumps at times; then will feel smooth again. Itches at times. She uses calamine lotion, which does help to relieve the itching and smooth the skin. Stated it eventually does come back though. Easily Winded: She has had respiratory conditions all of her life. This winded feeling, she has been having is different than that she stated. She gets the fast heartbeat really quick, can almost hear it; becomes winded and sits down. The episodes last about 15 minutes. She has had no appetite; she has lost almost 15 pounds in 2 months. Her weight was 223 pounds 2 months ago and now weighs 211 pounds. She mentioned her sleep pattern is bad. Some days she cannot fall asleep until 0400 and then wakes right back up around 0800. The patient underwent lab tests and procedures which included blood glucose: 100 on 22Apr2021, blood pressure measurement: 128/62 on 21Apr2021, body temperature: 97 degrees fahrenheit on 21Apr2021, haemoglobin: 5.5 on Apr2021, heart rate: 78 on 21Apr2021, myocardial necrosis marker: extremely elevated on 02Apr2021, oxygen saturation: 98 % on 21Apr2021. Therapeutic measures were taken as a result of rash on outer aspect of arm, Feels rough with fine bumps at times and Itches at times. The outcome of the events Itches at times, Feels rough with fine bumps at times, Rash on outer aspect of arm, Easily Winded was not recovered; Palpitations, Fluttering in Chest and Tightness, uneasiness in chest was recovering, while of the rest was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 68 | 2021-01-02 | itchy skin | After receiving vaccine, c/o burning throat, coughing, face itching, hot flashes. |
| 68 | 2021-01-05 | vaccination site pain |
bit achy and she can definitely tell where the injection was administered; This is a spontaneous rep...
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bit achy and she can definitely tell where the injection was administered; This is a spontaneous report from contactable consumer. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration, at the left shoulder on 29Dec2020 around 3:00-4:00pm at single dose for immunisation . Medical history included ongoing Sjogren'ssyndrome, Raynaud's disease, antiphospholipid antibody syndrome, two other conditions which the patient cannot remember, was on blood thinner, immunocompromised or on medication that compromises your immune system-all of which apply to her. Concomitant medication included hydroxychloroquine (PLAQUENIL), warfarin, aspirin all from about 15-20 years ago as a blood thinner. On 29Dec2020, patient felt like the vaccine has affected her a bit as she was feeling a bit achy and she can definitely tell where the injection was administered because sometime last night she rolled over and thought well she won't be sleeping on that left arm after getting the vaccine injection in her left shoulder. She was not sure if her feeling a bit achy is just the day, or related to the vaccine. Patient did not read the product paperwork until last night when she got home after having been administered the vaccine. She was given an approximate date of her second scheduled dose around 19Jan2021; that is not necessarily the date she will get the second dose; that depends on the next clinic date at the county health department. No plan to change dose unless advised to. The patient has not yet recovered from the events.
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| 68 | 2021-01-07 | rash, itchy skin, redness |
5 days after the vaccine, my right ear became itchy and red, then became swollen, Next day left ear ...
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5 days after the vaccine, my right ear became itchy and red, then became swollen, Next day left ear became itchier than the right ear and swelled more. Took Xyzal in day and Benadryl at night. It has continued on , on the 9th day, my head became itchy. On the morning of the 10th day, my face looks red and rashy with my right eye swollen
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| 68 | 2021-01-07 | itchy skin, rash with redness, redness |
Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left...
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Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; This is a spontaneous report from a contactable consumer, the patient. A 68 -year-old elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration in the left arm on 29Dec2020 at 02:30 PM, (at the age of 68 -years-old) as a single dose, dose number=1 for COVID-19 vaccination. Medical history included hypothyroidism and osteopenia. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxin and citalopram within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 02Jan2021, the patient woke up with a red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea. The patient was treated for red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea with diphenhydramine (BENADRYL) 50 mg x 1. The clinical outcome of red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 68 | 2021-01-09 | injection site pain |
Pain at injection site (resolved within 48 hours). Chills, lightheadedness, warm (not feverish), ab...
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Pain at injection site (resolved within 48 hours). Chills, lightheadedness, warm (not feverish), abdominal cramping, loose stool x 5 over 48 hours. Extreme fatigue (over 5 days)
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| 68 | 2021-01-10 | itchy skin |
Burning/pain in throat, itching around mouth, wheezing, coughing, and BP 195/100. Taken to the ER, ...
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Burning/pain in throat, itching around mouth, wheezing, coughing, and BP 195/100. Taken to the ER, received epinephrine breathing treatment and Benadryl Observed for 2 hours then discharged. Slept most of the following day.
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| 68 | 2021-01-11 | rash with redness, rash | red rash neck and chest area |
| 68 | 2021-01-12 | itchy skin |
Itching of tongue, face, under arms & groin, headache, intense chills & shakes, fever 101.9, stom...
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Itching of tongue, face, under arms & groin, headache, intense chills & shakes, fever 101.9, stomach pain, diarrhea Still experiencing fever and diarrhea.
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| 68 | 2021-01-14 | itchy skin |
Patient presented post Covid vaccine. Patient was experiencing itching on back of neck, L forearm, i...
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Patient presented post Covid vaccine. Patient was experiencing itching on back of neck, L forearm, inner thighs and tingling of lips. Patient advise to go to ED if symptoms worsened. Patient has personal 25 mg tab of Benadryl or 10 mg zrytec. Patient took zyrtec. Patient ok with POC. Patient has no further questions or concerns at this time.
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| 68 | 2021-01-16 | hives | Hives on legs, arms, buttocks, eyes, ears |
| 68 | 2021-01-18 | injection site pain |
Approx. 10 hrs after injection I developer soreness at the injection site and upper Left arm. The in...
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Approx. 10 hrs after injection I developer soreness at the injection site and upper Left arm. The injection site was tender to touch and a dull ache went down my left arm to the fingers. The symptoms persist into the day after the vaccination.
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| 68 | 2021-01-18 | injection site pain |
Approx. 10 hrs. after injection I developed soreness at the injection site and upper arm. Injection ...
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Approx. 10 hrs. after injection I developed soreness at the injection site and upper arm. Injection site is tender to touch. I was unable to lay on this arm as I went to sleep. I also developed a dull ache down my left arm to my fingers. These symptoms remain in the day following the injection
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| 68 | 2021-01-18 | injection site redness, injection site swelling |
Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , h...
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Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , headache joint pains , muscle pains , chest pains and nausea as well as Fatigue . I started taking Tylenol 500mg po q 6 hrs and that improve the sxs. The site of the injection was extremely red and swollen as well as lymphadenopathy underneath the left arm ( site of injection). The next day ( sunday) I noticed a swelling underneath the axilla going on top of the bra with blood exudate and looked as if I had bumped an object. The weakness continued during the next week and slowly the tiredness got better ( TOOK AT LEAST 7-10 DAYS).
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| 68 | 2021-01-19 | skin warm | Severe L arm pain, L face tingling, numbness, and warm to touch including eye area and eye swelling |
| 68 | 2021-01-21 | hives |
Chills, fever to 100.7, mild nausea, malaise, fatigue all resolving in 24 hours. A transient light r...
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Chills, fever to 100.7, mild nausea, malaise, fatigue all resolving in 24 hours. A transient light rash (hives) noted at bedtime 48 hours after injection, totally resolving by morning. Not sure this were real adverse advents,but very happy to have had a robust reaction indicating it's working! !!
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| 68 | 2021-01-21 | injection site pain | headache( did not take anything yet) chills tiredness muscle/joint pain injection site pain |
| 68 | 2021-01-23 | rash, itchy skin, hives | Moderate hive like rash which began 30 hours after vaccine. Severe itching and local swelling |
| 68 | 2021-01-24 | itchy skin |
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual was given vaccine at 3:30 pm. 20 minutes after rec...
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"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual was given vaccine at 3:30 pm. 20 minutes after receiving the vaccine individual developed itchy flushed on face cheeks, chest, and back. She was given Benadryl 50 mg IM in Right arm at 3:55 pm. 4:12 pm the itchy skin was less intensified and vitals were stable. Individual went home with family
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| 68 | 2021-01-25 | itchy skin |
PATIENT BECAME FLUSHED AND HAD ITCHING TO CHIN: AIRWAY PATENT: NO SIGNS OR SYMPTOMS OF RESPIRTATORY ...
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PATIENT BECAME FLUSHED AND HAD ITCHING TO CHIN: AIRWAY PATENT: NO SIGNS OR SYMPTOMS OF RESPIRTATORY DISTRESS, SHORTNESS OF BREATH OR CHEST PAIN: HEART RATE 62: 02 99% ON ROOM AIR: RESPIRATIONS 18: LUNGS CLEAR AND NO STRIDOR NOTED: PATIENT PROVIDED WITH WATER: PATIENT STATES SHE "SHE FEELS PRICKLEY ON THE FACE AND HEAD."
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| 68 | 2021-01-25 | vaccination site pain |
arm was extremely sore; injection was in the right arm, about 6 hours later of the vaccination, ther...
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arm was extremely sore; injection was in the right arm, about 6 hours later of the vaccination, there was mild tenderness; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), via an unspecified route of administration in right arm on 12Jan2021 03:45 at a single dose for covid-19 immunization. Medical history included fibromyalgia, and allergies to Flexeril, benzalkomium chloride, iodoprophnyl butylcarbamate, Neosporin. Concomitant medication included prednisolone, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), magnesium, cobamamide (VITAMIN B12 [COBAMAMIDE]), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and colecalciferol (VITAMIN D [COLECALCIFEROL]). The injection was in the right arm, about 6 hours later of the vaccination, on 12Jan2021, 22:00, there was mild tenderness. The following day, on 13Jan2021, the arm was extremely sore. 36 hours after the injection, the arm was no longer sore. The outcome of the events was recovered on 14Jan2021. No treatment was received for the events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.
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| 68 | 2021-01-26 | shingles, sensitive skin |
1/18/21 begin muscle cramp starting at lower rib on rt side 1/19/21 next was deep, severe, debilita...
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1/18/21 begin muscle cramp starting at lower rib on rt side 1/19/21 next was deep, severe, debilitating pain from mid front center to center back at level of last rib on rt Diagnosed w Shingles, no rash or blisters -severe debilitating nerve pain . Valacyclovir 2 grams a day for seven days 1/27/21 no rash or redness ever developed but nerve pain continues, skin still sensitive to touch, less stabbing sharp debilitating pain to now an aching nagging pain from mid center in a semi circle to mid back.
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| 68 | 2021-01-26 | itchy skin, redness |
26 hours post I took a hot shower. While drying off, I noticed my legs itching. I applied Vaseline ...
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26 hours post I took a hot shower. While drying off, I noticed my legs itching. I applied Vaseline Intensive Care lotion like I usually to after shower and noticed my legs and feet were pretty red. I called my husband in to look at my back, nothing on back, chest or arms. Considered taking a Benadryl due to itch and redness but afraid it would make me sleepy at 4:00 pm. Then over a period of about 15 minutes total after stepping out of the shower, it was fading quickly along with the itching and completely gone within 20 minutes. The lotion helped the itching about 75% initially.
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| 68 | 2021-01-26 | rash, itchy skin |
Broke out in a rash on my chest, both thighs, both arms Nothing until the next day and took one Ben...
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Broke out in a rash on my chest, both thighs, both arms Nothing until the next day and took one Benadryl seemed to help and stopped the itching. They are barely visual enough today I also had a tingling in the upper part of my mout about a half hour after the shot
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| 68 | 2021-01-26 | redness |
Hot, red flush on face (particularly cheeks and forehead), slightly puffy, mild tingling in lips I w...
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Hot, red flush on face (particularly cheeks and forehead), slightly puffy, mild tingling in lips I was observed for an extra 20-30 minutes. Vital signs were taken. Blood pressure up slightly, heart rate slightly elevated Sent home without treatment but recommended I should take antihistamine at home. I took a 12-hour allegra about 12pm and a single 25 mg benadryl tablet at bedtime. The symptoms lasted about 3-4 hours before resolving. They did not get worse from the immediate reaction. Recommended contacting my family physician for advice of what to do before 2nd shot which is scheduled for Feb. 15, 2021
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| 68 | 2021-01-26 | vaccination site pain, vaccination site swelling |
chills; Sore throat; some aching, like body aches; joint tenderness; some swelling at the injection ...
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chills; Sore throat; some aching, like body aches; joint tenderness; some swelling at the injection site; arm tenderness; This is a spontaneous report from a contactable consumer reported for self. This 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 13:30 on Arm Left at single dose (lot: EK9231, Expiry: 30Apr2021) for covid-19 immunisation. Give her a follow up appointment for a second dose, that will be 02 Feb at 1:20 PM. Medical History included arthritis and had surgery for right knee replacement 6 years ago (2015). They are trying to figure out, she has water in her ear she has had CT scans recently trying to check for any problems that could be corrected surgically and that was all clean. She has had a mammogram, she was not sure about the mammogram yet but she thinks they would have called her if there was a problem with that. Historical vaccine included Just mild stuff with the flu vaccine for immunisation on occasion she has had similar reactions that were very mild with the flu vaccine and last year she had none of that at all. She says when she has had any other vaccine, she had no reaction other than maybe a slightly sore arm. No other products. She did have some mild side effects. She was really glad she got this shot. She said she had experienced some chilling on 13Jan2021, these are all very mild symptoms. She had a sore throat on 13Jan2021, some aching, like body aches on 13Jan2021 and joint tenderness on 13Jan2021. She just got chilled every once in a while. It was not very bad. She said the sore throat had persisted about the same, but the coffee helped. She was having some swelling at the injection site that was about the same as when it began on 13Jan2021. She was having some arm tenderness on 13Jan2021. She did not have any adverse reactions yesterday (12Jan2021) she was so excited to get it. Outcome of the events was not recovered.
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| 68 | 2021-01-27 | vaccination site pain |
Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injectio...
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Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injection; couldn't lift her arm at all; left eye twitching; Chills; Nausea; no appetite; whole body ache; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 11Jan2021 5:15 PM at a single dose on arm for COVID-19 immunization. Medical history included ongoing shellfish allergy from 1975 (she carries epi pen), ongoing iodine allergy from 1975 (she carries epi pen), ongoing Mitral valve prolapse (for 20 years), blood pressure high, and cholesterol. The patient had mitral valve prolapse for about 20 years now. They are just watching it now. She just saw the cardiologist, and had an echo done. If the symptoms worsen, they will proceed. Concomitant medications included diltiazem for blood pressure high and atorvastatin for cholesterol, both from an unspecified date and ongoing; she has been on these medications for 30 years now. On 11Jan2021, the patient experienced facial tingling, immediate pain in arm from injection, couldn't lift her arm at all, left eye twitching, chills, nausea, no appetite, whole body ache, tired, whole body trembled, nervous. On 12Jan2021, the patient experienced back pain. The patient explained that on 11Jan2021, evening at 5:15pm, she received her first COVID 19 vaccine. The Pfizer vaccine was being given out at that time. She has shellfish and iodine allergies. So, they made her sit and wait 30 minutes after being injected. One of her daughters took her. On the drive home, a few minutes after leaving she developed facial tingling. At first, she thought nothing of it. She did have immediate pain in her arm from the injection. By the time she got home, she couldn't lift her arm at all. It was that painful. The next morning, she couldn't lift arm, and if she tried, she would be in pain. Also, her left eye started twitching right away also. That night she really noticed it. It was not a constant twitching. She thought at first it was because she was tired or from the pain in her body. But then she noticed the next day it was still doing that. It was still twitching. It is not constant, but it was here and there. She still had it on 13Jan2021, but so far nothing at the day of report (14Jan2021). She also had chills. She had on double clothes, and coverings on her feet and hands. The chills wouldn't go away. Her whole body trembled. On 13Jan2021, Wednesday morning, they went away. She experienced nausea and no appetite. Her whole body ached. It was so brutal. The problem was with her left eye. It didn't twitch constantly, but it got her nervous. She is pretty sure she is going to refuse the second dose. She has heard that the 2nd part is when most people have the worst side effects. So, she is not comfortable getting it. She also got back pain. It wasn't severe, but it was there. She is against getting the second shot. She stated that she is a medical assistant at a pediatric office. She doesn't have a prescribing doctor. She got it (vaccine) because of her age. She was advised to get it as she was around patients. Work gave them the option. The inability to move her arm ended in the middle of night at 4 am 14Jan 2021. She noticed she could move her arm. Her second dose is scheduled for 01Feb2021 at 8:45 am. She does work in a pediatric office. If the second part of side effects are worse, then she doesn't want to take the chance. The eye has her concerned. Outcome of the events were as follows: facial tingling recovered on 11Jan2021, immediate pain in arm from injection recovered on 13Jan2021, chills recovered on 13Jan2021, nausea recovered on 13Jan2021, no appetite recovered on 13Jan2021, whole body ache recovered on 13Jan2021, couldn't lift her arm at all recovered on 14Jan2021, back pain was recovering, while outcome for events left eye twitching, tired, whole body trembled, and nervous, was unknown. Information about lot/batch number has been requested.
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| 68 | 2021-01-27 | rash |
Rash on both arms and stomach; This is a spontaneous report from a contactable other healthcare prof...
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Rash on both arms and stomach; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiration date: unknown), intramuscular (left arm) on 13Jan2021 at 01:45 at a single dose for COVID-19 immunization. Medical history included known allergies. The patient is not pregnant. Concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and had not tested post-vaccination. The patient experienced rash on both arms and stomach on 16Jan2021 at 09:30. No treatment administered for the event. The event had not resolved.
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| 68 | 2021-01-28 | skin burning sensation, hair loss |
2 days after vaccine woke up at 1:30 am scalp was burning and face was tingling. Next day same thing...
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2 days after vaccine woke up at 1:30 am scalp was burning and face was tingling. Next day same thing and my pressure started going up. After 3-4 days, my hairline started receding slightly on the sides of my scalp in the front. This continued each day and I had to increase my blood pressure medicine and double the dose because it was getting so high. I was anxious and upset and am afraid to take the second dose because I feel that I will get a worse reaction, and am frightened.
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| 68 | 2021-01-28 | itchy skin | Itching all over body |
| 68 | 2021-01-29 | redness, itchy skin | Red area 2-3 inch diameter itchy |
| 68 | 2021-01-30 | skin warm |
Posterior head and neck tingling and warmth and flushing in cheeks. Resolved at after given 50 mg of...
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Posterior head and neck tingling and warmth and flushing in cheeks. Resolved at after given 50 mg of Benadryl P.O. Advise to follow up her PCP
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| 68 | 2021-01-31 | rash, injection site pain |
1. Red non-itchy rash on left upper chest. Treatment was Benedryl 25mg. Rash cleared in one hour a...
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1. Red non-itchy rash on left upper chest. Treatment was Benedryl 25mg. Rash cleared in one hour after Benedryl. 2. Injection site soreness in left arm. Treatment is Tylenol.
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| 68 | 2021-01-31 | itchy skin, redness |
45 minutes after I received the vaccine, I began to itch on the left side of my neck and face. The o...
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45 minutes after I received the vaccine, I began to itch on the left side of my neck and face. The outer part of my neck swelled. The left side of My face became puffy and red. I had sharp prickly feelings in my top lip. And my blood pressure went extremely high 169/100. All this lasted about six hours.
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| 68 | 2021-01-31 | hives, redness |
Chest pains 5 days after. Never had like that before And big red welt about three inches by 2 in...
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Chest pains 5 days after. Never had like that before And big red welt about three inches by 2 inches 2 weeks later. And arm is now aching
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| 68 | 2021-01-31 | injection site pain |
PATIENT REPORTS SEVERE ARM PAIN FROM SITE DOWN INTO WRIST AND FINGERS. PAIN IS SO SEVERE SHECANNOT L...
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PATIENT REPORTS SEVERE ARM PAIN FROM SITE DOWN INTO WRIST AND FINGERS. PAIN IS SO SEVERE SHECANNOT LIFT OR USE A SPATULA TO EVEN TURN EGGS OVER IN FRYING PAN. STARTED ON SUNDAY 1/24/21 3 DAYS AFTER RECEIVING FIRST DOSE OF VACCINE. PAIN MINIMAL AT INJECTION SITE, BUT PAIN ALSO OCCURS IN SHOULDER. UNABLE TO RAISE ARM ABOVE HEAD OR EVEN STRAIGHT OUT. WAS SEEN IN URGENT CARE. PROVIDER REPORTS NO SIGNS OF PROBLEMS AT INJECTION SITE. NO REDNESS, NO SWELLING, NO NECROTIC TISSUE.
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| 68 | 2021-01-31 | rash, hives | Systemic: Rash (other than injection site)-Medium, Systemic: Other- HIVES |
| 68 | 2021-01-31 | itchy skin |
Time- about half hour after receiving vaccine. Symptoms - tongue got numb, itched all over my body. ...
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Time- about half hour after receiving vaccine. Symptoms - tongue got numb, itched all over my body. Took benadryl when I got home. Called my doctor but they never called back. 1/29/21 morning - took a Zyrtec and that helped a lot. Still kind of itchy but symptoms are lessening.
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| 68 | 2021-02-01 | vaccination site pain |
Swelling under the left side of left breast; Mild headache; minor muscle pain in left and arms below...
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Swelling under the left side of left breast; Mild headache; minor muscle pain in left and arms below elbow on top of arm; minor soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL-1283 (also reported as "FL-1283"), intramuscular on left arm on 19Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin and dust molds. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. Concomitant medications included Atorvastatin, ergocalciferol (VIT D), Biotin and Glucosamine with MSM. The patient previously took first dose of BNT162B2 (lot number: EK92316) on 29Dec2020 12:45 intramuscular on left arm for COVID-19 immunization. On 19Jan2021 at 16:45, the patient had swelling under the left side of left breast, mild headache, minor muscle pain in left and arms below elbow on top of arm and minor soreness at injection site. Patient was most concerned about swelling. No treatment for the events. The patient had no COVID prior vaccination and not COVID tested post vaccination. The outcome of the events was not recovered.
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| 68 | 2021-02-02 | rash |
Following the Pfizer BionTech Covid 19 EUA, the Patient complained of rash on arms bilaterally, some...
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Following the Pfizer BionTech Covid 19 EUA, the Patient complained of rash on arms bilaterally, some anxiety related to rash. Vital signs: 11:05 am BP 148/78 HR, 11:10 am 117/79 HR 69, 11:15am BP 129/80 HR 75, Benadryl exlir 12.5mg/5mL administered at 11:15am PO. Vital signs: 11:20am BP 133/79 HR 67, 11:30 amBP 124/76 HR 63 Symptons of rash disappered at 11:30am. Vital signs: 11:45am BP 116/77 HR 63 ). Oxygen saturation stayed at 97 -99% the entire time. Patient reported felling fine. Pateint was released to home at 11:45 with spouse driving car.Pt told to follow up with ER or PCP if symptons reoccur.
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| 68 | 2021-02-02 | injection site pain | Pain at the injection site in the afternoon after my immunization. |
| 68 | 2021-02-03 | hives | Hives arm soreness and a headache |
| 68 | 2021-02-03 | injection site pain |
Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate he...
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Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate headache, chills, aching (muscles), fatigue, low-grade fever (100.2), mild nausea, sore upper arm Jan. 31: mild headache, mild muscle/joint ache, chills, fatigue, pain at injection site, loss of appetite Feb. 1: mild pain at injection site Feb. 2: all symptoms resolved
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| 68 | 2021-02-03 | rash, rash with redness |
Patient called into PCP office reporting red rash surrounding her mouth, extending to her chin and d...
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Patient called into PCP office reporting red rash surrounding her mouth, extending to her chin and down her neck. Patient also described throat as "scratchy".
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| 68 | 2021-02-03 | shingles |
individual called to report a shingles outbreak several days after her vaccine. She believes this to...
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individual called to report a shingles outbreak several days after her vaccine. She believes this to be related to the vaccination.
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| 68 | 2021-02-04 | injection site swelling |
6 hrs after injection swelling began and headache (About 9PM). Next morning swelling from shoulder t...
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6 hrs after injection swelling began and headache (About 9PM). Next morning swelling from shoulder to elbow & headache, chills, tool Tylenol. No appetite, very loose bowels at 10:00 am, (NOTE: NO fever) headache, chills continued all day & dizziness was added only when I moved my eyes like to glance at something or trying to read . Woke up, all symptoms were gone except a little swelling around injection site. 48 hours after injection, only very little swelling at injection site.
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| 68 | 2021-02-04 | hives | Hives on inside elbows both arms |
| 68 | 2021-02-04 | rash |
The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ...
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The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ache, nausea, rash on abdomen
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| 68 | 2021-02-04 | skin discolouration |
have two discoloration in my right thumb one black long line and one red line side by side around 1...
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have two discoloration in my right thumb one black long line and one red line side by side around 1 and a half inches long and behind it is a circular black and discoloration; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3247), via an unspecified route of administration on the right arm on 19Jan2021 12:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, supraventricular tachycardia and hearing loss from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE) and metoprolol tartrate (METOPROLOL TARTRATE). On 22Jan2021 05:00 AM, the patient stated, "I have two discoloration in my right thumb one black long line and one red line side by side around 1 and a half inches long and behind it is a circular black and discoloration." No treatment was received for the events. The outcome of the event was not recovered.
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| 68 | 2021-02-06 | injection site reaction | Headache. site of Injection. slight nausea. Flu like feeling. |
| 68 | 2021-02-07 | itchy skin, rash |
Beginning January 30,2021, I began to develop a rash on my right leg then within a few days it spre...
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Beginning January 30,2021, I began to develop a rash on my right leg then within a few days it spread to my left leg. Today, February 8, 2021, the rash is still there . I am taking an antihistamine to control the itch.
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| 68 | 2021-02-07 | redness, injection site redness |
Erythema at the injection site for 3 days, beginning 10 days post vaccine. Brief erythema at other ...
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Erythema at the injection site for 3 days, beginning 10 days post vaccine. Brief erythema at other sites on limbs, not raised or itchy.
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| 68 | 2021-02-07 | vaccination site itchiness |
Itch at site; This is a spontaneous report from a contactable consumer (patient). A 68-year-old fema...
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Itch at site; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3247) via an unspecified route of administration in the right arm on 20Jan2021 10:45 AM at a single dose as COVID-19 vaccine. Medical history included allergies to maybe penicillin. Concomitant medications (received within 2 weeks of vaccination) included trazodone, fluticasone propionate (FLONASE), and cetirizine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced itch at site on 22Jan2021 12:00 PM. Treatment was not received for the event. The event was non-serious in which did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. She has not been tested for COVID-19 since the vaccination. The outcome of the event was not recovered.
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| 68 | 2021-02-07 | rash |
Pfizer-BioNTech Covid 19 Vaccine EUA Rash Elevated blood pressure Elevated heart beat ...
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Pfizer-BioNTech Covid 19 Vaccine EUA Rash Elevated blood pressure Elevated heart beat Dizziness and weakness Observed on site by EMS and nurses for approximately 1 hour
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| 68 | 2021-02-07 | redness |
her arm was red, swollen, and growing; her arm was red, swollen, and growing; She had numbness in pa...
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her arm was red, swollen, and growing; her arm was red, swollen, and growing; She had numbness in parts of the ear and is now able to feel parts of the ear, but she is not sure if the numbness will go away; Caller mentioned that she can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 68-year-old female patient received her 1st bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/lot number: EK9231) single dose on 22Jan2021 10:45 AM at right arm for COVID-19 immunization. Medical history included COVID on 05Nov2020 but was mild only and she was not hospitalized; No medications aside from over-the-counter drugs. The patient was given a Z-pack and vitamin C and immune stuff like Zinc. Concomitant drugs included high blood pressure medication. Around 6:00 PM on 22Jan2021, the patient can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear - the same side of her arm she received the vaccine. The patient stated it was better on 25Jan2021 but still not 100 percent. The patient tried calling the emergency room and has read up and no one can give her any answers. She made an appointment this morning with her doctor to see what was going on, states not being able to hear messes with her equilibrium. The patient was supposed to have another dose on 12Feb2021 and wanted to know if she should. The patient currently still had partial hearing loss and was prescribed a Prednisone that she took for 5 days. Her arm did not hurt Friday through Sunday, however, on Monday, her arm was red, swollen, and growing. She was able to get partial hearing back after taking Prednisone. She had numbness in parts of the ear and was now able to feel parts of the ear, but she was not sure if the numbness will go away. The outcome of hearing loss was resolving, of other events was unknown.
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| 68 | 2021-02-07 | rash macular, vaccination site pain |
joint pain; dizzy; face a little swollen; splotches on both cheeks; burned; Feeling sick; Injection ...
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joint pain; dizzy; face a little swollen; splotches on both cheeks; burned; Feeling sick; Injection site pain; Headache; Muscle pain; tired; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration in the left arm, on 13Jan2021 14:30 at single dose for Covid-19 immunisation . Medical history included cyclic neutropenia from 1998, thyroid disorder from 2001. There were no concomitant medications. The patient experienced feeling sick on 13Jan2021 with outcome of recovering , injection site pain on 13Jan2021 with outcome of recovering , headache on 13Jan2021 with outcome of recovering , muscle pain on 13Jan2021 with outcome of recovering , tired on 13Jan2021 with outcome of recovering , splotches on both cheeks on 14Jan2021 with outcome of recovering , dizzy on 16Jan2021 with outcome of recovering , face a little swollen on 16Jan2021 with outcome of recovering , joint pain on an unspecified date with outcome of recovering , burned on 13Jan2021 with outcome of recovering. The patient received ibuprofen 400 mg to treat headache, muscle pain, joint pain. The patient is not sure if LOT number is EL1283 or EC1283. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 68 | 2021-02-08 | skin swelling, itchy skin, redness |
Left arm itching, swollen and skin on entire left arm was red and across shoulder to neck. Neck pain...
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Left arm itching, swollen and skin on entire left arm was red and across shoulder to neck. Neck pain and headache. Early evening I developed hoarseness and trouble breathing. Went to Emergency room. They administered IVwith Benedryl; Prednisone; and Pepcid. After an hour my breathing was better and some of the redness on arm was better. I went to physician on 2/5/2021 because of neck pain and was prescribed MethylPrednisolone Tablets, 4 MG. 6 day pack and was on day 3 when the symptoms started.
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| 68 | 2021-02-08 | itchy skin |
Severe migraine and head pain. Onset 24 hours after vaccine. Generalized itching from top of head ...
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Severe migraine and head pain. Onset 24 hours after vaccine. Generalized itching from top of head to toes. Both lasting about 48 hours
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| 68 | 2021-02-08 | injection site swelling, injection site pain | The site of the shot and upper arm is sore and a bit swollen. |
| 68 | 2021-02-09 | itchy skin, rash, dry skin, skin discolouration |
skin was lighter in color; it was really rough; lose; itches; Rash; pain; swollen lymph nodes; This ...
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skin was lighter in color; it was really rough; lose; itches; Rash; pain; swollen lymph nodes; This is a spontaneous report from a contactable consumer and contactable other health professional. A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration at arm left on 11Jan2021 at 11:30 at single dose for COVID-19 immunization. The patient medical history included rheumatoid arthritis, coronary artery disease, both from an unknown date and unknown and COVID-19 from Mar2020 to an unknown date. There were no concomitant medications. The patient previously took flu vaccine and pneumococcal vaccine and for both experienced sickness, chills and "couldn't eat". The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization and experienced swollen lymph nodes. The patient experienced swollen lymph nodes on 12Jan2021, the rash was first noticed on 13Jan2021 and started on the right under arm (the opposite side she got the shot), there was pain. On 15Jan2021 it moved to the left side. The right side was starting to get better though her skin was lighter in color. The left side was about the same, it was really rough, lose and itches. It looks like elephant skin. Therapeutic measures were taken as result of events and included topic treatment with MINERIN CREAM (therapeutic moisturizer). The patient outcome of swollen lymph nodes was recovered (within 2 days), the outcome of rash and related events was not recovered.
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| 68 | 2021-02-09 | itchy skin, rash |
vaccine of Feb 1; started amoxicillin and metronidazole on evening of Feb 2; early morning hours of ...
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vaccine of Feb 1; started amoxicillin and metronidazole on evening of Feb 2; early morning hours of Feb 8th had intense itching and rash. Called pharmacist who told me i was probably allergic to one of the antibx, even tho i had been taking them >5 days and to stop one of the antibx. Also told her i had had covid vaccine on 2/1. I stopped metronidazole but itching/rash continued whole day. Next day stopped amoxicillin and restarted Metronidazole. This is also day i had root canal surgery. Again itching and rash continued. Today, 2/10, I have stopped both antibiotics and itching/rash is still present but seems to be lessening. Resesarched online; called CDC, etc- no one knows about antibx and covid reactions occurring
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| 68 | 2021-02-10 | hives, rash | Developed a rash with hives |
| 68 | 2021-02-14 | injection site pain |
Immediately following the injection and till the next morning, my arm was tender at the injection si...
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Immediately following the injection and till the next morning, my arm was tender at the injection site. The following morning my arm was more painful at injection site. Around noon the day after the 2nd shot, I began to feel achy all over and couldn?t get warm. By 2:00 a headache began. At 3:01 I had a fever of 101.7*, at 4:02 it was 102.*, at 6:23pm it was up to 103.1*. The body aches and headache worsened. At 9pm I called a nurse advocate who said all symptoms were normal and to take 2 ibropfen for the fever. I slept most of the afternoon and evening. By 10:30, I woke up all sweaty and the fever had broken. On Feb. 11th, my arm was only slightly painful, I had no fever or aches, just felt tired. On the 12th, I was fine.
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| 68 | 2021-02-14 | injection site pain |
Sudden fatigue, chills, headache, painful arm from injection site to fingers, tingling in left hand ...
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Sudden fatigue, chills, headache, painful arm from injection site to fingers, tingling in left hand and fingers
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| 68 | 2021-02-14 | rash |
Symptoms occurred 8-12 hours after injection and were mostly gone within 24 hours. mild rash on abd...
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Symptoms occurred 8-12 hours after injection and were mostly gone within 24 hours. mild rash on abdomen, swelling of right breast, shallow breathing No treatment.
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| 68 | 2021-02-14 | injection site pain | infection site pain, tiredness, headache, chills, joint pain, fever, foggy thinking, feeling unwell |
| 68 | 2021-02-15 | injection site pain, itchy skin, skin swelling, redness |
After both doses had soreness around injection site on arm, lasting 3 days. After dose 1, 5 days aft...
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After both doses had soreness around injection site on arm, lasting 3 days. After dose 1, 5 days after I had itching, prickly tingly sensations everywhere, especially arms, legs, neck, and back. These lasted for 11 days after that, finally subsided. But then I got dose 2, and had sore arm, and next day, aches in muscles, low fever, congestion but all mild. Took ibuprofen and went away after 24 hours. 5 days later, the itching, tingling started up again and was more intense and everywhere. Have had some redness, swelling, red bumps in itchy areas, they come and go. Worse when I have hot flash. Itching is keeping me awake along with anxiety and restlessness. Hope this won't last for another 10 days, very uncomfortable.
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| 68 | 2021-02-15 | rash |
Pt developed rash on chest and underarms 3 days after first dose of COVID-19 vaccine. She was alread...
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Pt developed rash on chest and underarms 3 days after first dose of COVID-19 vaccine. She was already taking hydroxyzine for itching and zyrtec for congestion before reaction. Her PCP recommended she still get the second shot but take Benadryl and Pepcid 1 hr prior to the vaccine and q6h after for 5 days.
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| 68 | 2021-02-15 | redness | Red Face and burning lips/mouth. Lasted several hours, fine the next day. |
| 68 | 2021-02-15 | skin burning sensation, redness | Swelling of forehead and then eyes swollen, red, burning skin |
| 68 | 2021-02-16 | vaccination site pain |
out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck ...
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out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck was numb/Numbness in leg/jaws are numb; I'm feeling my teeth are still and my jaws are numb; felt very odd sensation as she was swallowing; was closing up but much wasn't closing up/it was not full open; swelling on her throat; Muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side; it hurts my neck area across my back; it hurts my neck area across my back; Stumbling; face was swollen; eyes looks like little switch; thirsty; felt very sluggish; nose started to running; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first single dose BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (anatomical location: arm left) on 29Jan2021 15:00 for COVID-19 immunization. Medical history included insomnia and asthma. The patient's concomitant medications were not reported. Patient stated, "I got the vaccine yesterday about 3 pm and I came home and I had dinner and sat down to watch TV at 9 O' clock, I turn the program on and I was out like a 'light' and this stuff knock me out (onset date: 29Jan2021). My dog has to wake me up licking my face at 3:15 this morning. I normally don't sleep long 4 hours and that's it. I'm 68 years old and I have insomnia (History) but when I woke up I was stumbling around, still have to sleep (onset date Jan2021), I took the dog out to walk and came back and saw myself in mirror, my face was swollen and my eyes looks like little switch. I noticed, I was thirsty and I went to get and drank, some coke because I felt very sluggish and I drank some coke and when I was swallowing the coke I felt very odd sensation as I was swallowing, I noticed that after swallowing. I have asthma (History) to begin with so I'm anticipated on having some of the symptoms it start showing up a bit, my nose started to running and I noticed that my whole entire face my head, down my back my neck was numb along with swelling on my throat, I felt okay but I felt it wasn't being, it was closing up but much wasn't closing up you know what I mean it was not full open. I also had muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side. I also noticed I went to a lovely person and when I went to bathroom I pull my pants down I felt numbness on my legs. So, my whole body was kind of having that not tingling sensation but numb and when I ran my fingers across my leg you know how you feel numbness when you run your fingers across a part of your body when it's numb that's exactly how I felt and that was about 3:30 this morning that happened I woke up by but I also want to ask question because I got to go back to my second shot. I'm wondering if I go back to my second dose am I going to have even more intense reaction to the stuff that I get this time." Patient further added "I was still trying to eat something but I'm feeling my teeth are still and my jaws are numb and this I got since yesterday (29Jan2021)." The outcome of events was unknown. Information on the lot/batch number has been requested.
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| 68 | 2021-02-18 | hives, rash |
Feb 5, 2021 at 8:45 started coughing as if having an allergic reaction to a cat. We stopped and g...
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Feb 5, 2021 at 8:45 started coughing as if having an allergic reaction to a cat. We stopped and got me some Claritin, cough drops, and water. Called my PCP and left message. Coughed an asthmatic cough Friday, Saturday, Sunday and Monday. On Monday, Feb. 8 called PCP again. We had a virtual visit. He said, it was not an allergic reaction. He prescribed Prednisone and Alburetol inhaler. On Thursday Feb . 11 I got a rash all over my body that came and went and I got Hives on the palms of my hands. Virtual visit with my PCP. He said that he retracted his statement from Monday and evidently I was having a reaction to the Vaccine. I kept taking the Steroid which I finished on Monday. The rash and hives bothered me till Monday. Tuesday and Wednesday rash and hives gone. On Thursday morning I woke up with a burning pain across my left side of my chest to the backside and pain on my knees. On Friday the pain was also on the backside of my waist. It felt like shingles. Went to see the NP at Dr. office. They don't think I have shingles. This is all still a reaction to the vaccine.
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| 68 | 2021-02-18 | injection site pain |
I had a serious case of COVID-19 in 3/2020. After the vaccine, I felt like I had the illness all ov...
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I had a serious case of COVID-19 in 3/2020. After the vaccine, I felt like I had the illness all over again. I got a fever of 101, loss of appetite, slept 16 hours a day, headache, slight nausea, some pain at injection site. This lasted about 48 hours. I took two Tylenol 20 hours after the vaccine as the headache was so bad. I got better within 48 hours. No medical help was sought.
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| 68 | 2021-02-19 | skin burning sensation, itchy rash |
Approximately 24 hrs after 1st Pfizer Covid-19 vaccine injection- itchy burning rash on inner right ...
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Approximately 24 hrs after 1st Pfizer Covid-19 vaccine injection- itchy burning rash on inner right wrist and arm. Subsequently moving to inner left wrist and arm, stomach, back, under breasts, vagina, bottom of feet
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| 68 | 2021-02-21 | shingles, rash with redness, itchy rash, rash vesicular |
1 week after injection, February 10th, 2 itchy red spots appeared on back of left thigh. Thought the...
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1 week after injection, February 10th, 2 itchy red spots appeared on back of left thigh. Thought they were bites, as I had no other symptoms. The itching and size of spots increased over a week, but did not find blisters until February 17th. Saw Nurse Practitioner on Feb. 18th, who sent swab to lab for verification of Shingles and started me on antiviral, valACYclovir (Valtrex), for 7 days. By Feb. 21. no new outbreaks, and 2 of 4 areas of outbreak were drying.
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| 68 | 2021-02-21 | injection site pruritus, injection site rash |
Approximately 2 days after the second injection, a large red flat rash (about 3" x 3") began to form...
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Approximately 2 days after the second injection, a large red flat rash (about 3" x 3") began to form on my R arm, around and beneath the injection site. Shortly after that, an extremely intense itching set in and lasted for 48 hours or so. The itching was extreme, and not helped by either Benadryl or topical hydrocortosone cream. The itching was worse than that produced by exposure to poison ivy. I experienced a similar reaction to the second Shingrix (shingles) injection, although the red rash that occurred after this injection was a bit raised and welt-like, in places. Itching was also extreme, and very difficult to tolerate. It, too, lasted about 48-72 hours. Interestingly, I did NOT have this type of reaction to my annual flu shot this year, nor have I ever had such a reaction before. I'd like to know what inactive ingredients are common to both the Shingrix and Pfizer vaccines, as I suspect that something like that is the culprit. Also seeking advice about what to do when boosters are recommended, if they are, for Covid-19.
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| 68 | 2021-02-21 | itchy skin, vaccination site pain |
Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat clo...
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Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat closed up a bit; Sore upper left arm at injection site; Headache; Fatigue; Later on sharp pains in left calf upon walking; Numbness in left facial cheek and left side of tongue; Numbness in left facial cheek and left side of tongue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included allergies or hypersensitivity. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a health facilty. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received second dose of varicella zoster vaccine (lot number and expiry date not reported) on 18Jan2021 at single dose for immunization. Five minutes after first shot of Pfizer Covid 19 vaccine, on 02Feb2021 13:35, it began itching by neck, shoulders, upper arms, legs, back; throat closed up a bit. The patient was administered 50 mg Benadryl, but itching continued. The patient had sore upper left arm at injection sight. They waited at the vaccination facility under care of 3 nurses for one hour. The patient was offered Epi-pen, but did not administer Epi-pen. The patient's husband drove her home. She had chest pains by heart once in the car. The patient had headache, fatigue, and later on sharp pains in left calf upon walking, numbness in left facial cheek and left side of tongue and difficulty swallowing. Clinical outcome of the events was not recovered.
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| 68 | 2021-02-21 | hives |
Hives over thirty to forty percent of body, neck ,thighs arms, torso. took allegra D daily for thr...
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Hives over thirty to forty percent of body, neck ,thighs arms, torso. took allegra D daily for three weeks..down to one twelve hour pull every twenty four hours
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| 68 | 2021-02-21 | rash, hives, itchy skin |
PT stated that she has severe itching all over her body including arms. Pt denies any airway issues....
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PT stated that she has severe itching all over her body including arms. Pt denies any airway issues. Pt did not display any hives but arms were red due to pt scratching. Pt stated this happened the first vaccine but did not tell healthcare workers at screening nor did she annotate it on form. Pt was not given epi but EMS assist was called and pt was escorted to Emergency Room.
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| 68 | 2021-02-21 | itchy skin, blister |
Started getting some burning around the left eye & nose.Same area I had shingles 10 years ago. By M...
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Started getting some burning around the left eye & nose.Same area I had shingles 10 years ago. By Monday left eye swollen shut. Saw opthmologist prescribed Acyclovir. Over a couple days swelling dissapeared and burning, itching subsided. The thing is, I had my second COVID dose on 02/10/2021, 10:00AM Pitzer Lot #9581. On 02/18/2021 late evening, started to feel burning in left eye nose area again, next morning eye swollen shut. Saw Dr, said I was having an allergic reaction and put me on prednesone and Amoxicylin. No reduction of swelling and burning, blisters were forming. Went to Urgent Care on 2/20/2021 and was prescribed Acyclovir again. Swelling now gone and itching burning diminished.
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| 68 | 2021-02-21 | injection site pain |
That evening, 2/17/21, I got home ate some soup in bed soon after, slept 10 hours! The next morning...
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That evening, 2/17/21, I got home ate some soup in bed soon after, slept 10 hours! The next morning went to work and then around 9:30 the chills started, checked my temp 99.8 decided to take myself home, at took temp again, 101.7 then an hour later 102.7 where it remained for the rest of 2/18/21. By the next morning no more chills and temp 97.6. I do have a lingering headache on both sides of my head which meanders down my neck. The site of the injection is still sore and seems to have moved 3 inches down my arm. And there is also a lingering phlegm problem building up at the back of my throat.
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| 68 | 2021-02-21 | injection site pain |
injection site pain, body ache , headache, stiff neck, dizziness, chills, swollen lymph glands in un...
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injection site pain, body ache , headache, stiff neck, dizziness, chills, swollen lymph glands in underarm area. acetaminophen 1000mg every 8 hours was effective for pain relief . bed rest
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| 68 | 2021-02-22 | injection site pain | Fever, chills, fatigue, ache, at injection site minor soreness. This went on for about 32 hours |
| 68 | 2021-02-22 | injection site pain |
I got the shot at 10:30am. My arm was mildly painful at the injection sight. During the next early ...
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I got the shot at 10:30am. My arm was mildly painful at the injection sight. During the next early morning (~2:00am Friday, Feb 19) I had the chills for about 2 hours. I had intermittent muscle pain, nausea, and fatigue. These symptoms resolved during the day Friday, February 19th.
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| 68 | 2021-02-23 | rash |
Swelling in throat, tongue, face and then eyes. fast heart rate. rash on face and dizziness and we...
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Swelling in throat, tongue, face and then eyes. fast heart rate. rash on face and dizziness and weakness Give prednisone and benydrl in IV and took 1 50mg prednisone at home. Weakness for 3 days and swelling has gone down
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| 68 | 2021-02-23 | vaccination site pain |
soreness at injection site; This is a spontaneous report from a contactable consumer. A 68-year-old ...
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soreness at injection site; This is a spontaneous report from a contactable consumer. A 68-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via unknown route of administration in her left arm on 26Jan2021 (at the age of 68-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient did not have COVID. On 26Jan2021 the patient experienced soreness at injection site. The clinical outcome of soreness at injection site was recovered on an unspecified date. It was also reported the patient was not tested for COVID after vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 68 | 2021-02-24 | rash macular, shingles |
*On Saturday, February 20, 2021, I began feeling a slight burning sensation under my left side, unde...
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*On Saturday, February 20, 2021, I began feeling a slight burning sensation under my left side, under my armpit area. I also noticed small, red blotches. *By Sunday, February 21, 2021, there were more blotches that had spread across to my back and across my chest on the left side. There was severe burning, zinging pain that traveled across my chest, under my left arm, and across to my back. * Monday, February 22, 2021, I visited the Doctor who confirmed it was shingles. She prescribed 1 gram of Valacyclovir (Valtrex) 3x daily for 7 days. *The shingles have now covered my entire left breast, under my entire left arm area with a huge patch on my back. It has become extremely uncomfortable with much burning, stinging, and zinging that travels along the rash area and down my left arm.
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| 68 | 2021-02-24 | injection site redness, injection site pruritus, hives, injection site swelling, injection site pain |
2.5 inch redness, swelling, itching, painful with a couple of hive looking spots at injection site ...
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2.5 inch redness, swelling, itching, painful with a couple of hive looking spots at injection site Also headache, fever, malaise
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| 68 | 2021-02-24 | injection site pain |
After first shot on 1/28/21: Very slight headache next two mornings and very slight arm at site of s...
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After first shot on 1/28/21: Very slight headache next two mornings and very slight arm at site of shot. After second shot on 2/20/21: Almost imperceptible arm soreness day after (when driving and arm touched driver door), slight nausea (extremely unusual for me) on afternoons of 2/21, 2/22 & 2/23 along with moderate afternoon fatigue those days (I napped which is extremely unusual for me). Alka Seltzer didn't help but CupOSoup eliminated the nausea completely.
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| 68 | 2021-02-24 | itchy skin, injection site redness, redness |
Redness @ injection site moving down arm to wrist, intense itching of arm with mild numbness, follow...
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Redness @ injection site moving down arm to wrist, intense itching of arm with mild numbness, followed by mild itching, swelling and redness of lips and perimeter of eyes, spike in blood pressure and dizziness, alleviated with paramedic?s IM inflection of 50 mg benedryl and a steroid pill at ER
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| 68 | 2021-02-24 | injection site pain |
Symptoms: chills, joint pain, severe headache with blurry vision, injection site soreness, muscle pa...
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Symptoms: chills, joint pain, severe headache with blurry vision, injection site soreness, muscle pain, feeling unwell - very sick, fatigue. I woke up 2/23/2021, Tuesday, with injection site tenderness upper left arm. Tuesday midday the headache began. By evening, I had chills, pronounced joint and muscle soreness, with further progression of headache to severe with vision changes, and a general malaise and feeling very ill. Like having the flu without fever or congestion. I did not seek medical treatment. Symptoms were treated with over the counter medicines and perscriptions medicines on hand, plus bedrest.
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| 68 | 2021-02-24 | itchy skin, injection site pruritus |
Within 15-minutes of vaccination, the patient reported pruritus around injection site, as well as pr...
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Within 15-minutes of vaccination, the patient reported pruritus around injection site, as well as pruritus and edema in her face, around her mouth and eyes. Patient denied SOB, CP, Abdominal pain, N/V, or HA. EMS evaluated patient on-site. The patient was hypertensive (174/86). Due to patient's complaint and physical exam, EMS administered Benadryl 50mg IV. EMS transported patient to Largo Medical Center Emergency Department. In the ED, the patient had bilateral palpebral edema, pruritus surrounding injection site spreading down the extremity, and lips were erythematous. No SOB or tongue/throat swelling noted. Patient was hypertensive (164/72). ED Physician administered PO Pepcid and Prednisone by provider in triage. The patient stated they felt improvement after the Benadryl treatment and requested to be discharged from ED. Patient was given information and strict return precautions about anaphylaxis.
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| 68 | 2021-02-24 | redness |
started: 2-16-21 after leaving had redness did not want to disclose information other than the react...
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started: 2-16-21 after leaving had redness did not want to disclose information other than the reaction she had. informed her without knowing allergies, her medical conditions, or medication she's taking (that may interact with recommendation therapy) I would feel uncomfortable recommending medication. recommended she see her pcp for treatment. verbalized understanding.
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| 68 | 2021-02-25 | injection site pain, redness |
15 mins after injection, head, face, neck and chest turned bright RED. Felt hot. Alerted staff . I...
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15 mins after injection, head, face, neck and chest turned bright RED. Felt hot. Alerted staff . I took 25mg ODT Benadryl. Observed by staff for 15 mins more. Skin returned to normal color. NO Swelling, No Breathing problems. Went home , no additional problems.(Slightly sore at injection site, expected).
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| 68 | 2021-02-25 | injection site pain |
Fatigue, Chills, Headache, sore arm at injection site. Took x2 extra strength Tylenol and took a na...
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Fatigue, Chills, Headache, sore arm at injection site. Took x2 extra strength Tylenol and took a nap. All signs and symptoms relieved by next day
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| 68 | 2021-02-25 | itchy skin |
I have itching all over my body, but especially behind knees and around my waistline where my pants ...
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I have itching all over my body, but especially behind knees and around my waistline where my pants fasten. Sometimes it is between my thighs.
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| 68 | 2021-02-25 | vaccination site pain |
a little tenderness on the injection site; diarrhea; nausea; This is a spontaneous report from a con...
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a little tenderness on the injection site; diarrhea; nausea; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer reported for herself that she received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261) at single dose on 24Jan2021 at 13:00 for COVID-19 immunisation. Relevant history included thyroid removal on 11Sep2019, and tumor removed from her appendix on May2020. Relevant family medical history was none. Concomitant Products included: Levothyroxinesince Sep2019 and Ongoing. FIBO tests in 2020 that were positive for Hydrogen FIBO. The patient experienced no symptoms by then except for a little tenderness on the injection site. On 26Jan2021, she experienced a sudden onset of diarrhea and nausea at 15:00. Treatment included Zofran. The patient stated that she did get the Vsafe contact but not today (26Jan2021). Outcome of event nausea was not resolved, outcome of other events was unknown. No emergency room required, no physician office visit. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.
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| 68 | 2021-02-25 | rash |
high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, w...
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high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, weakness, overall feeling not well.
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| 68 | 2021-02-26 | injection site pain, itchy skin, rash macular, injection site pruritus |
11:20 Eggy taste in throat, 11:45 on standing slight racing of heart, 1pm still noted eggy taste, 2:...
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11:20 Eggy taste in throat, 11:45 on standing slight racing of heart, 1pm still noted eggy taste, 2:30 eggy taste, slight shot ache, 4:30 light headache, 02/13/2021 2:30am woke with a rush feeling of med, started coughing, burst (spread) of warmth in center of chest, slight perspiration; 3:30am heart racing, warmth in chest, modest itchiness(arm, face & torso), soreness at injection site. 02/14/2021 7am burning/ itching injection site, & chest/torso arm red and square blotch about 1 1/2 inch very itchy and burning for several days. 02/23/2021 itchinesss better. Brown square area at site of injection. There is still a slight itch at times as if healing.
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| 68 | 2021-02-26 | itchy skin |
Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itch...
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Pfizer-BioNTech COVID- 19 Vaccine EUA Approx 5 minute post vaccination, patient began reporting itching. Shortly after, developed a dry cough and reported that her throat "felt funny." Patient began vomiting and having difficulty breathing, speaking in 1-2 word sentences. Pt received epi pen to left thigh, with some resolution of symptoms. Pt continued to have cough and nausea, chest pain. Gave 25 mg benadryl IM at 08:27 am. Patient received 2nd dose of Epi for increased SOB, difficulty breathing, and increasing cough, with some resolution of symptoms. Patient reported increased chest pressure. Began having seizure like activity at 08:30, lasting approx 20 seconds with no post ictal period noted. EMS arrived after 2nd dose of epi. Second "seizure like" activity after EMS arrival, lasting approx 20 seconds. During transport to ambulance, patient had 2 more episodes of seizure like activity with no post ictal phase. ED note states low suspicion for true seizure since patient was awake during episodes of tonic clonic movements, answering questions during, and did not have post ictal state.
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| 68 | 2021-02-26 | rash, skin discolouration, rash macular, injection site reaction |
Very distinct large red blotches about 5 inches long by 1 inch wide above the injection site. Also, ...
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Very distinct large red blotches about 5 inches long by 1 inch wide above the injection site. Also, a large rash with white bumps on chest area by shoulder. Additionally, a large brown spot on opposite shoulder from injection. Very sore arm for 3 days unable to lift it .
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| 68 | 2021-02-27 | rash, hives | Itchy, watery , red, swollen eyes with rash, hives, headache , shortness of breath. |
| 68 | 2021-02-27 | bruising |
Large black and blue mark on left arm slightly above the wrist, but approximately 12 inches down the...
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Large black and blue mark on left arm slightly above the wrist, but approximately 12 inches down the arm from the injection area. Could very well be a coincidence, but I did not bang my arm.
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| 68 | 2021-02-28 | injection site redness |
Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness. The injecti...
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Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness. The injection was on Friday and Saturday we woke up with the side effects. Sunday we were much better and Monday better.
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| 68 | 2021-02-28 | itchy skin |
Extreme itching around waist and hips and thighs started around 4:00 pm the day after receiving the ...
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Extreme itching around waist and hips and thighs started around 4:00 pm the day after receiving the first dose of vaccine and still continuing today 3/01/2021
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| 68 | 2021-02-28 | shingles |
Got a severe case of Shingles a week after vaccine was given. I was told to report this to you by my...
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Got a severe case of Shingles a week after vaccine was given. I was told to report this to you by my allergist office. Doctor's care said it might have had something to do with my immune system breaking down with shingles. My primary care physician seemed to think it was a coincident.
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| 68 | 2021-02-28 | itchy skin |
Patient complained of feeling itchy all over. No other symptoms reported. Patient was given 25mg of ...
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Patient complained of feeling itchy all over. No other symptoms reported. Patient was given 25mg of Benadryl and started feeling better soon after. Patient offered a second dose of Benadryl and declined stating that she would take it at home prn.
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| 68 | 2021-02-28 | skin discolouration |
pronounced swelling under left arm - lymph node. achiness. some discoloration. slight swelling under...
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pronounced swelling under left arm - lymph node. achiness. some discoloration. slight swelling under right arm (site of 2010 lumpectomy, with sentinal lymph node removed, so less swelling). swelling and achiness reduced but still present 1 week later.
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| 68 | 2021-02-28 | redness |
the lumpy, red area is not itchy, but it is tingling, and stings sometimes.; stings; lumpy, red area...
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the lumpy, red area is not itchy, but it is tingling, and stings sometimes.; stings; lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder; lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the right upper arm on 25Jan2021 at 11:30 at a single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications included Influenza vaccine in Dec2020 and Balance of Nature Fruits as supplement since Jan2021 - she started taking Whole Foods brand Balance of Nature Fruits pills and has been taking them off and on for the last couple weeks. On 27Jan2021, the patient had a lumpy, red area on the opposite shoulder from where she received the COVID-19 vaccine. She said she discovered the lumpy, red raised up bumps area on her left shoulder that morning. She said the lumpy, red area is on the back of her left shoulder, neck and hairline area. She said her husband said the lumpy, red area is a couple square inches in size. She said the lumpy, red area is not itchy, but it is tingling, and stings sometimes. She also asked if what she is experiencing is a side effect of the vaccine. The patient declined any treatment for the events saying she didn't know what to do. The event "lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder" had not resolved while the outcome of the rest of the events was unknown. Information on the batch/lot number has been requested.
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| 68 | 2021-03-01 | itchy skin, rash macular |
Itching on hands and forearms that started 2-3 days after shot and then blotches appeared btween 4-...
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Itching on hands and forearms that started 2-3 days after shot and then blotches appeared btween 4-5 days after shot
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| 68 | 2021-03-01 | injection site pain |
My heart rate and b/p increased evening after injection. My heart rate and b/p have been maintaine...
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My heart rate and b/p increased evening after injection. My heart rate and b/p have been maintained at normal ranges for years! B/P usually 122/76 and heart rate 76-80. Since I got that vaccine, each evening my heart rate has been 97, 87, 94, 90. B/P 133/85, 145/84. I had flu-like symptoms, headache, injection site pain and joint pain. They subsided.
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| 68 | 2021-03-01 | injection site swelling, injection site warmth, injection site mass | Pain in Left, swelling, Lump at injection, Area is Hot |
| 68 | 2021-03-01 | injection site pain |
soreness @ injection site initiated 2 hours later & persisted for days: fatigue & sleepiness initia...
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soreness @ injection site initiated 2 hours later & persisted for days: fatigue & sleepiness initiated after 2 hours & persisted for days after 16 hours of sleep; dull headache at base of skull initiated after 4 hours & dissipated after 48 hours.
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| 68 | 2021-03-02 | injection site tingling |
3- 4 minutes after injection I had tingling in my lips and a strange numb sort of feeling in my face...
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3- 4 minutes after injection I had tingling in my lips and a strange numb sort of feeling in my face, and then some "rubbery" weakness in my arms and legs. Treated in an ambulance at vaccine site with IV Benadryl, had some skin tingling, also given IV solumedrol and observed for almost 2 hours with no other symptoms. I was also hypertensive, probably due to anxiety.
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| 68 | 2021-03-02 | redness, itchy skin |
About 24 hours after the injection I had a painful lump about 3" in diameter, with itching and redne...
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About 24 hours after the injection I had a painful lump about 3" in diameter, with itching and redness. I iced it, took Tylenol and Benadryl at bedtime. Today it is less painful, but larger, redder and with itching. It is raised and looks like a small pancake on my arm. I did not have this reaction with my first dose.
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| 68 | 2021-03-02 | itchy skin |
Itching head to toes; This is a spontaneous report from a contactable consumer (patient). A 68-years...
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Itching head to toes; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04Feb2021 16:45 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Allergies to medications, food, or other products: pantoprazole sodium sesquihydrate (PAN), codein, clarithromycin (BIAXIN), atropine, pethidine hydrochloride (demerol). The patient experienced itching head to toes (non-serious) on 05Feb2021 with outcome of recovered. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 68 | 2021-03-02 | injection site pain |
Sore left arm near site the first 72 hours which I expected . Since then it feels like nerve pain ex...
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Sore left arm near site the first 72 hours which I expected . Since then it feels like nerve pain extend above and below the site.
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| 68 | 2021-03-02 | injection site pain |
Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general mala...
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Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general malaise, lasting almost 2 days
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| 68 | 2021-03-02 | skin discolouration | pt describes lightening of skin in arms/legs since vaccine |
| 68 | 2021-03-02 | vaccination site pain |
she has a cold sweat or something right now; She has not eaten anything.; her right arm felt like it...
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she has a cold sweat or something right now; She has not eaten anything.; her right arm felt like it was going to fall off it hurt so bad; she has ran a temperature and that finally broke but the highest was 102.4; She has been so weak she hasn't been out of bed hardly.; tired; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9265), via an unspecified route of administration from 29Jan2021 14:45 (2:45 PM) at single dose on right arm (as she was left handed) for COVID-19 immunization. Medical history included COVID (recovered) on an unspecified date. There were no concomitant medications. No additional vaccines administered on same date of Pfizer suspect. Patient previously got her flu and shingles shot at the end of "October". Patient took the vaccine last Friday (29Jan2021) at the age of 68 years old (reported as "68 and a half"). She does not know if that makes a "different" but her right arm felt like it was going to fall off it hurt so bad, on a scale of 1-10 it was about a 20. It was really tender she put a heating pad on it, she has been sleeping on the heating pad and it was mild now. It was only about a 3 now and it has come down, but it hurt like the dickens. Also she has ran a temperature and that finally broke but the highest was 102.4. Patient has slept around the clock and she has not been out of bed but like 30 minutes out of the last 24 hours (hrs) just to go the potty or drink something. Patient stated "almost gave up holding it was so long". She has been so weak she has not been out of bed hardly. Patient said that she has eaten since, "lets see Saturday night, Sunday, Monday". Patient has not eaten since Saturday night (30Jan2021) or gotten out of bed. She has not eaten anything. Patient has had COVID and recovered so she did not want to catch that again. She confirmed that she had COVID prior to received the vaccine. She called her primary care and she has a viral phone call tomorrow or visual phone call, whatever its called, she was trying to get over this mess, she feels warm, she was not registering a temperature right now but she had a cold sweat or something right now (01Feb2021). Patient has a call with him tomorrow so he will know about this incase Pfizer calls. Patient stated that she knows with a normal vaccine she might have an ache or something but this one hurt bad, maybe they pushed it in too hard or something she does not know. When asked for vaccination facility type, the patient answered that they had a vaccine clinic they had set up there in a conference room, they had an elaborate set up, go through certain places and there were several steps. Vaccine was not administered at facility (reported as "No hospital"). Patient further reported that her arm on 29Jan2021 (Friday evening) was tender. Patient lives by herself, she came home and does not know if she event ate. All she knows was she was real tired that Friday evening, it was tender and it got worse. Events did not require emergency room and physician room visit, reported as "Not to date but tomorrow she does not know if he will have her come in unless she spikes another fever or if he will do anything she may just ride it out". When asked for adverse events prior vaccinations, the patient answered "no none that she can remember. Sometimes she will have a sore arm that is why she gets it in the right arm because she is left handed thinkin her dominant hand will not have any problems but this one hurt really bad. Have they had many calls where this is really effecting arms really bad?". Patient also reported that her sister had the shot the same day and her arm was a little sore but that was all, she does not have NDC lot expiration for her sisters dose of the vaccine. She went to a different facility in a different location. Outcome of "her right arm felt like it was going to fall off it hurt so bad" was recovering, while for other events was unknown.
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| 68 | 2021-03-02 | vaccination site pain, vaccination site itchiness |
the injection site is still slightly pink and itches several times a day/ it was a little tender to ...
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the injection site is still slightly pink and itches several times a day/ it was a little tender to touch; the injection site is still slightly pink and itches several times a day/ it was a little tender to touch; the injection site is still slightly pink and itches several times a day/ it was a little tender to touch; This is a spontaneous report from a contactable consumer (reporting for herself). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL 1284, expiration date unknown) via an unspecified route of administration in the left arm on 17Jan2021 19:00 (at 68 years old) at a SINGLE DOSE for COVID-19 immunization. The patient was vaccinated in other vaccination facility. Medical history included controlled high blood pressure and allergies to Asprin and Acetaminophen, all from an unknown date. Patient was not pregnant at the time of vaccination. Concomitant medications included calcium, diltiazem 280, lisinopril, and "AREDS." The patient received these medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and has not been tested for COVID post vaccination. The patient reported that the adverse events started on 17Jan2021. It's been two (2) weeks since her first vaccine, and the injection site is still slightly pink and itches several times a day. At first, she thought it was a bug bite. It was a little tender to touch. Outcome of the events was recovering. The events were reported as Non-serious.
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| 68 | 2021-03-03 | injection site swelling |
I received the vaccine at 9AM on March 1st in my right arm. Everything was fine until 3 PM when my ...
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I received the vaccine at 9AM on March 1st in my right arm. Everything was fine until 3 PM when my right arm started swelling. I ran a temperature of 100.1, had fatigue and a headache, in addition to aches and pains. By Tuesday morning my right arm from the injection site to the elbow was twice it's normal size. My chest and underarm area were both significantly swollen. I had an 8:30 AM appointment on Tuesday with an allergist who advised me to take Benadryl, which I did. By Wednesday, my chest and abdominal area were both swollen. I had a lymphedema therapy appointment because I have lymphedema on my left side due to node removal. The therapist measured both arms and they were both swollen, including my chest and abdomen. The therapist advised me to see my oncologist as swelling in the Right Arm, (where i received the shot) was normal for COVID shots, but she could not explain the swelling in the chest or abdomen. Other than that my lymphatic system was working overtime. I called my oncologist on Thursday March 4, and they fit me in. Doctor examined me and he couldn't explain to me why I was swelling up the way I was. He has only seen arm swelling in his breast cancer patients. He is referring me to get a PET scan and advised me to see a breast surgeon as maybe the surgeon would know more about the lymph nodes.
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| 68 | 2021-03-03 | rash maculo-papular |
Maculopapular rash on abdomen, chest, sides and back, underside of arms. Noticed rash a few hours af...
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Maculopapular rash on abdomen, chest, sides and back, underside of arms. Noticed rash a few hours after vaccination. Next morning rash was worse. Went to the doctor. He said take antihistamine. And call next day if rash is worse. I called today because rash is worse.
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| 68 | 2021-03-03 | rash with redness | Malaise, fatigue, red rash over entire abdomen, inner arms, chest and inner thighs |
| 68 | 2021-03-04 | vaccination site pain |
Guillain-Barre syndrome; achy arm; tingling sensation from head to toe/whole body was tingling/weird...
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Guillain-Barre syndrome; achy arm; tingling sensation from head to toe/whole body was tingling/weird and scary on and off sensation; This is a spontaneous report from two contactable consumers (patient's cousin and patient herself). A 68-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration in right arm on 10Feb2021 10:30 AM at a single dose for COVID-19 immunisation. Medical history included anxiety. It was reported that the patient was "physically fit. She was thin and was about 5 feet." Ongoing concomitant medications included escitalopram (reported as "generic Lexapro") for anxiety, calcium, and multivitamins. The patient previously received flu vaccine in Oct2020. She also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) via an unspecified route of administration in left arm on 20Jan2021 10:30 AM for COVID-19 immunization and felt a little soreness in arm and light headache the same day. Two nights later, her scalp felt on fire and had tingling sensation in her face for three weeks. A week after the first dose, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put her on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation and noticed some spikes in her blood pressure. Her physician told her to take another 2.5 mg amlodipine if needed. After her second dose, she went to sleep with achy arm. she woke up that night with a tingling sensation from head to toe. Her whole body was tingling. It was a weird and scary on and off sensation. She stated it had improved during the past two days. The patient confirmed that she had no heart rate problems. She actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. She mentioned her 97-year-old mother and husband both got the two doses with no complication or reactions. The patient's cousin was "pretty sure that it's Guillain-Barre." The patient stated the Guillain-Barre syndrome has not yet been confirmed. She had an appointment with a neurologist. The outcome of 'tingling sensation from head to toe/whole body was tingling/weird and scary on and off sensation' was recovering, of remaining events was unknown.
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| 68 | 2021-03-04 | itchy rash, rash | I woke up at 2 am with an extremely itchy rash on my chest |
| 68 | 2021-03-04 | injection site hardening |
Induration at vaccine injection site, no redness noted, no pain, no shortness of breathe or difficu...
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Induration at vaccine injection site, no redness noted, no pain, no shortness of breathe or difficulty breathing.
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| 68 | 2021-03-04 | itchy skin, hives | Itching over entire body. One big hive on arm for 3-4 days |
| 68 | 2021-03-04 | skin warm, redness |
Right elbow became inflamed, red, warm and painful. Right upper arm was sore. Became dizzy at 11 A...
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Right elbow became inflamed, red, warm and painful. Right upper arm was sore. Became dizzy at 11 AM on 3/2 and slept for 3 hours. All expect the inflamed elbow were not a surprise. I treated my elbow with an ice pack during the day on 3/2 and by 3/4 it had improved. By 3/5 it was no longer inflamed, red or warm, but is still tender to lean on. I informed my doctor's office of this.
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| 68 | 2021-03-04 | itchy skin, redness |
Right hand tingling and left hand itchiness/redness 20 minutes after vaccine. After vitals taken, le...
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Right hand tingling and left hand itchiness/redness 20 minutes after vaccine. After vitals taken, left hand tingling resolved. PO Benadryl 25 mg given. BP 147/80 (pulse 80), then 151/82 (pulse 78).
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| 68 | 2021-03-04 | skin burning sensation |
week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pres...
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week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pressure; felt a weird sensation; Tingling in her head and her face; pain in the head and got increasing worse/scalp felt on fire/light headache; scalp felt on fire; she felt a little soreness in arm/12 hours my arm hurt; This is a spontaneous report from a contactable consumer (patient's cousin). A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/Lot number: EL9262), via an unspecified route of administration on the left arm, at age 68 years first dose on 20Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included ongoing anxiety from an unknown date. Ongoing concomitant medication included escitalopram 5 mg for anxiety, calcium and an unspecified multivitamins. The patient had flu vaccine in Oct2020. Patient's cousin called on behalf of cousin and reported that patient was very ill for having severe reaction to the COVID Vaccine. Patient was physically fit and thin received first dose of COVID vaccine on 20Jan2021, 10:30 AM. After her 1st dose, she felt a little soreness in arm, 12 hours her arm hurt and light headache the same day. Patient went to bed a little earlier than normal and slept a little longer since she was 69 years, its her body and it needed more sleep and woke up at noon and her arm was fine and very grateful to have the shot. Two nights later, on 22Jan2021, patient woke up in the middle of the night with tingling and pain in the head and got increasing worse, her scalp also felt on fire and had tingling sensation in her face for 3 weeks. Then, a week after the 1st dose on 27Jan2021, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation on an unspecified date and as she noticed some spikes in her blood pressure, her MD told her to take another 2.5 mg amlodipine if needed (once or twice a day as needed). She confirmed she had no heart rate problems but she actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. The outcome of the event 'eek after the 1st dose, her blood pressure went up to 210/101/noticed some spikes in her blood pressure' and 'tingling in her head and her face' was not recovered, for event 'she felt a little soreness in arm/12 hours my arm hurt' was recovered on 21Jan2021, while for the other events, it was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187054 same patient/drug, different event
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| 68 | 2021-03-05 | bruising |
As expected, my left arm was very sore the day following the vaccination. However, since then, my ar...
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As expected, my left arm was very sore the day following the vaccination. However, since then, my arm has gotten very painful, especially from the shoulder to the elbow. I cannot raise the arm,have limited range of motion, sometimes tingling, needles and pins. For about 10 days, the underarm, the armpit, turned red, black and blue and bruised looking. This has begun to subside. But the pain continues to increase. I have seen my personal physician twice and have had a shoulder X-ray,a neurological exam of the arm, also a vascular ultrasound. I am still waiting for an appointment with an orthopedic specialist.
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| 68 | 2021-03-05 | injection site redness, injection site warmth, injection site swelling | Day 3 after vaccine, arm is swollen & red at vaccine site, warm to touch |
| 68 | 2021-03-05 | pain of skin |
Lightheaded, nausea, headache, eyes dry with itchiness and pain; joint and muscle discomfort; low gr...
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Lightheaded, nausea, headache, eyes dry with itchiness and pain; joint and muscle discomfort; low grade temp, fatigue, hair and scalp hurt. Symptoms lasted about 36 to 48 hours.
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| 68 | 2021-03-05 | rash |
rash on lower back within an hour after vaccine. It disappeared soon. At 2:00 am on March 4th - wo...
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rash on lower back within an hour after vaccine. It disappeared soon. At 2:00 am on March 4th - woke with severe headache, musle and joint pain, chills, nausea, genarlly feeling unwell.
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| 68 | 2021-03-05 | injection site pain |
shot given at 1045 am. arm soreness at injection site. ltook two 500 mg tyleno at 1 pm and laid dow...
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shot given at 1045 am. arm soreness at injection site. ltook two 500 mg tyleno at 1 pm and laid down for a nap, woke up at 1:30 pm with heavy headache at top of head about 3 inches in circumference. at 4:30 pm began to have body aches, more in my legs but generally all over. temp went up 1 degree. had these symptoms till the next day which began lessening about noon and by 4 pm they were gone except I had arm soreness and I have continued to have heavy headaches every day which is somewhat relieved by scalp massage and tyleno.. lingering effects of vaccinenone
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| 68 | 2021-03-06 | skin warm |
About 11 hours after receiving vaccine vomited repeatedly, had chills and then short periods of feel...
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About 11 hours after receiving vaccine vomited repeatedly, had chills and then short periods of feeling very warm. Taste was off- many foods just did not taste good. General body aches, ambulation unsteady, blood sugar went up to over 700. This lasted until about 11 the next morning.
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| 68 | 2021-03-06 | rash |
patient received 2nd dose of pfizer COVID vaccine in left arm on 2/27/2021. she reports on 3/2/202...
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patient received 2nd dose of pfizer COVID vaccine in left arm on 2/27/2021. she reports on 3/2/2021 that she developed a rash on her abdomen.
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| 68 | 2021-03-07 | rash macular, redness, dry skin |
1st Vaccine Injection: I developed small red spots on my arms and hands bilaterally, and also devel...
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1st Vaccine Injection: I developed small red spots on my arms and hands bilaterally, and also developed a red, rough, dry patch of skin on my left supra-pubic area for which I had continual itching for a period of 2 weeks. 2nd Vaccine Injection: I developed a cylindrical area on my supra-pubic area approximately 1 week after the injection, which continues intermittently at this time ( over 1 month later) becoming slightly red with a rough, dry patch of skin on the right side of the area.
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| 68 | 2021-03-07 | injection site redness, injection site swelling |
Fever, chills, joint pain, headache, swelling at the injection site. All but swelling resolved afte...
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Fever, chills, joint pain, headache, swelling at the injection site. All but swelling resolved after 48 hours. Injection site continues to have redness and swelling about 3 inches in diameter, 72 hours later.
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| 68 | 2021-03-07 | itchy rash, rash |
Five days after my 1st vaccine, I broke out in a rash on my inner arms, back of neck, top of both ha...
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Five days after my 1st vaccine, I broke out in a rash on my inner arms, back of neck, top of both hands and left side of my stomach area. Small red bumps (welt-like) and extremely itchy. No other symptoms. Just a rash.
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| 68 | 2021-03-07 | redness |
Patient developed swelling and redness in the face, tightness in the chest, and nausea in the stomac...
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Patient developed swelling and redness in the face, tightness in the chest, and nausea in the stomach.
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| 68 | 2021-03-07 | injection site pain |
SITE WAS SORE FOR A COUPLE OF DAYS; SLIGHT FEVER THE FIRST AND SECOND DAY; TEMPERATURE ROSE BUT NOT ...
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SITE WAS SORE FOR A COUPLE OF DAYS; SLIGHT FEVER THE FIRST AND SECOND DAY; TEMPERATURE ROSE BUT NOT MUCH. UPON WAKING DAY TWO, I HAD A VERY PRONOUNCED ACHE IN THE BACK OF LEFT SHOULDER AND THE ACTUAL SHOULDER BLADE WAS SORE AND PAINFUL TO THE TOUCH. I DID NOTHING THE FIRST DAY OF THE DISCOMFORT (THINKING IT WOULD GO AWAY). I NOW APPLY CBD/THC BALM ON THE AREA 3 TIMES A DAY AND I'VE BEEN TAKING EXTRA STRENGTH TYLENOL , TWO TABLETS, THREE TIMES A DAY. I AM SLEEPING IN A ZERO-GRAVITY MODE ON MY SLEEP NUMBER BED...OTHERWISE I CAN'T SLEEP AT ALL. I HAD A HOLE IN MY ROTATOR CUFF SURGUCIALLY REPAIRED ABOUT 18 MONTHS AGO AND THE PAIN I HAVE NOW ACTUALLY FEELS LIKE MY SHOULDER FELT BEFORE AND FOR AWHILE AFTER THE SURGERY! I AM BEGINNING TO WONDER IF THERE IS A RELATIONSHIP TO THE TWO EVENTS.
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| 68 | 2021-03-07 | injection site hardening | STIFFNESS AT THE INJECTION SITE. |
| 68 | 2021-03-07 | injection site pain |
Within 3.5 hours of receiving my 1st Pfizer COVID 19 vaccination injection, I developed a headache, ...
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Within 3.5 hours of receiving my 1st Pfizer COVID 19 vaccination injection, I developed a headache, EXTREME lethargy, initial chills and later on sweats, cold sensation at the roof of my mouth, and within 6 hours a sore arm at the injection cite. I ended up sleeping off and on for the next 29 hours. The headache, the lethargy and sore arm persisted past 24 hours. The headache was gone after about 28 hours. The sore arm was gone by the morning of the 2nd day (Monday). The lethargy lasted for 36 hours but was completely gone by the morning of the 2nd day (Monday).
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| 68 | 2021-03-08 | vaccination site hardening, skin mass |
Pt has erythematous, edematous, firm, hard nodule on L shoulder next to vaccine site. Appears vacci...
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Pt has erythematous, edematous, firm, hard nodule on L shoulder next to vaccine site. Appears vaccine was administered too high on the arm.
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| 68 | 2021-03-08 | shingles |
Shingles; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female p...
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Shingles; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration (Injected into left arm up high below the shoulder) on 04Feb2021 (at age of 68 years old) at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient experienced shingles on 05Feb2021. The outcome of event was unknown. She did not know if it was related and didn't care. Her concern was the ER doctor did not seem to be too concerned. The pharmacist thought she should call and let Pfizer know and tell her what to do next. She would like to know if she should continue to get next shot. She had not heard it was one of the side effects. She stated she was hoping she nipped it in the bud, but said it would get worse. If got shingles like any herpes virus, if take the medication at the onset, it help with the breakout. It still took two weeks to get out of system. She had a lot of fat and was not sure if it went into the muscle.
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| 68 | 2021-03-08 | shingles |
Shingles; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female p...
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Shingles; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on 05Feb2021. The outcome of event was unknown. It was reported that the ER doctor didn't think getting the second vaccine would be a problem and her pharmacist said there may be an issue and instructed her to call Pfizer for more information. Information about lot/batch number has been requested.
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| 68 | 2021-03-08 | itchy rash, hives |
Within 15-minutes of vaccination, the patient reported a diffuse pruritic rash with hives, dizziness...
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Within 15-minutes of vaccination, the patient reported a diffuse pruritic rash with hives, dizziness, blurred vision, and SOB. EMS evaluated the patient on-site. Patient was hypertensive (173/92). EMS administered 50mg Benadryl IV and 2L Oxygen via nasal canula. Given past medical history of allergic reactions, EMS transported the patient to Hospital Emergency Department. In the ED, the patient remained hypertensive. EKG demonstrated NSR, rate 75bom, no ST-T changes, no ectopy, and normal PR & QRS intervals. Blood work was unremarkable. After administration of Benadryl the patient noted improvement of their hives and was discharged with a diagnosis of allergic reaction secondary to COVID vaccine that caused acute hives.
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| 68 | 2021-03-08 | injection site pain, injection site swelling | couldnt stay awake, headache, disorientation, swollen and pain at site |
| 68 | 2021-03-08 | redness, itchy skin | throat closing, redness, itching generally |
| 68 | 2021-03-09 | rash macular, rash |
A rash 5" x 7" on my back, rash on neck; spots on various parts of the body; This is a spontaneous r...
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A rash 5" x 7" on my back, rash on neck; spots on various parts of the body; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 68-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ENS318, Expiry date: unknown), via an unspecified route of administration on 28Jan2021 at 08:30 am (age at the time of vaccination was 68-years-old) on left arm at single dose for covid-19 immunisation. Medical history included hypothryoidism, high blood pressure, C-Diff. The patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID), lisinopril, desvenlafaxine, solifenacin. The patient A rash 5" x 7" on my back, rash on neck, and spots on various parts of the body on 29Jan2021 at 07:00 am. The adverse event result in Emergency room/department or urgent care. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received Decadron IM 10 mg shot & Medrol 4 mg tab as treatment for the events. The outcome of the events was not recovered.
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| 68 | 2021-03-09 | itchy skin |
Patient received the Covid-19 vaccine. She reports symptoms of dizziness, high heart rate, sweaty. ...
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Patient received the Covid-19 vaccine. She reports symptoms of dizziness, high heart rate, sweaty. 1145: Patient states she feels like she has a sensation of swelling, itchy legs. Patient is requesting Benadryl. 1147 Benadryl 25mg given by RN. Phone call made to patient's son to come to the clinic to accompany patient home. 1217 Patient states she feels much better, slight dizziness. 1244 Patient's son arrived. Patient states she feels better and wanted to walk herself out of the clinic. Patient will contact her PCP if she has anymore questions or concerns. Vitals taken: 1135: 158/98 120 96% RA 16R 1142: 162/98 110 99% 2L 18R 1152: 160/92 83 98% 2L 18R 1244: 150/80 108 98% RA 18R Treatment/intervention patient was given: 25mg Benadryl PO
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| 68 | 2021-03-09 | itchy skin, rash with redness |
Swollen red area with small rash and itchy.Started two days after injection. Lasted for 4 days. Us...
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Swollen red area with small rash and itchy.Started two days after injection. Lasted for 4 days. Used antihistamine cream. Condition improved
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| 68 | 2021-03-09 | vaccination site pain |
got dizzy and almost passed out; got dizzy and almost passed out; had slight pain at injection site/...
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got dizzy and almost passed out; got dizzy and almost passed out; had slight pain at injection site/awoke with moderate pain (5/10); This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL9262), via an unspecified route of administration at the site of left arm at 12:45 on 28Jan2021 at single dose for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. Clinical course: patient was vaccinated about 12:45 pm with no ill effects. When she went to bed, she had slight pain at injection site. She awoke with moderate pain (5/10) about 1 am. She got up to get some paracetamol (TYLENOL). On the way to the kitchen, she got dizzy and almost passed out. She found a chair and rested. She went back to bed (with no paracetamol). No other problems. No other vaccine received in four weeks. No other medications received in two weeks. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. Adverse reactions did not result any serious consequences. The outcome of events was recovered on an unspecified date.
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| 68 | 2021-03-10 | itchy skin, redness, hardening |
Circular induration 3 cm Pruritus Erythema No treatment required. The 3 symptoms listed above are ...
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Circular induration 3 cm Pruritus Erythema No treatment required. The 3 symptoms listed above are still present. Symptoms are mild
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| 68 | 2021-03-10 | redness, injection site pain |
Heart Palpitations, uncontrollable Even Resting in bed,,, heart rate stayed double as normal to 15...
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Heart Palpitations, uncontrollable Even Resting in bed,,, heart rate stayed double as normal to 155 and flucuated between 130 - 155 for 2 days. Heart rate would not return to my normal rate of 62-68 BPM for 2 and half days. ALSO Left arm at injection site, pain and soreness. ALSO Left underarm to left breast, very sore, swollen lymp areas, left arm pit inflamed, red and swollen. 2 days since shot.. heart rate back to normal, but left arm and left underarm very sore, swollen
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| 68 | 2021-03-10 | rash, rash papular |
Patient is a 68yo F who received her first dose of Pfizer vaccine today. She developed an immediate ...
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Patient is a 68yo F who received her first dose of Pfizer vaccine today. She developed an immediate raised nonpruritic rash to the bilateral forearms. Denied any other symptoms including swelling, throat symptoms, CP, SOB, difficulty breathing, weakness, etc. Pt states she typically will have a rash reaction to many medications, vaccinations or other environmental agents. She was given 50mg Benadryl and patient observed for 35 min total. Rash resolved. No other symptoms.
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| 68 | 2021-03-10 | itchy rash, rash, rash with redness | Red itchy rash on lower legs.. also a bit swollen , red bumps Lasted for 3 days |
| 68 | 2021-03-11 | injection site reaction |
Complaint of "prickly" sensation after vaccine at site in L deltoid, down to full five fingers. Not...
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Complaint of "prickly" sensation after vaccine at site in L deltoid, down to full five fingers. Noted a bit of sciatic; has historically, not upon arrival. No apparent rash, itching, no shortness of breath; throat a bit dry. BP 142/80; pulse 62; p ox 98; fairly normal vitals for her. As sat and monitored, increased BP to 162/90. After 10-15 minutes, arm better; BP 148/76. Felt stable; wanting to leave as going to MD with husband. After walking in hall, felt "sharp pain in coccyx", lost balance and leaned on wall. BP 150/90. At this point, decided to be evaluated by ED; rapid response and transported by wheelchair.
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| 68 | 2021-03-11 | injection site pain |
Extreme soreness at injection site left arm Noted at approximately 8:00 AM 03/07/2021; difficulty l...
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Extreme soreness at injection site left arm Noted at approximately 8:00 AM 03/07/2021; difficulty lifting left arm at same time. Wave of extreme fatigue at approximately 10:30 AM 03/07/2021 fell asleep in chair until approximately 12:00 PM 03/07/2021. Upon awakening, could not lift my left foot until approximately 2-3 minutes later on 03/07/2021. My left foot was not asleep, I know the difference; it was like my left foot was paralyzed. When I was able to get up out of the chair I looked in a mirror to check for signs of stroke-SMILE. No signs, checked one eye at a time; equal vision in both.
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| 68 | 2021-03-11 | itchy skin, rash |
Patient received vaccine at local health department clinic on 2/18 and started experiencing itching ...
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Patient received vaccine at local health department clinic on 2/18 and started experiencing itching and a rash during the monitoring period. Also complained of nausea. Patient has h/o autoimmune disorder and rosacea. Took 50mg diphenhydramine prior to arrival in this reporters facility ED. patient states very anxious about receiving vaccine. symptoms resolving discharged home from ED
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| 68 | 2021-03-11 | shingles, rash |
Shingles with severe pain and rash, took acyclovir and oxy for pain. I was bedridden for 2 1/2 week...
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Shingles with severe pain and rash, took acyclovir and oxy for pain. I was bedridden for 2 1/2 weeks with pain,. Still having pain at the end of 4 weeks.
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| 68 | 2021-03-11 | shingles | Shingles, Valacyclovir |
| 68 | 2021-03-12 | injection site pruritus, vaccination site swelling | Extreme itching, swelling at vaccination site more than a week later |
| 68 | 2021-03-13 | injection site swelling, injection site pain | Pain in left armpit, swelling and soreness at injection site, fatigue |
| 68 | 2021-03-14 | rash papular |
68 yo female who received her 1st dose of Pfizer vaccine for covid 19 developed an immediate raised ...
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68 yo female who received her 1st dose of Pfizer vaccine for covid 19 developed an immediate raised non pruritic rash on her bilateral forearm. Patient denied any other adverse reaction. Patient reports a rash to be common with other IM injections of vaccinations. She was given 50mg Benadryl and was observed and monitored for 35 minutes following the administration. Patient was discharged home.
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| 68 | 2021-03-14 | injection site swelling, injection site pain, injection site redness, injection site rash |
I did not have any reaction at time of vaccine however one week later I developed rash, swelling, pa...
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I did not have any reaction at time of vaccine however one week later I developed rash, swelling, pain and redness at site of shot.
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| 68 | 2021-03-14 | injection site swelling, injection site redness |
Left-arm swollen and red from the injection site to elbow and hard to the touch. I woke up with th...
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Left-arm swollen and red from the injection site to elbow and hard to the touch. I woke up with this the morning after the injection. As of today 3/15/2021, the whole area is still swollen and red.
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| 68 | 2021-03-14 | rash with redness, itchy skin |
While reading in the waiting room I realized that I was scratching my hand vigorously because it itc...
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While reading in the waiting room I realized that I was scratching my hand vigorously because it itched so much. The underside of my arm looked redder, like it had a fine rash. I felt too weak to get up and walk to the desk (15 feet) where I was supposed to report such things. A worker was disinfecting chairs and came near, so I asked for his help. He let me hold his arm and took me back to the nurses. My pulse was slightly lower than my normal resting pulse rate, but blood pressure ok. They wheeled me to Urgent Care. My head was itching and I did not feel that I could stand up with any confidence. Eventually they gave me a shot of Benadryl (25 mg) and an oral medicine to soak up histimines in my stomach. I went home, where at around 4 PM I began to feel more normal. I took Benadryl the next day when I started itching again.
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| 68 | 2021-03-14 | injection site pain, injection site swelling |
chills, fever, congestion, extreme tiredness, swelling and pain at injection site, swelling of finge...
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chills, fever, congestion, extreme tiredness, swelling and pain at injection site, swelling of fingers, swelling under arm
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| 68 | 2021-03-15 | hives |
Burning in left arm then swelling. Immediately after. Then a few hives, then slight tongue swelling ...
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Burning in left arm then swelling. Immediately after. Then a few hives, then slight tongue swelling within 1.5 hours.
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| 68 | 2021-03-15 | shingles, rash |
First three days regular side effects, chills, fever, nausea and occasional dizziness (reported on a...
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First three days regular side effects, chills, fever, nausea and occasional dizziness (reported on app to CDC). Day 4 pain in right hip began. By day 7 rash had appeared on right buttocks and hip and below waist on right side. Day 12 formerly diagnosed with shingles.
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| 68 | 2021-03-15 | hives | Hives on face |
| 68 | 2021-03-15 | itchy skin, vaccination site mass |
afraid; lump formed at the site of the injection; Itches also; This is a spontaneous report from a c...
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afraid; lump formed at the site of the injection; Itches also; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), via an unspecified route of administration, in the left arm, on 09Feb2021 09:45 at a single dose (at the age of 68-years-old) for COVID-19 immunization in a public health department. The patient received the first dose of BNT162B2 (lot number: EL1283) on 19Jan2021 09:30, in the left arm (at the age of 68-years-old) for COVID-19 immunization. Medical history included asthma and known allergies with sulfa and penicillin (reported as "pennicillian"). Concomitant medications included losartan; amlodipine; potassium chloride (POTASSIUM CHLORIDE CR WM); and hydrochlorothiazide; all taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had a lump formed at the site of the injection appearing the second day (11Feb2021) after injection. The lump was not going away. Itches also. The patient did not know if she should see a doctor or not. The patient wanted to know if she should take Benadryl or take pain relief. The patient was afraid. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The events were considered non-serious by the patient. The patient has not recovered from the events.
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| 68 | 2021-03-15 | rash with redness, itchy skin |
severe itching and a red rash across a large area in my mid back area; severe itching and a red rash...
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severe itching and a red rash across a large area in my mid back area; severe itching and a red rash across a large area in my mid back area; This is a spontaneous report from a non-contactable consumer (patient). This 68-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; lot number El9265) via an unspecified route on 05Feb2021 at 11:30 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (lot number EL1283) on 15Jan2021 at 19:15 in the left arm for COVID-19 immunization. The patient previously received sulfa drugs from an unknown date for an unknown indication and experienced allergy. On 12Feb2021, the patient experienced severe itching and a red rash across a large area in her mid back area. The patient did not receive any treatment for the events. The outcome of severe itching and red rash across a large area in her mid back area was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 68 | 2021-03-16 | itchy skin |
ConstNt itching all over the body. I called my doctor and she advise cream over the counter. Now is ...
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ConstNt itching all over the body. I called my doctor and she advise cream over the counter. Now is not that bad, but I still itchy but not like before.
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| 68 | 2021-03-16 | injection site pain |
Got shot at 8:15am on 3/8/2021. Felt fine all day other than arm slightly tender & sore at shot site...
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Got shot at 8:15am on 3/8/2021. Felt fine all day other than arm slightly tender & sore at shot site. Went to bed around 11:30pm, woke up at 1am chilling & aching, freezing cold, couldn't get warm, added another blanket & went back to sleep. Woke around 6:30am on 3/9/2021 still achy & chilling & feeling headachy, took a Tylenol & went back to bed for an hour. Got up again around 7:30m, felt better & continued to slowly feel better throughout the day but just a little out of sorts all day. Felt much better on Wednesday 3/10/2021 but not completely 100% until Thursday 3/11/2021. I had the virus in January & the effects felt just like when I had the virus. I also understand the vaccine contains the virus to allow your system to make itself immune to it. I am a small person = 5' tall, 110 lbs. I wondered if the amount of the dosage I received was too strong for a small person. I understand that the same amount of dosage is given to each patient, but I'm sure it can affect smaller people differently than someone of more body mass. Anxiously awaiting my 2nd shot scheduled for March 29 and wonder if I will have adverse effects again. I will certainly watch for any next time. Hope this info helps.
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| 68 | 2021-03-16 | injection site rash, injection site reaction |
Patient called the day after her 1st Covid vaccine, stating she had developed a itchy rash at the in...
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Patient called the day after her 1st Covid vaccine, stating she had developed a itchy rash at the injection site.
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| 68 | 2021-03-16 | blister, itchy rash | itchy rash/blisters in toes and heel and sole of the feet |
| 68 | 2021-03-16 | rash, itchy skin |
she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; bu...
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she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; burning and itching with bleeding; swelling in lips; Blood in stool/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Blood leaking around rectum/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Face and Neck Burning/hot face and neck was flushed; hot face and neck was flushed; Tingling in tongue, lips, face; Tingling in tongue, lips, face; throat felt tight; lips were puffy; thought she was starting to shake; anaphylactic event; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration in left arm (left shoulder area) on 06Mar2021 17:45 at SINGLE DOSE for COVID-19 immunisation. The patient had no additional vaccines administered on same date of the Pfizer vaccine. The patient had no prior vaccination within 4 weeks. Medical history included upset stomach after eating banana's last year (2020). There were no concomitant medications. The patient had no family medical history relevant to events. The patient previously took bactrim and pneumonia vaccine and experienced anaphylactic reaction to both. On 06Mar2021, the patient experienced anaphylactic event, allergic reaction, face and neck burning, hot face and neck was flushed, tingling in tongue, lips, face, swelling lips, throat felt tight, and lips were puffy. On 07Mar2021, the patient experienced rash, blood in stool, blood leaking around rectum, burning and itching with bleeding. The patient further reported that she had a 'serious life threatening event' after first dose of the Pfizer Covid 19 vaccine on 06Mar2021. Hospital papers say 'anaphylactic event.' Tingling in lips tongue and face, hot face and neck after vaccine, swelling in lips, rash started yesterday evening (07Mar2021), bloody stools for a few hours yesterday evening (07Mar2021) but has resolved. The patient was seen in emergency room (ER) via ambulance. The patient asked if there was a chance the preservative in the vaccine caused her reaction and if the potassium in the vaccine causing her anaphylactic reaction. Additionally, the patient reported that she had a severe allergic reaction this past Saturday to the Covid Vaccine, stated the nurse sent her back to the pharmacist who told her she was having an allergic reaction to the vaccine. The patient reported having a hot face and neck was flushed, after the vaccine, she stated she had tingling in her tongue, lips, and face. And she stated her throat felt tight also, her lips were puffy, and a lot of heat of neck and face, thought she was starting to shake. The patient reported the pharmacist gave EpiPen in thigh and 20 mg tablet of Benadryl and called 911, and took her to the local hospital. Patient also reported that she has not seen this doctor yet she asked to see her and has an appointment with her. The patient also stated that her new PCP was not aware of the reaction to the vaccine at this time. The patient further mentioned that she was still having a rash that broke out. She reported that her tongue was tingling and she still has some swelling in her lips. Patient continues to clarify she still has swelling and some tingling on the tip of tongue and half back on her tongue. She stated that the swelling was persisting and that Benadryl or Prednisone does give some relief but it comes back. Patient mentioned being on a 4 day cycle of Prednisone, takes two in the morning with food. The patient clarified the location of the rash as a rash on both arms that was inside of both of the arms, like a pink rash, she states it was on face and on knees around the front and back of her knees like a red rash. She continues it was on the neck down to the collar bone around the back of her neck, like if she was a bust statue it would be all in that area from the collar bones at that point up and around the back of the shoulder blades. It goes all the way around face and neck. Patient also further reported that she had a scary reaction last night (07Mar2021), she said she had blood in her stool, leaking blood around rectum and it had like a burning itch, when she wiped it was blood, she continued to say when she wiped it was like 'giblets.' She stated was stool, blood, and giblets. Patient stated this lasted for about and hour and half or 2 hours until the stool stopped and it was about 1:30 am before she finally went to sleep, she was so tired on an unspecified date. She stated she took Benadryl right away. She continued to report the bleeding has resolved completely as of this point and reported a regular bowel movement today (08Mar2021). She has two Epi Pens from the drug store that was prescribed but she was afraid to use it, and she thought to see what happens if she uses the Benadryl. She received the Epi shot at the drug store, at (pharmacy), when her reaction broke out, on 06Mar2021, in her thigh, for the allergic reaction. This was her first time ever receiving EpiPen (Lot 029F20AA, expiration Mar2022, and NDC is 0093-5986-27). The ER doctor prescribed her 0.3 mg every 5-15 minutes as needed for anaphylaxis, and not to exceed 3 doses. She received the Benadryl at the drug store, 120mg tablet, first dose was given at drug store. Patient reported she was given prednisone IV in hand through IV at ER, she doesn't know how much that was, then was given Prednisone to go home with- 20mg tablets take 2 a day for 4 days, which she started Sunday morning, 07Mar2021. She was told she experienced a life threatening allergic reaction. Patient was taken to the ER in the ambulance, the paramedic who was with her said she was his first COVID reaction patient. ER doctor told her not to take the second dose of Pfizer vaccine, and to be cautious if taking the EpiPen, she states her heart was racing because of the EpiPen and was told it was because she was not younger that her body did not handle the Epi like younger people do and was told she could have a heart attack from the EpiPen. She was scared because she was not covered fully, since she can't get the second shot of Pfizer, and she was afraid of the Epi Pen, so she was really in a tough spot. ER doctor stated she may be able to take the Johnson and Johnson vaccine, as the second, but she needs to talk to her Primary care about that. The ER doctor continued to tell her it would have to be a special case where she was in a hospital setting in case she has another serious reaction, she was concerned for not receiving the second dose because that means she was not completely covered with one vaccine. She was afraid of the Epi-Pen since she can get a heart attack from it because of her age. The patient mentioned she was tested in Oct (clarified as 14Oct2020) for Covid due to having a viral infection at that time but was negative. Added the ER paper work says ED anaphylaxis. The patient wanted to ask about finding out the ingredients in Pfizer vaccine and the ingredients in the Johnson and Johnson vaccine. She saw the list on the fact sheet of Pfizer's ingredients and in a few places it says Potassium, 3 different ingredients, and several months ago, she quit eating bananas, bananas have potassium, and they were giving her stomach upset, diarrhea, she used to eat them all her life, she noticed that there was a lot of potassium in the medicine. Doctor wanted to know if she would be able to take the Johnson and Johnson vaccine. He said if she got the second shot, of the Johnson and Johnson, that it would have to be a special case, like in a hospital setting, and there would have to be medical people in a medical center, to take care of her was she has a reaction to it as well. He advised that she take the Johnson and Johnson than not taking it, because by not taking it, she was very vulnerable to catching COVID 19. And patient wanted to know was it a preservative that was causing the reaction. It was reported that rash began around 10PM, bloody stool began between 11 PM and 12:30 AM, all other symptoms within 15-20 minutes, it began around 6PM, maybe sooner 5:55 PM, she was in denial, it felt like tongue and lips tingling, she did have a reaction before to a different shot. The anaphylactic reaction required emergency room visit. Patient was not hospitalized and was in observation in ER. On 08Mar2021, the patient recovered from blood in stool, rectal bleeding, and burning and itching with bleeding. The patient had not yet recovered from severe allergic reaction, hot face and neck was flushed, tingling in tongue, lips, face; lips were puffy, and rash. The outcome of throat felt tight, thought she was starting to shake, she was so tired, and swelling in lips was unknown.
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| 68 | 2021-03-17 | injection site swelling, injection site bruising, itchy skin |
Arm swollen and black and blue at the site, 101 temperature for 5 hours, chills - took Tylenol and...
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Arm swollen and black and blue at the site, 101 temperature for 5 hours, chills - took Tylenol and iced arm as of this date arm is start to go down bruise getting bigger starting to itch
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| 68 | 2021-03-17 | injection site pruritus |
Immediately after injection, she had itching to the left arm site. She waited 15 minutes, then nurse...
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Immediately after injection, she had itching to the left arm site. She waited 15 minutes, then nurse asked her to wait another 15 minutes. Seen by physician with itching still present and given Benadryl 25 mg orally and watched another 20 minutes with resolution of symptoms.
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| 68 | 2021-03-17 | itchy rash, injection site pain |
Injection site pain12 hours after then chills fever up to 100 for almost 36 hours. Body aches especi...
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Injection site pain12 hours after then chills fever up to 100 for almost 36 hours. Body aches especially back hips neck . Itchy rash at end of fever andafter fever subsided lasted for five days. I typically with fever get a rash. Nausea, body aches all over swollen neck glands
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| 68 | 2021-03-18 | sensitive skin |
At first just a sore arm but on the 13th in the evening noticed burning in my legs which over the ne...
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At first just a sore arm but on the 13th in the evening noticed burning in my legs which over the next few days became severe there and moderate over other areas of the body with skin being very sensitive to clothes rubbing on it. This had happened before with the shingles vaccine given 10/11/2012 which was reported to VAERS. That resulted in two neurologist visits and an MRI finding nothing. But symptoms continued and Lyrica 50mg and 75 mg was needed to function and sleep. This lasted with varying degrees of intensity about the life of the vaccine and happened again with a Fluvirin given on 10/17/214 with symptoms starting on the 31st and lasting for quite awhile requiring Lyrica.
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| 68 | 2021-03-18 | injection site pain |
Heart flutters and tickling in bronchial tube for several hours. In the past when I had this reacti...
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Heart flutters and tickling in bronchial tube for several hours. In the past when I had this reaction to a different combination of medications, it progressed to spasms and I couldn't get my breath for several minutes. My reaction to the covid vaccine didn't progress to that degree, so I didn't report it. A friend suggested that I contact you to see if it is safe for me to take the second shot since the reaction is often stronger after the second dose. I am scheduled to receive that second shot Monday. My only other reactions to the first dose were chills and fatigue, and minor soreness at site of injection.
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| 68 | 2021-03-18 | injection site pain |
I had significant pain at site of injection starting about 1 day after initial injection. From that...
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I had significant pain at site of injection starting about 1 day after initial injection. From that time unitl now I experienced shoulder and muscular pain intermittently around the injection site and throughout my left shoulder region. Sharp pains occurred with certain movements and at unexpected time. On 3/18/21 I experienced serious pain at the injection site and radiating down my left arm. I was unable to move my arm due to the pain. The pain was so severe (10 out of 10) that I couldn't sleep and I was concern it might be a heart attack. I went to an urgent care center, They did an EKG and assuerd me that it wasn't a heart attack. The physican diagnosed a frozen shoulder and asked about the timing of my Covid vaccine. I followed up the next day with my primary care physician and he suggested I report this as possibly related to vaccination. The pain today is still centered right at the injection site.
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| 68 | 2021-03-18 | vaccination site pain |
Initial injection slight pain; I could not raise my left arm, very sore; I could not raise my left a...
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Initial injection slight pain; I could not raise my left arm, very sore; I could not raise my left arm, very sore; my hearing felt like I was in a bubble, continued to walk slow to my car still felt like head in a bubble; feel slightly dizzy; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number ), dose 1 via an unspecified route of administration, administered in arm left on 12Feb2021 (Lot Number: EN6201) as single dose for covid-19 immunization. Medical history included sulfa allergy (reported as sulfa based) from an unknown date and unknown if ongoing. Concomitant medications reported as in two weeks included unspecified allergy nasal spray. The patient previously took codeine and experienced allergy. On 12Feb2021, at 13:00, the patient experienced initial injection slight pain; I could not raise my left arm, very sore; my hearing felt like I was in a bubble, continued to walk slow to my car still felt like head in a bubble; feel slightly dizzy. There were no treatments provided for the events, and no noted COVID testing post vaccination. The outcome of events was not recovered.
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| 68 | 2021-03-18 | itchy skin |
Itching all over her body; tongue was numb; The initial case was missing the following minimum crite...
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Itching all over her body; tongue was numb; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 03Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/lot number: EL8982) via an unspecified route of administration in the left arm on 28Jan2021 15:55 (at the age of 68-years-old) as a single dose for COVID-19 immunization. The patient medical history included allergy to all antibiotic and eggs. The patient had no family medical history relevant to event. Concomitant medications were not reported. The patient previously received flu shot in Sep2020 for immunization in which she had no reaction. The patient did not administered additional vaccines on same date of the Pfizer suspect. On 28Jan2021, half an hour after the vaccination, the patient experienced a bad reaction-itching all over her body and her tongue was numb. She was still itching but was better; she has taken Zyrtec and all kinds of things for this event. The patient did not visit emergency room and physician office. The numb tongue had gotten better but then Monday it was numb again. She took more Zyrtec and it was better today. No relevant tests performed. The caller said she was really upset because her doctor told her that she cannot take the second vaccine due to her reaction. She wanted to know if she has any protection from just one dose. The outcome of the events was recovering.
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| 68 | 2021-03-18 | rash, skin warm, hives, rash with redness, itchy skin |
RECEIVED SECOND DOSE OF PFIZER ON TUESDAY (3/16) AND HAD SLIGHT HEADACHE THRU THE NIGHT, BUT TOOK NO...
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RECEIVED SECOND DOSE OF PFIZER ON TUESDAY (3/16) AND HAD SLIGHT HEADACHE THRU THE NIGHT, BUT TOOK NOTICE OF ITCHING ON RIGHT CALF ON THURSDAY. DISCOVERED I HAD A VERY RED RASH/HIVE? FROM MY RIGHT KNEE MOST OF THE WAY TO MY ANKLE AND SEVERAL SMALLER BLOTCHES. THEY WERE ITCHY AND HOT. USED SUNBURN LOTION WHICH HELPED SOME WITH ITCHING. IT SEEMS TO BE FADING BUT STILL ITCHY. THOUGHT IT SHOULD BE REPORTED...BUT CERTAINLY BETTER THAN COVID.
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| 68 | 2021-03-18 | injection site pain |
Two days after receiving the shot, in addition to soreness at injection site, both my arms and hands...
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Two days after receiving the shot, in addition to soreness at injection site, both my arms and hands suddenly started tingling, like pins and needles. That was on Feb. 11th, and now, March 19th I still have tingling everywhere from my neck down to my feet. Mostly arms and legs. It has gotten worse at times, then is milder, I notice it most when I try to fall asleep. The paresthesia keeps me awake or wakes me up. It also makes my heartbeat increase, along with hot flashes. I've been to the ER two times, have taken antihistimines but they do not agree with me. My doctor thinks it's a neuropathic reaction to the virus and will go away but it's been over 5 weeks and is still there. I will see a neurologist soon to rule out other possible causes, but I've never had paresthesia before, so think it must have been the Pfizer vaccine.
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| 68 | 2021-03-18 | rash |
Very painful skin rash on back and chest. Still spreading as of 3-12-2021 and preventing sleep. Doct...
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Very painful skin rash on back and chest. Still spreading as of 3-12-2021 and preventing sleep. Doctor prescribed triamcinolone acetonide 0.1% for two weeks maximum. Still symptomatic after 1 week twice a day but seems to be calming down.
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| 68 | 2021-03-19 | rash |
36h after first vaccine dose, started experiencing rash all over lower extremities. Rash still prese...
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36h after first vaccine dose, started experiencing rash all over lower extremities. Rash still present on 3/19/21. PCP advised against 2nd vaccine dose. No show on 3/19/21 appointment.
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| 68 | 2021-03-19 | injection site pruritus, bruising, injection site rash, injection site swelling |
Bruising, which is typical for me Exactly 10 days post vaccination, on 03/18/2021 I developed swelli...
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Bruising, which is typical for me Exactly 10 days post vaccination, on 03/18/2021 I developed swelling, rash and itching at injection site Uncomfortable, but not miserable Treating w/topical Benadryl during day and oral Benadryl at night
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| 68 | 2021-03-19 | itchy skin, rash | Head to toe rash and itching still evident on skin after 2 and a half weeks |
| 68 | 2021-03-19 | injection site pain, injection site pruritus |
Soreness and itching at injection site. Swollen lymph node on my collar bone. Soreness in left brea...
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Soreness and itching at injection site. Swollen lymph node on my collar bone. Soreness in left breast.
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| 68 | 2021-03-20 | pain of skin |
1st night: arm pain peaked in the middle of the night, but better by morning 3 days after injection...
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1st night: arm pain peaked in the middle of the night, but better by morning 3 days after injection: had pain in left shoulder blade and about 5-6" radius of very tender scalp that hurt to barely touch 4 days: left shoulder blade pain better....tender scalp remains 5 days: pain has moved up toward shoulder..lesser pain on scalp 6 days: left shoulder pain gone, but now have arthritis type pain in left shoulder and back area and neck area...still some scalp pain 7 days: continued arthritis type pain in left shoulder and back area and neck area...still some scalp pain 8 days: still a little arthritis pain in left shoulder and back area and still a little scalp pain for the shoulder blade, shoulder, back and neck pain, I used ice
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| 68 | 2021-03-20 | injection site redness, injection site warmth, injection site swelling |
Fever - 101; Muscle aches; Joint aches; Headache; Sinuses hurt; Chest hurt; Tired (All side effects ...
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Fever - 101; Muscle aches; Joint aches; Headache; Sinuses hurt; Chest hurt; Tired (All side effects were gone the next day with the exception of fever - I keep running a very low-grade fever 99.5 into day 3) 2nd day after injection - Injection site had redness going down to my elbow, very warm, and felt swollen
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| 68 | 2021-03-20 | vaccination site pain |
Minimal soreness at injection site; headache; some lethargy; This is a spontaneous report from a con...
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Minimal soreness at injection site; headache; some lethargy; This is a spontaneous report from a contactable consumer reported that: A 68-years-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EL3248; Batch/Lot Number: EK9231), dose 1 via an unspecified route of administration, administered in Arm Left on 16Jan2021 as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 06Feb2021 as single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus, patient is allergic to sulpha, tetracycline, shellfish, IV dye. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received concomitant medications from unspecified date at unspecified dose frequency and an unspecified indication included: sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE) phytosterols nos (CHOLESTOFF ORIGINAL), colecalciferol (VITAMIN D [COLECALCIFEROL]), acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID; ASCORBIC ACID]). On 16Jan2021 08:PM, the patient experienced minimal soreness at injection site, headache, some lethargy. Outcome of the events were recovered.
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| 68 | 2021-03-20 | redness, skin irritation |
No problems until around 1PM noticed a irritation, marked with bright red areas on inside of upper ...
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No problems until around 1PM noticed a irritation, marked with bright red areas on inside of upper portion of cheeks and some redness under top lip. Progressed quickly - and around 4PM noticed discomfort increasing. Around 1430 my upper lip began to swell and it looked like their was fluid under reddness. On my way to ER the swelling continued , and got worse traveling to the other side of my lips and above my lips to under my nose. While at ER my bottom lip started to also swell.
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| 68 | 2021-03-20 | shingles |
she developed shingles on the opposite arm of the vaccine arm; she is in a lot of nerve pain.; This ...
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she developed shingles on the opposite arm of the vaccine arm; she is in a lot of nerve pain.; This is a spontaneous report from a contactable consumer via medical information. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number : EK9231; expiry date : Apr2021) via an unspecified route of administration, in Arm Right on 05Jan2021 10:00 as single dose for protect against covid. The patient medical history and concomitant medications. The patient previously took mortin and had allergy ongoing, influenza vaccine (Flu shot) and had pain (She got a Flu shot 3 years ago in her left arm and the pain didn't go away for 9 months. States that for the next 2 years she got her flu shot in the right arm). Patient had the 1st dose on 05Jan2021, and was due next Friday for her 2nd dose, but she has come down with shingles on her opposite arm on 11Jan2021. She doesn't know if it has anything to do with the vaccine. Has it been reported before, and can she get the 2nd dose. Shingles was reported as worsened. She has shingles on the left arm, hand, wrist, and fingers; she was in a lot of nerve pain in Jan2021. The pain started 6 days after she got the vaccine; pain and tingling. Then 2-3 days later, she noticed some red marks by her elbow. She went to a clinic and was diagnosed with Shingles and was started on Valacyclovir 1gm tablet, 1 tablet 3 times daily for 7 days. The next day she called the doctor, and had a tele-visit and the doctor was able to see some lesions. She told the doctor how much pain she was in, so the doctor prescribed Gabapentin 100mg. She was told to start off with 1 daily at night to help with sleep because she wasn't sleeping because the pain was so bad, then after 5 days she can take 1 twice daily as needed. States that it hasn't been 5 days yet, so she was still only taking it once at night, and she was able to sleep over 4 hours at a time, which was great. She wishes she could jump ahead and start taking it twice a day already because she was in pain all day long, but she was following the directions. States that the pharmacist said she could take Tylenol in between, so that was what she is doing. States that she was getting more lesions, but they are faint and are mostly on the palms of her hands and in between her fingers. The outcome of the event Shingles was recovered 11Jan2021; for Nerve pain was unknown.
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| 68 | 2021-03-21 | injection site pruritus |
Runny nose and prickly skin like hives were going to occur. I took an eighth of 25 mg Atarax and Cla...
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Runny nose and prickly skin like hives were going to occur. I took an eighth of 25 mg Atarax and Clariton D. Again at night. The site was itchy. I used Benadryl cream and massage, which was affective. At no time did I feel sick or unable to go through my normal, retired life. Today is Monday. I am fine.
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| 68 | 2021-03-21 | bruising |
pain in arm, mild bruising, headache. Headache got worse on Wednesday , it is getting better today...
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pain in arm, mild bruising, headache. Headache got worse on Wednesday , it is getting better today. Patient has been taking Tylenol PM patient no longer has headaches, feeling much better. Taking Tylenol PM as needed.
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| 68 | 2021-03-21 | hives, rash |
severe rashes, hives, swollen joints, fatigue (sleeping 19-20 hrs/day), pending biopsy results expec...
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severe rashes, hives, swollen joints, fatigue (sleeping 19-20 hrs/day), pending biopsy results expected to confirm Sweet's Syndrome.
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| 68 | 2021-03-22 | injection site pain |
I had difficulty walking after approximately 27 hours of vaccination, severe pain in groin on both s...
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I had difficulty walking after approximately 27 hours of vaccination, severe pain in groin on both sides. Within approximately 48-72 hours I developed a severe bursitis on my left elbow, approximately 6 inches from the vaccination site - I had never had a bursitis before. The difficulty walking lessened after a few days, but I am still sore, possibly due to bursae by joints. I had a severe headache after approximately 48 hours which lasted for approximately 5 days. My arm is still sore at the injection site more than 2 weeks after the vaccination.
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| 68 | 2021-03-22 | pain of skin |
very painful arm for a week, nausea, muscle pains and weakness, sharp pains in knees, dizziness, bra...
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very painful arm for a week, nausea, muscle pains and weakness, sharp pains in knees, dizziness, brain fog, all my skin felt like it a bad sunburn its still not back to my normal state, cronic sinus issues for about 2 weeks with headaches,
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| 68 | 2021-03-23 | injection site mass | ROUND DIME SIZE LUMP ADJACENT TO INJECTION SITE. APPEARED SHORTLY DAYS AFTER REC. INJECTION |
| 68 | 2021-03-23 | rash |
Waited 15 minutes at clinic. Driving home felt tingling in tongue. Went to Hartford Hospital Urgen...
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Waited 15 minutes at clinic. Driving home felt tingling in tongue. Went to Hartford Hospital Urgent Care. Developed sunburn rash on arms and upper torso. Given 50 mg benadryl and prednisone injection at 2:52 PM. Observed for 90 minutes. Discharged with prescription for 40 mg prednisone for three days. Had telehealth appointment with Dr on 3/24. Told to continue with prednisone and avoid Pfizer boosters in the future. No breathing issues any time. Pulse ox before prednisone 98% after 100%. rash resolved.
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| 68 | 2021-03-23 | rash |
slight rash on chest; sore arm; This is a spontaneous report from a contactable consumer (patient). ...
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slight rash on chest; sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 20Feb2021 09:15 (Lot Number: EL9269) at the age of 68 years old as single dose for covid-19 immunisation. Medical history included known allergies: iodine, shellfish, penicillin, Cipro, Nitrofurantoin, wool. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced sore arm, slight rash on chest on 20Feb2021 15:30. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.
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| 68 | 2021-03-24 | injection site redness, injection site pruritus, hardening, bruising, hives |
A large bruise was evident when I removed bandaid night of receiving injection. 2 days later a large...
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A large bruise was evident when I removed bandaid night of receiving injection. 2 days later a large red ring- almost like a hive- was spread around the bruise and I could feel a hard knot in that area. There is also some itching at the site of the redness.
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| 68 | 2021-03-25 | rash with redness, rash | A large red rash on lower back Hydrocortisone cream Benadryl |
| 68 | 2021-03-25 | hives |
Two days after receiving the vaccine, and daily after that, I got hives in the morning. They were m...
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Two days after receiving the vaccine, and daily after that, I got hives in the morning. They were mostly on my upper legs, but on 24 March, I also had them on both buttocks. They would itch first, and then the hives would pop up. They would disappear after about 30 minutes to an hour for the rest of the day. But then, the next morning, I would get them again. I didn't know if it was from the vaccine or not. On 24 March, I decided to not take my Linzess the next morning because the hives always came out about 2 hours after taking it. I've been on Linzess for months, so I didn't really think that the hives were from that, but since I stopped taking it 2 days ago, I haven't had hives at all. Could it possibly be a contraindication from Linzess and the vaccine? I'm worried about getting the 2nd vaccine on 4/1.
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| 68 | 2021-03-26 | injection site pain |
All adverse effects have lasted for six (6) plus days post-injection unless otherwise indicated: inj...
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All adverse effects have lasted for six (6) plus days post-injection unless otherwise indicated: injection site arm sore, fatigue, sleepiness, joint pain, diarrhea, bad nightmares for four (4) nights and bad dreams (unusual for me) for two plus nights after (I had nightmares after the first covid shot, too), minor dizziness for three days, chills, depression.
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| 68 | 2021-03-26 | redness |
Paralysis of arm and hand on side (L) where vaccine was administered. Extreme pain (Fire -like) shoo...
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Paralysis of arm and hand on side (L) where vaccine was administered. Extreme pain (Fire -like) shooting up and down the leg on the opposite side (R) with very bad joint pain. This went off & on through the night/early morning in the first 22 hrs after vaccination. Woke with most pain gone, L hand red and sore, minor headache. Through out the following week I have experienced difficult pain and instability of some joints.
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| 68 | 2021-03-26 | injection site pain |
Severe pain at injection site does not go away so far(10 days after injection). I were taking Tyleno...
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Severe pain at injection site does not go away so far(10 days after injection). I were taking Tylenol, not help much.
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| 68 | 2021-03-29 | vaccination site pain, vaccination site redness, vaccination site swelling, vaccination site itchiness |
"covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking s...
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"covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; headache; slight fever; malaise; This is a spontaneous report from a contactable other health professional (patient herself). A 68-years-old contactable female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA, formulation: solution for injection. lot number: EN6202) vaccine via an unspecified route of administration, in left arm on 23Feb2021 18:45 as single dose for covid-19 immunisation. Medical history included hypersensitivity (allergies) to medications, food, or other products. The patient was not diagnosed with COVID-19 before vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin D and calcium. On 24Feb2021 at 15:00, the patient experienced "covid arm"-2.5-inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site, headache, slight fever, malaise. The reporter classified the events as non-serious. Treatment received for the adverse event was ibuprofen, ice and Benadryl. The outcome of events was not recovered.
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| 68 | 2021-03-30 | skin irritation, pain of skin |
Her left arm and face were numb; mass/swelling on her face; The left side of her face is drooping; f...
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Her left arm and face were numb; mass/swelling on her face; The left side of her face is drooping; face became swollen; face became swollen and inflamed; face was still swollen and sore; This is a spontaneous report from a contactable consumer (patient) and a contactable nurse. This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208, expiration date: 30Jun2021) via intramuscular in the left arm on 12Mar2021 at 14:10 at single dose for COVID-19 immunisation. Medical history included hyperlipidemia, pneumonia and flu. The patient had family medical history of diabetes. Concomitant medications included estrogens conjugated (PREMARIN) ongoing. The patient was not pregnant. The patient no other vaccine in four weeks or other medications in two weeks. The left side of the patient's face became swollen and inflamed. Five days later the left side of her face was still swollen and sore. The left side of her face was drooping. Events started date was 12Mar2021 at 15:00 PM. No treatment for AE was received, except events "mass/swelling on her face" and "Her left arm and face were numb". The patient had no COVID prior vaccination, no COVID tested post vaccination. A nurse reported that the 2nd dose was scheduled for 05Apr2021. The patient had last blood work (reported as BW) on Sep2020 with comments: normal. The left side of patient's face was drooping on 14Mar2021. The nurse stated patient went to ER. Her left arm and face were numb. They noticed a mass/swelling on her face. Outcome of the events "mass/swelling on her face", "Her left arm and face were numb" was unknown, of the other events was not recovered.; Sender's Comments: A contributory role of BNT162B2 to event the left side of her face is drooping is considered possibly based on temporal association and known safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-03-30 | vaccination site warmth |
It became very hot and it became black and blue; it bleed and went black and blue; It became very ho...
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It became very hot and it became black and blue; it bleed and went black and blue; It became very hot and it became black and blue; it bleed and went black and blue; It became very hot and it became black and blue; it bleed and went black and blue; My arm had gotten very swollen; I wasn't feeling well but I was light headed; I felt very fatigue; I wasn't feeling well but I was light headed; I felt very fatigue; I wasn't feeling well but I was light headed; I felt very fatigue; I might have a Strep throat for me; I began to feel my throat bothering me as of today my throat feels raspy; This is a spontaneous report from a contactable consumer (reporting for herself). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205, expiration date: unknown), via an unspecified route of administration in her right arm on 05Mar2021 as single dose for COVID-19 immunization. The patient medical history included allergy and had prosthetic left knee. Concomitant medications were not reported. The patient previously took tobramycin (NEBRACIN) for unspecified indication and experienced sensitivity. On an unspecified date, the patient reported that when she took the inoculation at that moment she developed a form of a response or reaction rather and they had to put her into the medical cubicle for observation and to treat her at that moment. Her arm had gotten very swollen. It became very hot and it became black and blue, it bleed and went black and blue and she was sitting in the medical cubicle for approximately an hour and a half until the medical staff said that she was really not to be and when she did leave she wasn't feeling well and she was light headed, her breathing was not anyway affected but she felt very fatigue. That itself now was not an issue. They started giving her ice on that particular area where the inoculation took place and she consistently for that an hour and a half used the ice on her right arm until she finally left an hour and a half later. As the weekend preceded, the patient began to feel that her throat bothering her as of today and her throat felt raspy. It was reported that she might and she was not sure because she has not gone to the doctor yet that she might have a Strep throat when she has an allergic reaction to something that her body does not accept very well. The outcome of the events was not recovered.
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| 68 | 2021-03-30 | vaccination site pain |
Soreness in left arm for two days.; This is a spontaneous report from a contactable consumer (patien...
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Soreness in left arm for two days.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female consumer (patient-non pregnant) received the first dose of the bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EN6201, Expiration Date: unknown), via an unspecified route of administration in Arm Left On 09Feb2021at 13:30 single dose for Covid-19 immunization. The patient medical history was not reported. concomitant medication included Levothyroxine, Pravastatin, Valacyclovir. The patient had not received other vaccine in four weeks. The patient was not diagnosed prior and post to the COVID-19 vaccination. On 09Feb2021 at 02:30 PM, the patient experienced soreness in left arm for two days. The outcome of event was recovered.
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| 68 | 2021-03-30 | rash maculo-papular |
angioedema/swollen lips, fingers and toes and slight swelling of tongue; diffuse blanching maculopap...
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angioedema/swollen lips, fingers and toes and slight swelling of tongue; diffuse blanching maculopapular eruption/itchy raised rash /Rash was wide spread and there was a concentration on injection site; This is a spontaneous report from a contactable consumer (patient herself). A non-pregnant 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202), via an unspecified route of administration, administered in arm left at the age of 68 years old on 25Feb2021 18:00 at single dose for covid-19 immunization. Medical history included high blood pressure, hashimotos thyroditis, eczema, osteopenia, hepatitis b, and allergies to penicillins, erythromycin nitrofuran analogues, oxycodone. Concomitant medications included metoprolol and hydrochlorothiazide. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient began to develop itchy raised rash on 05Mar2021, 8 days after 1st injection. Rash was wide spread and there was a concentration on injection site. Took Advil and Claritin and used cold packs. On morning of 08Mar2021 patient awoke to swollen lips, fingers and toes and slight swelling of tongue. Went to urgent care. Diagnosed with angioedema and diffuse blanching maculopapular eruption. Placed on steroid pack and cetirizine. Because of time lapse between injection and rash, the patient sought counseling on whether or not to proceed with second shot. Treatment Steroids and antihistamine were received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. Event result in emergency room/department or urgent care. Events were reported as non-serious, no seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 68 | 2021-03-30 | redness |
blood pressure was checked and it had skyrocketed to 204/110; blood pressure had dropped to 95/58; s...
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blood pressure was checked and it had skyrocketed to 204/110; blood pressure had dropped to 95/58; she was lightheaded; feel chest pressure; facial flushing and warmth; facial flushing and warmth; redness on her neck and chest; This is a spontaneous report from a contactable retired registered nurse (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right deltoid on 06Mar2021 10:09 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for anaphylaxis prophylaxis; famotidine (PEPCID) taken for anaphylaxis prophylaxis; cetirizine hydrochloride (ZYRTEC) taken for anaphylaxis prophylaxis; methylprednisolone acetate (MEDROL) taken for anaphylaxis prophylaxis. The patient previously received H1N1 vaccine (Sanofi Pasteur, lot number: UP006AA, expiry date: 15Mar2011) on 27Oct2009 and experienced anaphylaxis. Patient had no other vaccines on the same day as the suspect product. The patient experienced blood pressure was checked and it had skyrocketed to 204/110 (hospitalization (from 06Mar2021 to 08Mar2021)) on 06Mar2021, felt chest pressure on 06Mar2021 10:29, facial flushing and warmth on 06Mar2021 10:29, redness on her neck and chest on 06Mar2021 10:29, she was lightheaded on 08Mar2021, blood pressure had dropped to 95/58 on 08Mar2021 21:43. Clinical course: Caller states that she received her first dose of the product on 06Mar at 10:09am. Caller states that to provide some history, in Oct2009, she had anaphylaxis from the H1N1 Vaccine and in 2017, she finally found an allergist who specialized in medication allergies. Caller states that since then, any time she takes the Flu Vaccine, she pre medicates with a combination of antihistamines and a proton pump inhibitor. Caller states that in preparation of the COVID vaccine, her allergist prescribed her a Medro Dose pack and antihistamines and a proton pump inhibitor for preparation, starting three days prior to the vaccine, in order to prevent anaphylaxis. Caller states that 20 minutes post receiving the vaccine, she started to feel chest pressure, she had facial flushing and warmth, and redness on her neck and chest. Caller states that her blood pressure was checked and it had skyrocketed to 204/110. Caller states that she did not have anaphylaxis though. Caller reports that with her blood pressure being so high, they had to call paramedics, and the caller went via ambulance to the ER at about 1130am on 06Mar2021. Caller states that she spent 6 hours in the ER, and then she was put in the hospital for the next two days. Caller reports she was admitted to the hospital for her blood pressure because the ER could not get it below 185 systolic. Caller states that all her labs were negative for everything, and they checked heart attack markers that were all negative. Caller had an EKG and a stress test and those were both negative as well. Caller had blood work done, EKG and stress test that were all normal. But caller states that it took a while to get her blood pressure down. Caller states that she was talking with her allergist and he said that if she gets the second dose of the vaccine, it would need to be in a hospital setting, with an IV already in place, and caller does not think insurance will cover all that. Caller states that she did speak with an Infectious Disease doctor, who told the caller that she needs to get the second dose of the product for COVID coverage, but how would the caller move forward with getting the second dose, following what happened to her? Caller is wondering how much protection the vaccine provides after just one dose? Caller is also wondering, the hospital gave her at least two or three doses of Solu-Medrol, and caller is wondering if having received steroids in the hospital would reduce the efficacy of the COVID vaccine, and if so, by how much? Event Details: Caller had the vaccine, and the reaction started on 06Mar2021, and she was admitted on the same day. Caller was discharged from the hospital on 08Mar2021 around 330pm. Caller reports that the morning of her discharge from the hospital, her blood pressure had gotten back to 135 systolic, but before it was time for her to go down for the stress test, it was back to 159, and down while she was in nuclear medicine, it got to 160 systolic. Caller reports that the day she was discharged, she went home and got settled in, and she took her blood pressure and it was down to 128/78, but then that evening, things got spinning around her, and lights were flickering in her head, and she was lightheaded, and her blood pressure was 110/63 at 9pm and by 9:43pm, her blood pressure had dropped to 95/58. Caller states that it has not been a fun trip. Caller reports that the next morning, her blood pressure was back up to 139/78, but then later in the day she was lightheaded again, and by 9am her blood pressure was 111/69. Caller states that since then, her systolic blood pressure has been between 110 and 126. Caller states that there is nothing else she can think of. Caller states that she felt fine the morning of getting the COVID vaccine, she was looking forward to getting it, and she got herself on the list and made sure to consult with her allergist so that she would have prophylactic medications ready to go. Caller states that she does have a history of hypertension, but her blood pressure was 128/72 the morning of getting the COVID vaccine. The outcome of the events Blood pressure high and Blood pressure dropped was recovering, of the other events was unknown. The reporter considered the event blood pressure had skyrocketed to 204/110 was related to the suspect vaccine.; Sender's Comments: Based on the temporal association and known drug safety profile, a possible contributory role of vaccination with BNT162B2 to the reported event blood pressure increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 68 | 2021-03-30 | vaccination site redness, vaccination site warmth |
injection site became warm, firm, and had redness in a ring around the needle site; injection site b...
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injection site became warm, firm, and had redness in a ring around the needle site; injection site became warm, firm, and had redness in a ring around the needle site; injection site became warm, firm, and had redness in a ring around the needle site; soreness/pain; This is a spontaneous report from a contactable consumer. A 68-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 29Jan2021 11:15 as single dose for covid-19 immunisation. Medical history included hypertension, bacterial throat infection 4 weeks prior to vaccination with petechaie treated with azithromicin which resulted in an allergic reaction of itching and mild skin rash. Concomitant medication Losartan 50 mg, fish oil 500 mg, colecalciferol (VITAMIN D3 1000). The patient had allergies to penicillin, sulfa and azithromycin. On an unknown date two weeks after the vaccine the patient experienced injection site became warm, firm, and had redness in a ring around the needle site and soreness/pain. She had redness, soreness, warmth, and pain after the injection for about 2 days. No treatment was given to the patient for events.The patient had no Covid prior vaccination. Patient was not Covid tested post vaccination. Patient did not received other vaccine in four weeks The outcome of the event was not recovered.
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| 68 | 2021-04-02 | vaccination site pain, vaccination site warmth |
Fatigue; soreness at injection site; warmth at injection site; diarrhea; This is a spontaneous repor...
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Fatigue; soreness at injection site; warmth at injection site; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 07Feb2021 14:15 (at the age of 68-years-old) as single dose for COVID-19 immunization. The patient medical history included Hypertension, Atrial fibrillation, Mitral Valve Prolapse. No known allergies. The patient concomitant medications included Lisinopril, Metoprolol, Eliquis, Calcium, Biotin. On 08Feb2021 09:00 AM patient experienced fatigue, soreness at injection site, warmth at injection site, diarrhea. No other vaccine in four weeks. No COVID tested post vaccination. No COVID prior vaccination. No treatment received. The outcome of the event was not recovered.
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| 68 | 2021-04-06 | rash |
Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vo...
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Fever chills nausea from 10.30 pm 23 march 2021. Wednesday same. Wednesday evening extreme nausea vomitting fever severe trembling and chills. During the night nightmares and migraine woke me up. Tried to go to the bathroom but collapsed and knocked my head on the wall. Could not get up crawled to the bathroom and tried to pull myself up but fell headfirst and hit my nose and cheek on the toilet. Cut nose and hurt cheek bone. Felt terrible head spinning and unable to get up/ Crawled to bed; Live alone. Could not even find the telephone; Woke up and tried to get up. Freezing cold. Finally called Ambulance Their doctor refused to send an ambulance and said " go to your GP its not an emergency". I was disgusted barely could walk but somehow drove to the GP. he was closed so went to emergency. the Dr in charge of the vaccination center was there but did not accept it was the vaccine; Finally on the verge of collapse another lady took me to the entrance of emergency. I was finally seen:; Same thing. Dr there told me its not an emergency and to go and see my GP. I was so sick and told him th eGP was not there; His reply " There are plenty of others to see" It was the nurse who persisted and even thought may be I had covid and did the PCR test. I started uncontrollably shivering and was freezing. I had a fever. they did blood tests lung x ray and finally a urine test, Full of blood leucocytes and protein. The same wonderful nurse said its bad. I was by then vomitting again and thought I would die; Uncontrollable shivering ; taken to the lab or a pelvic cat scan;Couldnt even get to sip water. SEVEN hours later the same DR who told me I was not an emergency came in and said " You will have to be hospitalised as you have a serious kidney infection. Acute pyelonephritis. I vomitted on him! Taken to a ward 25 March until 29 March. Rocephin antibiotics. Allergy to that too with migraines and skin rash; They changed the antibiotics. After five horrible days I finally went home on antibiotics Ofloxacine
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| 68 | 2021-04-06 | itchy skin |
pulse went up; Itchy all over her body; blood pressure was elevated; Very tired/fatigue; This is a s...
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pulse went up; Itchy all over her body; blood pressure was elevated; Very tired/fatigue; This is a spontaneous report from a contactable physician. A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 11:20 (at the age of 68-years) as single dose for COVID-19 immunization. Medical history included multiple allergies. There were no concomitant medications reported. Her cousin had a similar reaction to flu vaccine. On 20Mar2021, The patient experienced pulse went up, blood pressure was elevated, very tired and fatigue on 20Mar2021.On 22march, the experienced itchy all over her body. The patient was hospitalized for pulse went up from 20Mar2021 to 21Mar2021. The other events (blood pressure elevated, tired/fatigue, itchy) were reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: it was 132/86 on 20Mar2021. At 18:15 pm elevated to 146/91, heart rate: pulse went up to 125 and stayed up for many hours on 20Mar2021 pulse of 118, at 18:15 pm pulse of 153. Therapeutic measures were taken as a result of pulse went up. The outcome of increased heart rate was recovered, elevated blood pressure and pruritus was recovering and fatigue was not recovered Additional information on lot/batch number has been requested.; Sender's Comments: Based on the information currently available and plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events pulse went up, blood pressure was elevated, very tired and fatigue, and itchy all over her body cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 68 | 2021-04-12 | itchy skin, redness |
full-blown narrow angle glaucoma/ she had narrow angle glaucoma before/had not had any attacks and w...
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full-blown narrow angle glaucoma/ she had narrow angle glaucoma before/had not had any attacks and was not on any medication for it previously; full-blown narrow angle glaucoma/ she had narrow angle glaucoma before/had not had any attacks and was not on any medication for it previously; Hands and wrist got red and itchy; Hands and wrist got red and itchy/ Back of right leg was itchy; Back of right leg was itchy and had a couple of bumps; This is a spontaneous from a contactable nurse (patient). A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) at the age of 68-years-old, intramuscular in left arm on 12Jan2021 at 08:40 at single dose for COVID-19 immunization and paracetamol (ARTHRITIS PAIN RELIEVER ACETAMINOPHEN, lot number: 9ER0473, expiration date: Mar2021), via an unspecified route of administration from an unspecified date at an unspecified dose and frequency for an unspecified indication. Medical history included narrow-angle glaucoma; arthritis probably on 2000 in which she had both knees replaced in 2016, she has had different issues with arthritis since then; and hypertension. The patient has no known allergies. Concomitant medications included lisinopril for hypertension and naproxen sodium (ALEVE). No additional vaccines were administered on the same date as BNT162B2. The patient received a flu shot on Dec2020. She experienced worst arm pain from the newer pneumonia shot. She thought it was the Prevnar. The older one she did not have. On 12Jan2021 at 18:00, about 8 hours after vaccination (as reported) which was administered in a hospital, the patient experienced a full-blown narrow angle glaucoma. She was told that she had narrow angle glaucoma before. She saw a doctor prior to this though, back in Nov2020, for a routine visit and everything was normal. She had not had any attacks and was not on any medication for it previously. That night of the vaccine, she had rainbow colored halos around both eyes. She called her ophthalmologist and spoke to the doctor who was on call that night. He wanted to see her the next morning. Her pressures were a little high and they started her on drops. She then saw her regular ophthalmologist that afternoon. She had been seeing him every 4 months for the narrow angle glaucoma previously and had been fine since her last visit in Nov2020. It seemed like a coincidence. She reported since she knew it would take a while for all of the data to come back and she has not gotten the second one. The specialist said it could be triggered from the vaccine. Name of the drops she put on was Alphagan P. She no longer has it. She believed it was 1%, one drop in each eye, twice daily. She was taking a sample of that and currently, was taking generic Brimonidine 0.2% ophthalmic solution, 5mL, one drop in each eye twice daily. The patient was also on pilocarpine hcl. She went to an institute for a specialist. Nobody saw if there was anything in the literature. She reported to VAERS. She was calling to see if Pfizer has heard if there were any other cases. Someone did call her back and she tried to search the data base. She was not very tech savvy. She has not had any problems. Nothing like that before hand. No problem since then. She has no known allergies. The only other thing was weird was that on 12Jan2021 at 16:00, 6-8 hours later (as reported), both her hands and wrist got red and itchy, to the point she went outside and stuck them in a snow bank. She did not have an anaphylactic reaction. She then said maybe some transient itching in other places and mentioned some bumps on the back of her right leg that were itchy. She did not know if it was worthy of reporting. She used to be 5 feet. She shrunk and it occurred before the vaccine. It was age related. The next dose, she may get the Johnson and Johnson, something that does not have the MRNA in it. She did not have to go to the hospital, but saw 3 different doctors for appointments for glaucoma. She needed significant intervention based on that. It was the beginning of using eye drops, which she never had. When she went to bed, she still had the halo's and when she woke up, they were gone. So, they went away on their own some time during the night. Her pressures were still elevated in her eye though compared to normal. When she went in at 08:00, the visual check was not as good as it normally was. She did not know, but guesses she was 20/40 and normally was about 20/25. It just wasn't as good as it was prior. Now it was back to 20/25. She mentioned that she takes some over the counter stuff and lisinopril for blood pressure. She took ALEVE afterwards but she takes Aleve every day. About 4 pm, she also took TYLENOL. She could not take antihistamines or decongestant because they could trigger. She was looking at the vaccine to see if there was an ingredient that could have caused it and she did not find anything. She wanted to make sure the TYLENOL did not cause it. She was just looking at other variables. That was the one thing that was not normal to her. She was just trying to figure it out. She almost never takes TYLENOL and may have gotten rid of it. She then clarified that it was generic, ARTHRITIS PAIN RELIEVER ACETAMINOPHEN. She only took one. Once you think you are itchy, then everything is itchy. She used a mirror to see the back of her leg and was able to see her hands. She did not see any other bumps or redness though. She did not do anything about itchiness or redness. It got her attention, but she did not talk to any doctor about it. It went away. When it happened, she was concerned. She did not know how to characterize it. Somewhere between not serious and medically significant. She did not seek treatment for it. She was unable to confirm seriousness of bumps on her leg as well but mentioned that it went away. She was unable to determine if it was going to get worse. She could not take BENADRYL because of her eyes. She could not even treat it and take an antihistamine. The action taken in response to the events for paracetamol was unknown. The outcome of the events was recovered on an unspecified date in 2021. The events "angle full-blown narrow angle glaucoma/ she had narrow angle glaucoma before/had not had any attacks and was not on any medication for it previously", "Hands and wrist got red and itchy", and "Hands and wrist got red and itchy/ Back of right leg was itchy" were assessed as serious medically significant.; Sender's Comments: Based on the close temporal relationship, the association between the events "angle closure glaucoma aggravation, erythema, and pruritus" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 68 | 2021-04-14 | rash with redness, rash, skin spots, bruising |
Covid Vaccine related ITP.......red pinpont rash on both legs, blood blisters on lips, tongue, gums ...
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Covid Vaccine related ITP.......red pinpont rash on both legs, blood blisters on lips, tongue, gums and roof of mouth, blood streaks and bruises all over body, platelets dropped to 0 more than once. I was in Urgent Care, 2 ER's and hospitalized from March 14-24, 2021. I was given 84 bottles of immunoglobulin intravenously and high potency steroids (90 mg., 80 mg.). This did not bring my platelets up so our daughter contacted the wife of the physician who passed from this after his vaccine who in turn gave our daughter the name of another physician who had seen and treated this after the Covid vaccine. He,together with my physicians, came up with an aggressive treatment plan for me. I was given one Vincristine treatment and injections of Nplates to jumpstart my body. This had never before been seen where I was located, as the Covid vaccine is so new. I was a perfectly healthy woman who only took vitamins and had not even had a cold all winter. Everything else was ruled out.
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| 68 | 2021-04-17 | cellulitis, rash |
She had a horrible rash and cellulitis; patient travelled to Florida and got very sick and went to a...
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She had a horrible rash and cellulitis; patient travelled to Florida and got very sick and went to a clinic there.She had a horrible rash and cellulitis and was treated with antibiotics.She still is not ok but the rash is much better; She had a horrible rash; This is a spontaneous report received from a contactable pharmacist. A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 17Mar2021 (Batch/Lot Number: ep6955) (at the age of 68-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if patient had been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 intramuscular, administered in Arm Left on 25Feb2021 (Batch/Lot Number: EN6200) as a single dose for COVID-19 immunization. On 17Mar2021, the patient travelled to florida and got very sick and went to a clinic there. She had a horrible rash and cellulitis. The events result in doctor or other healthcare professional office/clinic visit. She still was not ok, but the rash was much better. Therapeutic measures were taken as a result of events included antibiotics (unspecified). The outcome of the event rash was recovering, and other events was not recovered.; Sender's Comments: The event cellulitis most likely represents intercurrent medical condition that is assessed as unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-04-18 | skin tightness |
01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21 4 days later I e...
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01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21 4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
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| 68 | 2021-04-20 | vaccination site swelling, cellulitis |
cellulitis; swelling on left arm/vaccine location= Left arm; Aches and pains; This is a spontaneous ...
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cellulitis; swelling on left arm/vaccine location= Left arm; Aches and pains; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 18Mar2021 14:00 (at 68-years-old) as single dose for COVID-19 immunization. Medical history included CLL, known allergies: penicillin. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2, on 25Feb2021 11:00 AM (at 68-years-old), administered in Right arm for COVID-19 immunization. Facility type vaccine was in Pharmacy or Drug Store. The patient did not have other vaccine in four weeks, the patient had other medications in two weeks. Patient had no covid prior vaccination, and had not been tested for covid post vaccination. The patient experienced swelling on left arm followed by cellulitis within three days, went on cephalexin 500 mg three times a day for seven days. Aches and pains continuing since then. Aches where she have never ached before. And she was in great shape so this is an unwelcome surprise. Events started on 21Mar2021 15:45 with outcome of recovered with sequelae. Information on lot/batch number has been requested.
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| 68 | 2021-04-23 | rash |
Increased blood pressure/Blood pressure was high/Blood pressure went up to 176/102; High heart rate/...
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Increased blood pressure/Blood pressure was high/Blood pressure went up to 176/102; High heart rate/Heart rate went up to 122; Mild rash; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# EL9269), via an unspecified route of administration on 30Jan2021 (at the age of 68-years-old) as single dose for COVID-19 immunisation. Medical history included ongoing hypertension, connective tissue disorder. Concomitant medication(s) included TRIAM HCTZ, amlodipine, hydroxychloroquine, cyclobenzaprine, KLOR-CON (It's Potassium CLCRWM Tablet). On 30Jan2021 (Monday, same day of vaccination), patient experienced increased blood pressure/blood pressure was high/blood pressure went up to 176/102, high heart rate/heart rate went up to 122, mild rash. Patient went to EMT and tested for vitals. And that's when blood pressure and heart rate were found to be high. Therapeutic measures were taken as a result of events included Benadryl. The patient underwent lab tests which included blood pressure: increased/high/went up to 176/102 and heart rate: high/went up to 122 on 30Jan2021. Patient was just leery of taking the Pfizer for second shot because of the problem the high blood pressure and the heartbeat and would like to find out if she can for second shot and can get another vaccination. The outcome of the events was unknown.
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| 68 | 2021-04-23 | vaccination site itchiness, vaccination site redness |
Noticed a 3 quarters of an inch area at injection site that looks like a mosquito bite that has been...
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Noticed a 3 quarters of an inch area at injection site that looks like a mosquito bite that has been scratched; Feel mild itchiness at vaccination site; Redness at the injection site with a diameter of 3/4 inch; This is a spontaneous report from a contactable Consumer. This 68-year-old non-pregnant Caucasian female Consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an Intramuscular injection in left arm on 25Jan2021 at 15:45 as a single dose for COVID-19 immunization. The patients medical history included allergic to penicillin. The patients concomitant medications were not reported. The patient did not undergo any investigations. The patient had not received any additional vaccines on same day of the COVID vaccine. The patient had not received any vaccines with 4 weeks of vaccination. The patient received other unspecified medication with 2 weeks of COVID vaccination. Prior to vaccination the patient was not diagnosed of COVID-19. Post vaccination the patient was not tested for COVID 19. On 02Feb2021 at 14:00, 8 days late, the patient noticed a little bit of itchiness. The patient did not think much of it and the patient did not think it was anything really noticeable, but her husband told her that she had some mild redness. On 03Feb2021, the patient noticed 3 quarters of an inch area that looks like a mosquito bite where it gets bigger and redder as one scratches. The patient not scratching the area, but it looks the patient had a mosquito bite and scratched it. She confirms this was located at the injection site of her left arm. The patient explained that this area at the injection has not got any worse. It was the same. It just started; she did not imagine it was going to get any worse. The patient did not require any emergency room or physician office. The patient did not receive any treatment for the events. While she was sitting on hold waiting to speak to someone, she was reading online and found a doctor that had the same reaction as her except it was with Moderna's vaccine, and the patient also found others that had what they call an 8-day reaction. From reading these articles, it seems she has this reaction because its building up her immune system. The caller just wanted to make sure this is okay and that she can received the second vaccine. Caller states what she read was that it was okay to receive the second vaccine but just to receive the second one in her other arm. Outcome of events was not recovered.
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| 68 | 2021-04-24 | vaccination site pain |
fever 103.4; Injection site pain; tiredness; headache; chills; joint pain; nausea; This is a spontan...
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fever 103.4; Injection site pain; tiredness; headache; chills; joint pain; nausea; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old non-pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 30Mar2021 at 10:45 (Batch/Lot number was not reported) as a single dose (at the age of 68-years-old) for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing, and high cholesterol from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included pravastatin at 40mg taken for an unspecified indication, start and stop date were not reported; benazepril at 20mg taken for an unspecified indication, start and stop date were not reported; and esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) at 40mg taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever 103.4 on 31Mar2021 at 20:30, injection site pain on 31Mar2021 at 20:30, tiredness on 31Mar2021 at 20:30, headache on 31Mar2021 at 20:30, chills on 31Mar2021 at 20:30, joint pain on 31Mar2021 at 20:30, and nausea on 31Mar2021 at 20:30 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 103.4 on 31Mar2021. Treatment was not received for any of the events. The outcome of the events fever 103.4, injection site pain, tiredness, headache, chills, joint pain, and nausea was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 68 | 2021-04-27 | injection site discomfort |
4-23-21 Discomfort at injection site, otherwise feeling very good. 4-25-21 At approx. 10 PM exper...
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4-23-21 Discomfort at injection site, otherwise feeling very good. 4-25-21 At approx. 10 PM experienced rapid onset of acute nausea and mild vertigo. 4-26-21 After a sound night's sleep by 7 AM, the above (4-25) symptoms diminished. However, by 10 AM nausea symptoms became acute AND vertigo symptoms markedly increased, making the room look like it was spinning. Patient was able to bed rest until 1 pm and felt much better with symptoms markedly diminishing to low level 'dull nausea'. 4-27-21 After sound sleep, all above symptoms tapered off, leaving patient with very low energy level, yet able to perform ADLs--and feeling more homeostasis by 8 PM.
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| 68 | 2021-04-30 | vaccination site pain, vaccination site swelling |
today she is off kilter again; feels a heaviness in her eyes; all that coughing like something is ir...
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today she is off kilter again; feels a heaviness in her eyes; all that coughing like something is irritating her lungs and she can't stop; it was making her lungs hypersensitive.; all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2; burning in her stomach and a stomach ache; burning in her stomach and a stomach ache; never has that much energy when she was normal/had tons of energy; woke up on day 4 in the middle of the night and her lungs were pinching, pinching, pinching, like and asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it; tired; had weakness with climbing stairs and with exertion/ zapping her energy; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 07Apr2021 14:40 (lot number: EW0150) at age of 68 years as single dose for COVID-19 immunisation. Medical history included low vitamin D, lungs were working at 75% the capacity of an 84 year old and not 68 year old and asthma attacks. Concomitant medications included vitamin D2 and D3 and regular vitamins for low vitamin D, had been taking that for 6-7 weeks, tiotropium bromide (SPIRIVA RESPIMAT) 2.5mcg takes 2 inhales a day in the morning and salbutamol sulfate (PROAIR) 2 puffs and a special medication because her lungs were working at 75% the capacity of an 84 year old and not 68 year old and put her on an asthma medication to open her lungs. Patient got a flu shot every year and got it in Jan2021 and nothing. Patient stated that her symptoms were mild. Patient stated on day 1 after she got the shot she had nothing, that was 07Apr2021. Stated the next day (08Apr2021) she did not have injection site soreness but 2 inches below the injection site the muscle was hard and swollen and sore and remained that way for days 2, 3 and about day 4 it started to recede and day 7 it was tender. Stated it was one muscle and it was below the injection site, not at the injection site. Stated it was a lifting muscle, if she lifted her arm up it could only go so far and she would feel it and drop her arm down. Stated she got the injection in her left arm as she used it the least. Stated on days 2 (09Apr2021), 3 and 4 she had weakness with climbing stairs and with exertion, she could do it but she would notice it was more of a struggle. Stated that today she was off kilter again. Patient relayed that she looked all over online to see if she was sick with something. Stated she was tired on days 3 (10Apr2021) and 4 and that on days 5 (12Apr2021) and 6 she had tons of energy and she worked from dawn to dusk waxing floors and never has that much energy when she was normal. Stated that all of a sudden on day 5 and 6 she was perfect and then toward the evening of day 6 she thought it was her as she had to go to the Secretary of States and stand in line to renew her license and she did well and got home and started feeling tired. States she woke up last night of day 6 (13Apr2021) with a burning in her stomach and a stomach ache and it woke her and made her feel like she had food poisoning or something like that and nothing happened and she took 2 Tums and it kind of settled that down. Stated on day 7 (14Apr2021) she woke up and the stomach part was gone and all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2, which is not much for most people but she feels and she took Motrin and after that she still feels a heaviness in her eyes and her temperature is 98.6 and she is normally in the 97's and was running a 2 degree fever and now maybe a 1 degree fever and she felt it in her eyes and didn't feel sick. Stated she felt fatigued like she want to take a nap but didn't feel ill. Stated whatever was going on was zapping her energy. Stated she woke up on day 4 (11Apr2021) in the middle of the night and her lungs were pinching, pinching, pinching, like an asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it. Stated this hadn't happened and she had been taking the special medication for 3 weeks now and it was very rare for her to get those attacks and this was worse than any. Patient relayed that today all day even with the special medication to open her lungs she can feel in her lungs that they were, she can't explain it, like they are gripping and releasing and gripping and releasing a little but. Stated she knew she was having some kind of asthma thing going on, it was not making her cough it was making her lungs hypersensitive. Stated she was expecting everything and she did read and nobody had symptoms that last more than 7 days and she was expecting them to be gone tomorrow, or she hopeed anyways. Stated the last 10 days had been easy-peasy and all of a sudden she was waking with all that coughing like something was irritating her lungs and she can't stop. Patient provided that it woke her husband up with her coughing for half an hour. States this lasted half an hour and was more than normal and something really irritated her lungs, shouldn't have happened as she is on the other thing every day and has not had an attack with that. Patient stated her provider didn't know as it was so relatively minor and was unusual but minor and she did not feel like it was life threatening. Stated her brother had Covid and she did not feel like she was trying to breathe and couldn't, or suffocating and dying. She did not feel that. The air irritated to even breathe and made her cough and couldn't stop and that was the first time she had to use an inhaler on top of on inhaler and something made her lungs respond to nothing there. Stated it may be her immune system thinking something was there, the headless thing in her lungs. Patient stated she thought she was over it and then got the fever not understanding if the fever was Covid related and she stayed at home and didn't go out until yesterday it was the 1st day out since Thursday and how could she have caught anything if she wasn't near anybody. Stated these were just thoughts in her head. Outcome of events was unknown.; Sender's Comments: The reported event of asthma aggravated was assessed as possibly related based on temporal association. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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| 69 | 2020-12-31 | itchy skin | Itching of both arms and hands for approximately one hour. No treatment. Fully recovered. |
| 69 | 2021-01-04 | itchy skin | Mild itching - no signs of distress at discontinuation of monitoring - asked to f/u w/ PCP |
| 69 | 2021-01-04 | vaccination site pain |
slightly painful enlarged left axillary node that is on ipsilateral side of injection; slightly pain...
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slightly painful enlarged left axillary node that is on ipsilateral side of injection; slightly painful enlarged left axillary node that is on ipsilateral side of injection; paraspinal muscle pain resolved by next day; In evening had mild pain site injection gone in a day; This is a spontaneous report from a contactable physician (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EK5730), intramuscular on the left arm on 20Dec2020 12:00 at SINGLE DOSE as COVID-19 immunization at the hospital. Medical history included Graves disease. The patient also had allergies with penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), acetylsalicylic acid (BABY ASPIRIN), and colecalciferol (VITAMIN D). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 21Dec2020 in evening, the patient had mild pain site injection gone in a day (22Dec2020). On 22Dec2020 (day after injection), the patient then had paraspinal muscle pain resolved by next day (23Dec2020). The patient took ibuprofen (MOTRIN) in evening and gone by morning. Day 7 (28Dec2020), the patient noticed slightly painful enlarged left axillary node that was on ipsilateral side of injection which was still present (no treatment was received for the events). The patient recovered from the event of mild pain site injection on 22Dec2020 and paraspinal muscle pain on 23Dec2020 while not recovered for the remaining events.
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| 69 | 2021-01-07 | injection site redness, injection site warmth, injection site swelling |
Injection site is red, swollen, hot. Muscle aches, feverish, headache general malaise. I took Tylen...
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Injection site is red, swollen, hot. Muscle aches, feverish, headache general malaise. I took Tylenol, Advil and used ice for the headache.. The side effects didn?t start until day after the vaccine. This is the third day post vaccine side effects are starting to subside.
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| 69 | 2021-01-07 | vaccination site pain |
fever; she was dehydrated; unable to sleep until 3:30am; Headache; body aches; Chills; Pain / receiv...
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fever; she was dehydrated; unable to sleep until 3:30am; Headache; body aches; Chills; Pain / received the vaccine on 18Dec2020, at that time she only had symptoms of pain; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number CJ1685) via an unspecified route of administration on 18Dec2020 at single dose in the right arm for COVID-19 immunization. Medical history included gum surgery on 29Dec2020. Concomitant medication included amoxicillin trihydrate (AMOCILLINE) from 29Dec2020 post gum surgery. The patient received the vaccine on 18Dec2020. At that time she only had symptoms of pain (onset date 19Dec2020). On the night of 04Jan2021, she had chills and needed 3 blankets and 2 robes. Three hours later her chills were gone and she had a temperature of 105 degrees (fever onset date 05Jan2021). She also had a headache (headache onset date 04Jan2021). She took two paracetamol (TYLENOL) and was unable to sleep until 3:30am. She woke at 9am (05Jan2021). She checked her temperature again and it was 99.2. This was after going 12 hours without taking paracetamol. Then she had body aches (body aches onset date 04Jan2021) but no headache. She thought she was dehydrated and she drank some water. Her headache was gone. She was scheduled for the second vaccine on 08Jan2021. She was told that her body would respond stronger and the symptoms be worse since she responded 17 days after getting the vaccine. The event pain (after vaccination, on 19Dec2020) was resolved on 19Dec2020, chills was resolved on 05Jan2021, fever was resolving, headache was resolved on 05Jan2021, body aches was resolved on 05Jan2021. The outcome of "unable to sleep" and "she thought she was dehydrated" was unknown.
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| 69 | 2021-01-10 | injection site warmth, injection site redness |
Fever ranging from 100.2 degrees F to 102.2 degrees F for 36 hours, moderate relief with Tylenol. ...
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Fever ranging from 100.2 degrees F to 102.2 degrees F for 36 hours, moderate relief with Tylenol. Joint pain for 72 hours with mild relief with Tylenol. Loss of appetite for 24 hours. Left deep armpit pain for 4 days, just subsiding but still evident. Left deltoid injection site warm and red with redness tripling in size over 3 days (covered entire deltoid region.) Site remains warm and red since initial injection but seems to be improving today (day 4 post vaccine)
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| 69 | 2021-01-11 | skin burning sensation, sensitive skin |
Fatigue, Intermittent stabbing pains moving everywhere around my body continuously; skin sensative ...
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Fatigue, Intermittent stabbing pains moving everywhere around my body continuously; skin sensative to touch with burning feeling, swollen glands under armpits, neck.. Lasting now over a week. Some lessening with GabaPenton prescription after telehealth consult. His thinking it was neuropathic pain.
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| 69 | 2021-01-12 | hives |
She reported some hives but refused to be evaluated by fire rescue. At 10:16 am verbalized to feel ...
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She reported some hives but refused to be evaluated by fire rescue. At 10:16 am verbalized to feel better and went home.
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| 69 | 2021-01-14 | hives, itchy rash |
Itchy rash/ hives neck area, trunk; Itchy rash/ hives neck area, trunk; This is a spontaneous repo...
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Itchy rash/ hives neck area, trunk; Itchy rash/ hives neck area, trunk; This is a spontaneous report from a contactable consumer (patient) reported that a 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiration date: not reported), via an unspecified route of administration on the left arm on 08Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included psoriasis and allergies to Penicillin; both from unknown dates. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine and rosuvastatin calcium (CRESTOR) taken from unspecified dates for unspecified indications. On 08Jan2021, the patient experienced itchy rash/hives neck area, trunk with outcome of recovering. As treatment, patient received Benedryl (as reported). Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot number was already obtained.
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| 69 | 2021-01-14 | injection site pruritus, skin peeling, injection site redness, injection site inflammation, injection site swelling, injection site hardening |
The patient reports that the following morning, January 13th, after receiving the second dose of the...
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The patient reports that the following morning, January 13th, after receiving the second dose of the vaccine, at the injection site, her arm was red, swollen, inflammed, and had peeling skin around it. Additionally, she reports that at the injection site, it was firm/hard, hot, painful, and itching. The patient saw FNP, on January 14th, and was administered an IM dose of cortisone, and prescriptions for Keflex and a Medrol dose pack. The patient was instructed to return to Doctor's office on January 15th to allow her to observe the site again.
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| 69 | 2021-01-14 | vaccination site pain |
experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pa...
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experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pains/aches and pains around her body; severe pain in injection arm; injection site very painful; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. She reported that the evening of her first dose, she experienced severe pain in injection arm on 06Jan2021. She stated that night injection site very painful. She had to take Tylenol Extra Strength overnight. She stated that she woke up and she was fine. On 09Jan2021, she reported feeling fatigued, dry cough, extreme fatigue, diarrhea, aches/pains, and aches and pains around her body, but no fever. She woke up this morning on 11Jan2021, experiencing pain in her back where kidneys, still fatigued but no fever. She has taken the Covid test and does not have the results. She wanted to know if these are side effects of the vaccine or is this potentially the Covid virus. The events were assessed non-serious. The outcome of severe pain in injection arm, injection site very painful was recovered, of fatigued was not recovered, of other events were unknown. Information on the lot/batch number has been requested.
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| 69 | 2021-01-16 | injection site pain | Headache Fever 100.3 Muscle ache Fatigue Pain at injection site |
| 69 | 2021-01-17 | rash, itchy rash |
After 4 days, I developed a rash around my collar area/neck. Actually looked more like a burn, and ...
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After 4 days, I developed a rash around my collar area/neck. Actually looked more like a burn, and itched slightly.
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| 69 | 2021-01-19 | injection site pain |
Patient advises that she had developed injection site soreness on the night of her injection. The ne...
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Patient advises that she had developed injection site soreness on the night of her injection. The next day, she started with symptoms of generally feeling unwell and headache. She also reports that several days after the vaccine, she had some shortness of breath, dizziness, and weakness but did not seek medical care. Patient states she had fatigue, muscle pain, chills, sweating, and runny nose on 1/15/2021. On 1/18/2021, patient complains of headache. COVID test was ordered and patient was advised to go to Urgent Care for exam if she felt she needed to see a doctor. COVID test resulted negative.
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| 69 | 2021-01-19 | injection site pain |
Patient describes Soreness at injection site, later experienced body aches, headache, fever that is ...
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Patient describes Soreness at injection site, later experienced body aches, headache, fever that is rising and hoarseness in voice
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| 69 | 2021-01-20 | vaccination site pain |
Injection into left arm hurt upon injection; The arm got very sore and felt like lead-I could barely...
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Injection into left arm hurt upon injection; The arm got very sore and felt like lead-I could barely raise my arm up without assistance of the other arm; The arm got very sore and felt like lead-I could barely raise my arm up without assistance of the other arm; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the left arm on 07Jan2021 at 14:00 at a single dose for COVID-19 immunisation. Medical history included HBP (hypertension). The patient was not pregnant at the time of vaccination, has not received any other vaccine within four weeks, and did not have COVID prior to the vaccination. Concomitant medication included losartan (also reported as other medication in two weeks). The patient previously took Aleve and experienced allergies. On 07Jan2021 at 02:00 PM, the patient experienced injection into left arm hurt upon injection and as the hours wore on, the arm got very sore and felt like lead-she could barely raise her arm up without assistance of the other arm. However, it dissipated within 24 hours and felt fine thereafter. The patient did not test positive for COVID post-vaccination. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 69 | 2021-01-24 | redness, rash, itchy skin |
Rash on my legs a week after the vaccine; little reds dots and sometimes it would itch and sometime ...
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Rash on my legs a week after the vaccine; little reds dots and sometimes it would itch and sometime not. I showed it to my nurse practitioner who I work with; put Zetifil lotion/creme. That didn't really do anything and then it went away and was pretty gone away when I had the second shot 1/7/2021. When I got the second shot it came back.
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| 69 | 2021-01-24 | itchy skin, rash | left hand broke out, neck, face, itchy, |
| 69 | 2021-01-25 | injection site bruising |
2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vom...
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2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vomiting 3:00-extreme headache (took aspirin for pain) -lower back hurt -pain in right shoulder, elbow, wrist -couldn?t lay on right side (bruising at site but no swell -couldn?t move without vomiting -woke up at midnight completely wet with sweat and sweating continuing even today Tuesday -weakness all over (felt like I had had the FLU) ? I knew there was potential for side effects before taking the vaccine...I was totally unprepared for so many symptoms and how intense they were and what little I could do to relieve any of them. Never had fever that I am aware of. Today I?m weak and sweating is unreal. ?? Should I prepare/expect my second dose around Feb. 14 to have the same effect on me.? Not looking forward to that. I was almost ready to go to the ER I was getting so dehydrated and weak.
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| 69 | 2021-01-26 | redness |
first 24hours nothing, second night was woke by pain in arm, swelling, redness, slight fever, headac...
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first 24hours nothing, second night was woke by pain in arm, swelling, redness, slight fever, headache, felt under the weather. Third day more swelling, redness and headache. Today, forth day, swelling going down still red, no headache and feeling better in general. Took tylenol for headache and pain.
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| 69 | 2021-01-27 | itchy skin, redness |
Received vaccine in left deltoid at 1055 am. Once outside, she noticed redness and itching of right ...
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Received vaccine in left deltoid at 1055 am. Once outside, she noticed redness and itching of right shoulder. Observed in clinic for 5-10 minutes. Stated the itching had subsided. Left clinic.
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| 69 | 2021-01-28 | rash with redness, rash macular, hives, redness, injection site tingling, injection site warmth, itchy skin |
Hot, tingling feeling in arm just below injection site.....drippy sensation going down about 4 inche...
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Hot, tingling feeling in arm just below injection site.....drippy sensation going down about 4 inches below site.....within 2-3 minutes....lasted 15 minutes 25 minutes after injection itchy spot on opposite hand......small hive with redness......lasted 10 minutes 75 minutes later itchy lower neck and upper chest with a red blotchy rash. About a 4x5 inch area, also itchy mildly scalp.........lasted about 20 minutes
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| 69 | 2021-01-28 | itchy skin |
When I got the shot I sat out there 15 minutes to wait. I got an odor in my mouth. My nose started i...
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When I got the shot I sat out there 15 minutes to wait. I got an odor in my mouth. My nose started irritating a little bit. So then i left it alone because I didn't now if that was part of a reaction. When i got home i still had the odor in my mouth. i drank cold water and it went away. I waited. I felt sore on my arm but it wasn't that bad but as the hours went on it started getting more sore and painful. My arm was sore up to my shoulder and the back. After that the pain started traveling towards to my chest and i started getting pain in my chest. i took Tylenol (1 500 mg extra strength at 11:15 PM). So i waited 15 minutes to go to sleep. i got up the next day and everything was the same, i started putting ice on it and gave it time. I took another Tylenol but the pain was in my chest again a little bit. The third day the pain didn't come back in my chest and from then i was alright. I also started getting an itch.
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| 69 | 2021-01-29 | shingles |
2 days after injection, I broke out in Shingles (confirmed by the Dr. on my scalp, left side of fore...
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2 days after injection, I broke out in Shingles (confirmed by the Dr. on my scalp, left side of forehead and radiating toward my left eye. MD stated it was too coincidental not to be related to vaccine. I had NO s/s of illness prior to injection. MD would not allow me to take 2nd dose.
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| 69 | 2021-01-29 | hives, itchy skin |
Five Hive like welts, spread over both feet, top and side . Tremendously Itchy constantly, cannot s...
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Five Hive like welts, spread over both feet, top and side . Tremendously Itchy constantly, cannot sleep, As bad or worse 48 hours later. Remedies: Oral: diphenhydramine 25mg every 6 hours, Topical: lidocaine, hydrocortisone 2.5% cream, gel ice pack Red welts and somewhat swollen. Possible bites?
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| 69 | 2021-01-29 | injection site pain |
Vaccination given higher than ideal location. Immediate pain with needle insertion. Immediate pain...
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Vaccination given higher than ideal location. Immediate pain with needle insertion. Immediate pain when medication injected.
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| 69 | 2021-01-29 | skin peeling, redness, vaccination site swelling |
Vaccine arm swollen, woke up with hand tingling, and red palm. Red palm and tingling went away withi...
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Vaccine arm swollen, woke up with hand tingling, and red palm. Red palm and tingling went away within 30 minutes. But 2-3 hours later three fingers had peeling. Also wrinkly fingers. Increased water and added electrolytes. Notified doctor, who instructed to elevate and ice arm, and to start benadryl. Also take benadryl before next vaccine. Left arm may still be slightly swollen, but most swelling gone by 12 hours. Sore arm for a couple days, intermittent headache which took tylenol for. Fatigue, still.
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| 69 | 2021-01-29 | injection site pain |
a few days after my covid shot my right should be to hurt. I am left handed and have had a torn rot...
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a few days after my covid shot my right should be to hurt. I am left handed and have had a torn rotor cuff in my left arm and now my right arm where the shot was given is having the same painful symptoms as a torn rotor cuff. Before the shot i had absolutely no problems with my right arm
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| 69 | 2021-01-30 | injection site pain | Flu symptoms: chills, diarrhea , headache, sore left arm (injection site) |
| 69 | 2021-02-01 | injection site pain |
2:AM on Feb 18 started chills while sleeping. Had hot tea and blankets and it subsided. fever of ...
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2:AM on Feb 18 started chills while sleeping. Had hot tea and blankets and it subsided. fever of 100-101 throughout the day. Sleeping. Pain at injection site . Symptoms lasted about a day and a half. This was the first dose!
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| 69 | 2021-02-01 | hives | Chills x 24 hours, felt feverish, hives onset 01/21/2021 |
| 69 | 2021-02-01 | injection site pain |
Left arm injection site tenderness from 01/12/2021 through 01/19/2021. Severity on 1-10 scale = 5. R...
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Left arm injection site tenderness from 01/12/2021 through 01/19/2021. Severity on 1-10 scale = 5. Resolved with no intervention. Fatigue from 01/12/2021 through 01/21/2021. Severity on 1-10 scale = 7. Resolved with rest. No residual. Received 2nd dose on 02/01/2021 in right deltoid at 1:22 pm. Temp on day of dosing was 97 degrees - normal for me. 02/02/2021 AM right arm soreness, achy all over, and chilled. By 1 PM temp was 100.1. Took 500 mg of Acetaminophen, fLuis?s and rest
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| 69 | 2021-02-01 | injection site discomfort | Some discomfort on injection, muscle soreness afterwards. No treatment needed. |
| 69 | 2021-02-02 | injection site redness, injection site bruising, injection site swelling, injection site warmth |
At injection site in right arm, bruising developed, and redness appeared approximately 3 inches belo...
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At injection site in right arm, bruising developed, and redness appeared approximately 3 inches below injection site. It was a large red area about size of a small apple. The raised area was red and warm. Fever 102.9 Nausea Dizziness Bladder control dysfunction - once Persistent headache.
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| 69 | 2021-02-02 | itchy skin, injection site pain |
Waited 15 min as required. On drive home around 3:15 p.m. developed tingling in lips and tongue no ...
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Waited 15 min as required. On drive home around 3:15 p.m. developed tingling in lips and tongue no swelling, It eventually subsided. At around 8 p.m. back began to itch no rash nor hives and subsided within 15 min. guess. Soreness in arm next morning with slight headache. Soreness at vaccine site all day and night unable to raise arm over head. Wednesday morning Feb. 3 less soreness at site and able to raise arm above head.
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| 69 | 2021-02-03 | hives, itchy skin |
4 hrs after shot severe hives, itching beginning on arms. Over time hives rest of body. 4 days lat...
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4 hrs after shot severe hives, itching beginning on arms. Over time hives rest of body. 4 days later still have hives. Feel anxious, took benadryl
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| 69 | 2021-02-03 | hives | Hives 48hrs after patient received the vaccind |
| 69 | 2021-02-03 | injection site pain, injection site redness, injection site swelling |
INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, FEVER, INJECTION SITE SWELLING, INJEC...
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INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, FEVER, INJECTION SITE SWELLING, INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL FLU LIKE SYMPTOMS
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| 69 | 2021-02-03 | vaccination site pain |
Injection site soreness; tiredness; muscle pain; feeling unwell; This is a spontaneous report from a...
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Injection site soreness; tiredness; muscle pain; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 14Jan2021 at 09:00 at a single dose in the hospital for COVID-19 immunization. Medical history included autoimmunity of unknown origin and seafood allergy. The patient is not pregnant at the time of vaccination. Concomitant medication included folic acid, methotrexate, multivitamins (vitamins nos), and fluoxetine hydrochloride (PROZAC). The patient experienced injection site soreness, tiredness, muscle pain, feeling unwell for 30 hours on 14Jan2021 at 12:00. The patient did not receive treatment for the events. Outcome of the events was recovered on 15Jan2021. Information on batch/lot number was requested.
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| 69 | 2021-02-03 | itchy skin, injection site pruritus |
at 1128 EMT, (MD), and (PHN) responded to clt in observation area. c/o mild itchiness at vaccinati...
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at 1128 EMT, (MD), and (PHN) responded to clt in observation area. c/o mild itchiness at vaccination site. Vitals taken at 1130 am: BP 110/82 HR 70. PT AxO x4. c/o progression of internal itchiness to left arm and lower body, mild dizziness and confusion/"foggy." 50 mg Benedry PO elixer given at 1135 am. Vitals recheck at 1150 am: 145/90, 80 HR. Clt exhibited s/s anxiety. At 12 pm Pt states feeling better, denies dizziness, states is more focused, denies CP, denies s/s tight throat or swelling. no swelling noted. states itchiness is better. left site at 12 pm, PHN instructed Pt to f/u with PMD in 24 hours.
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| 69 | 2021-02-03 | rash with redness, vaccination site pain |
dizziness/dizzy; little headache; felt like she had the flu/flu-like symptoms; body aches; low grade...
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dizziness/dizzy; little headache; felt like she had the flu/flu-like symptoms; body aches; low grade fever that never went over 101.4/low grade fever between 99.6 and 100; red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised/rash was across her chest, breasts, and above her belly button, but not on her back; pain in her right arm which got stronger at the injection site overnight/sore arm; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date: Apr2021), via an unspecified route of administration on 15Jan2021 at 12:30 at a single dose on the right arm for COVID-19 immunization. The patient has a medical history of having covid infection in Aug2020 where her symptoms were low grade fever and headaches only. The patient also stated that when she gets a virus, she always gets this kind of rash. The patient is in an ongoing year -long antibody study where they check for antibodies every 3 months. The results of the 1st titre was 270 after her 10-day quarantine period, and in Dec2020, it was still 270. There were no concomitant medications. The patient reported that she had a sore arm on Friday, the day of the vaccination, 15Jan2021. She experienced pain in her right arm which got stronger at the injection site overnight. Then on Saturday 16Jan2021 at 11:00 AM all her symptoms started. She developed a low grade fever that never went over 101.4, a little headache, dizziness, and body aches. She stated that it was weird because she rarely gets sick, but she felt like she had the flu. She is getting a low grade fever between 99.6 and 100, flu-like symptoms and was dizzy. Then on the night of Saturday 16Jan2021, when she went to bed she had a red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised. The rash was across her chest, breasts, and above her belly button, but not on her back. The patient reported that she still has the rash, and that it has actually gotten worse; it's spread more across her whole chest which is typical. Since when she gets a virus, she always gets this kind of rash; it doesn't itch; it's just kind of there and it's always in the same place whenever she gets it. The outcome of the event 'red rash on her chest and upper abdomen; it was diffuse not pinpoint, wasn't raised/rash was across her chest, breasts, and above her belly button, but not on her back' was not recovered while the outcome of the other events was unknown.
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| 69 | 2021-02-04 | redness, rash |
About 8 days after vaccine, 02/02/2021, I noticed a 1-2 inch circular redness with light rash, and s...
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About 8 days after vaccine, 02/02/2021, I noticed a 1-2 inch circular redness with light rash, and slight swelling with mild soreness. It is lighter red today, 02/05/2021, and has not increased in diameter.
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| 69 | 2021-02-04 | redness, injection site rash, injection site redness |
Almost immediately a bright red rash appeared from injection site to the wrist. Also left side of t...
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Almost immediately a bright red rash appeared from injection site to the wrist. Also left side of tongue swollen. It was suggested that my husband purchase and administer benadryl which we did - 2 tablets. After 30 minutes we went to the car. My face was bright red (cheeks) and swollen. Within 20 minutes of taking the benadryl symptoms subsided.
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| 69 | 2021-02-04 | injection site pain | Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain for two days. No treatment. |
| 69 | 2021-02-05 | injection site swelling |
Nickel size 1/2 inch swelling at injection site. EMS evaluated. Bandaid removed and client did arm...
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Nickel size 1/2 inch swelling at injection site. EMS evaluated. Bandaid removed and client did arm exercise and felt better and swelling went down.
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| 69 | 2021-02-07 | shingles |
1/28 vaccinated, 1/29 fatigue, 1/30 pt started experiencing right side pain below breast, 2/5/21 pt ...
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1/28 vaccinated, 1/29 fatigue, 1/30 pt started experiencing right side pain below breast, 2/5/21 pt went to PCP and was diagnosed with Shingles.
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| 69 | 2021-02-07 | itchy skin | Arm is very sore and itchy. Headache, fatigue, restless. Just did not feel well. Lasted one day. |
| 69 | 2021-02-07 | injection site pain | Injection site pain night after injection |
| 69 | 2021-02-07 | itchy skin |
Just had the shot, waited 20 minutes and left and then went to get groceries and started itching in ...
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Just had the shot, waited 20 minutes and left and then went to get groceries and started itching in my neck first and went down underneath my breasts, stomach, and arms around 3:30, 4:00 o'clock. Saturday evening burning and itching is really bad. Put some topical creams on it. Next day itching was less bad but I was sore and tender. Today the itching isn't as bad, but its hot to the touch.
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| 69 | 2021-02-07 | injection site warmth, cellulitis, injection site redness, injection site hardening, injection site swelling |
Patient received the vaccine on 01/27/2021. 10 days later, she developed swelling, redness, hardene...
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Patient received the vaccine on 01/27/2021. 10 days later, she developed swelling, redness, hardened area with wormth at injection site. Measurements are 12 cm in length and 9.5cm in width. Per Dr. it looks like cellulitis. He prescribed Bactrim. Patient is scheduled for her second injection on 02/17/2021.
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| 69 | 2021-02-07 | itchy rash, rash, itchy skin |
felt like she was having the onset of pneumonia; muscle and body aches; muscle and body aches; ongoi...
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felt like she was having the onset of pneumonia; muscle and body aches; muscle and body aches; ongoing congestion in one nostril/stuffiness; felt tired and run down; feeling itchy/Her head, neck and back are very itchy; rash/like a fever type rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3249, unknown expiration), via an unspecified route of administration in the left shoulder area on 16Jan2021 at 11:15 AM at a single dose for COVID-19 immunization. Medical history included COPD (has it for lots of years) and nickel sensitivity. She does not have any reactions to her previous unspecified vaccines but had a normal reaction like sore arm. Concomitant medication included bimatoprost (LUMIGAN). The patient previously received flu vaccine and pneumonia vaccine, both for immunization in 2020 around the end of Sep or beginning of Oct. The patient reported side effects regarding the COVID vaccine and said she was a little confused and unsure if she was having a problem or if she should see a doctor. On 16Jan2021 at 11:15 AM, she had the first dose of the COVID vaccine and afterward she had a lot of effects which were mostly muscle and body aches in Jan2021. She also experienced some ongoing congestion in one nostril but saw this as just more congestion and that she was having to blow her nose more in Jan2021. She did the (app name) report but didn't report the stuffiness. She did report that in the first few days she felt like she was having the onset of pneumonia and felt tired and run down (Jan2021). Two days ago, she started feeling itchy (Jan2021) and she didn't know what it was, she didn't know if she ate something or what. Now she has developed a rash (Jan2021) which is ongoing until now. Her paperwork said the rash would happen right away if it was caused by the vaccine. The patient wanted to know if this is something she should be concerned about and if the rash could appear or started this long after she had the vaccine. Her second dose is due on 06Feb2021. The patient wanted to know if the vaccine contains nickel or any metal substances in it since she had compared her rash to her nickel sensitivity. The patient wanted to know if rash is a side effect from the vaccine and how long it will last. She didn't put rash down for the safety check either as she didn't know if it was caused by the vaccine. Today her rash, she is so itchy. She does have it on her neck and certain areas but not everywhere. It looks like what would happen after a bad fever. It is not raised but is like a fever type rash. She did note that she had an increase dose of a medication eye drops (Lumigan; Lot: T and a 0 or O followed by 544, and NDC: 0023320503. Expiry: Jan2022) around the time the rash started but after getting the vaccine. Her head, neck and back are very itchy. She mentioned that she waited 2 days and did not put this event in the (app name). She would have reported it yesterday, but she didn't get one yesterday. She also noted that it was very dry there and cold and a person is going to get dry skin. She does have an allergic to metal and wondered if that was in the product. In her neck area, it looks just like when she would wear a cheap necklace. No treatments received. The events did not require emergency room or physician office visit. The patient has no prior vaccination within four weeks. The patient had not yet recovered from events rash/like a fever type rash and congestion in one nostril/stuffiness; while unknown outcome for the remaining events.
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| 69 | 2021-02-07 | injection site pain |
headache body chills body aches eye throbbing All symptoms were a milder version of what I experienc...
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headache body chills body aches eye throbbing All symptoms were a milder version of what I experienced when I had Covid -19 in NOvmeber 2020. I also had slight injection site pain that radiated to the left side of my neck
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| 69 | 2021-02-08 | itchy skin |
The vaccine recipient complained of itching and tingling around the mouth, face, and nose . Per ...
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The vaccine recipient complained of itching and tingling around the mouth, face, and nose . Per Dr. recommendation, pt. received 50 mgs of PO Benadryl. Three set of vital signs were taken. Water was provided . Vaccine recipient was taken home by her husband via wheelchair . Initial vitals at 11:38: BP : 144/104, pule 72, RR: 20, O2 98%. 11:40: O2 99%, pulse: 72 1145: 99%, pulse: 68 1147: BP: 130/80, pulse: 68, 99%. 1200: BP: 130/65, O2 99%, pulse: 65, RR: 18 1205: pt. denied any further symptom/itching. Pt. was released to her husband via wheelchair.
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| 69 | 2021-02-09 | vaccination site pain |
Soreness at shot site; fatigue; migraine; This is a spontaneous report from a contactable consumer (...
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Soreness at shot site; fatigue; migraine; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 12Jan2021 at 14:30 at a single dose, for COVID-19 immunization. Relevant medical history included allergies to sulfa drugs. Concomitant medications included escitalopram, alprazolam, paracetamol (TYLENOL), simethicone (GAS X), and vitamin D. The patient previously took aspirin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the Facility. On 12Jan2021, at 14:30, the patient experienced soreness at shot site, fatigue, and migraine. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination. Information on the lot/batch number has been requested.
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| 69 | 2021-02-09 | rash with redness |
she had a reaction on her face. She described it as her cheeks turning red, rashy, and itchy; my eye...
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she had a reaction on her face. She described it as her cheeks turning red, rashy, and itchy; my eyes were just little bit itchy; This is a spontaneous report from a contactable nurse reporting for self. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), intramuscular on 22Jan2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included letrozole (FEMARA), Antioxidants and Vitamins. The patient had a reaction on her face. She described it as her cheeks turning red, rashy, and itchy. Within 24 hours, it went away. She mentioned that she used a different face mask yesterday and wasn't sure if it is a reaction from the vaccine or from her face mask. Her eyes were just little bit itchy. It started about an hour and a half and within three hours it was gone. Outcome of events was recovered.
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| 69 | 2021-02-10 | injection site redness | Site: Redness at Injection Site-Mild |
| 69 | 2021-02-11 | skin warm |
Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over he...
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Patient sitting in chair, alert and oriented x 3, skin color was ashen. Patient felt strange over her chest, light headed, patient said she feels like she was going to pass out immediately after vaccine administration. VS 100/60 mmHg, pulse 64, RR 22. Patient complaints of headache, nausea and skin clamy and warm. Site manager made aware, o2 @ 2 L via nasal cannula administered. EMS transport to hospital. Daughter was made aware via VM, unable to reach 3x attempts.
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| 69 | 2021-02-14 | vaccination site mass |
7.9 cm mass right upper extremity anterior to shoulder joint read by radiology as being a vaccine re...
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7.9 cm mass right upper extremity anterior to shoulder joint read by radiology as being a vaccine reaction. Getting smaller but not entirely gone.
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| 69 | 2021-02-15 | injection site redness, injection site pruritus, injection site swelling |
Fatigue, chills, headache, temperature (100.5), loss of appetite, restless sleep, swollen arm at in...
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Fatigue, chills, headache, temperature (100.5), loss of appetite, restless sleep, swollen arm at injection site, red injection site that is about 4? long, itching injection site. Injection site still red, swollen and itching. Taking Tylenol and using topical Benadryl for itching. Appetite returned on 2nd day. Fever, fatigue and chills lasted 1 day.
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| 69 | 2021-02-16 | shingles | Shingles rash from stress of the vaccine |
| 69 | 2021-02-17 | redness, itchy skin, rash |
redness; lumps on her head; swelling of the face/swelling on the side of her face; swelling of her e...
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redness; lumps on her head; swelling of the face/swelling on the side of her face; swelling of her eye; swelling of the back; rash/rash all over the body; itching; This is a spontaneous report from a contactable Physician. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at the age of 69 years via unspecified route of administration in the right arm on 28Jan2021 13:00 (lot number EL6982 and expiry date unknown) at single dose for Covid-19 immunization in a facility. Medical history included drug allergic to penicillin, liver problems 17 or 18 years ago and has fully recovered from the liver problems. The patient was admitted to the hospital because her liver enzymes were high; ongoing high blood pressure, ongoing cholesterol (blood cholesterol abnormal), ongoing blood pressure (blood pressure abnormal). Concomitant medication included ongoing atenolol for blood pressure, ongoing lovastatin for cholesterol, ongoing losartan for high blood pressure, ongoing vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) for unspecified indication, aminobenzoic acid, biotin, choline bitartrate, folic acid, inositol, nicotinamide, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, vitamin b12 nos (B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CHOLINE BITARTRATE;FOLIC ACID;INOSITOL;NICOTINAMIDE;PANTOTHENIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;VITAMIN B12 NOS]) from unspecified date for unspecified indication. The patient received first dose of BNT162B2 at the age of 69 years on 07Jan2021 13:00 (lot number EL3246) in the right arm for Covid-19 immunization and had no side effects. The patient has no prior vaccinations within 4 weeks. On 31Jan2021, the patient experienced swelling of the face, swelling of her eye, swelling of the back, rash and itching. The reporter (a retired physician/husband) was calling regarding his wife who received the second dose on 28Jan2021 and on Sunday 31Jan2021 she got swelling of the face and eyes and went to the ER for 5 or 6 hours. The patient received cortisone and Benadryl and she was some improved. Today (unspecified date) she was still getting more swelling of the face and redness. The reporter clarified that the patient received the second dose on 28Jan2021 at 13:00 in the right arm. The patient noticed 31Jan2021 in the evening swelling of her face, swelling on the side of her face, swelling of the eyes and swelling on her back, also some lumps on her head. The patient was a little improved at the ER, but today there was more rash all over the body and itching and it was getting worse. The reporter added that the rash appears on one side and then disappears and went to another part of the body. The patient underwent lab tests and procedures which included lab tests: normal on unspecified date, neck x-ray: showed no significant, it was normal except for degeneration of C5-C6 on unspecified date. The patient received treatment with the events swelling of the face/swelling on the side of her face, swelling of her eye, swelling of the back, rash/rash all over the body, itching, lumps on her head. The outcome of the events was not recovered. The events swelling of the face/swelling on the side of her face, swelling of her eye, swelling of the back, rash/rash all over the body, itching was reported medically significant.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all reported events cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-02-18 | itchy skin |
Itchiness along left arm, lower legs, and back - improved after receiving Benadryl . BP 155/79 (puls...
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Itchiness along left arm, lower legs, and back - improved after receiving Benadryl . BP 155/79 (pulse 65), 157/83 (pulse 68); O2 sat 99%-100%.
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| 69 | 2021-02-18 | rash |
severe skin rash on buttocks area, burning sensation, developed about 36 h ours after first doze of ...
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severe skin rash on buttocks area, burning sensation, developed about 36 h ours after first doze of vaccination, lasted 5 days, treated with mupirocin oitment
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| 69 | 2021-02-19 | skin spots | Petichiae platelets being monitored |
| 69 | 2021-02-19 | itchy skin |
Recipient received the vaccine. While she was in the observation period, she started to have an itch...
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Recipient received the vaccine. While she was in the observation period, she started to have an itch. It started with the top of her head and then spread to the rest of her body. EMS was onsite and checked her vital signs, which were normal. She took benadryl, 50 mg by mouth. She was observed for 30 more minutes. Her symptoms resolved and she went home.
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| 69 | 2021-02-21 | pain of skin |
I'm 69 and never really had but a few random minor hot flashes when I experienced menopause at age 5...
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I'm 69 and never really had but a few random minor hot flashes when I experienced menopause at age 50. However, it isn't on the list of side effects but I've had hot flashes every few hours since about and 2 hours after my first dose injection. For the most part they are mild but come on every 1 to 4 hours while I'm awake. I had a terrible one like I'd never had before where I was soaked through my clothes almost exactly 24 hours after the shot the following day. They are still occurring now 72 hours after the shot. they are mostly bothersome and will hopefully subside in the next few days. Other than that I only had the normal local tenderness on my arm.
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| 69 | 2021-02-22 | itchy rash, rash |
5 inch patch of chicken pox like rash at sternum and also on lower back. Raised, sesame size itchy a...
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5 inch patch of chicken pox like rash at sternum and also on lower back. Raised, sesame size itchy and slightly painful rash. Noticed it a day after vaccine as a "bumpy" area. Then it progressed. Now at day 5 it is starting to clear up.
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| 69 | 2021-02-22 | injection site swelling, injection site pruritus, injection site redness |
After approximately 12 hours, the injection site became red, swollen and itchy with second inoculat...
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After approximately 12 hours, the injection site became red, swollen and itchy with second inoculation.
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| 69 | 2021-02-22 | injection site pain |
sore arm - started about 24 hrs later and lasted about 2 days severe headache - started about 24 hr...
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sore arm - started about 24 hrs later and lasted about 2 days severe headache - started about 24 hrs later and persists still chills and sweating - started about 36 hours later and persists still stomach ache and diarrhea - started the 15th, worsened over days and still persists fever - although I felt like I had a fever i did not record a fever until the 21st-22nd--it was 100.2
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| 69 | 2021-02-23 | injection site redness, injection site pruritus, injection site rash | 2+ inch Red, itchy rash around the injection site |
| 69 | 2021-02-23 | injection site rash |
I got a rash in the area where the 1st vaccine was after my 2nd shot. Went to my primary and was gi...
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I got a rash in the area where the 1st vaccine was after my 2nd shot. Went to my primary and was given an antibiotic. took pill for couple of days and it cleared up after a day and a half.
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| 69 | 2021-02-23 | injection site pain |
Injection site still sore two weeks after injection. Soreness causes sleep loss and pain seems to be...
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Injection site still sore two weeks after injection. Soreness causes sleep loss and pain seems to be circular around injection site (like a ring around my arm)
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| 69 | 2021-02-23 | redness |
Patient arrived to ED with itchy throat, facial swelling and erythema and tachycardia. Patient was g...
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Patient arrived to ED with itchy throat, facial swelling and erythema and tachycardia. Patient was given Benadryl and Pepcid (dose and route unknown), and sent home with a prescription for Methyprednisolone 4 mg dose pack and Ventolin for home use. Patient reports reactions to other medications in the past, having an extensive allergy list.
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| 69 | 2021-02-23 | skin warm, redness |
She got the vaccine which was fine, at the end of the 20 minute waiting period had a spot the size o...
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She got the vaccine which was fine, at the end of the 20 minute waiting period had a spot the size of a dime, really sore and pink. On her way home she started having bowel issues, got home and an hour to hour and half later got explosive diarrhea, which lasted 24 hours. The spot on her arm got larger, more tender and felt warm to touch. It got to be the size of a half softball size, no swelling. Then she started having trouble breathing, could not walk as far or fast without breathing problems. She then took it easy, and the breathing issues got worse for 36 hours. On Sunday her arm was better, less sore and the diarrhea had stopped. She then stopped improving and on Tuesday 2/16/21, she was told to go to the minute clinic on 2/18/21 and when she got there her pulse rate was 40, her oxygen level was 93, and her BP was elevated. The NP there she got her oxygen level up to 94, was real raspy in her lungs. She was sent to the UC and they sent her to the ER. She was seen in the ER and isolated her, did an EKG, had a chest x-ray, gave her breathing treatments, and waited on her results, which all came back fine. They gave her 150 mg of Prednisone, another breathing treatment and within 1 1/2 hours her oxygen level was up to 97 and all of her tests were negative and they sent her home. She has now been home since last Thursday with nebulizer treatments Ipratropium bromide and Albuteral sulfate 3 times a day, rescue inhaler 4 puffs every 6 hours, Advair twice a day as well. She does have a FU with her doctor tomorrow for recheck. She feels that she is almost back to normal.
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| 69 | 2021-02-23 | vaccination site rash, vaccination site redness, vaccination site itchiness |
The itching was located just below the injection site at a spot where the skin was a little red; The...
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The itching was located just below the injection site at a spot where the skin was a little red; The itching was located just below the injection site at a spot where the skin was a little red; terrible itching in her left arm; out of balance, her balance was messed up; nervous; Sweaty; Feeling hot; felt like her heart was racing fast; felt dizzy/terrible lightheadedness; Feeling anxious; trouble sleeping; sharp pain in her muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health care professional reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot EL9263) via an unspecified route of administration at arm left on 24Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included drug allergies, IV contrast reaction. The concomitant medication was not reported. It was reported patient got the Pfizer COVID 19 vaccine Sunday 24Jan2021 at 13: 00PM in the left arm. She was scheduled for the second dose of the vaccine 16Feb2021. she got the vaccine and was perfectly fine; she started the wait time of 45 minutes and about 10 minutes into it she got really hot and felt like her heart was racing fast; felt dizzy on 24Jan2021. A nurse practitioner and a doctor came over and sat with her; she got some water and she was okay. They thought it was anxiety related to coming into a crowd, but for the next 36 hours she continued to feel anxious and on edge; she felt like she had too much caffeine. That night she had trouble sleeping; she had sharp pain in her muscles on 24Jan2021, it would be in one of her thighs then the other one. This was about 12 hours after the vaccine. States she took some tylenol and it did help. Adds she just continued to feel anxious and she was sweaty. States she has never has anything like this before. Today she felt perfectly fine; all of her symptoms had resolved. Then today, when she was driving to a routine GYN exam and she experienced a terrible itching on her left arm on 24Jan2021. It was sudden and startled her. The itching was located just below the injection site at a spot where the skin was a little red, feathery red, just below the injection site. Now the itching has stopped but it is still red. she couldn't hardly feel it being injected, she doesn't usually have reactions to vaccines, she never had anything, but she has a few drug allergies, and she was separated out, she was flagged to wait 45 minutes after, instead of the 15. She does have an IV contrast reaction, and some other things, nothing she knew was in the vaccine, she was fine and wasn't worried that she was aware of. She thinks she got too hot, she had on a coat, she was sitting and panning through stuff, reading on her phone, and all of a sudden she had terrible lightheadedness, she never fainted in her life, she is pretty sturdy, she didn't know what to think, she was lightheaded, and it was not vertigo, not like the room was flying, but she was like out of balance, her balance was messed up, and she sat there a minute, she was too hot, she got out of her coat, and it got worse, she could feel her heart racing, and she was talking to herself, she thinks she nervous, she could feel her heart pounding, and was instructed to raise her hand if she had issues, so she raised her hand, a nurse practitioner came over, she raised her hand, and the doctor making rounds came over and he said take off your mask off, she did, that helped somewhat, it was that blasted mask, she couldn't get enough air, he gave her water, she thinks she got too hot and perhaps got nervous and didn't think she was she said she's not been around people, and was suddenly in a huge crowd, everyone was appropriately distanced, it was an extreme presentation, after 5-6 minutes, she was good, it went away, but for 36 hours she didn't feel right, she could feel sometimes her balance wasn't right, she was just not herself, she could do her usual, she lives on a farm, she did usual farm stuff, but was not herself, and in the night, she woke several times, her heart was beating too fast, too much, but she went back to sleep, and she told her son, she said it felt like she had had 4-5 cups of really strong coffee. So the next day she was ok. Absolutely her normal, and then she didn't think anything about it, and was driving to a routine GYN exam, which was canceled last moment due to an emergency, she was driving and suddenly her arm started itching, this was Tuesday, so 48 hours after, not the site, it was distal, underneath it, maybe 2-3 inches under injection site. The site did nothing, she looked that night, no redness, lump, no raised area, no warmth, nothing, but then she had itching, intense itching like poison ivy, and she scratched and thought wait a minute, at her appointment she looked at her arm, this area was 3-4inches under the site, that was red, feathery looking and flat, macular, not raised, no induration, no warmth, no lump, no pain, it was feathery dusty red and the next day it was gone, she did nothing to it, she thought to put hydrocortisone, and looked at it, but it was so faint and wasn't itching. The seriousness was reported as non-serious. The outcome of the events was Feeling hot was recovered on 24Jan2021; Heart rate increased; felt dizzy; Muscle pain; Sweaty was recovered on 25Jan2021; Feeling anxious was recovered on 26Jan2021; Vaccination site rash; Vaccination site erythema recovered in 2021. Vaccination site pruritus was recovering; Difficulty sleeping; Loss of balance, Nervous was unknown.
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| 69 | 2021-02-23 | redness, itchy skin |
severe generalized pruritis and erythema. diphenhydramine 50mg PO. Epinephrine autoinjector 0.3mg IM...
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severe generalized pruritis and erythema. diphenhydramine 50mg PO. Epinephrine autoinjector 0.3mg IM.
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| 69 | 2021-02-24 | injection site rash, injection site pruritus, hives |
Within 15-minutes of vaccination, the patient reported rash, hives, itchiness, and potential swollen...
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Within 15-minutes of vaccination, the patient reported rash, hives, itchiness, and potential swollen lips, tongue, eyes or face. EMS monitored the patient on-site. No further details were provided from clinical site.
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| 69 | 2021-02-25 | rash | 2 days after vaccine started with rash, body aches, joint pain. Treated but continues |
| 69 | 2021-02-25 | injection site swelling, injection site pain |
69 yr old female felt dizzy and lightheaded in observation area. Pt was moved to medical room and bp...
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69 yr old female felt dizzy and lightheaded in observation area. Pt was moved to medical room and bp was taken and in the 190?s systolic. Pt has a bump on the injection site of her arm with some tenderness. Pt stated her bp has been high and pt is on a new blood pressure Med she didn?t know the same to. Pt rested for over 30 minutes and bp reduced to 180?s systolic. Pt states she gets dizzy when she gets high blood pressure reactions and she is due for her meds now and forgot them at home. Pt states her husband will bring her home to take her meds and she?ll see how she feels . If she feels worse she?ll go to the hospital . Pt also states she will see her primary doctor to have her meds adjusted since she is on the lowest dose. Pt lump on her injection site was decreased and pt signed a release to be let back into the observation area where she checked out.
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| 69 | 2021-02-25 | injection site pain |
Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep th...
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Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep that night, and continuing throughout the entire next day and night (02/24/2021), finally subsiding over the course of the next day (02/25/2021). Side effects included: Injection Site Pain; Tiredness; (raging) Headache; Muscle pain; Chills; Joint pain; What felt like fever (in between shuddering chills) - not evident in temperature; Nausea (non-productive); Feeling unwell; (tender) Lymph nodes. Debilitating and confusing. Glad to have received the vaccine in any case (small price to pay).
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| 69 | 2021-02-25 | hives, injection site reaction, injection site hives, rash with redness |
Nine days after vaccination a red baseball size area (circumference) with hive/welts within the area...
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Nine days after vaccination a red baseball size area (circumference) with hive/welts within the area around the injection site. Three days later hives/welts are gone but a red rash is visible.
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| 69 | 2021-02-25 | injection site swelling, injection site rash, injection site warmth, injection site redness, injection site pain |
Per Client received first COVID 19 vaccine in left deltoid on 2/1/2021 and had mild discomfort at si...
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Per Client received first COVID 19 vaccine in left deltoid on 2/1/2021 and had mild discomfort at site for one day. Received second COVID 19 vaccine in left deltoid on 2/22/2025 and next day notice a reaction. Per Client left arm, vaccine site was hot to touch, tender, red raised whelps and swollen. Per Client left arm is still with all the previous descriptions. Per Client did take Tylenol for tenderness and has not seek any medical attention. Client also report to receiving both vaccines in left arm only due to already existing complication with right arm. Writer suggested that Client follow up with PCP and continue to monitor left arm, client verbalized plan to follow up with PCP or emergency attention if needed.
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| 69 | 2021-02-25 | itchy skin |
Started with headache and tired, then chills, then left breast itchy, then arm and armpit became sor...
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Started with headache and tired, then chills, then left breast itchy, then arm and armpit became sore, body aches and backache all night. I took Bismuth 525mg at 9am, acetaminophen 1000mg at 11am, felt better for a few hours, took acetaminophen 500mg at 6pm.
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| 69 | 2021-02-25 | injection site nodule, rash with redness, injection site reaction, injection site rash, injection site pruritus, injection site pain, injection site mass |
Two days after receiving my Covid-19 second vaccine (Pfizer) I removed the bandage. I discovered a ...
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Two days after receiving my Covid-19 second vaccine (Pfizer) I removed the bandage. I discovered a large area with red rash. Actually the there was also bruising and rash within the affected area. I would have periods when it was very itchy to points where it was extremely sore and tender. Upon this submittal, 48 hours from onset I also seem to have a large knot/lump in that area.
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| 69 | 2021-02-26 | injection site pain |
02/25/2021 Pfizer-BioNTech COVID-19 Vaccine EUA 02/26/2021 Mild soreness at site of injection 1 da...
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02/25/2021 Pfizer-BioNTech COVID-19 Vaccine EUA 02/26/2021 Mild soreness at site of injection 1 day after first shot; soreness only on that day - no longer sore 02/27/2021 Fever 100.2 degrees F and fatigue 2 days after first shot; took (2) 325mg of Tylenol gel caps and rested/slept
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| 69 | 2021-02-27 | injection site pain |
On the 14th day post vaccine 2 my right arm was sore near area of injection site. Rest of my arm wa...
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On the 14th day post vaccine 2 my right arm was sore near area of injection site. Rest of my arm was fine. I also felt tired and general malaise. Within 12 hours and after taking 2 Alleve tablets I felt much better
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| 69 | 2021-02-27 | hives, rash |
Rash and hives on face, neck, shoulders and chest beginning on 2/26/2021, the 5th day after shot and...
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Rash and hives on face, neck, shoulders and chest beginning on 2/26/2021, the 5th day after shot and getting worse on 6th day after shot. Took antihistamine and applied cortisone cream. Called dr. Office and spoke to nurse on call. Periodically applied ice and soaked areas with cool water with baking soda. Hives began to subside on 2/28/2021.
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| 69 | 2021-02-28 | injection site pruritus, injection site rash |
On the evening of February 25, 2021, the injection site began to itch intensely and a rash developed...
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On the evening of February 25, 2021, the injection site began to itch intensely and a rash developed. From that evening through today, March 1, 2021, the itching has diminished though it does still itch somewhat. The rash continues, expanding out from the injection site. I have experienced no pain nor fever associated with the rash.
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| 69 | 2021-02-28 | rash with redness |
broke out with some red rashes on chest and on face, on the bottom of face/it has behind my ear that...
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broke out with some red rashes on chest and on face, on the bottom of face/it has behind my ear that was the rashed I have; I got a lump on the back of my ear and it is only on the left side where I took the injection; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8982, expiry date: unknown), via an unspecified route of administration, on 24Jan2021, at single dose, for covid-19 immunization. Medical history included diabetes mellitus and urinary tract infection (UTI). Concomitant medication included amlodipine; ciprofloxacin; losartan; metformin; metoprolol; insulin human, insulin human injection, isophane (NOVOLIN 30/70); insulin human, insulin human injection, isophane (NOVOLIN 70/30); rosuvastatin and unspecified antibiotics that was taken from 11Jan2021 to 15Jan2021 for UTI. On 24Jan2021, on the same day of vaccination, the patient broke out with some red rashes on chest and on face, on the bottom of face and got a lump on the back of ear and it was only on the left side were she took the injection. The patient stated, "it's just on my chest, it's just red rashes on my chest and it has behind my ear that was the rashes I have. But it is on the left side only, it is not all over." The patient was wondering if it was normal to break out like that as it occurred on the same day she received the vaccine and asked what she should do. The date of the second dose was reported to be on 14Feb2021. No treatment was given for the events. The patient reported she does her blood sugar twice a day (unknown results). The outcome of the events was unknown.
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| 69 | 2021-02-28 | vaccination site pain, vaccination site swelling |
muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; pa...
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muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; headaches/The headache is above her ear and the pain is "past 10"; She recalled experiencing "swelling around her eyes" and "had some swelling" after the 1st dose of the Pfizer-Biontech COVID19 vaccine/left eye swelling; had some swelling; Dizziness/Lightheadedness; Vomiting; Blurry vision; She said the left arm pain started immediately after receiving the COVID-19; Injection site swelling; she is sweating something fierce under her arms; peeing on herself (running to bathroom more); lady asked her to call her when she got home, and she forgot, saying her mind wasn't there; acid reflux taste in mouth/she tasted the COVID-19 Vaccine shot when it was administered; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982; expiration date: unknown) at the age vaccination of 69-year-old via an unspecified route of administration in the upper left arm on 19Jan2021 08:00 (also reported as 11Dec2020) at a single dose for covid-19 immunization. Medical history included was hit by a truck a GM and the truck busted her legs up, ongoing RSD (Reflex Sympathetic Dystrophy) pain since 1991 and was prescribed with oxycodone/acetaminophen (PERCOCET), rheumatoid arthritis from 1991 to an unknown date, spinal cord implant is in her spine, and goes from her spine to her waist, and from her waist to both legs, and down to her ankles from 1991 to an unknown date and migraine when she was 12 or 13 years old. There were no concomitant medications. She received the vaccine in a hospital. The patient previously had a flu shot for immunization but was allergic to the flu shot. It was reported that a patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine on 19Jan2021 08:00. On 19Jan2021, the patient reported that she said she had a slight headache, left eye swelling, dizziness, vomiting, blurry eyes, sweating up under her arms, and peeing on herself (running to bathroom more) after receiving the COVID-19 Vaccine. It was reported that the patient had injection site swelling on 19Jan2021. She said she has never had any side effects like what she is experiencing now after getting the COVID-19 Vaccine. She reported that her mild headache turned severe over the weekend, and she had to wrap a towel around the back of her head, so she could lay down. She said the headache pain was a sharp pain at the bottom of the back of her head and neck. She clarified she had migraines when she was 12 or 13 years old, but the headache pain she had now is nothing like the migraines she had then. She further clarified that her severe headache feels like a knife in the back of her head and neck. She said the pain is more severe on the right side of her head than the left. She said right now she has pressure in the front of her head with a slight headache. She additionally clarified that the swelling in her left eye comes and goes and is persisting. She said her left eye didn't swell close, but her granddaughter told her it looks like something is wrong with her left eye. She added that she had dizziness this morning when she was going to work. She said she stumbled when she was walking this morning but drove to work anyway. She said when she got to work, she wasn't feeling well on an unspecified date, so she decided to go back home. She said when she was walking to her car, she stumbled again, and fell against her car. She reported when she first got the COVID-19 Vaccine (19Jan2021), she was driving in a bad way. She said after she got her COVID-19 Vaccine, she picked up an elderly lady she sits with, and the elderly lady told her she wasn't normal. She said the elderly lady told her she was too relaxed while she was driving, like she was in a daze. She said the elderly lady said she was scared for her and herself when she was driving. She said the elderly lady asked her to call her when she got home, and she forgot, saying her mind wasn't there. She mentioned that she had to wait 15 minutes after receiving her COVID-19 Vaccine (19Jan2021), and when she was driving home, she had to pull over and get out of her car to vomit. She said she had an acid reflux taste in mouth before she threw up. She said she threw up a little bit last night when she had a severe headache. Clarified her eyes are constantly blurry now. She said she has to put her glasses on to see but has to turn her head sideways in order to see anything past her blurriness. She said her burry eyes are worse at night. She stated that she was sweating something fierce under her arms, she said she has to take 3 showers a day now to get rid of the sweating and smell under her arms. She said she has never sweated like that before. She reported her left arm is sore too. She said the left arm pain started immediately after receiving the COVID-19 Vaccine (19Jan2021). She said she has swelling too, and has been rubbing her left arm with alcohol, but the left arm soreness is still there. She reported that she tasted the COVID-19 Vaccine shot when it was administered. She has blown off calling her doctor when she first experienced her side effects, but then her headache got worse. She said she so spoke to doctor 30 minutes before calling Pfizer. She said she told her doctor if her headache comes back, she is going to the emergency room when she gets off work after tonight. She stated that she has been experiencing headaches/muscle spasms that have been getting worse. She says they last 15-20 minutes and then it stops. The headache is above her ear and the pain is "past 10". Yesterday night (unspecified date), the headache was so severe that she wanted to go to the ER but was too tired. The patient reported that she was taking ibuprofen (ADVIL) for her slight headache. She said she took the Advil for a couple days and nights, and her headache eased up some with the Advil. She reported that 2 days ago she bought aspirin, caffeine, acetaminophen (EXCEDRIN MIGRAINE). She also reported that she started taking Ibuprofen when her headaches became severe. She said the Ibuprofen eased the headache, but the headache comes back. Reported she took pain medicine prescribed from a doctor way back, and the prescription pain medication doesn't ease her headache pain. She clarified that the medication was dispensed in a pharmacy was oxycodone, acetaminophen (PERCOCET). She called her doctor when she returned home from work this morning, and her doctor told her to call Pfizer to report her side effects. She reported when she went to work this morning, she got lightheaded. She took Percocet and other medications, but it hasn't relieved it. She says it's not a migraine. She recalled experiencing "swelling around her eyes" and "had some swelling" after the first dose of the Pfizer-Biontech COVID19 vaccine on 19Jan2021. She reported on 02Feb2021 that she was calling back today to report that her headaches were worse. She said her headaches are not a migraine, but more like a muscle spasm in the right side of her head, above her ear. She said the pain is between her neck and ear on the right side of her head. She said the headache pain feels like it is as big as a golf ball. She said her headache pain is so severe, the headache pain wakes her up in a cry. She said the headache pain lasts 15-20 minutes, and then eases up slightly. She said the headaches have been happening twice at night, and twice during the daytime. She said the headache pain doesn't last long. She mentioned that she has been doing self-remedies. She said she ate a spoonful of mustard to ease the headache, and the spoonful of mustard did ease her headache. The patient inquired if she should get the second COVID-19 Vaccine if she is continuing to experience headaches after receiving the first COVID-19 Vaccine. The outcome of the events headache, eye swelling, blurry vision, frequency urinary were not recovered, as for the events dizziness, vomiting, vaccination site pain and vaccination site swelling were recovering, while the outcome of the other events was unknown.
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| 69 | 2021-03-01 | injection site pain, injection site mass, injection site swelling |
1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelin...
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1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelings of fatigue, soreness at injection site with swelling, slight throbbing in back of head/neck, later in PM ate late lunch Big Mac meal around 3:00 but not hungry though had no breakfast, aching in knee and hips began to become constant with movement. Slept a couple of hours and began to feel chilled to bone rest of evening, headache continued, thirst and frequent urination (1 1l2 hr apart), had stopped all medication to allow shot to work. Friday late evening early Saturday Am chill became violent in shakes used blankets/plastic sheets/socks to get warm. Slept in 2 hrs increments all night. Saturday sipped fluids
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| 69 | 2021-03-01 | injection site pain |
Injection site pain; tiredness; muscle pain; chills; swollen lymph nodes. Symptoms started three hou...
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Injection site pain; tiredness; muscle pain; chills; swollen lymph nodes. Symptoms started three hours after injection and lasted a day and a half, except swollen lymph nodes and injection site pain that lasted a couple of days longer. Patient took acetaminophen and symptoms resolved without further treatment.
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| 69 | 2021-03-01 | injection site pruritus, injection site rash |
SEIZURE SYMPTOMS SOON AFTER. About 15 mins after I had early signs of focal aware seizure (aura) - p...
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SEIZURE SYMPTOMS SOON AFTER. About 15 mins after I had early signs of focal aware seizure (aura) - pins and needles in the face, hands, feet, and very warm face. (RASH AND ITCHING AROUND INJECTION SITE NEXT DAY AND ONGOING. ) Slowly, twitching started sporadically lasting 1 - 3 seconds with 5 - 10 minutes in between. Length of twitching stayed the same but slowly became more often. I knew something was going to happen, so I did not want to go home not knowing if it would become more severe or when it would become severe. As time wore on, twitching and body movement increased especially in left thigh where a stronger seizure usually starts. In time, it became almost constant with arm, shoulder and leg movement and then increased to sporadic whole body movement. Took Klonopin. Took about 15 - 20 minutes to take effect I was attended to by doctor and EMS.
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| 69 | 2021-03-01 | injection site hardening |
Woke up (6a) with head ache, body aches, loss of appetite, fuzzy thinking, raised hard area at injec...
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Woke up (6a) with head ache, body aches, loss of appetite, fuzzy thinking, raised hard area at injection site - 5in long, 3in wide - slept most of day. Symptoms mostly gone by 3/2 7am, with exception of raised area at injection site and mild fuzzy thinking. Took two tylenol for headache 6p
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| 69 | 2021-03-01 | itchy rash, rash |
when I arrived home both my cheeks had a speckled rash. - It went away Five days later I started to ...
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when I arrived home both my cheeks had a speckled rash. - It went away Five days later I started to get red blotches bigger than a quarter on my left neck 7 or 8 total and one each on my arms . the one on my right arm was a little bit larger than a golf ball. All are raised and very itchy. Have an appointment for tomorrow with dermatologist
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| 69 | 2021-03-02 | redness | 9 pm noticed red puffy area on face with burning sensation Woke up 3/03 with headache |
| 69 | 2021-03-02 | itchy skin, rash, redness |
All over body rash the afternoon after getting the vaccine. Extremely itchy legs. Symptoms dissipa...
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All over body rash the afternoon after getting the vaccine. Extremely itchy legs. Symptoms dissipated by mid-morning the next day. Went to urgent care. Only had a little bit of rash at that time. Doctor suggested Benadryl and Zyrtec. Had a bad flare-up of redness on the back and under the arms on the way home from the appointment. Took Benadryl when I got home. That helped a lot. Took Zyrtec in the morning and Benadryl in the PM for the next 2 days. No more rash, just a little bit of itchiness.
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| 69 | 2021-03-02 | injection site pain, injection site swelling, rash | Arm still sore and swollen at injection site. Noticed rash this morning. |
| 69 | 2021-03-02 | itchy skin, injection site pain |
Extreme fatigue for 3 days Itching all over body Soreness in right arm where the vaccine was recei...
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Extreme fatigue for 3 days Itching all over body Soreness in right arm where the vaccine was received Treatment: cortisone cream and tylenol 2 days after vaccine Outcome: Improved and better on 4th day
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| 69 | 2021-03-02 | itchy skin, hives, rash with redness, redness |
Pt developed a reddened rash over the left antecubital fossa approx. 10-15 min after she received he...
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Pt developed a reddened rash over the left antecubital fossa approx. 10-15 min after she received her vaccination. It was her first dose in the PFIZER series. Pt received her vaccination in the L arm and started noticing an itchy sensation to the left antecubital fossa. Realized it was reddened and alerted staff. This RN noted reddened rash, approx. 6 inches in length, with one raised hive to area. Pt denied any difficulty breathing or trouble swallowing/speaking. Pt was speaking in full sentences throughout whole event. Pt's vital signs were obtained with HR 70, 97% on room air for oxygenation, and BP 152/88. Pt was given 25mg of Benadryl PO by this RN. Pt was reassessed at approx. 0804 and noted that the itchiness was going away as well as the rash. She continued to hold conversation and denied any further symptoms. Redness within rash was fading and pt states she just had a slight burning sensation to the area. Repeat BP was 160/90. Pt was released home at 0815 with her husband. Rash improved and pt denied any further concerns or symptoms. recommended to get Benadryl to have at home in case needed.
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| 69 | 2021-03-02 | itchy skin |
Pt did report some tingling to tip of tongue and declined staying past her 30 minute time frame with...
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Pt did report some tingling to tip of tongue and declined staying past her 30 minute time frame with itching to rt leg. She stated that she had both tingling in her tongue at times and has had "Itchy skin jthis winter" patient states she has no other signs/symptoms of reaction. Staff encouraged her to stay longer than 30 minutes but she continued to decline. Bp was 153/67 p 80, RA sats of 99% per RN at 1315 and at 1324 bp was 158/75, pulse 87 and 97%RA. Patient states minimal itching to leg, no tingling and continues to decline being monitored at this time even with staff conversation/encouragement to stay additional 15 to 30 minutes. Encouraged her to notify her PCP of events and signs/symptoms to call 911
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| 69 | 2021-03-02 | vaccination site mass |
raised bump on arm at injection site; Chest pain; This is a spontaneous report from a contactable co...
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raised bump on arm at injection site; Chest pain; This is a spontaneous report from a contactable consumer reported for herself (also reported as nurse). A 69-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiration date unknown) via an unspecified route of administration on the left arm on 25Jan2021 at 12:15 PM at a single dose for COVID-19 immunisation in the hospital. Medical history included asthma and hypertension (controlled), sulfa allergy all from an unknown date. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), simvastatin and spironolactone. The patient previously took propylene glycol and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced well defined raised bump on arm at injection site and chest pain both on 25Jan2021. It was reported that chest pain on the evening of 30Jan2021 resolved after 45 minutes after taking 2 aspirin, followed by 2 more after 30 minutes. The events were assessed as non-serious by the reporter. The patient was recovering from well defined raised bump on arm at injection site and chest pain. The patient has not been tested for COVID-19 since the vaccination.
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| 69 | 2021-03-02 | itchy skin |
sore arm. Cannot raise above my head; Sore arm; numbness and tingling of lips and tongue; numbness a...
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sore arm. Cannot raise above my head; Sore arm; numbness and tingling of lips and tongue; numbness and tingling of lips and tongue; Back began to itch; Slight headache; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) via an unspecified route of administration on the left arm on 01Feb2021 14:30 at a single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, IBS, indigestion, heart burn, colon polys removed, Morton neuroma, torn meniscus left and right, total hyst with bilat oophorectomy and tonsils removed, Shellfish allergy and many medication allergies. Concomitant medication included metoprolol, hydrochlorothiazide, colecalciferol (VIT D3), zinc and pyridoxine hydrochloride (B6). The patient previously took epipen for shellfish allergy. Sat in waiting area 15 minutes as directed. After leaving in car about 10 min. Into ride home she experienced numbness and tingling of lips and tongue on 01Feb2021 15:00. Eventually subsided by 5 pm. Back began to itch, no rash nor hives subsided in about 10 min. Sore arm started about 17:00. Slight headache during night and sore arm continued esp. to lay on left arm impossible. At 8:18 a.m. still sore arm. Cannot raise above my head. No swelling in arm at injection site. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events numbness and tingling of lips and tongue and Back began to itch was recovered on 01Feb2021 while outcome of the other events was not recovered.
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| 69 | 2021-03-03 | injection site pain, injection site swelling |
Muscle pain, joint pain, chills, fever, and pain at the injection site. overall feeling unwell. a li...
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Muscle pain, joint pain, chills, fever, and pain at the injection site. overall feeling unwell. a little swollen at the injection site.
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| 69 | 2021-03-03 | itchy skin, hives, redness, itchy rash |
Rash that itches; Hives are still bright and red, they are not on my face anymore or my neck, just m...
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Rash that itches; Hives are still bright and red, they are not on my face anymore or my neck, just my chest; Scalp itches something awful/back of legs itch/ankles itch/fingers itch; Redness on my arms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date. Concomitant medication included losartan and atorvastatin for blood pressure high. The patient reported that they were having a mild, they believe reaction. They were not in anaphylactic shock, their face hasn't swollen 'up to size' (not clarified), nothing like that. They have a rash that itches, have hives on their chest, but their scalp itches something awful, the back of their legs itch, their ankles itch, and their fingers itch. They don't have any swelling, but they do have redness on their arms, well they did last night. The redness of their arms is gone, but the hives are still bright and red and they are not on their face anymore or neck, just the chest. The events occurred on 30Jan2021. The patient took antihistamine as treatment for the events. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.
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| 69 | 2021-03-03 | vaccination site pain |
She said she has a run of pain that pops up here, and there, and everywhere/pain going down her body...
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She said she has a run of pain that pops up here, and there, and everywhere/pain going down her body; Headache; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264; expiry date: unknown) intramuscular in the left arm, on 01Feb2021 between 16:00-16:30, at a single dose, for COVID-19 immunization. Medical History included Right-sided Breast Cancer over 30 years ago. No lymph nodes were involved, so she didn't need chemotherapy or radiation. She had breast reconstruction and right mastectomy performed. She also had 2 hip replacements. Other medical history included nerve disorder and car accident. She has had bad nerves since she was 18 years old. She said she hasn't worked in over 30-something years because she worked so much to raise her kids by herself and send them to college. She said her psychiatrist and a doctor told her she had to stop working. She walks 5 miles every day and has no underlying conditions. Concomitant medications included an unspecified nighttime medication for her nerves and pain medication because she was in a car accident. The patient previously received first dose of BNT162B2 (Lot Number: EK9231) in the left arm, on 11Jan2021 for COVID-19 immunization. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient did not have previous immunization with a Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. The vaccine was administered in a Field. The patient reported that she got her second Pfizer COVID-19 Vaccine dose on 01Feb2021. After she got the second COVID-19 vaccine shot she was okay for a while, then she had a little injection site pain immediately after receiving the COVID-19 vaccine injection. She said the injection site pain was gone, clarifying if she mashes the injection site, the injection site doesn't hurt. She was only able to have shots on her left arm because she had a right mastectomy, so she can't have anything on her right side. On 02Feb2021, the big boom hit, and it has been all day. She has been breathing well and has no temperature. On the same day (02Feb2021) the patient experienced run of pain that pops up here, and there, and everywhere. She had a headache, as well. She was concerned if should take anything for the pain. She does not want to do what is not right. She wanted to do things the way that Pfizer has suggested. She put heat around face, neck, and arms, but now the pain was going down her body. She has been microwaving rice in a bag and using the heated bagged rice to apply heat to her face, neck and arms. She had a physical recently with unknown results, but she had no recent blood work. The events did not require emergency or physician visit. Outcome of the event injection site pain was recovered on 02Feb2021, while for the other events was not recovered.
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| 69 | 2021-03-03 | redness, itchy skin |
Shortly following injection, the patient complained of chest tightness, itchy throat, and mild eryth...
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Shortly following injection, the patient complained of chest tightness, itchy throat, and mild erythema of the skin with pruritus. Serial vital signs were monitored for almost 2 hours and were stable. She was in no acute distress. 8 mg of dexamethasone was administered with improvement of her symptoms.
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| 69 | 2021-03-04 | injection site redness, injection site warmth, injection site pruritus, injection site pain, injection site discolouration | 5 inch raised red, itchy, hot to touch, sore, mark at injection site on left arm. |
| 69 | 2021-03-04 | rash | Anaphylactic reaction: full body rash. |
| 69 | 2021-03-04 | injection site warmth, injection site pain, injection site redness, injection site pruritus, injection site swelling |
Evening of injection, at the injection site, it felt sore and warm to the touch. Started to turn re...
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Evening of injection, at the injection site, it felt sore and warm to the touch. Started to turn red. Upon wakening the next morning, the site was warm, red, raised and itchy. It looked like a red hive, about the size of a 50 cent piece and upper arm was slightly swollen. Third day the redness spread across the arm, warm, sore and swollen. The redness was going down into the elbow to wrist area. My arm was quite swollen. I contacted my PCP, and had a video conference that day. I also sent photos of my arm to a chart website. He saw my arm and ordered Prednisone 20 mg for three days; as he felt it was an allergic reaction to the COVID injection. Also was instructed to continue with Benadryl, Tylenol and ice. It took nine days for everything to subside.
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| 69 | 2021-03-04 | itchy skin, rash |
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extre...
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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt complained of blurred vision and anxiety 15 min after injection. After another 10 min, pt complained breathing was becoming difficult. She refused oral Benadryl. I called 911. Paramedics gave her IM Bendaryl. Pt refused to go to ER as symptoms had improved. She waited an additional 20 minutes in pharmacy before going home.
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| 69 | 2021-03-05 | itchy skin |
Itching from head, neck, arms, hands 25 minutes after administration Given patient's own dye-free be...
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Itching from head, neck, arms, hands 25 minutes after administration Given patient's own dye-free benadryl 25 mg po at 1500 at 1507, she was having continued itching and flushed at 1515, itching reduced, flushing improving at 1518, itching to hands, neck improved Face still flushed and sweating
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| 69 | 2021-03-05 | itchy skin |
One week after Vaccine #1 I began to have swelling & itching of the face-eyes, lips and cheeks, extr...
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One week after Vaccine #1 I began to have swelling & itching of the face-eyes, lips and cheeks, extreme itching of both hands, massive diarrhea and some difficulty swallowing. I took oral benadryl (50 mg) and prednisone (@ 50 mg) and applied cold packs to my face and hands. I also took Allegra 180 mg LA 2x/daily for two weeks after the reaction. Vaccine dose 2 was administered on 2/17/2021 (Pfizer, Lot # EN6201) at Hospital, . One week after that (2/25/2021) I again had facial swelling and itching and massive diarrhea. I took Benadryl 25 mg and Allegra 2x/day and continue to do so. The facial swelling/itching continued. In addition I had, since the first vaccine, extreme fatigue, resulting in a decrease in my ability to walk (down from 3 miles to just over 1 mile) and to swim (shortness of breath, reduction in ability to swim laps). I visited my Rheumatologist on 3/2/2021 and he administered an injection of methylprednisolone to try and tamp down the continuing reaction. That seems to have made a difference.
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| 69 | 2021-03-05 | injection site swelling |
Patient reported moderate swelling of left arm that extended to left clavicular area for less than 2...
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Patient reported moderate swelling of left arm that extended to left clavicular area for less than 24 hours. Reports taking Claritin and using warm compress.
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| 69 | 2021-03-05 | injection site pain |
Within minutes of receiving the first dose of Pfizer vaccine, I began feeling dizzy, lightheaded, ...
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Within minutes of receiving the first dose of Pfizer vaccine, I began feeling dizzy, lightheaded, and off balance. This was followed by nausea, itchiness under my lip, fatigue and pain at the injection site. These were gone the next day except for nausea which lasted a few more hours.
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| 69 | 2021-03-06 | pain of skin |
Around 1 am woke with chills, myalgia, fever to 100.5. Didn't take anti-pyretic. Slept on and off. A...
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Around 1 am woke with chills, myalgia, fever to 100.5. Didn't take anti-pyretic. Slept on and off. At around 3am woke up. Walked to bathroom to urinate. Stood up, started severe nausea and retching. The next thing I remember is finding myself on the ground in the bathroom, retching into the shower area. Called my husband (we are both physicians). My shirt was completely drenched. I was unable to stand up for 5-10 minutes. He noted a 6" hole in the wall (completely through the sheetrock) behind me. I had no memory (and still don't) or falling or hitting my head. He walked me back to bed. My BP was 110/65, pulse was around 70, pulse ox was normal. Continued retching not as severe. Took one Zofran. Eventually fell asleep. In the morning noticed a painful area at the left posterior part of my scalp. There were flakes of sheetrock there. The next day I was tired, felt slightly off balance, otherwise ok. Feeling of vague fuzziness, off-balance continued for a few days, then resolved.
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| 69 | 2021-03-06 | injection site rash, injection site swelling, injection site pain, injection site pruritus |
I received the 2nd dose of the Pfizer vaccine on 3/2/21. My reactions to the vaccine: 1st dose on ...
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I received the 2nd dose of the Pfizer vaccine on 3/2/21. My reactions to the vaccine: 1st dose on 2/9/21: a little sleepy and a bit sore at the site of the injection. Both symptoms were gone within 24 hrs. 2nd dose on 3/2/21: tired and sleepy the next day and a little itchy rash and sore arm at the site of injection that was about one inch in diameter. The sleepiness and tiredness were gone within 24 hrs. The itchy and sore part of my arm at and around the injection site lasted for about 5 days. I put on Benadryl cream and took Tylenol and that helped. I also put on aspercream to take away some of the pain because I'm a side sleeper and it hurt to sleep on that side. Today is Sunday (3/7/21) and there is no more itchiness or pain but I still feel a little hard bump when I rub around the site of the injection. That doesn't bother me because the sore arm and itchiness at the site of the injection are gone.
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| 69 | 2021-03-06 | skin discolouration, hives |
Pain in my lower right side and back. Hives on my upper legs and upper arms. Purple spots on my shin...
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Pain in my lower right side and back. Hives on my upper legs and upper arms. Purple spots on my shins. Extreme fatigue resulting in shortness of breath when I walk a very short distance. Coughing up very small traces of blood. Muscle and joint pain. In particular sore abdomen, back and upper shoulders. Pain is sharp when I cough or move a certain way. Sometimes it is just a persistent aching.
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| 69 | 2021-03-06 | itchy skin |
c/o Itching from head to toe. No redness or whelps noted; Denies breathing problems; B/P 140/80. Re...
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c/o Itching from head to toe. No redness or whelps noted; Denies breathing problems; B/P 140/80. Resp 18. Pulse 88. Benadryl 25 mg PO provided; Declined ambulatory service.
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| 69 | 2021-03-07 | injection site warmth, injection site redness, injection site pain |
Injection site and surrounding area became hot, red, sore and painful approx 27 hr after injection. ...
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Injection site and surrounding area became hot, red, sore and painful approx 27 hr after injection. On 3/7 symptoms had improved and nearly resolved. 3/8 redness and pain worse today.
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| 69 | 2021-03-07 | injection site pain |
My second COVID-19 vaccination injection on Friday morning, 2/19/2021 resulted initially (starting o...
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My second COVID-19 vaccination injection on Friday morning, 2/19/2021 resulted initially (starting on Saturday, the day following the vaccination} in a sore right wrist and a much more painful right arm that steadily grew in intensity and spread rather rapidly into my upper torso. By the following day (Sunday, 2/21) my breasts became very sensitive and I had severe pains across my back. This may or may not have been the beginning of a banding type MS exacerbation, but by Monday, 2/22, it was clear that I was experiencing a full-blown and seriously disabling exacerbation. Both legs experienced the tingling and numbness I have had in a prior exacerbation, and by the time I was able to talk to Dr. (my neurologist) on Monday afternoon (2/22), the numbness had progressed upward into my lower abdomen and I was no longer able to stand at all. It appears highly likely that the MS attack was triggered by the response of my immune system's reacting to the discomfort and severe body pains that occurred following the vaccination. I told Dr. of the total loss of feeling and use of both legs and was experiencing a increasing numbness from toes up to abdomen. Before ordering the high doses of corticosteroids used to stop my exacerbation, Dr. sent me to the Emergency Room for testing to make sure I did not have an infection that could be covered up by the steroids. When this testing did not show any such infection, the ER administered an IV infusion of 1 gram of solumedrol, followed by gradually decreasing high oral doses of prednisone. As of this date, numbness has started decreasing and some limited utility of right leg has returned. Still i can no longer stand and perform even the minimal movements to-and-from wheelchair to bed or toilet without substantial physical help (not needed before this exacerbation) from my sole caregiver, my husband.
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| 69 | 2021-03-07 | itchy skin |
My whole body itched. I changed into silky pajamas and took 2 over-the-counter benadryl, laid down a...
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My whole body itched. I changed into silky pajamas and took 2 over-the-counter benadryl, laid down and took a nap for 2 hours. When I woke up, my body no longer itched. I kept pajamas on for the rest of the day.
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| 69 | 2021-03-07 | itchy skin |
itching/ itching on her face, arms, head/ itching in her scalp, ears, head, face, neck and a little ...
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itching/ itching on her face, arms, head/ itching in her scalp, ears, head, face, neck and a little bit in my arms and legs; itching/ itching on her face, arms, head/ itching in her scalp, ears, head, face, neck and a little bit in my arms and legs; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262, Expiration date: Unknown, NDC number: Unknown), intramuscularly in left arm on 26Jan2021 14:00 at single dose for COVID-19 immunisation in clinic. The patient's medical history included thyroid issues, back issues, she had done some reading and she has allergies to some antibiotics, one of them being sulfa, allergic to bicillins, she has a whole host of antibiotic allergies which she investigated prior to receiving the vaccine and she was told it wasn't an issue. Concomitant medications were none. The patient previously took azithromycin (ZITHROMAX), levofloxacin (LEVAQUIN), omeprazole (PRILOSEC), levothyroxine and experienced allergy to all drugs. The patient did not receive prior vaccinations (within 4 weeks). The patient did not administer additional vaccines on same date of the Pfizer suspect. It was reported that the caller received her COVID-19 vaccine yesterday at 14:00. She had no problems at all. She was feeling some itching on her face, arms, head on 28Jan2021. She was wanting to know was there any kind of sulfa product in the COVID-19 vaccine. Caller confirms she had no problems at all with the administration of the vaccine. She didn't feel a thing. It was very organized. The caller states the itching began about an hour ago on 28Jan2021. Caller clarifies she actually received her first vaccine on 26Jan2021 14:00. On her vaccine record card, she sees EL and the third digit was either a 9 or 4. She was able to look at her husband's vaccine card and it looks like a different person wrote on his and she sees "EL9262" on his card so she assumes that was what was written on hers. Caller explains she has thyroid issues and back issues, but she considers herself to be in pretty decent health. Caller states she received her first Pfizer vaccine dose 2 days ago and today around 5 pm started itching in her scalp, ears, head, face, neck and a little bit in my arms and legs. No rash. Allergic to sulfa, also allergic to "the cillins", caller states she did her research before she got the vaccine. "Enquired was there any sulfa in the vaccine or not." No investigation assessment. The patient did not require a visit to emergency room and physician office. No relevant tests. The outcome of the events was unknown.
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| 69 | 2021-03-08 | rash |
had second covid shot approx. 3 weeks ago, past two weeks has had rash intermittent, decreased appe...
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had second covid shot approx. 3 weeks ago, past two weeks has had rash intermittent, decreased appetite, ache, last weekend had bodyaches/flu symptom, diarrhea. Today has upper lip swelling (3/3/21)
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| 69 | 2021-03-09 | injection site swelling |
Client c/o swelling to the site of vaccination. Client seen and assessed by EMT and vital signs are...
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Client c/o swelling to the site of vaccination. Client seen and assessed by EMT and vital signs are: BP 210/90, O2 98, HR 78. Vital signs were reassessed and client was advised to go to the ER but refused to be transported by EMT. Pt. stated that she would drive herself but advised to call someone to take her and she called her son to come meet with her and accompany her to the ER. Client cleared but strongly advised to go to the ER.
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| 69 | 2021-03-09 | itchy skin |
Pt. c/o itching to the left palm of hand which then progressed to generalized itching. No rash note...
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Pt. c/o itching to the left palm of hand which then progressed to generalized itching. No rash noted on pt. skin. Pt. seen and assessed by EMT and vital signs are BP 118/80, HR 65, O2 sat 98. Pt. stated that no other symptom was felt. Pt. observed scratching body. Pt. advised to call MD or go to ER if symptoms worsen and cleared to go home by EMT. Pt. verbalized understanding.
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| 69 | 2021-03-09 | injection site pain |
Received COVID vaccine on 2-22-2021 an hour later started to have right arm pain at the site of the ...
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Received COVID vaccine on 2-22-2021 an hour later started to have right arm pain at the site of the injection. Since has had multiple issues and concerns, such as SOB, dizziness, joint and right arm pain, fatigue and nausea that started about an hour after receiving her vaccine. She said she has SOB at rest but with any type of exertion she is gasping for air. Rates her joint pain off the charts with walking and is bent over.
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| 69 | 2021-03-09 | shingles | Shingles |
| 69 | 2021-03-09 | vaccination site redness, vaccination site rash, vaccination site itchiness |
Shoulder was a little sore; Arm soreness; itchiness, a rash, and a big area of redness on her left a...
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Shoulder was a little sore; Arm soreness; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A 69-year-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number reported as "ELI283 or EL1283"), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure (abnormal) and cholesterol (abnormal). Concomitant medications included blood pressure medication and cholesterol. The consumer was reporting on behalf of his 69 year old wife. She received the first dose of the BNT162B2 vaccine on 30Jan2021. On 06Feb2021, she started to experience itchiness, a rash, and a big area of redness on her left arm which was the injection arm. He stated he heard that the second dose can cause more side effects and he stated they both experienced arm soreness after the first dose on an unspecified date. Consumer stated, first of all thank you guys for making this vaccine. He and his wife received the vaccine (unspecified vaccine) their first dose last Saturday, a week ago yesterday and had no reaction to it at all, their shoulder was a little sore but that's it. Yesterday night, last night his wife noticed that the arm where she had the vaccination it has like a rash and he knows this online that Moderna has something called COVID arm but it doesn't say anything about Pfizer. He meant it's not to bother it itches a little bit you put some anti-itch cream on it wasn't a big deal. He was kind of concerned about the next you know they got the next one coming on the 18th, so, does she should change arm, do it on the other arm. Consumer added that that would be fine, he knows you guys want to know if there was any reaction so that you can log it in and that was basically why he called. They were going for their next shot they were going to the hospital and there were professionals there so pretty much ask them what they should do. Should they change arm or nothing to worry about if they do it again that was not the problem he just wanted to let you guys know that there was some kind of reaction a rash. Consumer stated he just put Cortaid cream on it and itch went away. The patient underwent lab tests and procedures which included lab work on 27Jan2021: doctor did for cholesterol, blood pressure reasons and everything was fine. The outcome was recovered for the event itchiness; and unknown for the rest of the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021170691 same reporter and drug, similar events, different patient
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| 69 | 2021-03-09 | skin warm, bruising, redness |
Temp over 102 first night, over 100 second night, chills third night. Malaise, fatigue, difficulty c...
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Temp over 102 first night, over 100 second night, chills third night. Malaise, fatigue, difficulty concentrating Large muscle aches, pain in both sides of my neck Left arm red, hot, bruised Feels like the flu after 4 days
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| 69 | 2021-03-10 | redness, itchy skin |
Hands turn red, beginning itching on body and hair and when got home my legs were swolled . At arou...
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Hands turn red, beginning itching on body and hair and when got home my legs were swolled . At around 4pm I awoke and my heart was beating haed ans fast, My rate was 200/110,
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| 69 | 2021-03-10 | rash, itchy skin |
PATIENT DEVELOPED SKIN RASH AND ITCHINESS INVOLVING ARMS AND LEGS FOLLOWING DAY OF THE VACCINE. STAR...
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PATIENT DEVELOPED SKIN RASH AND ITCHINESS INVOLVING ARMS AND LEGS FOLLOWING DAY OF THE VACCINE. STARTED IN ANTIHISTAMINES FOR RASH AND ITCHINESS.
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| 69 | 2021-03-10 | injection site hives, hives |
Woke up with a perfect C in hives...raised, red, itchy bumps...about 2' from injection site. Treat...
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Woke up with a perfect C in hives...raised, red, itchy bumps...about 2' from injection site. Treated with oral Benadryl and topical hydro-cortisone. Notified my doctor, who spoke with an allergist and assured me it was ok. Duration...about 3 days of hives, the C remained pink for a few days more and I treated it with aloe gel.
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| 69 | 2021-03-11 | injection site pain | Chills, fever, headache, tiredness, nausea, injection site pain, muscle pain |
| 69 | 2021-03-11 | injection site swelling |
Day of injection arm swollen and sore by 7 pm. Next morning woke up with headache, body ache, chill...
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Day of injection arm swollen and sore by 7 pm. Next morning woke up with headache, body ache, chills and extremely tired. These symptoms last all day and night. Slept most of day and laid around. Next morning still felt tired but aches and chills gone. 5 days later, midday headache and body ache started again with chills and tired feeling. Lasted 4 hours and then stopped. Never ran a fever or had any other symptoms. Never saw a doctor just road it out. Seem to be fine now, 8 days later but still feel tired off and on. Might just be because I'm old.
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| 69 | 2021-03-11 | shingles | Developed shingles a day after injection. Lasted 3 weeks. |
| 69 | 2021-03-11 | rash with redness, rash, rash macular, itchy skin |
Exactly 2 weeks after receiving 1st shot got a blotchy red rash on face and itching. Took benodryl ...
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Exactly 2 weeks after receiving 1st shot got a blotchy red rash on face and itching. Took benodryl for 2 days then claritin for 2 more days and it cleared up. Then exactly 2 weeks after receiving 2nd shot got rash and itching again in same location and cleared up using same process as 1st incident.
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| 69 | 2021-03-11 | injection site rash |
Within the first 15 minutes, I had neuropathy of my fingers and toes which lasted about 10 days. Wh...
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Within the first 15 minutes, I had neuropathy of my fingers and toes which lasted about 10 days. When I mentioned the neuropathy to a nurse on-site, they took my blood pressure, the systolic of which had sky rocketed 70 points. Over the next 30 minutes, my blood pressure only came down 20 points. The following week, my average blood pressure was 125/73. Shortly after the neuropathy ended, twelve days after receiving the vaccine, the COVID arm rash appeared on my upper left arm, which remained for about a week.
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| 69 | 2021-03-12 | injection site pain |
Flu like symptoms 2 days after injection. Lethargy, headaches, sore arm at the injection site. Fev...
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Flu like symptoms 2 days after injection. Lethargy, headaches, sore arm at the injection site. Fever, but no chills
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| 69 | 2021-03-12 | itchy skin |
PATIENT STATED SHE FELT ITCHY GENERALIZED, 20 MINUTES AFTER VACCINE WAS ADMINISTERED. VITALS SIGN...
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PATIENT STATED SHE FELT ITCHY GENERALIZED, 20 MINUTES AFTER VACCINE WAS ADMINISTERED. VITALS SIGNS TAKEN. ALL NORMAL LIMITS FOR PATIENT. ASSESMENT WAS MADE AND FOUND NO REDNESS, NO HIVES, NO SHORTNESS OF BREATH.
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| 69 | 2021-03-13 | rash papular, rash, hives |
Hives. Not swollen or itchy, but large irregular shaped red marks on upper chest and back, upper st...
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Hives. Not swollen or itchy, but large irregular shaped red marks on upper chest and back, upper stomach and upper arms
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| 69 | 2021-03-14 | injection site nodule, injection site hardening, hives, itchy skin, injection site warmth |
After about 24 hours, developed hard, hot knot at injection site, about golf ball size. Fully resolv...
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After about 24 hours, developed hard, hot knot at injection site, about golf ball size. Fully resolved in 6 days. No therapy needed. Developed itchy skin on abdomen and back starting at about day 3. If scratched for relief, welts up quickly. 3 lesions present, now for 3 weeks. Rx with hydrocortisone 1% cream which provided symptomatic relief.
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| 69 | 2021-03-14 | rash |
BLURRED VISION AND ALMOST FAINTED THEN RASH BEGAN IN TORSO AND BREAST AREA. NEXT DAY THE RIGHT EYE ...
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BLURRED VISION AND ALMOST FAINTED THEN RASH BEGAN IN TORSO AND BREAST AREA. NEXT DAY THE RIGHT EYE GOT REALLY SWOLLEN ALMOST SHUT
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| 69 | 2021-03-14 | injection site pain, injection site redness, injection site swelling | Fever Chills Muscle Aches Fatigue Pain, redness and swelling at injection site |
| 69 | 2021-03-14 | injection site pain |
First dose 12:30pm metallic taste, slight nausea, brief light headed. Approx 1:20pm moderate arm sor...
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First dose 12:30pm metallic taste, slight nausea, brief light headed. Approx 1:20pm moderate arm soreness lasting 2 days. Second dose administered about 3:00pm about 1hour later injection site soreness. Next day about 4:30pm extreme arm pain, 100.4 fever and chills. Took 2 Tylenol. Approx 11:30pm no fever or arm soreness.
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| 69 | 2021-03-14 | injection site swelling, injection site redness |
Injection site red and swollen., Nausea and diarrhea. Headache,. Tiredness. Muscle pain. Temperature...
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Injection site red and swollen., Nausea and diarrhea. Headache,. Tiredness. Muscle pain. Temperature (102). Severe chills.
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| 69 | 2021-03-14 | itchy skin, blister |
Patient received the Pfizer COVID-19 vaccine on 3/8/21 (first dose) in the left arm. She woke next ...
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Patient received the Pfizer COVID-19 vaccine on 3/8/21 (first dose) in the left arm. She woke next morning with blisters on the left hand, then developed widespread pruritis that only involved the left side of the body. Had swelling around left eye. No frank hives, no SOB or dyspnea. Treated in ER with oral Benadryl. Now 1 week later, she still has itching throughout the entire left side, from scalp down to feet. Still taking Benadryl once daily now. Wondering about whether to get the second vaccine.
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| 69 | 2021-03-14 | rash, itchy rash |
Patient started experiencing an itching rash all over body the evening after receiving the vaccine. ...
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Patient started experiencing an itching rash all over body the evening after receiving the vaccine. She is treating with over the counter antihistamines and topical creams (Benadryl, aveeno)
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| 69 | 2021-03-14 | blister, shingles |
Severe nerve/muscle pain starting 3/10/2021. Appearance of shingles blisters on 3/14/2021. Pain wors...
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Severe nerve/muscle pain starting 3/10/2021. Appearance of shingles blisters on 3/14/2021. Pain worsening.
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| 69 | 2021-03-15 | injection site pruritus |
After 1st vaccine, 5 days after shot, noticed an itchy, light pink circular area below shot site. No...
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After 1st vaccine, 5 days after shot, noticed an itchy, light pink circular area below shot site. No rash, just itchy, about inch & half in diameter. Lasted 3 days, then went away. After 2nd vaccine which was given in same arm, the next day after shot, noticed the same itchy, light pink patches on upper arm, but several patches and bigger in diameter. Lasted 3 days. also with 2nd vaccine I had a low grade fever (101) the following day but was the fever was gone that evening.
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| 69 | 2021-03-15 | hives, itchy skin |
Delayed anaphylactic reaction - intense flushing of entire body with itching and hives, drop in BP, ...
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Delayed anaphylactic reaction - intense flushing of entire body with itching and hives, drop in BP, swelling of tongue
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| 69 | 2021-03-15 | itchy skin, injection site rash | Rash, about 3" in diameter around injection site. Slight itching. |
| 69 | 2021-03-16 | rash | Fever 101 degrees, joint aches, lasting 8 hours; rash on upper trunk lasting 3 days |
| 69 | 2021-03-16 | injection site reaction, shingles | huge shingles outbreak. Face, neck, ear, head. All on injection site side |
| 69 | 2021-03-17 | itchy skin, hives |
Client reports 3-4 hours after vaccination developed s/sx of lip swelling and hives. Self reported t...
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Client reports 3-4 hours after vaccination developed s/sx of lip swelling and hives. Self reported to a quick care center and was treated with benadryl and was instructed to take daily x4 days, during which time s/sx resolved. Last dose taken on 3/10/2021. Client reports that on 3/13/21 s/sx returned with swelling of lips. Reported to the ER on that day and was again treated with benadryl. Denied any problems with breathing so declined epi. On 3/14 s/sx included itchy scalp and neck and back pain. Reports to have seen PCP on 3/16 and was prescribed singular daily and an antihistamine (not benadryl). Symptoms have since resolved.
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| 69 | 2021-03-17 | injection site pruritus |
Itching and rash around site on left arm starting Tuesday, 3/16 sometime in the morning. It has been...
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Itching and rash around site on left arm starting Tuesday, 3/16 sometime in the morning. It has been fairly consistent since that time.
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| 69 | 2021-03-17 | injection site redness, injection site pruritus, injection site pain, injection site rash |
On 3/16/2021 at 7:30pm, 4.5 days after vaccine, injection site began to itch, and a red, slightly bu...
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On 3/16/2021 at 7:30pm, 4.5 days after vaccine, injection site began to itch, and a red, slightly bumpy patch appeared - approximately 2.5 x 3 inches in diameter. Patient self-treated area with "Sting Stop" gel [Active ingredients (HPUS): Echinacea augustifolia 1X 10%, Ledum palustre 1X 10%, Urtica dioica 1X 10%. Inactive ingredients include Citronella oil & Eucalyptus oil in a water gel base.] Wheal itched intensely and was very slightly burning and tender for 24 hours. There was no fever nor other symptoms. By 7:00 am on 3/18/2021, the itching and rash were greatly diminished.
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| 69 | 2021-03-18 | injection site pruritus, injection site redness, injection site swelling |
Increased blood pressure and heart rate. Chills - fever- headache - body aches - sick to my stomach ...
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Increased blood pressure and heart rate. Chills - fever- headache - body aches - sick to my stomach - tireness - swollen and red arm at injection site along with some itching. Woke up with these symptoms next day after vaccine. Blood pressure, heart rate, and other symptoms were better by day 2 but swollen arm and redness still persists. Still have a slight headache.
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| 69 | 2021-03-18 | hives |
Individual itchy welt/Hive erupting in different location days after 2nd booster; This is a spontane...
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Individual itchy welt/Hive erupting in different location days after 2nd booster; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP letter sent in cross referenced case follow up. A 69-year-old female patient recieved second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: CL9Z62), via an unknown route of administration at arm Right on 26Jan2021 (at approximately 03.25 PM) at single dose for covid-19 immunisation. The patient medical included Hypertension - Controlled w/medication, Elevated Cholesterol & Triglycerides - Controlled w/medication, Hypothyroidism - Controlled w/medication, Moderate Gastritis - Controlled w/medication, as needed, Osteoarthritis, Peripheral Neuropathy, Pre-Syncopy, Generalized Granuloma Annulare, Tendonitis, Onycholysis (Nail Avulsion: left big toenail removed on 25Jul2011 & right one removed on 10Nov2014), Hiatus Hernia, Mild Diverticulosis in Sigmoid Colon; Surgeries included: Malignant Melanoma - Excised from right forearm; no recurrence in Nov1988, Reduction Mammoplasty in Nov1993, Benign Tumor removed / L breast in Nov1993, Gall Bladder Cholecystectomy in 1998, Hysterectomy in Oct2011, Bariatric Sleeve Gastrectomy in Dec2012, Hernia Repair in Dec2012, Lypomas (benign fatty tumors) excised in May2013, Dual IDC Lumpectomies / L breast in Oct2017. Past drug reaction included hydroxychloroquine (Plaquenil) caused allergy, tetracycline caused stomach upset (with so many other available antibiotics on the market today, Tetracycline is no longer an Issue), pentoxifylline ER (Trental) caused multiple side effects. Historical vaccine included Typhoid Vc on 24Dec2008; Tetnus on 26Dec2008; Pneumo on 26Dec2008; Influenza on 24Dec2008, 19Oct2009, 22Nov2010, 30Nov2011, 21Nov2012, 28Oct2013, 03Nov2014, 03Nov2015, 23Oct2016, 06Oct2017, 13Sep2018, 21Sep2019, 23Sep2020: all at 0.5 cc dose and Prevnar 13 on 23Sep2020 at 0.5 ml. Family History was as follows: father (deceased) had arteriosclerotic heart disease / thromboembolism / artery occlusion; paternal family history of diabetes & heart disease; mother (deceased) had arteriosclerotic heart disease / renal failure; maternal family history included cancer & hypertension; siblings had hypertension, coronary artery disease & diabetes. Concomitant medications included levothyroxine sodium (SYNTHROID) for hypothyroidism at 50mcg / once daily, atenolol (TENORMIN) at 25mg 3 per day - 50mg in a.m. & 25mg in p.m., letrozole (FEMARA) at 2.5mg / once daily, vitamin D3 at 3000iu once daily, cyanocobalamin (VITAMIN B12) at 1000mcg / once daily, ascorbic acid (VITAMIN C) at 500mg / once daily, folic acid at 1mg / once daily , hydrochlorothiazide at 25mg / once daily, pantoprazole sodium sesquihydrate (PROTONIX) at 40 mg / originally: once daily - now: every other day, alprazolam (XANAX) at 0.5mg, as needed, paracetamol (TYLENOL, caplets) 500 mg ea. -or- arthritis strength; 650mg ea., cetirizine hydrochloride (ZYRTEC, 10mg), alginic acid/aluminum hydroxide/sodium bicarbonate (GAVISCON) and simvastatin (ZOCOR) at 40mg / once daily, Late Night. Past drug event included: Tetracycline- Stomach upset only; with so many other available antibiotics on the market today, Tetracycline is no longer an Issue; Pentoxifylline Er (Trental) - Multiple side effects. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL3346) via an unspecified route of administration, on 05Jan2021 at about 17:00 (at the age of 69-year-old) as a single dose in the right arm for COVID-19 immunization and experienced vaginal bleeding 06-JAN-2021 06:30 recovered on 17-JAN-2021, Fear and Paranoid in Jan2021. On 26Jan2021, the patient received 2nd Pfizer Covid-19 "booster" vaccine at approximately 03.25 PM and on 30Jan2021 in the evening, the patient experienced Individual welts (Hive/Urticaria) erupting at different location starting 4 days after 2nd booster vaccine on 26Jan2021 (Time of onset: PM). A single itchy welt / hive erupted on the upper portion of the left side of back (below the shoulder blade). Eventually subsided. On 01Feb2021 late afternoon, another single itchy welt / hive erupted on the back of left hand (near the thumb). That eventually subsided. On 02Feb2021 early morning, a single itchy welt / hive erupted on the top my right forearm (just below the elbow). After several minutes, it receded. A couple of hours later, one flared up on the side of my right thigh (approximately 3 inches above the knee). That, too, eventually went down. On 03Feb2021, patient went to the office of a physician board certified in allergies & immunology. Physician (He) said the reaction was due to my body creating antibodies (for protection against the Coronavirus) after receiving the booster shot days earlier and it's a delayed response & would eventually stop. The patient was not hospitalise due to the event. No treatment was received. Still experiencing events. On 09Jan2021, ER (emergency room) Blood work results included urinalysis. Patient stated that any additional test results, if required, would to be obtained from Physician. Outcome of the event was not recovered. Information regarding lot/batch number has been requested.
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| 69 | 2021-03-18 | sensitive skin |
Sore arm; body aches; fatigue; headache; upper stomach cramp; chills; sensitive skin; symptoms got w...
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Sore arm; body aches; fatigue; headache; upper stomach cramp; chills; sensitive skin; symptoms got worse; This is a spontaneous report received from contactable consumer, the patient. A 69-year-old elderly female received the first dose of BNT162b2 (solution for injection; Lot EN6201 expiry not provided) as a single dose via unspecified route in the right arm on 14Feb2021 at 11:30 AM (at 69-years-old) for COVID-19 immunisation. Relevant medical history included asthma, hypothyroidism, and high blood pressure (BP). The patient has an allergy to penicillin, sulfonamide (sulfa), eggs, shellfish and peanuts and all tree nuts. Concomitant medications sans posology/indications included levothyroxine sodium (SYNTHROID), valsartan (DIOVAN), atenolol (TENORMIN), amlodipine, and diazepam (VALIUM NOVUM). The patient did not receive any other vaccines on the same date. The patient denied being diagnosed with COVID-19 prior to the vaccination. The patient reported that on 16Feb2021 at 05:00pm she experienced a sore arm, body aches, fatigue, headache, upper stomach cramps, chills , sensitive skin (no hives) and these symptoms got worse on the second day and continue (fifth day not including day of vaccine), The patient was tested for COVID via nasal swab PCR on 19Feb2021 and was negative. There was no treatment received. The outcome of the events, sore arm, body aches, fatigue, headache, upper stomach cramps, chills, and sensitive skin (no hives), was not recovered.
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| 69 | 2021-03-18 | redness |
immediately following injection within 1-2 minutes, she developed severe facial flushing followed by...
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immediately following injection within 1-2 minutes, she developed severe facial flushing followed by flushing and redness of the bilateral forearms and hands. She received 25mg of Benadryl and was observed for 1 hour. Symptoms resolved within the next hour or so. S
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| 69 | 2021-03-19 | injection site pain |
10 hrs after vaccine woke to pain in muscle approx 1 1/2 inches below injection site. About 12 hou...
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10 hrs after vaccine woke to pain in muscle approx 1 1/2 inches below injection site. About 12 hours latter, discomfort moved to muscle around injection site, no longer below it. approx 36 hours after injection, muscle sore only when touched. All discomfort fron Vaccine gone within 48 hours.
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| 69 | 2021-03-19 | injection site pain, injection site warmth, injection site redness |
3/18 Chills and slight temperature. Sore arm 3/19 Injection site warm and red 3/20 arm still warm, ...
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3/18 Chills and slight temperature. Sore arm 3/19 Injection site warm and red 3/20 arm still warm, but less than previous day slightly ref
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| 69 | 2021-03-19 | injection site pain, injection site swelling | Chills, body aches, lethargy, pain and swelling at injection site |
| 69 | 2021-03-19 | injection site pain |
Had a fever from 101.4 - 101.9 from onset through late evening on 3/19. Treated with Tylenol that lo...
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Had a fever from 101.4 - 101.9 from onset through late evening on 3/19. Treated with Tylenol that lowered the fever but didn't take it away. Other symptoms included nausea, loss of appetite, muscle aches, pain in both eyes, pain in the lower backside of my head, pain at injection site. Fatigue. Slept all day and through the night. 3/20/2021 8:50 am - as I complete this form I still have side effects even though most symptoms are gone now; Currently, extremely fatigued with a headache that is at the back of my head only. Soreness at injection site. Other symptoms are gone.
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| 69 | 2021-03-19 | hives, injection site rash |
Rash on injection site, swelling on the arm, chills, rash on vaginal and anal area, hives on chest, ...
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Rash on injection site, swelling on the arm, chills, rash on vaginal and anal area, hives on chest, back, and arms, fatigue, and muscle aches
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| 69 | 2021-03-20 | rash |
Body rash. Abdomen, legs, back. Still in progress Spreading. Like hives. No itch presently All...
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Body rash. Abdomen, legs, back. Still in progress Spreading. Like hives. No itch presently All started the following morning 03/20/2021
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| 69 | 2021-03-20 | injection site pain | Dizziness, headache and tired. Arm at injection site was sore. Lasted two days. |
| 69 | 2021-03-20 | hives | Headache, diarrhea, nausea, welts on face, general weakness and body pains. |
| 69 | 2021-03-20 | rash, itchy skin | Swelling, rash, itch, tenderness within 2 days |
| 69 | 2021-03-20 | skin laceration |
passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my hea...
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passing out; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head; I fell on a tile floor & hit my head resulting in a 1.5 inch gash in the back of my head.; Chills; fatigue; nausea; lightheadedness; vertigo; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EM9810) via an unspecified route of administration, administered on the left arm on 26Feb2021 15:15 at a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included calcium carbonate (OS-CAL) and vitamin. The patient previously took BNT162B2 for COVID-19 immunisation (first dose on the left arm at 01:30 PM, lot number: EL 1283); and SHINGRIX vaccine in 2019, codeine and cipro and experienced allergies. On 27Feb2021 03:30 PM, the patient experienced chills, fatigue & then sudden nausea & lightheadedness that resulted in passing out. Unfortunately, the patient fell on a tile floor & hit her head resulting in a 1.5 inch gash in the back of her head. When she went to the ER, it was determined that she now had vertigo (which she never had before) but obviously hard to tell if it was a side effect of the vaccine or from the fall. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events which included CT scan, ekg, chest X-ray, bloodwk (unknown results) and Epley maneuver. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient is not pregnant. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 69 | 2021-03-21 | injection site pain |
Had Covid 19 December 2020 with severe Total Body Aches, Headache, fatigue. Recovered after 4 weeks...
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Had Covid 19 December 2020 with severe Total Body Aches, Headache, fatigue. Recovered after 4 weeks bedrest. I had no pain at injection site till the next morning. I also felt I had Covid 19 all over again with fever 100.3 X 3 days. Tylenol would not take the symptoms away.
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| 69 | 2021-03-21 | redness |
I felt dizzy, nausea, felt unwell, weak, faint, started to slump over, was collapsing, hands turn re...
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I felt dizzy, nausea, felt unwell, weak, faint, started to slump over, was collapsing, hands turn red, tightness in the upper part of my body, lips tingling, tightness / swelling in my cheeks and mouth, very severe headache. I was rushed over to ER. Next day still had tingling of lips, felt unwell. By third day, felt better. I had an anaphylactic reaction to the vaccine. Three of my systems were adversely effected. Dr. and others are UNDERREPORTING the anaphylactic reactions cases. Just because I didn't die or an Eppie Pen was not given to me. doesn't mean I should not be included in the statistics.
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| 69 | 2021-03-21 | injection site pruritus, injection site pain |
Pain at site in arm, March 16th (day after) Diahhrea & low grade fever March 17th, 18th Friday, M...
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Pain at site in arm, March 16th (day after) Diahhrea & low grade fever March 17th, 18th Friday, March 19th, itching at injection site on left arm, no pain just very, very itchy Took Immodium, Wed 17th & 18th and Tylenol for low grade fever, sweating. Took Benadryl Sat. 20th after topical did nothing, Today, March 21st. No pain in arm just continues to itch at injection site
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| 69 | 2021-03-21 | itchy skin, redness |
Patient woke up in the morning after her vaccine, her arm was swollen and red all the way to her elb...
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Patient woke up in the morning after her vaccine, her arm was swollen and red all the way to her elbow, and her arm was painful and heavy and tingling. This continued until the following day with the tingling and swelling. The arm is still red and it is hot to the touch and is extremely itchy. Benadryl helps with the itching.
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| 69 | 2021-03-21 | itchy rash |
Pruritic rash on face and bilateral forearms, slowly developing over 48 to 72 hours from vaccination...
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Pruritic rash on face and bilateral forearms, slowly developing over 48 to 72 hours from vaccination.
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| 69 | 2021-03-22 | rash |
Day 1 - 10 hours after- tightness in upper chest/throat and soreness in left arm. Day 2 - Woke up wi...
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Day 1 - 10 hours after- tightness in upper chest/throat and soreness in left arm. Day 2 - Woke up with my finger joints stiff, swollen and throbbing with pain (this subsided on day 4) Day 3 - No symptoms Day 4 - Woke up with rash (burning) on right side of my neck, and headache.
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| 69 | 2021-03-22 | rash |
Patient had adverse reaction to shot #1 including rash, increased heart rate, nausea so she decided ...
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Patient had adverse reaction to shot #1 including rash, increased heart rate, nausea so she decided that she wanted to get Moderna instead of Pfizer. Appointment was scheduled and she received her 2nd shot Moderna. Side effects included 3 days of severe symptoms of fatigue, nausea, vomiting, chills, fever and over all severe body aches. Aside from the above, no other reactions noted from 2 different vaccines. Patient was called and educated.
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| 69 | 2021-03-22 | rash, itchy skin, redness, hives |
Swelling of face, throat, around eyes, hives ,rash on face and neck and some on right arm and itchin...
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Swelling of face, throat, around eyes, hives ,rash on face and neck and some on right arm and itching. Swelling has subsided but redness and some hives and itching continues 7 days post first shot.
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| 69 | 2021-03-22 | injection site pain |
Symptoms: Severe headache, nausea, muscle aches, very tired, left arm pain, dizziness, weakness - be...
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Symptoms: Severe headache, nausea, muscle aches, very tired, left arm pain, dizziness, weakness - began some time in early morning of March 21 Called Emergency Room. Spoke to ER doctor who recommended: 2 Tylenol, 1/2 Benadryl, plenty of fluids, eating light, light activity level I followed these except used only 1 extra strength Tylenol which I repeated twice during the day. Spent most of day sleeping. Improvement by morning of March 22. March 22 - tiredness continued so limited activity.
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| 69 | 2021-03-23 | injection site pain, injection site pruritus |
Took the 1st shot Thurs. Feb 25, no effects, 21 days later took 2nd shot on Thursday 3/18/21. That n...
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Took the 1st shot Thurs. Feb 25, no effects, 21 days later took 2nd shot on Thursday 3/18/21. That night my arm was sore, came down with aches, headache, tiredness, then chills, fever, weakness, dry heaves, light headedness but did not passout. Stayed in bed for two days, Friday n Saturday. Got up Sunday layed around all day. Got up Monday, Tuesday and today, Wednesday the 24th with headache and feelilng blah, no energy. Vaccine site still slightly sore and itches too. still not feeling myself, today is Wed. Mar 24. May not have any bearing on vaccine but too much of a coincidence.
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| 69 | 2021-03-23 | rash with redness, itchy skin, rash papular, injection site reaction |
sore arm initially after injection on monday mar 22- next day arm was itchy and also felt tired and...
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sore arm initially after injection on monday mar 22- next day arm was itchy and also felt tired and had slight temperature of up to 99.6 the second evening-around the second day by 10PM felt great except arm felt very itchy (removed bandaid as thought maybe latex issue?) and tried not to scratch- wed morning mar 24, had swollen lymph nodes left arm and also red rash at injection site and a bit lower and off to one side and some raised red dots-had no issues with initial vaccine shot- baby book shows that I had delayed rash reaction to child hood vaccines in 1952
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| 69 | 2021-03-24 | skin spots |
4d after vaccination patient started experiencing nosebleeds (lasting ~10 minutes with compression) ...
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4d after vaccination patient started experiencing nosebleeds (lasting ~10 minutes with compression) and developed petechiae on her hand. Recommended ER for evaluation and laboratory work (CBC/CMP) after discussion
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| 69 | 2021-03-24 | hives, itchy skin | Broke out in hives and swelling in face and itching |
| 69 | 2021-03-24 | vaccination site pain | Constant pain in vaccination area of my left arm |
| 69 | 2021-03-24 | redness, rash, skin irritation, skin peeling |
Facial rash-swelling, leakage, redness, flaking.(Dermatitis) Folliculitis-upper lip(likely bacterial...
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Facial rash-swelling, leakage, redness, flaking.(Dermatitis) Folliculitis-upper lip(likely bacterial etiology with infectious nature. Seen on 3/22/21-Methodist healthcare Minor Emergency, Seen 3/24/21. Dermatology, Seen 3/24/1921-Regional One Health. Allergic reaction from COVID vaccine. Medication prescribed-Medrol(pak):4 mg orally daily clindamycin, desonide, triamcinolone
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| 69 | 2021-03-24 | skin warm |
Fever, muscle and joint aches, eyeball aches, loss of appetite, extreme fatigue. On the first day af...
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Fever, muscle and joint aches, eyeball aches, loss of appetite, extreme fatigue. On the first day after the second dose (Tuesday, March 16, 2021), I slept 19 hours, sat up for 1 hour, and went back to bed and slept another 16 hours. Upon waking on the second day after the vaccination (Wednesday, March 17, 2021), the fever had broken and the aches were not as severe but still present. No food or drink were consumed as I slept the entire time. On the third day after the vaccination (Thursday, March 18, 2021), aches were gone, but I was so weak with little energy. In addition, I had lost 3.5 pounds since the day of the vaccination. I could not find a thermometer (as well as was too tired to look), so I cannot tell you what my temperature was, but my face/forehead was hot to the touch.
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| 69 | 2021-03-24 | skin discolouration | Flushed sensation with rosy cheeks, given Benadryl with improvement |
| 69 | 2021-03-24 | injection site pain | Headache,chills, joint pain, fatigue, injection site pain, nausea |
| 69 | 2021-03-24 | itchy skin, redness |
PCP notified health department his ct reported when receiving her 2nd vaccine on 3/6/21, she did not...
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PCP notified health department his ct reported when receiving her 2nd vaccine on 3/6/21, she did not feel vaccine liquid going into her arm, asked the vaccinator if that was normal, told yes. PCP responded, not normal, called ?Moderna manufacturer (Pfizer was given per ct consent form), was told ct should have received another dose right at that time. 3/18/2021 a third dose of Pfizer vaccine was administered to the client as lead vaccine RN felt possible loss of too much vaccine when 2nd dose given, discussing with client she may have a strong reaction following this dose. 03/21/21- f/u phone call-ct very happy to have had a reaction! Sore, red, itchy arm and a bit of a headache after the third dose.
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| 69 | 2021-03-24 | rash | Systemic: Allergic: Rash Generalized-Mild |
| 69 | 2021-03-26 | rash papular |
About 20 Chicken pox-like papules (no pus or scab) emerging on the knuckles of 7 fingers, palm of le...
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About 20 Chicken pox-like papules (no pus or scab) emerging on the knuckles of 7 fingers, palm of left hand, above and below the knee on left leg, bottom of big toe on right foot. These 3-7mm papules(?) multiplied by day 2, some white heads in middle of red, inflamed and painful to the touch 3-7mm patches. When a few were lanced (to relieve pressure and be able to use my hands), they bled minimally, but no solids, fluid or pus. It wasn't until the afternoon of day two that I determined they were a result of the vaccine. Prior to that, I explored numerous possibilities and nothing fit. It was a Saturday, so I couldn't call my doctor. Throughout the evening of day 1 and all day 2 I had chills and some body aches.
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| 69 | 2021-03-26 | redness, skin burning sensation, rash with redness |
Pfizer-BioNTech COVID-19 Vaccine EUA I had no symptoms after the first Pfizer vaccine. On Tuesday, ...
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Pfizer-BioNTech COVID-19 Vaccine EUA I had no symptoms after the first Pfizer vaccine. On Tuesday, March 23, 2021 I had the second vaccine and had flu symptoms the next day with body aches and fatigue. I felt better the day after that-Thursday. This morning, Saturday, as soon as I got out of bed, my face burned and turned bright red. I looked like I had a sunburn. My arms, especially around my elbows turned an angry red. They didn't burn as badly as my face. Around an hour later, the redness subsided, but my face still feels hot. I don't feel like myself and am taking it easy today. I want to report this so you are aware of the reaction. I take no medications and am extremely healthy. My last vaccine was in 1976.
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| 69 | 2021-03-26 | itchy skin, hives | hives & itching |
| 69 | 2021-03-27 | vaccination site pain |
mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; jo...
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mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; joint/muscle pain; joint/muscle pain; injection site pain; headache; labored breathing; dry-heaving after second syncope; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LOT 6205 (as reported)), via an unspecified route of administration in the right arm, on 08Mar2021, at a single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included sertraline; docusate sodium, ferrous fumarate (FERRO-SEQUELS); and multivitamin - all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201) on 15Feb2021 17:00 in the right arm for covid-19 immunization at 69-years-old. The patient did not have covid prior vaccination. The patient did not receive any other vaccines in four weeks. The vaccine was given at the public health clinic. The following day on 09Mar2021 15:30 after a short walk, the patient experienced flu-like symptoms, chills, joint/muscle pain, injection site pain, headache, syncope (2x) with mild seizure, labored breathing, and dry-heaving after second syncope. The patient was then taken by ambulance to the ER (resulted in an emergency room visit) and was given saline fluids via IV. The vitals and EKG were "ok" on 09Mar2021. The patient recovered relatively quickly and was released. The only symptoms remaining on 11Mar2021 were mild headache and mild nausea. The patient had not recovered from headache and nausea at the time of the report; while recovered outcomes on Mar2021 for all the other remaining adverse events. The patient was not covid-tested post-vaccination.
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| 69 | 2021-03-29 | rash papular |
Red and purple bumps scabs covering both legs and arms; Red and purple bumps scabs covering both leg...
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Red and purple bumps scabs covering both legs and arms; Red and purple bumps scabs covering both legs and arms; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 22Jan2021 at 15:45 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, allergies to medications, food or other products, and was not diagnosed with COVID-19 prior to vaccination. The patient had no concomitant medications and had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 26Jan2021 at 16:00 she had red and purple bumps scabs covering both legs and arms; further reporting they looked like flea bites. She reported that they checked everywhere and there were no fleas and no bed bugs. The events were reported as non-serious and did not require hospitalization. The events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was provided for the events in the form of oil on her body. The clinical outcomes of red and purple bumps scabs covering both legs and arms were not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 69 | 2021-03-30 | rash |
Anaphylactic reaction: full body rash; Anaphylactic reaction: full body rash; This is a spontaneous ...
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Anaphylactic reaction: full body rash; Anaphylactic reaction: full body rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at 69-year-old on 22Feb2021 (lot number: EL9267, expiration date unknown), at single dose for COVID-19 immunization. Medical history included cardiac disease, triple bypass operation, diabetes, thyroid, high blood pressure, known allergies: penicillin. The patient was not diagnosed with COVID prior vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. On 01Mar2021 the patient experienced anaphylactic reaction: full body rash. The event resulted in doctor or other healthcare professional office/clinic visit. The COVID was not tested post vaccination. The patient received treatment for the events, included unspecified medications. The outcome of the events was not recovered.
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| 69 | 2021-03-30 | redness, itchy skin |
My face started swelling, itching, red; My face started swelling, itching, red; My face started swel...
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My face started swelling, itching, red; My face started swelling, itching, red; My face started swelling, itching, red; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient receivedfirst dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL8982), via intramuscular route of administration, in the left arm on 27Jan2021 (at the age of 69-years-old) as single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive concomitant medications. The patient did not underwent any lab investigation. Consumer stated, "I am just reporting that I did had a reaction slight reaction to the Shot, Pfizer Shot that I received two days ago. It came about approximately 8 hours after I had the shot my face started swelling, itching, red, so I took couple Benadryl at night, got up the next morning and it was still really swollen, itchy, red. So, I have been on the Benadryl for the last two days. When I got up this morning it is considerably better but I just wanted to let you know that there was a reaction, I am assuming that's probably but easiest way to handle it just take Benadryl until it goes away. Is that correct?". When paraphrased the above concern, consumer stated, "I have already taken Benadryl and it helped and I am just kind of wondering how this will probably last?". Consumer stated, "Well it is getting better, I mean I don't need to go to the doctor. I just want to make a report because I know you are trying to get all the information you can on vaccination." Consumer stated, "Just when I took it or they gave it to me, is that what you want? 27Jan2021, that is when I received the shot." Consumer added, "I haven't received the second one yet. It's due in February." Outcome of the events were recovering.
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| 69 | 2021-03-30 | itchy skin, hives, itchy rash, skin swelling |
last night she couldn't sleep; Itchy Hives/Welts/welts are annoying; on her inner thighs, groin, wai...
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last night she couldn't sleep; Itchy Hives/Welts/welts are annoying; on her inner thighs, groin, waist and arms pits; developed welts and itching; Rash, Hives and welts, and states they are itchy; start with a small regular size and get bigger and elevated on the skin; start with a small regular size and get bigger and elevated on the skin; This is a spontaneous report from a contactable Nurse (patient). A 69-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration as single dose 1st dose in left arm on 22Jan2021 (Lot # EL9741), 2nd dose in right arm on 12Feb2021 (Lot # EM9809) for COVID-19 immunisation. Medical history was none. There were no concomitant medications. On 06Feb2021, 2 weeks after receiving her first dose, the patient experienced itchy hives, welts/welts are annoying; on her inner thighs, groin, waist and arms pits, developed welts and itching, rash, hives and welts, and states they are itchy. Patient also reported she received her 1st Covid dose on 22Jan2021 which is clarified that this is when the hives and welts started (under clarification). On unspecified date the patient experienced start with a small regular size and get bigger and elevated on the skin. On 03Mar2021 she couldn't sleep. The event itchy hives was considered medically significant by reporter. Course of events: Two weeks after receiving her first dose she developed welts and itching that has persisted through today. She has not changed medicines, foods, soaps or detergents. She has been taking Benadryl for about a month now for the itching. She reported rash, hives and welts, and stated they are itchy. They started with a small regular size and get bigger and elevated on the skin. The welts are annoying; on her inner thighs, groin, waist and arms pits. She ruled out foods or any products she had, and she wasn't taking anything new. She was using Benadryl Extra Strength Cream on her hives and after a few minutes it resolved, but last night (03Mar23021) she couldn't sleep, it usually resolved after a few minutes, but this time it lasted over an hour, states she had to just keep slathering it on because it wasn't helping. The outcome of itchy hives, welts/welts are annoying; on her inner thighs, groin, waist and arms pits, welts and itching, rash, hives and welts, and states they are itchy was not recovered, of start with a small regular size and get bigger and elevated on the skin, last night she couldn't sleep was unknown. A Product Complaint was filed. The reporter assessed the events hives and welts as related to the vaccine.
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| 69 | 2021-04-01 | hives, itchy skin |
Left side of neck, site of injection, elbow, joints and muscles down left side; Left side headache c...
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Left side of neck, site of injection, elbow, joints and muscles down left side; Left side headache continuing to spread; Left jaw, cheek, nasal area swelling; left eye sagging/ occasional eye droop; Tired; general aches mostly on left side; wobbly; hives; skin itching; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534 and expiration date not provided) via an unspecified route of administration, administered in left arm on 15Mar2021 15:45 as a single dose for COVID-19 immunisation. Medical history included hypertension, chronic dry eye, Bells Palsy, arthritis, allergies to penicillin, injected iodine and food sensitivities. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan, multivitamin and ciclosporin (CEQUA). On 15Mar2021 15: 45, the patient experienced left side headache continuing to spread. Left jaw, cheek, nasal area swelling and left eye sagging (previous site of Bells Palsy attack)-Left side of neck, site of injection, elbow, joints and muscles down left side. She was tired and progressed to general aches mostly on left side and was somewhat "wobbly" on 15Mar2021 15:45. She later had hives and skin itching on an unspecified date in Mar2021 which lasted a couple of days. Tiredness continues and swelling in face and occasional eye droop at 4 days out. No treatment was given in response to the events. The outcome of the event fatigue was not recovered while the outcome of the rest of the events was recovered on an unspecified date in Mar2021. The patient has not been tested for COVID-19 post vaccination.
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| 69 | 2021-04-01 | shingles |
Shingles; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female p...
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Shingles; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:00 (Batch/Lot number was not reported) as single dose at the age of 69 years old, for covid-19 immunisation. Medical history included allergy to penicillin and quinolones, and patient cannot eat cheese and other ages food (not an allergy, a sensitity). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient takes unspecified concomitant medications. The patient previously took ciprofloxacin and codeine and experienced allergy with these medications. The patient previously received first dose of bnt162b2 on 11Feb2021 at the age of 59 years old for COVID-19 immunization (product: COVID 19, brand: Pfizer, lot number: EI3302, administration time: 01:00 PM, vaccine location: right arm). The patient did not receive any other vaccine four weeks prior to COVID vaccination. The patient experienced shingles on 12Mar2021 19:00. Therapeutic measures were taken as a result of shingles as Veltrex and triamcinolone were given as treatment to the patient. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was hospitalized due to the event on an unspecified date. The patient has not recovered from the event. Information on the lot/batch number has been requested.
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| 69 | 2021-04-02 | redness, itchy skin |
itching; Little red pustules would swell into a whitehead, burst & scab over; Pretty soon my whole b...
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itching; Little red pustules would swell into a whitehead, burst & scab over; Pretty soon my whole body was covered in these red marks; This is a spontaneous report from a contactable consumer. A 69-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2; Solution for injection via unspecified route of administration on Left arm on 22Jan2021 14.30 at single dose for covid-19 immunization. other medical history includes Asthmatic, anemic, HBP, osteoarthritis, hypothyroidism, reflux, and allergic to Demerol. Other medications received in two weeks are acetaminophen 650 tablets. Calan SR, losartan, Si. It was reported that the day after the injection, I started itching - terribly! Little red pustules would swell into a whitehead, burst & scab over. Pretty soon my whole body was covered in these red marks & I was itching constantly!!!!! I had to take, plus get up in the middle of night, to take a Benadryl tablet each time to help me. It has been 2 ½ weeks now, and I am still itching constantly. Red Pustule development has lessened - finally. I'm actually hesitant to get the next inj scheduled in 5 days. I'm afraid these symptoms are going to magnify greatly. On 22Jan2021 14.30 adverse event was started and did not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was "Not recovered".
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| 69 | 2021-04-03 | skin mass |
raised place on the right wrist/ a raised place on the right and then there is a smaller place on th...
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raised place on the right wrist/ a raised place on the right and then there is a smaller place on the left; This is a spontaneous report from a contactable consumer or Other Health Professional. A 69-years-old female patient received first dose of BNT162B2 (solution for injection: Batch/Lot Number: EL9265) via an unspecified route of administration at left arm on 28Jan2021 15:30 as single dose for covid-19 immunisation. The patient Medical history and concomitant medications were not reported. There is no prior Vaccinations within 4 weeks. The patient experienced raised place on the right wrist on 30Jan2021 with outcome of re-covering, a raised place on the right and then there is a smaller place on the left wrist on 31Jan2021with outcome not recovered. She had to bend her hand to see the one on the left. The place on her right wrist is a tad smaller now. The place on the right wrist is wider than a quarter. The left one is smaller than a dime. She is planning on getting the second dose but has not scheduled it yet.
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| 69 | 2021-04-06 | vaccination site mass, vaccination site pain |
If she laid her arm on it, it was painful on the left side where she got the injection between her l...
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If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla; couldn't go back to sleep; very tired; weak; She had the lump and that was in the lymph node; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; irregular heart beats; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; baseball sized lump. It was hard/where she got the injection; It looked like it was connected to the breast because it was so huge.; Fever blister; heart beating so out of rhythm; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 18Mar2021 at 12:20 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing coeliac disease; hypothyroidism, is diabetic and has irregular heartbeat from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for hypothyroidism; hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN/HCTZ MYLAN) taken for blood pressure measurement; metformin, glipizide and pioglitazone hcl taken for diabetes mellitus; acetylsalicylic acid (ASPIRIN 81) taken for thrombosis; metoprolol taken for heart rate irregular, cyanocobalamin (VIT B12) taken for an unspecified indication, all from an unspecified start date and ongoing; famotidine, rosuvastatin, vitamin d2, vitamin d3 and potassium, all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: EN6198, NDC: 59267-1000-1, expiry: unknown) on 27Feb2021 at 1:40PM for COVID-19 immunisation. The patient got her last shot on 18Mar2021. The first day was fine. She woke up the next morning at three or four with her heart beating so out of rhythm it was crazy. It took almost the whole day. She called her cardiologist and couldn't get into them and she didn't want to go to the ER. She didn't have a way to prove any of that. She also got a baseball sized lump. It was hard. If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla. It extended underneath the axilla. She wasn't able to get in with the cardiologist because she waited to late in the day. She couldn't get off the couch that day because her heart was so out of rhythm. She was very tired and wanted to just lay down. She hates going to the hospital. She doesn't want to go to the hospital. She has a history of irregular heartbeats. She should have gone in and had an EKG. She has pictures of the lump if those are needed. HCP information: Her doctor had said if she had anything like any abnormal heart beats to come in and get an EKG. She also had a fever blister on 22Mar2021 that she hasn't had in years and was asking if this influences her immune system. She had the lump and that was in the lymph node and now a fever blister on the top lip. Heart beating so out of rhythm: it lasted all that day. She took a nap after she talked to the doctor's office and slept for several hours. When she woke up it was kind of back in rhythm, but it was going in and out. It wasn't as frequent as it was prior to nap. Prior to the nap it was almost continuous. It slowed down a lot on the 19Mar2021 and was gone by 20Mar2021. Outcome of event: She has PAC's and PVC's anyway. That is why she follows up with the cardiologist. They haven't been so out of rhythm as they were after the vaccine. She couldn't go back to sleep. She still has them occasionally and that is kind of normal for her. She was weak and tired. Baseball sized lump: it has gone down. She took pictures to show her friends who were all getting the shots. It is gone now. It might have started on 20Mar2021. She woke up with the lump on Saturday. She has recovered completely. Her daughter said she needed to get it checked out. Reporter had heard of a lump on the breast was a side effect. It looked like it was connected to the breast because it was so huge. Seriousness criteria: It was irritating because it was so big. It was painful if she put her arm down. It was like her breast were engorged. Causality: Heart beating so out of rhythm: she hasn't had it that bad, so she thinks it was. She had it a long time ago, maybe once before, but it never lasted that long or took her down like that. She is not the only one that has had the complaint of irregular heartbeats. She put on social media what she experienced and how weak she got. Several friends said that happened to them as well. She doesn't know their history. Reporter declined to do a report on her friends. That was another reason she didn't go to the hospital. She thought it was a normal side effect. She thinks she found on her paperwork about the lump in the lymph nodes. The patient underwent lab tests and procedures which included electrocardiogram: unknown results and heart rate: irregular on an unspecified date. The outcome of the event fever blister was not recovered, while of the rest was unknown. Reporter seriousness for heart beating so out of rhythm was reported as disabling.; Sender's Comments: Based on the information currently available and the plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events 'heart beating so out of rhythm ', 'baseball sized lump (where she got the injection/It looked like it was connected to the breast because it was so huge)' cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-04-09 | redness |
Weight: Gained 25lbs; Arm is slightly tender; arm might get a little stiff; excruciating leg crampin...
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Weight: Gained 25lbs; Arm is slightly tender; arm might get a little stiff; excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh/the same pain occurred on the opposite leg around noon and lasted for 15 minutes; excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh/the same pain occurred on the opposite leg around noon and lasted for 15 minutes; the inside of her thighs were a little red on the side, both legs from her thighs to her knees; the shot is already fogging her mind; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 08:30 (Lot Number: ER8727; Expiration Date: 31Jul2021, at age of 69 years old) at a single dose for covid-19 immunization. Medical history included allergies: Penicillin, Ampicillin, hair color product. The patient's concomitant medications were not reported. She was allergic to Penicillin, and Ampicillin. As a child, always reacted strongly to any vaccination she was given with a fever and flu like symptoms for a couple of days. With Ampicillin, she thought she was having a heart attack. Was told to stop Ampicillin immediately because she could get a heart attack. This was when she was 25 years old and she never went to the ER. She was allergic to a hair color product in the 1990s and it made her scalp itch really badly. Was given a cortisone shot, which she reacted immediately breaking out head to toe in hives. Has no NDC/LOT/EXP for the vaccinations she reacted strongly to as a child. Stated this was in the 1950s or early 1960s. Clarified she did not have a heart attack with Ampicillin, but it felt like she was having one. Has had cardiograms per her request and her heart and heart walls are perfect. The patient received the first dose of the Covid vaccine at 8:30 a.m. this morning on 26Mar2021. Caller reports around 11 a.m., she experienced excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh, states that the pain lasted 15 minutes. The patient reports the same pain occurred on the opposite leg around noon and lasted for 15 minutes, states that "the pain was so excruciating that she could barely stand up and it was so agonizing it was unbelievable." The patient noticed that the inside of her thighs were a little red on the side, both legs from her thighs to her knees. The patient states that she has not been in the sun, and didn't think it was anything alarming, but this is abnormal for her, states that she received the vaccine in the right arm and her upper torso is fine and her head is clear, asked if anyone else had reported this reaction. She was planned to received the second dose on 16thApr in the early afternoon. The patient stated the COVID shot was already fogging her mind. The patient felt pretty good after first shot. Felt nothing. Fifteen minutes before leaving the diner she got a leg cramp. Was sitting in a booth and didn't think much of it. Attributed it to the way she was sitting. Around 11AM when she got back to her garage, she was in agony. It hurt from the top of her rear all the way down the side to the back of her knee and rolled to the inside of her thigh. She was in such agony and didn't know if she could get out of her chair and walk. By the time she reached her apartment it has subsided. An hour later, same thing happened in the left leg. She was laying in bed and texting because she didn't' know if she would get any other reaction. This leg cramp was even worse. She was in tears. Got off bed to try and walk it off. Initial leg cramp happened in right leg. Was excruciating. Both times it lasted for 15 minutes. Both cramps were from her buttocks, all down to her knees, and rolled over into her thigh. Didn't know if that was a reaction. It is not typical of anything written on Pfizer's information or that she had heard. She was concerned. Heard about blood clots, but not with this particular product. Stated second leg cramp subsided. If it hadn't, she wouldn't have gone to the ER. Leg cramps was so excruciating. Originally thought it was coincidental and stated she will be 70 on (Date withheld). To say she has never had leg cramps before would be a lie. The way the leg cramps were timed was kind of weird. It was absolutely the same kind of cramp and location just on the a different leg. Weight: Gained 25lbs. Doesn't have COVID or any symptoms. Tested three to four months ago and was negative. Received first dose COVID-19 Vaccine today, 26Mar2021, at 08:30AM. First leg cramp began 11:00AM in right leg. Second leg cramp began Noon in left leg. Each time lasted 15 minutes. Not having leg cramps right now. Could barely talk when having leg cramps. Was worried about getting clots in legs. Otherwise she would think it was because she was getting older. She doesn't get leg cramps very often. Doesn't know when the last time she had leg cramps prior to today. Nurse technician at vaccine faculty stated caller's allergy history wouldn't be a problem and she only had to sit for 15 minutes. Received the COVID-19 Vaccine and hardly felt it. Waited for 15 minutes. She was fine until 11AM. She was fine now, but her arm might get a little stiff tomorrow. Arm was slightly tender. Surprised she felt something in her legs. Doesn't know whether to associate it with COVID-19 Vaccine or not. Has nothing to complain about in the upper torso or from the waist up. Wants to know if this is a reaction or coincidence. Stated she expected to have a stiff arm. The outcome of the event "Cramps in legs" and "pain" was recovered on 26Mar2021. The outcome of other events was unknown.
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| 69 | 2021-04-12 | injection site nodule, bruising |
Received shot too low. The nerve was damaged. A ball was formed on the injection site. Bruising.Two ...
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Received shot too low. The nerve was damaged. A ball was formed on the injection site. Bruising.Two months later there is still swelling and pain.
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| 69 | 2021-04-14 | skin warm |
Client complained of tingling/numb feeling in left arm from elbow to fingers 5 minutes after receivi...
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Client complained of tingling/numb feeling in left arm from elbow to fingers 5 minutes after receiving COVID vaccine. Hands and fingers warm to the touch, injection site clear. Observed and vital signs stable. Numbness and tingling resolved 45 min after start. Client home with instructions to follow up with primary care.
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| 69 | 2021-04-26 | bruising, itchy rash |
itchy rash; bruise; slight ache upper arm; This is a spontaneous report from a contactable consumer ...
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itchy rash; bruise; slight ache upper arm; This is a spontaneous report from a contactable consumer (patient). This 69-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and expiry date unknown), via an unknown route on 18Feb2021 at 10:45 (at the age of 69-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history and concomitant medications were not provided. The patient had no known allergies. The patient had no prior Covid vaccination and Covid tested positive after post vaccination. On the same date after vaccination, the patient had no immediate reaction, only slight ache upper arm which resolved by day 2. On 23-Feb2021,(5th day) the patient had bruise appeared at site. On 24-Feb2021, (Day 6) a slightly itchy rash appeared and on day 7 rash became very itchy and the rash area about 3x6 was red, raised and warm. Resolved almost completely by day 9. The patient did not receive any treatment. Outcome of the events slight ache upper arm, bruise and itchy rash was recovered.
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| 69 | 2021-04-28 | vaccination site pain |
it'll feel like little flutters; Heart palpitations; Shortness of breath; Didn't feel like normal se...
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it'll feel like little flutters; Heart palpitations; Shortness of breath; Didn't feel like normal self; Site pain; Chest pressure; Difficulty sleeping because of heart rate; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EP7534), via an unspecified route of administration administered in right arm on 29Mar2021 at 09:20 (at the age of 69-year-old) at hospital facility as SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within four weeks. The patient had no relevant medical history. Patient reported that she has people in the family that have had heart problems. Concomitant medication included unspecified vitamins. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EM9990 or EM9890) administered in the right arm on 08Mar2021 (at the age of 69-year-old) for COVID-19 immunisation and had a little fast heart rate but not constant, little fatigue and site pain. The patient previously took steroid injections 2 years ago (2019) and had heart palpitations before. The patient further mentioned that normally after the steroids wear off, the heart palpitations go away. The patient reported that she did not have any problems following the first dose of the COVID-19 vaccine. Caller reported that she had a little fatigue and site pain for just a couple of days but that everything was fine. Patient reported that she felt a little heart palpitations for maybe a day or two and then it was gone following the first dose of the COVID-19 vaccine. After she got the second dose of the COVID-19 vaccine on 29Mar2021, she noticed the heart palpitations again and a little shortness of breath. The heart palpitations and shortness of breath were nothing that she felt that she had to run to the emergency room or anything over. The patient reported that now it was getting difficult for her to sleep sometimes at night because of the heart rate. The patient also reported that she was trying to figure out that from this length of time between her second dose of the COVID-19 vaccine on 29Mar2021 and time of call on 14Apr2021, could the heart palpitations be a side effect from the COVID-19 vaccine. Patient also mentioned that when she experienced heart palpitations before, a whole work up was ordered and she was referred to cardiology and that nothing was found during the work up after previous experience with heart palpitations. The patient also mentioned that she has been fine, that she has been able to work and walk and that she gets her 10,000 steps every day. After getting the COVID-19 vaccine, she was tired and didn't feel like her normal self. The patient also reported that when the time had arrived to get the second dose of the COVID-19 vaccine, about a week before, she may have had a little fast heart rate but not constant. It was also reported that following her second dose of the COVID-19 vaccine on 29Mar2021, the fatigue started about the same time as it did following the first dose, on the second day post-vaccine on 30Mar2021. Patient reported that she was kind of tired and just taking a nap during the day. The fatigue was still ongoing. It was also reported that patient was starting to feel better other than the heart palpitations. The patient reported that yesterday, 13Apr2021, she felt great and could do her normal routine, other than feeling chest pains and palpitations. The heart palpitations are not constant, but are more regular during the day than she was used to. The heart palpitations were really bad last night, 13Apr2021, and that she had difficulty sleeping because of heart rate (couldn't hardly sleep at all). The patient's doctor was scheduling her for an echocardiogram. The patient's doctor did an electrocardiogram (EKG) on her on 08Apr2021 and there was nothing there (normal). The patient's doctor was scheduling her for a stress echocardiogram. The patient also mentioned that after returning from the physician's office, her husband went back and looked at the symptoms from the COVID-19 vaccine information sheet. The patient reported that her husband thought that she needed to call to eliminate everything, that they are trying to figure out why the patient was experiencing the heart palpitations. The patient also mentioned that 2 days ago she got on her treadmill to walk and went for 30 minutes. Patient reported that it normally takes her 5 minutes to recuperate, but that time it took her 20 minutes before she felt comfortable after her walk. The patient also reported that the site pain was nothing serious following both doses of the COVID-19 vaccine. The site pain began shortly after receiving the vaccine and went away after the second day following both vaccines. The shortness of breath probably started about 5 days after she got the second dose of the COVID-19 vaccine. The shortness of breath wasn't enough that she felt that she needed to run to the emergency room. It just felt like when she would breathe, especially at night as she normally breathes with her mouth closed at night, the patient felt like she had to open her mouth to breathe because she can still feel the pressure in chest. The patient was still experiencing the heart palpitations. The heart palpitations are a little worse because they happen so often. Patient reported that initially, she would have a few heart palpitations and then go for hours with none. Patient reported that now, she was feeling the heart palpitations quite a bit. Patient reported that it feels kind of like a little pressure in her chest and then it'll feel like little flutters. The patient further reported that she experiences a little pressure in her chest when she experiences the heart palpitations. At times, the chest pressure would go away, but she always feels the chest pressure there now. The chest pressure has gotten worse over the past couple of weeks and that she was thinking that it would go away like the first one did. Patient reported that she went to the doctor last week and was given an EKG. Patient reported that the EKG was fine and that her physician was scheduling other tests to make sure it's nothing with her heart. The patient didn't think that the heart palpitations and shortness of breath were from the COVID-19 vaccine, but that her husband looked at the vaccine information paper after her doctor's appointment and said she should call Pfizer. The patient had not yet recovered from heart palpitations, shortness of breath, fatigue, and chest pressure while outcome of the rest of the events was unknown.
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| 69 | 2021-04-30 | injection site pain, rash |
Tenderness on the injection site; some aches and pains on her body; Can't get out of bed/she couldn'...
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Tenderness on the injection site; some aches and pains on her body; Can't get out of bed/she couldn't' stand up; Her arm was so sore/arm hurt a bit; Bone in body hurt and everyplace she has arthritis was worse; Bone in body hurt and everyplace she has arthritis was worse; Carpal tunnel reacted adversely; A prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via unspecified route of administration at arm left on 02Feb2021 08:00 AM at single dose for COVID-19 immunization. The patient's medical history included arthritis and she has had surgeries. Concomitant medication was not reported. The patient received her 1st dose of the Pfizer Covid vaccine on 02Feb2021 and said she was fine up until the night of the same day wherein she woke up from her sound sleep feeling absolutely in pain. Mentioned that the parts of her body where she had arthritis and her carpal tunnel acted up which she has never experienced before and said that she normally did not have problems like this. She also cannot get out of bed and said that her husband had to her help her out and she also had a rash. Currently, she was still experiencing tenderness on the injection site and some aches and pains on her body but not as bad as it previously was. The patient had bone in body hurt and everyplace she has arthritis was worse. The patient had the injection on 02Feb2021 at 8AM, and did ok with it, her arm hurt a bit, not bad, and that night she went to bed, and it was every bone in her body hurt and everyplace she has arthritis was worse, and her carpal tunnel reacted adversely, her arm was so sore, she can't believe it, now she has developed a rash. Her arm hurt that night, is a little tender now, it was not real red, just tender. Her husband had to help her out of bed, she could not stand up, she was not a baby, she has had surgeries, she responds well to that kind of thing, so this was unusual. Yesterday she was in bed all day, she did not get out of bed until 5PM. This all came on all of a sudden, she woke out of a sound sleep, she was totally terribly miserable. States her rash through lasted through yesterday, now she has developed a rash, a prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting, but she is sure it will fade, she has had reactions to things before. No further details provided. She has not had any other tests or anything lately. No injections, none of that. Would like to know if she has to get her 2nd dose or not. The outcome of the events her arm was so sore/arm hurt a bit, bone in body hurt and everyplace she has arthritis was worse, Carpal tunnel reacted adversely was recovering/resolving. The outcome of the events rash, pain and cannot get out of bed/she could not stand up was unknown. The outcome of the events tenderness on the injection site was not recovered/not resolved.
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| 69 | 2021-05-04 | injection site pain, injection site swelling |
Injection site pain and swelling; Injection site pain and swelling; mild headache and sensitivity to...
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Injection site pain and swelling; Injection site pain and swelling; mild headache and sensitivity to light; mild headache and sensitivity to light; muscle pain around shoulders and neck; muscle pain around shoulders and neck; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6201)), via an unspecified route of administration, administered in arm left on 08Feb2021 14:00 (at the age of 69-years-old) at single dose for COVID-19 immunization, the patient was not pregnant at the time of vaccination. The patient medical history included bronchitis chronic, uterine cancer from an unknown date and unknown if ongoing. The patient previously received codeine and experienced drug hypersensitivity within 2 weeks. The patient concomitant medications were not reported. The patient did not receive any other vaccines and was not tested for covid test prior to the COVID vaccine. On 08Feb2021 18:30 (04 hours and 30 minutes after the vaccination), the patient experienced injection site pain and injection site swelling, mild headache and sensitivity to light (headache), (photophobia), muscle pain around shoulders and neck (arthralgia), (neck pain). The patient did not received treatment for the adverse event. Seriousness of the event was reported as non-serious. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected
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| 69 | 2021-05-04 | itchy skin, redness, rash papular |
Very tired; The rash is red, bumpy, and itchy/ a rash across her shoulders and upper chest area abov...
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Very tired; The rash is red, bumpy, and itchy/ a rash across her shoulders and upper chest area above her breasts/Light bumpy rash all over my face; Itchy/ itchiness; The rash is red, bumpy, and itchy; High fever; This is a spontaneous report from a contactable consumer (patient). A 69-year-old patient received second dose of (COVID-19 VACCINE) , expiration date 30 Jun 2021, on 30 Mar 2021 09:30 at single dose in left arm for COVID-19 immunization. Medical history included ongoing Diabetes mellitus from Feb 2004. Concomitant medication included diabetes medication. The patient previously received first dose of vaccine, Expiry Date: 30 Jun 2021 on 09 Mar 2021. The patient previously received Penicillin and Sulfa for severe tonsil and adenoid inflammation and experienced anaphylactic shock. They told her to remember not to ever take these medications. The patient had completed the second dose of the Covid vaccine on 30 Mar 2021. On 31 Mar 2021 she had a high fever for 24 hours but was not sure how high it was. On 05 Apr 2021, she started to have a rash across her shoulders and upper chest area above her breasts. This had been going on for about ten days. The rash was red, bumpy, and itchy. She asked could she take Benadryl to calm it down a bit. She stated the rash on the shoulders and chest was red and bumpy. In the symptoms that they had listed on the handout, it stated that unless the rash covers the whole body, its just part of your symptoms. The rash only covers her shoulders and back the upper part and went across her chest, not her whole body. It showed up on and off on her face, but it's not itchy. The rash on her chest and shoulders had been going on for 10 days. She also became very tired on 10 Apr 2021, which was unusual. She stated the itchiness started then the rash. She was still itchy, and after she showered last night, she put some really good cream caller First Aide used for all kinds of rashes like Psoriasis and eczema. She put it on her shoulder and top part of her chest. It calmed down the itching and the redness. The longer she was up the itching stared, and she put cream on that area again. It's keeping it at bay. She noticed the rash on her face last night after she washed her face. That was the third or fourth time when she noticed it. She noticed it on 10 Apr 2021, but could have been coming and going before that. Anytime she was washing her face and brushing her teeth she notices it. It's a light bumpy rash all over her face. She felt very tired when she went to bed and took a nap on Saturday and Sunday. The outcome of High fever was resolved on 01 Apr 2021. The outcome of Very tired was unknown. The outcome of The rash is red, bumpy, and itchy/ a rash across her shoulders and upper chest area above her breasts/Light bumpy rash all over my face was resolving. No follow-up attempts are needed. No further information is expected.
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| 69 | 2021-05-10 | bruising | cardiac arrest |
| 70 | 2021-01-04 | vaccination site pain, vaccination site redness, vaccination site swelling |
sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had ...
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sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had the virus or bad flu; could not hardly open eyes/eyes were very heavy; could not hardly open eyes/eyes were very heavy; chills; tiredness; headache; muscle pain; weakness; Joint pain; Fever; Injection site swelling and redness; Injection site swelling and redness; injection site pain; Nausea; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left upper arm, on 21Dec2020 (at the age of 70-years-old) at a single dose for COVID-19 immunization. Medical history included COVID-19 (lasted 3 weeks), high blood pressure (family history in mother and father), lumpectomy, breast cancer, radiation treatment, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, fibroid tumors, fibroid tumors surgery, thyroid problem, bone density problem, and lower lobe left of lung piece cut out (not cancer). The patient previously received chemotherapy (MANUFACTURER UNKNOWN) for breast cancer, pethidine hydrochloride (DEMEROL) for post fibroid tumors surgery and experienced swollen hands and arms, influenza vaccine (MANUFACTURER UNKNOWN) in 2020 (usually gets swelling/red arm), and oxycodone hydrochloride;paracetamol (PERCOCET) and experienced feeling sick. Concomitant medications included unspecified medications for high blood pressure, thyroid problem, and bone density problem and unspecified nasal spray, water pill, and vitamins. The patient experienced could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, injection site swelling and redness, injection site pain, nausea, sweats, and feeling of unwellness like she had the virus or bad flu on 22Dec2020. The clinical course was reported as follows: The patient felt fine the day when injection was given, but the next day, it was like she had COVID again. She had COVID 3 months ago and it lasted for 3 weeks. It was the same symptoms she had. She could not open her eyes hardly. They were very heavy. The patient had the chills, temperature, sweats, and injection site pain (the next day). There was also swelling and redness that remained for 6 days. The patient reported that if she still puts her hand on it now, there is some sensitivity. She also had tiredness and headache. The patient reported that she only had each of these symptoms for 24 hours (as reported) and the headache was gradually improved. The patient had muscle pain and weakness. She laid down and all she could do was sleep for 24 hours. The patient had nausea for 4 days. She did not have swollen lymph nodes. The patient underwent lab tests and procedures which included blood pressure: 120/80 on an unspecified date and bone density: unknown results on an unspecified date. The clinical outcome of could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, sweats, and feeling of unwellness like she had the virus or bad flu was recovered on an unspecified date, nausea was recovered on 26Dec2020, and injection site swelling and redness and injection site pain was recovered on 28Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
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| 70 | 2021-01-05 | rash |
severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash ...
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severe headache, dizziness, vomiting, elevated bp, turned pale, legs shaking scratchy throat, rash to face and throat,
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| 70 | 2021-01-06 | injection site redness |
Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pf...
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Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pfizer-BioNTech. Administered by her place of work. Vaccine was administered in left arm. Had same symptoms as when she had COVID in 10/2020 these symptoms lasted for 12 hours. Started the following day 24 hours after vaccine administration. Symptoms include injection site redness for 6 days, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, and overall feeling of un wellness lasting 12 hours. First symptoms was eyelid heaviness and weakness. No treatment, symptoms resolved on their own. Second vaccine due 1/11/2021. Was covid positive 10/2020- no appetite, aches, chills, sweating, weakness, heavy eyelids, fatigue, ongoing for 3 weeks. Has had difficulty in the past to flu vaccines with local injection site reactions. 09/2020 flu vaccine no symptoms. Has had pneumonia vaccine with no difficulties. Has not received shines vaccine yet.
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| 70 | 2021-01-11 | injection site swelling, injection site redness, injection site hardening, injection site pain |
Stinging pain when injected. Swelling at injection site--hard bump about size of an egg. Redness. So...
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Stinging pain when injected. Swelling at injection site--hard bump about size of an egg. Redness. Soreness. Swollen lymph nodes under left arm and in neck
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| 70 | 2021-01-11 | vaccination site pain |
fever of 105F; chills; severe headache; arm pain; This is a spontaneous report from a Pfizer-sponsor...
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fever of 105F; chills; severe headache; arm pain; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable healthcare professional (HCP). A 70 year-old female patient (pregnancy information not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 18Dec2020 (at the age of 70 years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to receiving the vaccination it was not reported if the patient had been tested for COVID-10. It was also not known if she received any other vaccinations in 4 weeks or other medications in past 2 weeks. On 18Dec2020, the patient received the first dose of the COVID-19 vaccine and had arm pain that lasted for a few hours at that time. Seventeen days post first vaccination (approximately 04Jan2021), she developed a fever of 105F, chills and severe headache which have now resolved. She wanted to know if she should get the second vaccine in series given her side effects. it was not reported if the patient was hospitalized or treated for the events.The clinical outcome of the events of arm pain, fever of 105F, chills and severe headache was recovered on an unspecified date. It was not reported if the patient was tested for COVID-19 after receiving the vaccination. Information about batch/lot number has been requested.
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| 70 | 2021-01-11 | redness | sweating, lightheaded, tingling/numbness in both hands, high blood pressure, swollen arm/redness |
| 70 | 2021-01-14 | rash |
At approximately 10:30pm on 1/14/2021, resident was noted to have a rash on her face, hands, arms, a...
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At approximately 10:30pm on 1/14/2021, resident was noted to have a rash on her face, hands, arms, and chest. VS:100.2, 113, 20,108/59, 84% room air. applied nasal cannula at 4-L, telephoned Physician orders 6mg Decadron one time order, a second set of Vitals , reads 99.3, 110, 20, 106/60, 90% on 4-L N/C. On coming shift advised. At approximately 2:00am on 1/15/2021, resident congested and coughing. BP 151/70, pulse 124, temp 98.1 forehead, resp 20 and pulse oc 79% on 3L. At approximately 2:30am PRN cough syrup and breathing tx. Resident's condition began to worsen with breathing tx. This LPN updated at 0248 doctor on resident's condition. Doctor gave permission for resident to go to hospital. At 4:19am the Er called to say resident passed away.
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| 70 | 2021-01-14 | blister |
Vaccine was adminstered subcutaneously instead of IM. It blistered and broke open, small amount of ...
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Vaccine was adminstered subcutaneously instead of IM. It blistered and broke open, small amount of liquid. The administration was done close to shoulder joint. Photos are available. PLEASE ADVISE: Should I get 2 IM vaccine administrations?
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| 70 | 2021-01-14 | redness, rash macular |
approximately 2:35pm after the first dose of Covid-19 Pfizer was given, patient's face became red an...
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approximately 2:35pm after the first dose of Covid-19 Pfizer was given, patient's face became red and splotchy. Lip felt numb/tingling. Not itchy and no breathing issues. Gave Benadryl 50mg and the reaction subsided.
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| 70 | 2021-01-17 | injection site pruritus |
Patient complained of local itching around injection site approximately 15 minutes after vaccination...
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Patient complained of local itching around injection site approximately 15 minutes after vaccination. Patient had history of allergies to other meds and pharmacist administered diphenhydramine by mouth to patient. Patient said itching went away within a few minutes of taking diphenhydramine. Pharmacist continued to monitor for an additional 45 minutes. Patient had no further complaints
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| 70 | 2021-01-17 | redness |
Patient received COVID pfizer vaccine at 0801PM. Patient left after 20 minutes after observation. Pa...
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Patient received COVID pfizer vaccine at 0801PM. Patient left after 20 minutes after observation. Patient was travelling with husband at the car when she experienced warm/hot cheeks, flushing and concerned with history of previous reaction. When patient arrived ( approximately 835pm), patient sat down on the chair. The redness started to extend to her neck and it was then decided to place the patient to the stretcher. Vitals signs were done in which the BP was 183/104 and 174/101 (845pm). The redness spreaded to her forehead and neck. Benadryl 50mg PO was then given (847pm). Patient BP was taken again which was 182/122 , pulse 80, RR 24 (855pm). Patient then complained about pressure in her throat, eyes (right eyes slightly swollen ) and face. It was then decided that epinephrine (859PM) be used but unfortunately the trainer box was removed so the epinephrine was not actually given. The BP documented was then 193/112 (0859PM). EMS was then called as the epinephrine was administered per protocol. EMS arrived (0910 PM) and BP at that time was 230/112, pulse 70. Patient was started with heart monitor and IV. EMS then took her to the Emergency across the street with husband.
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| 70 | 2021-01-18 | itchy skin |
After receiving first dose of Pfizer COVID-19 vaccination, patient reported feeling itching along he...
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After receiving first dose of Pfizer COVID-19 vaccination, patient reported feeling itching along her neck, back, and head. Patient was given 25 mg Benadryl and watched for additional time. Patient stated that her symptoms had resolved and she was discharged home in stable condition.
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| 70 | 2021-01-18 | rash |
Received first COVID vaccine at 4:30 on Monday, 1/11; Morning of 1/12 had expected symptoms of heada...
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Received first COVID vaccine at 4:30 on Monday, 1/11; Morning of 1/12 had expected symptoms of headache, chills, tiredness; Evening of 1/12 at about 6:30 pm diarrhea approximately 5 - 6 times and febrile about 99.3 (normal temp is around 96.8 - 97.4); Night of 1/12 about 11:00 pm got very dizzy, bad nausea, headache worse and this continued until about 3:30 - 4:30 am on 1/13; day of 1/13 chills and headache continued throughout day, lessening by early evening; Evening of 1/13, about 8:00 pm developed rash on head, face, neck and chest and took a Benadryl, which knocked me out and given no sleep the night before, I slept until noon of Thursday and returned to what I consider full health by 4:00 pm, about 72 hours after receiving the shot.
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| 70 | 2021-01-19 | redness |
After 45 minutes post vaccine my tongue felt fat. I did not have trouble breathing or swallowing. Af...
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After 45 minutes post vaccine my tongue felt fat. I did not have trouble breathing or swallowing. After approximately 1hour the tongue no longer felt fat but started feeling rough and a red spot about 1/4 inch has developed on the top/side of my tongue. I have not consulted treatment at this time.
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| 70 | 2021-01-21 | skin warm | Flushed hot face and neck, blood pressure 265/117 |
| 70 | 2021-01-21 | rash, rash papular |
Patient received first COVID vaccine on 1/13/2021 (left deltoid). Scheduled for second 2/2/2021. -...
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Patient received first COVID vaccine on 1/13/2021 (left deltoid). Scheduled for second 2/2/2021. - Rash began 1/18/2021 right upper back. Large patch of erythematous based small vesicular papules on right upper back just above bra line. Does not extend past spinal cord. Right lateral breast 3 small patches of less red fine papules.
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| 70 | 2021-01-24 | injection site redness, injection site warmth, injection site mass |
3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, r...
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3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; 3in x 3in lump at injection site, red in color and hot to touch; his arm remains very tender to touch; Lost sleep due to pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EJ1686, expiry date unknown) intramuscular at the left arm on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included COVID-19 prior to vaccination; HTN, High cholesterol, and Asthma, all from an unknown date. The patient is not pregnant. Concomitant medications included ASA, carvedilol, ferrous sulfate, losartan potassium, magnesium, rosuvastatin, calcium carbonate, colecalciferol (CALCIUM + VITAMIN D, pantoprazole sodium sesquihydrate (PROTONIX), budesonide, and formoterol fumarate (SYMBICORT). The patient had previous allergies with Zocor, Prolia, Evista, Daypro, Amlodipine, and Lisinopril. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Since the vaccination, the patient had not been tested for COVID-19. On 08Jan2021, 12:00 PM, the patient experienced 3in x 3in lump at the injection site, red in color and hot to touch. She lost sleep due to pain, his arm remains very tender to touch. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events vaccination site mass, vaccination site erythema, vaccination site warmth and vaccination site pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-01-24 | injection site redness, injection site pain, injection site pruritus, injection site swelling |
Noticed raised, red area to left of injection site this AM. It itches but and sore to touch. Injec...
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Noticed raised, red area to left of injection site this AM. It itches but and sore to touch. Injection site is not sore.
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| 70 | 2021-01-25 | rash | Rash on lower part of body, hands, face and arms its like a mosquito bite |
| 70 | 2021-01-25 | vaccination site pain |
entire body felt sore; Her soreness/aching is mainly in her back, arms left deltoid, and legs; Her s...
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entire body felt sore; Her soreness/aching is mainly in her back, arms left deltoid, and legs; Her soreness/aching is mainly in her back, arms left deltoid, and legs/sore arm from the injection; Her soreness/aching is mainly in her back, arms left deltoid, and legs; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included ongoing high blood pressure, ongoing eye disorder, high cholesterol, and overweight. Concomitant medications included amlodipine, losartan, and metoprolol all from 2003 and ongoing for high blood pressure; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) for the eyes; and medication for high cholesterol. At night of 11Jan2021, the patient's entire body felt sore. Her soreness/aching is mainly in her back, arms left deltoid, and legs. She had a sore arm from the injection which started immediately. Outcome of the "entire body felt sore" and "soreness/aching in her arms left deltoid/sore arm from the injection" was not recovered while of the remaining events was unknown.
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| 70 | 2021-01-25 | hair loss |
have noticed a definite loss of hair . will be given blood work for thyroid and iron deficiency at...
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have noticed a definite loss of hair . will be given blood work for thyroid and iron deficiency atorvastatin used since 2017 without this side effect hair is noticeably and suddenly shedding ...seems to nave started post injection
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| 70 | 2021-01-26 | injection site redness, injection site pain, injection site swelling | Injection site swelling, redness, and slight soreness |
| 70 | 2021-01-27 | rash | Rash on both arms and on chest. I am not sure if this is from the vaccine or from the Liver Disease. |
| 70 | 2021-01-27 | redness | Red arm lasting 48 hours after vaccination |
| 70 | 2021-01-27 | vaccination site mass, rash, vaccination site redness, vaccination site itchiness, vaccination site pain |
Red spot where I had the vaccine and it was itchy; Red spot where I had the vaccine and it was itchy...
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Red spot where I had the vaccine and it was itchy; Red spot where I had the vaccine and it was itchy; it still hurts and when I touch it; Pain on my arm; Rash; I do feel like a little bit of a bump; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing thyroid disorder (Verbatim: Don't have a thyroid). Concomitant medication included ongoing levothyroxine for thyroid disorder. The patient stated on 16Jan2021, "I had the COVID Vaccine on the 14th (14Jan2021). I had just pain on my arm, no side effects. But today I noticed that I had a red spot where I had the vaccine and it was itchy, so I had, but it is mild. It is nothing that's all over me, I have got a rash or anything. Just on the side it looks little red and itches and it still hurts and when I touch it, I do feel like a little bit of a bump, little bit. Is this an allergic reaction and therefore for my second dosage, will that be may not react or what?" Clinical outcome of the events was unknown.
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| 70 | 2021-01-29 | skin laceration |
Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone ...
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Acute fainting episode during the night following the day of the vaccine. Hit my head on the stone floor and was unconscious. Taken to ER in ambulance. All diagnostics were normal and after blood pressure returned to normal and getting 4 staples in my scalp I was released. Since coming home I have been very ill with weakness, vertigo, nausea, and headache.
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| 70 | 2021-01-29 | rash with redness, rash macular, itchy skin | Hot Red blotchy rash cheeks followed by red blotchy itchy outer arms |
| 70 | 2021-01-30 | itchy rash, rash, hives |
Small prickly rash all over back and parts of stomach. Also larger hives in the rash. No pain or ...
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Small prickly rash all over back and parts of stomach. Also larger hives in the rash. No pain or other issues Just itchy
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| 70 | 2021-01-31 | shingles | Shingles on Tuesday. Two visits to ER to determine what it was. Pain right side and back. |
| 70 | 2021-02-02 | itchy skin | 2021-009824 Patients neck swelled and became itchy. Patient was treated with Benadryl |
| 70 | 2021-02-02 | blister |
Next day after shot-I have herpes and my mouth, tongue and genitals were broke out with blisters the...
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Next day after shot-I have herpes and my mouth, tongue and genitals were broke out with blisters the worse I have ever had and bad cramps-still having the cramps that go with it a week later. Worried about having the 2nd shot-my husband passed a yr. ago and I am alone.
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| 70 | 2021-02-02 | skin tightness |
PATIENT COMPLAINED OF TIGHTNESS ACROSS CHEEK AND HEADACHE. 11:35 BP 121/81, HR 70, RR 16 11:40 BP 12...
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PATIENT COMPLAINED OF TIGHTNESS ACROSS CHEEK AND HEADACHE. 11:35 BP 121/81, HR 70, RR 16 11:40 BP 122/68, HR 69, RR 16 11:45 BP 121/78, HR 70, RR 16 11:55 PATIENT LEFT SITE IN STABLE CONDITION
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| 70 | 2021-02-02 | injection site pain |
Sneezing, congestion, headache, pain at injection site. Slight upset stomach. Have taken acetaminop...
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Sneezing, congestion, headache, pain at injection site. Slight upset stomach. Have taken acetaminophen and Sudafed.
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| 70 | 2021-02-02 | rash, hives, itchy skin |
The evening of Feb 2 at 10 pm I woke up with rash/ hives fully covering both hands and arms, my ent...
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The evening of Feb 2 at 10 pm I woke up with rash/ hives fully covering both hands and arms, my entire back, stomach and underneath my breast area. I also had some fluid building under my left lower. By this morning, 2/3, rash/hives had disappeared in all the fore mentioned areas and now was on both of my thighs and back of my hands . I was feeling itchy earlier that day and hives had broken out on the left side of my next but within an hour or so disappeared, I am currently experiencing a lot of itchiness. When I checked by body an hour ago, the rash/hives are again beginning to reappear. These are my only symptoms.
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| 70 | 2021-02-03 | injection site pain | Fever 100, pain at injection site, body aches, chills, headache |
| 70 | 2021-02-03 | skin burning sensation, itchy skin, dry skin |
arm has been sore; looked like she had a sunburn all over her body/sunburn looking skin felt like he...
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arm has been sore; looked like she had a sunburn all over her body/sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on; looked like she had a sunburn all over her body/sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on; looked like she had a sunburn all over her body/sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on; looked like she had a sunburn all over her body/sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccination site: left, almost her shoulder) on 14Jan2021 13:45 as COVID vaccine. The vaccine was administered at clinic. Vaccine not administered at military facility. There were no concomitant medications. Patient had no prior Vaccinations (within 4 weeks). The patient previously took acetylsalicylic acid (ASPIRIN), ibuprofen and NSAIDS wherein she was allergic. This was years and years ago. When she took the products, she had silver dollar size hives from head to toe. Patient asked if there was any of this in the vaccine. The patient previously got shingles vaccine on 2019 (2 years ago) at the pharmacy wherein she had a sore arm and a bruise. The patient had no other relevant history. Patient reported she just got home from the emergency room. It was explained that on 14Jan2021 (yesterday) she got the vaccine. On 15Jan2021, her arm had been sore today since getting up but about 1pm today she looked like she had a sunburn all over her body. Her husband gave her 2 diphenhydramine (BENADRYL) and rushed her to the emergency room. They told her that they can't say for sure but that was likely that it was caused by the vaccine. The soreness was about the same. Looking like she had a sunburn all over her body, that was gone. The patient further explained the sunburn looking skin felt like her skin was on fire and her clothes itched, they felt like she had sandpaper on. There have been no other treatments. She remarks she had to wait so long in the emergency room by the time they saw her it had resolved. Investigation assessment/relevant tests were not performed. The emergency room told her the Benadryl likely knocked it out. They offered Tylenol and an IV but she declined; she felt there was no reason since she was doing better. She was told to take 2 more diphenhydramine 25mg in 6 hours. No physician office visit required for the events. She was supposed to get the second dose on 04Feb2021 but was told to ask if she should still get it. The outcome of arm has been sore was not recovered, while other events recovered on 15Jan2021. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
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| 70 | 2021-02-03 | itchy skin |
feels itchy; burning; tingling and paresthesia all over her body; This is a spontaneous report from ...
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feels itchy; burning; tingling and paresthesia all over her body; This is a spontaneous report from a contactable physician. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 12Jan2021, and she has had a serious reaction since; she felt itchy, burning, tingling and paresthesia all over her body. She has been on Benadryl for it. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events itchy, burning sensation, paresthesia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 70 | 2021-02-03 | rash |
mild rash; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female ...
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mild rash; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL1284), first dose via an unspecified route of administration at the right upper arm on 18Jan2021 at single dose for covid-19 immunization. The patient had no medical history, no concomitant medications and no investigation assessment. The patient got her first COVID vaccine on 18Jan2021, and has broken out in a mild rash, and it was, she has had this when she had the shingles vaccine, she broke out with that too, so this was consistent with her with vaccines and other medications, and she has been on diphenhydramine hydrochloride (BENADRYL). She almost felt a little rash coming on the evening of 18Jan2021, and by the 19Jan2021, she clearly had a rash on the back. She started diphenhydramine hydrochloride, and it was almost gone. Her primary care doctor just retired, she was in limbo, she did not have a new one yet. This was her first dose. The patient stated that she didn't want to get COVID and to get back to normalcy. NDC, expiry, dose were not listed on vaccination card. On the back, says she was supposed to get the second on 08Feb2021, she didn't know if this information was needed, but there were no openings period to get it on the 08Feb2021, so she was scheduled to get the second one on 11Feb2021. The outcome of the event was recovering.
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| 70 | 2021-02-04 | injection site pain |
I was sneezing non stop; injection site was sore; can't taste; nose started running/ my nose was lik...
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I was sneezing non stop; injection site was sore; can't taste; nose started running/ my nose was like a faucet, non stop, clear; asked if it can it give her COVID since her symptoms were similar to COVID; asked if it can it give her COVID since her symptoms were similar to COVID; I felt scratchy in my throat; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248 and expiration date not provided), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took shingles vaccine for immunization and experienced shingles. The patient reported that she got her first dose of the COVID vaccine on 13Jan2021. On 17Jan2021 night and into 18Jan2021, she felt scratchy in her throat. She did not think anything of it because the temperature change was not unusual in the patient's state and so she thought it was that. But, on 19Jan2021, her throat was more scratchy and then her nose started running more. By Wednesday, 20Jan2021, her nose was like a faucet, non stop, clear and her throat was definitely scratchy and she was sneezing non stop. Her injection site was sore too which she totally expected. Now, her physician has given her a steroid pack and did a rapid test, which was negative but the following day they are doing a PCR test, so, she will see. She also stated that she can still smell but can't taste and that started last night, 20Jan2021. She asked if they were seeing these. And if this was listed or being reported and if she should get the second dose. She went on to state that "I would not call my symptoms severe and I'm having my PCR tomorrow, but when they mention to me that they have had other patients with this experience". She also asked if it can it give her COVID since her symptoms were similar to COVID and other people are having symptoms. She also reported that 4 months ago, she got her first shingles vaccination and "it knocked me on my butt, I still haven't got the second injection but I got shingles" and asked should she have gotten the COVID vaccine if she just got over shingles 3-4 weeks ago. She reported that she got her first dose of the COVID vaccine on 13Jan2021 and her second dose is scheduled for 30Jan2021 (17days apart). She did not have a question about the timing of the vaccine, only mentioned when her second dose was due and the it was 17 days after the first. She wanted to know if Pfizer was seeing a lot of this, and it could this her body reacting to the vaccine. She wanted to know what she should do with the second vaccine, if she should get it. She works at a school and has been making sure to wash her hands and everything. The outcome of the events Rhinorrhoea, and Vaccination site pain was unknown. The outcome of the event ageusia was not recovered while the outcome of the rest of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082498 same drug/event, different patients
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| 70 | 2021-02-04 | shingles, blister | Shingles. Severe pain and blisters on right side shoulder neck and head |
| 70 | 2021-02-04 | injection site pain |
The following morning, I experienced a slight fever (99.1), mild headache, and pain to the touch at ...
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The following morning, I experienced a slight fever (99.1), mild headache, and pain to the touch at the injection site. These lasted only one day.
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| 70 | 2021-02-05 | injection site bruising, itchy skin | Achy arm and bruising at site of injection. Day of and less day after injection. |
| 70 | 2021-02-05 | itchy skin |
My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening,...
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My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening, but symptoms continued and migrated from there. The arm remained sore for 3 days and then began to itch. This itchiness continued on and off for the next 2 days. My neck and shoulder were also sore. The shoulder continued to be sore for about 4 days. I had an intermittent headache, also for 4 days. The worst part though, is the nausea, which also comes and goes. But it can last for many hours and now, even after 8 days, I am still experiencing this. I can find nothing in the writings about this vaccine to corroborate this side effect and I am therefore worried about the second shot.
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| 70 | 2021-02-05 | injection site pain | Pain in injection site. |
| 70 | 2021-02-06 | hives, redness, itchy skin | Itchy skin on arms and upper back. Red welts Indigestion that lasted 5 hours. |
| 70 | 2021-02-07 | vaccination site pain |
Got the first dose of the vaccine yesterday. About an hour after is when her arm starting getting so...
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Got the first dose of the vaccine yesterday. About an hour after is when her arm starting getting sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from 21Jan2021 to 21Jan2021 as SINGLE DOSE (first dose) for COVID-19 immunisation. Medical history included none. There were no concomitant medications. The patient is a 70/yo female who is very concerned that she 'took half of a Tylenol Migraine' yesterday morning before receiving her first dose of Pfizer-Biontech Covid19 vaccine. She stated she came home, started reading on the internet, and is worried now that the dose won't be efficacious. She also reports a sore arm and wants to know 'if that's a good sign' of immune response. She also stated that her doctors 'don't know, and told me to call you'. Got the first dose of the vaccine yesterday. About an hour after is when her arm starting getting sore. It got progressively more sore throughout the day. This morning it has improved but is still sore when she raises her arm. Treatment: Took Tylenol. This was before she read this article. The nurse was the one who told her to take Tylenol. She goes for her second dose on 11Feb2021. The patient got the first dose of the COVID Vaccine yesterday. Before she went to get her shot she was getting a migraine so she took half of a Tylenol Migraine. She read that if you take Tylenol before getting the vaccine that it can effect the efficacy, the patient was asking if this was true. The outcome of the event was recovering.
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| 70 | 2021-02-07 | hives, itchy skin |
Patient reported that with her 1st COVID vaccine, she later broke into hives and was "itchy" and was...
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Patient reported that with her 1st COVID vaccine, she later broke into hives and was "itchy" and was given steroids and Benadryl q 6 "for a few days" by PCP. When patient arrived at vaccine clinic, some remnants of hives were still present on her face. She reported no SOB, no itchiness. She stated that since it happened, her hives had improved but the "scars on my face are still there." PCP consulted. Requested that Benadryl be administered prior to immunization. Pt received 2nd COVID vaccine. She was then accompanied to the waiting room, where she was seated near EMS as a precaution. EMS monitored patient for 30 minutes without any events prior to discharge.
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| 70 | 2021-02-08 | skin tightness |
PATIENT COMPLAINED OF TIGHTNESS ACROSS CHEEK AND HEADACHE. 11:35 BP 121/81, HR 70, RR 16 11:40 BP 12...
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PATIENT COMPLAINED OF TIGHTNESS ACROSS CHEEK AND HEADACHE. 11:35 BP 121/81, HR 70, RR 16 11:40 BP 122/68, HR 69, RR 16 11:45 BP 121/78, HR 70, RR 16 11:55 PATIENT LEFT SITE IN STABLE CONDITION
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| 70 | 2021-02-08 | redness |
Patient received 1st dose of Pfizer vaccine on 1/25/2021. On 2/2/2021, patient c/o right knee joint ...
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Patient received 1st dose of Pfizer vaccine on 1/25/2021. On 2/2/2021, patient c/o right knee joint pain and non-painful and non itchy circular reddened lesions on bilateral lower legs and b/l feet. No drainage of the skin noted. No fever and no flu like sx noted.
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| 70 | 2021-02-09 | hives |
Due to me having a previous reaction 48 years to Penicillin they asked me to wait 30 minutes after v...
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Due to me having a previous reaction 48 years to Penicillin they asked me to wait 30 minutes after vaccination instead of 15 minutes. I left and about 10 minutes after I left, all of sudden I started feeling, I started feeling hives on the roof of my mouth. I could feel with my tongue blister things on the roof in my mouth. Within in a few minutes they began to burst and liquid came out. I did call my doctor and they had someone call me and to make an appointment with an allergist. I do not remember the Allergist's name but I am scheduled to see her tomorrow 2/11/2021 at 8:30 AM. I spoke with my doctor and 2 people. As of today my mouth is still a little sore, my tongue feels funny and swollen.
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| 70 | 2021-02-09 | vaccination site pain |
First dose to muscle of left arm left muscle superbly sore; This is a spontaneous report from a cont...
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First dose to muscle of left arm left muscle superbly sore; This is a spontaneous report from a contactable physician (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 21Dec2020 11:00 at single dose injection to muscle of left arm for Vaccination. There were no medication history and no concomitant medications. The patient had her first dose of Pfizer COVID-19 Vaccine she thought on 21Dec2020. She reported first dose of Pfizer COVID19 Vaccine to muscle of left arm, and out 1 hour after dose administered the patient experienced left muscle superbly sore probably onset about 12:00 noon on 21Dec2020 for about 3 days, when she recovered completely. The outcome of event was recovered on 24Dec2020. The physician considered Pfizer COVID19 Vaccine was related to the even.t First dose to muscle of left arm left muscle superbly sore. Information on Lot/Batch number has been requested.
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| 70 | 2021-02-09 | skin laceration |
Pt had a Covid shot on 02-08-2021.She went home and the next Morning she got out of bed and ended ...
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Pt had a Covid shot on 02-08-2021.She went home and the next Morning she got out of bed and ended up passing out and hitting hev head on a coat rack. she came into the Dr on 02-09-2021. She has a Left frontal 1cm Laceration, abrasion at right scalp, bridge of Nose with a shallow 4mm laceration . Black eyeon the right side
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| 70 | 2021-02-09 | injection site pain |
Vaccine was given too high, into my shoulder. Injection was only one finger width from top of should...
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Vaccine was given too high, into my shoulder. Injection was only one finger width from top of shoulder. Pain at time of injection (3:20 p.m.). Reminded me of the pain one would experience getting a cortisone shot. Three to four hours later pain in shoulder was substantial. Unable to lift arm, at all. Pain continued throughout the night. Twenty-four hours later some improvement in arm mobility and marked pain. Forty-five hours later not yet at full mobility and with slight to moderate pain. Feel more attention to vaccine injection site is needed.
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| 70 | 2021-02-10 | hives | Hives Claritin and topical anti-itch gel |
| 70 | 2021-02-10 | itchy rash, hives, rash | Itchy rashes in the left side of the neck 3 hives |
| 70 | 2021-02-10 | shingles, rash |
shingles; Pain; This is a spontaneous report from a contactable consumer (patient husband). A 70-yea...
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shingles; Pain; This is a spontaneous report from a contactable consumer (patient husband). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261) via unspecified route on arm single dose for COVID-19 immunization on 21Jan2021, about 15:00, at 70-year-old. Medical history included: diagnosed allergies, compromised immune status, endocrine abnormalities, genetic / chromosomal abnormalities, respiratory illness, diabetes, obesity. The patient had a whole list of concomitant product medications (unspecified). The patient came down with shingles four and a half hours after the vaccine (21Jan2021, about 19:00 - 19:30), emergency room visited. They noticed a rash on her back which got worse, so she was taken to the hospital on 26Jan2021 and was diagnosed with shingles. She's still in the hospital but has gotten better. She was currently hospitalized for the shingles and related pain on 26Jan2021 that was more than she could handle. The patient had a few blood tests; urinalysis; a lot of sugar testing; and negative on the COVID test prior to them admitting her to the hospital. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved.
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| 70 | 2021-02-11 | injection site pain |
Arm hurt at site of shot, Very Tired, Very Thirsty (drank 3 full glasses of water in a couple minute...
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Arm hurt at site of shot, Very Tired, Very Thirsty (drank 3 full glasses of water in a couple minutes), Weak leg, (briefly, Aching, Dry eyes even with home humidifier on furnace, ribs hurt for about 5 min. and wheezing upon awakening at 4:45am, most symptoms gone by about 7:30am, Thursday.
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| 70 | 2021-02-11 | redness |
blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumpin...
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blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; blood pumping to my head and became very hot; face turned red and was hot to the touch; facial muscles became weak on both; difficult to make facial expressions; my mouth began to tremble; chills; facial muscles became weak on both; difficult to make facial expressions; This is a spontaneous report from contactable consumers. An 70-year-old female non-pregnant patient received her first dose bnt162b2 (BNT162B2; Solution for injection; lot number: EL9283) via an unspecified route of administration at Left arm on 28Jan2021 12:30 at single dose for COVID-19 immunisation at Clinic. Medical history included high blood pressure, high cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR), amlodipine, calcium carbonate simethicone. There was no other vaccines in four weeks. The patient previously took iodine had contrast, procaine hydrochloride (NOVOCAIN) had drug allergy, omeprazole (PRILOSEC) and had drug allergy, olmesartan medoxomil (BENICAR) had drug allergy. Five minutes after the injection 28Jan2021 12:35, patient felt blood pumping to her head and became very hot. Her face turned red and was hot to the touch. Then, facial muscles became weak on both sides and made it difficult to make facial expressions. Lastly, her mouth began to tremble and had chills. Symptoms subsided about 30 minutes after the injection. she worried about getting the second injection. The patient received treatment with Liquids/electrolytes. The events result in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in 2021.
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| 70 | 2021-02-14 | injection site pain |
Dose 1: mild pain at injection site Dose 2: moderate pain at injection site; fatigue, chills, musc...
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Dose 1: mild pain at injection site Dose 2: moderate pain at injection site; fatigue, chills, muscle aches, low grade fever (100), headache
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| 70 | 2021-02-14 | injection site pain | Intermittent pain in arm several inches away from injection site which has continued for 10 days. |
| 70 | 2021-02-14 | rash |
Patient reported nausea, vomiting, weakness, chills, unable to keep food down, face broke out in ras...
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Patient reported nausea, vomiting, weakness, chills, unable to keep food down, face broke out in rash around eyes and rash on hand. Patient reported symptoms lasted over a week. Went to ED, given IV fluids and discharged home.
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| 70 | 2021-02-14 | rash, itchy rash | Very itchy Rash on thighs , some on legs. |
| 70 | 2021-02-15 | injection site pain |
2/10 I had pain at injection site, mild fever and some chills, and extreme fatigue. The fatigue ...
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2/10 I had pain at injection site, mild fever and some chills, and extreme fatigue. The fatigue continued through mid-day, 2/15
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| 70 | 2021-02-15 | injection site pruritus |
Date and time of vaccination: (list both if they received both shots): 1/12/21 0830; 2/12/21 1500 Br...
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Date and time of vaccination: (list both if they received both shots): 1/12/21 0830; 2/12/21 1500 Brand and lot of vaccine: 1st EL9262 , 2nd EN9581 extreme fatigue, itching underarm of injection site, lightheadedness, poor appetite
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| 70 | 2021-02-15 | redness, itchy skin | Itching, burning, red, swollen hands and feet. |
| 70 | 2021-02-15 | itchy rash, rash |
pt stated that right after the vax she got really bad back pain. Later that day she had muscle pain...
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pt stated that right after the vax she got really bad back pain. Later that day she had muscle pain, joint pain and fatigue. Next day she still had muscle and joint pain. On 2/15/21 she had developed a itchy rash on both elbows and later spread almost over her entire body. Pt contacted her PCP which instructed to go to the ER. She was given prednisone and Benadryl at the ER. They wrote her a rx for prednisone and she is to FU w/ PCP on 2/19/2021.
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| 70 | 2021-02-16 | rash, bruising |
Low platelets; Rash on her body; Bruising; This is a spontaneous report from a contactable consumer....
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Low platelets; Rash on her body; Bruising; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3249), via an unspecified route of administration in the right arm on 19Jan2021 at a single dose for covid-19 immunization. Medical history included ongoing diabetes mellitus since 2011 (reported diagnosed 10 years from this report, ongoing congenital heart defect which patient was born with but did not find out until she was in her 50s; does not bother her too much; one of the major arteries has a 90 degree angle vs. an S curve, mild multiple sclerosis; no longer has this as she has not had another relapse; she was diagnosed almost 30 years ago; she has never had another attack since she had 2 of them and was on medication that did damage to her liver, breast cancer; patient is a breast cancer survivor and issues with magnesium levels. There were no concomitant medications. On 28Jan2021 the patient had blood work done for her kidney doctor. They withdrew blood from her arm. They had a hard time stopping the bleeding afterwards. They finally got it to stop and put regular cotton balls and a band aid on it. By the time she was walking out she was bleeding out of her arm she felt in her coat. They were able to stop the bleeding again. This was at about 10 AM. Patient went home and afterwards was called back and instructed to go to the ER for critical care. Her platelets were low at 10,000 at that time. They got to the ER and they checked her platelets and they were down to 8,000. They administered some steroids; Prednisone. They decided to admit her after giving the treatment in the ER. After that her platelets came back to 11,000. The next morning on 29Jan2021 her platelet count was 7,000. They started administering the same drug through an IV. He thinks it was still a steroid. They did it in smaller amounts and overnight the next day her platelets were up to 26,000 on 30Jan2021. They continued the treatment during the night again and on Sunday they were 36,000 and they released her that day late on Sunday. They went back and did blood work yesterday on 01Feb2021. The local doctor said her platelets are up to 61,000. The patient was getting blood work every Monday and Thursday for 3 weeks. Th patient had blood work and platelets checked before the vaccine and they were normal. The patient was hospitalized from 28Jan2021 to 31Jan2021 due to the event. The patient also noticed rash on her body and bruising maybe on 21Jan2021 or 22Jan2021. The bruising was really bad on her left hand by her wrist. It was really dark. She was also bruised everywhere they poked her with an IV and bruises where they put the heart monitor on her and pressed down to stick it to her. The bruising is still all over her body. It has stayed about the same. The one on her hand is still severe. The other from where she has been poked are starting to clear up. Overall it was about the same. The outcome of event bruising was not recovered, low platelets was unknown while rash on her body recovered on unspecified date.
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| 70 | 2021-02-16 | injection site redness, injection site rash |
Today, 2/17/2021, a small rash around the I head toon site area appeared. No sorry was must red ras...
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Today, 2/17/2021, a small rash around the I head toon site area appeared. No sorry was must red rash.
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| 70 | 2021-02-17 | shingles |
shingles/I've had shingles before, this was the 4th time; shingles/I've had shingles before, this wa...
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shingles/I've had shingles before, this was the 4th time; shingles/I've had shingles before, this was the 4th time; kidney infection; hurting on my waist around the back; diverticulitis; Her blood pressure went up to 211/92; does not feel well; afraid of taking it if it will be any worse; sick; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot: EL3248, expiry 30Apr2021), intramuscular on 23Jan2021 08:15 at a single dose in the left arm for COVID-19 immunization (prevention because she has autoimmune). Medical history included Behcet's syndrome and Sjogren's syndrome, both are overactive immune system problem/autoimmune diseases, which were diagnosed 20 years ago; diagnosed allergies; compromised immune status; respiratory illness; genetic chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; and patient have had shingles before. Family history was reported as none. Concomitantly, she was just taking daily medications that were not relevant. There was no prescriber for the vaccine. It was through a hospital. It was reported that vaccination was given at 08:15 to 08:30. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered the same date of the Pfizer suspect. Patient had not had prior vaccinations (within 4 weeks). Patient received her first dose of the Pfizer vaccine on Saturday 23Jan2021. She stated, on Tuesday 26Jan2021, patient was hurting on the waist around the back. On Wednesday, 27Jan2021, that next morning, she went to see her internal doctor and they thought a kidney infection or not; he was not sure if she had a kidney infection or what was going on. Patient went home and it got worse and patient went to the ER (Jan2021), also reported as ended up going to the ER. They did a CT scan gave her medicine. They did a CT scan and said it was not her bladder or anything (Jan2021). They thought it was diverticulitis; nothing helped. They gave her medication and she kept getting sick (2021). No further details provided on medication given. On Friday, 29Jan2021, early morning, patient went back to the ER, they did another CT with contrast it wasn't diverticulitis, but it was shingles, and patient have had shingles before, this was the 4th time. It was reported that when the doctor came in, he thought this was shingles and she has had shingles previously. She has had it about 3 other times and the pain was just off the scale (Jan2021). Her blood pressure went up to 211/92 and they were giving her morphine for the pain (Jan2021). She was questioning if she should get the second dose. She has two autoimmune diseases and it was an overactive immune disease. She took the one vaccine and her doctor said to contact Pfizer being as it is kind of new and especially since she has the autoimmune issues. She would like to know if it is safe for her to have the second vaccine. She does not know if she will be over this. She does not feel well (Jan2021). She was afraid of taking it if it will be any worse (Jan2021). Patient felt all right until she had the vaccine, on Tuesday the problem started (26Jan2021). They were giving her medication for the shingles and for the pain. Patient stated that "it set something off". Patient was still sick (2021), still taking pain pills. Patient didn't know how many days she has. Her second vaccine is on 13Feb2021. As sick as she has been, and her overactive immune system and if she still has the shingles those can last a long time, she doesn't want to go through what she went through. This was a lot of pain and with shingles they can last, 6 months or a year. The nurse called her back and told her to report to Pfizer. Patient was taking the medicine for the shingles right now. She doesn't know what will happen. She doesn't want to be sick. Patient asked for the efficacy after 1 dose and how much protection it has. She did fill out something because she talked with someone else. She confirmed it was through VAERS and not with Pfizer. She said the pain around her waist was a little better because they gave her the medicine for shingles and she has pain pills. She said one was Valacyclovir and she could not remember the name of the other. Patient had required two trips to ER. First one was on 27Jan2021 and went to internal medicine doctor and that night went to the ER. They did CT scan and it was not bladder or anything. Second visit on 29Jan2021 and did CT with contrast and the doctor thought it was shingles since she had shingles three times before. She has had them internally. The doctor said it would not necessarily need to be externally break outs. The next two times she did not break out. She did not have anything around her waist. Therapeutic measures were taken as a result of the events hurting on my waist around the back, kidney infection, diverticulitis, shingles, and sick. The outcome of the event hurting on my waist around the back was recovering. The outcome of the event kidney infection, diverticulitis, shingles, sick, blood pressure went up to 211/92, does not feel well, and "afraid of taking it if it will be any worse" was unknown.
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| 70 | 2021-02-18 | itchy rash, rash, hives |
Itchy rash on chest and hives on chest. No treatment other than topical anti itch cream. Itching sto...
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Itchy rash on chest and hives on chest. No treatment other than topical anti itch cream. Itching stopped after 24 hours. Still have spots today, but no more itching.
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| 70 | 2021-02-18 | hives |
Patient developed hives 1hour after injection which persisted until evening. She took Benadryl 50mg...
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Patient developed hives 1hour after injection which persisted until evening. She took Benadryl 50mg at 7pm and woke this morning and hives had resolved.
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| 70 | 2021-02-18 | injection site pain, injection site warmth, injection site swelling, injection site redness |
redness, pain , swelling and warmth at site that progressed over several days. became painful to li...
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redness, pain , swelling and warmth at site that progressed over several days. became painful to lift left arm. treated with antibiotic (keflex 500 tid for 10 d) and medrol dose pack, zyrtec and famotadine 40 at night
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| 70 | 2021-02-21 | hives |
2 days after started developing hives by the 3rd day all upper body was covered and upper lip was sw...
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2 days after started developing hives by the 3rd day all upper body was covered and upper lip was swollen - - that day I took a flight and went directly to emergency room - was given a shot of methy/PredniSolone sodium and a prescription for tablets - 2 a day for 5 days
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| 70 | 2021-02-21 | redness, hives |
5min after vaccine as per daughter, her mother began complaining of "burning " in her chest , itchi...
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5min after vaccine as per daughter, her mother began complaining of "burning " in her chest , itching in her throat, lump in her throat, hives/redness noted on throat and chest. RRT responded and accompanied patient to ED
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| 70 | 2021-02-21 | injection site pain |
7 hours after injection, experienced extreme tiredness. Overnight, awoke with body aches, joint pai...
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7 hours after injection, experienced extreme tiredness. Overnight, awoke with body aches, joint pain, and injection site pain. Early morning awoke to body aches, headache, and extreme fatigue. While not chilled, needed three layers on top and two layers on bottom and on feet. Temperature at 8AM was 97.0. Voracious appetite and ate normally and with vigor. Slept for 3.5 hours and awoke to fever of 100.3 and voracious appetite. Ate normally. Body aches and joint pain were gone. About an hour later, temperature returned to normal but headache persisted. No longer fatigued, but still tired. Headache persisted that evening and still present at this writing, 8AM Monday.
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| 70 | 2021-02-21 | injection site pain |
Aside from expected soreness at injection site, no adverse reactions through rest of Feb 10 and a...
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Aside from expected soreness at injection site, no adverse reactions through rest of Feb 10 and all of Feb 11 and 12 Starting February 13 and continuing through today (Feb 22), I have had the following symptoms: Vestibular migraine - very severe at the beginning, receding with time, but still concerning Nausea - on and off for full period, no relation to food intake Fatigue - tired most all of the time, could fall asleep at any time Balance - variable for this period, no falls, but do not feel safe to drive
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| 70 | 2021-02-21 | redness |
Onset of vaccine: 17:19 Onset of symptoms at 17:25 with tongue tingling to entire tongue Onset of ot...
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Onset of vaccine: 17:19 Onset of symptoms at 17:25 with tongue tingling to entire tongue Onset of other sx at 17:27: red hands Patient opted to stay in waiting room until hand concern She ambulated without assistance to medical center She was given Benadryl 25 mg po with water, tolerated well at 17:47 VS taken and stable 128/74 RR: 14 Pulse 82 At 18:00, sx of tongue tingling improved, but tinnitus BL worsened - this is common for patient She was discharged to home at 18:07 with her partner Instructed to call PCP in AM, and watch for other developing sx of allergy/anaphylaxis overnight
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| 70 | 2021-02-22 | injection site swelling |
A small reddish bump on my arm at the injection site, my arm is sore any tender to the touch. The bu...
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A small reddish bump on my arm at the injection site, my arm is sore any tender to the touch. The bump is getting larger in size.
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| 70 | 2021-02-22 | hives | Developed urticaria 1 week following vaccination |
| 70 | 2021-02-22 | hives | Hives, Diarrhea |
| 70 | 2021-02-22 | rash papular, itchy rash, skin discolouration |
Raised red bumps (size of quarter) on back of forearms. Only one or two bumps, very itchy. Started...
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Raised red bumps (size of quarter) on back of forearms. Only one or two bumps, very itchy. Started on left arm, moved to right arm. Small round raised bumps on lower, inside of left forearm (about 3-4.) Then gastoinstestinal symptoms with diarrhea (second bout more severe.) Subtle red coloration on trunk that when stroked with finders turned white. Trunk itching, genitals itching. Hot burning hands, feeling of unease. The symptoms have lasted for days. Injected on 2/5 still having symptoms on 2/23. Taking Benadryl.
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| 70 | 2021-02-22 | itchy skin, pain of skin, redness, hives |
When I left facility I had a mild headache. After getting on the highway face turned beet red with ...
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When I left facility I had a mild headache. After getting on the highway face turned beet red with mild swelling. Throat felt tight but not closed. An hour later the headache was worse. Took a Tylenol and slept for an hour. Woke up itchy. Glands on right side of neck very sore with pain radiating to base of skull. Swelling in face subsided after a few hours. Later at night I was still itchy with some small red hives on my arms, legs, and stomach. Arm very sore. Woke several times during the night with nausea. Woke up morning of the 20th with mild dizziness, upset stomach and severe diarrhea, Serious headache all day. Hives subsided but was still itchy. On the 21st felt much better but still with diarrhea. Today is the 23rd and no diarrhea since this morning.
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| 70 | 2021-02-22 | injection site warmth, injection site swelling, injection site redness |
pt stated that went to bed w/ a sore are the night after receiving the covid vax. She woke up the ...
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pt stated that went to bed w/ a sore are the night after receiving the covid vax. She woke up the next day w/ unbearable pain all over her body, body aches, joint pain, head ache, back ache. She felt like she had fever but she said it was only 99. Her left arm was swollen, red and hot around the injection site. Pt states she still has shaky, achy legs and swelling in left arm. Pt called her PCP and left message for them to give her a CB.
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| 70 | 2021-02-23 | itchy skin |
30 minutes after the shot my center of my nose and spreading to high upper lip and roof of my mouth ...
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30 minutes after the shot my center of my nose and spreading to high upper lip and roof of my mouth got numb. In addition I had a ?tickle? down the left side of my throat. Three days later I was itchy on my lower arms and upper legs. I also had a headache off and on for several days.
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| 70 | 2021-02-23 | itchy skin |
Pt reports sudden onset of itchy palms. Pt denies any other symptoms. symptoms resolved with no tr...
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Pt reports sudden onset of itchy palms. Pt denies any other symptoms. symptoms resolved with no treatment. PT denies Transport.
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| 70 | 2021-02-23 | hives | Severe hives |
| 70 | 2021-02-23 | injection site pain |
extreme cold internally, head ache and tremors within 10 or 15 mins. Sat for 20 more minutes, then ...
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extreme cold internally, head ache and tremors within 10 or 15 mins. Sat for 20 more minutes, then walked to parking garage. Breathing became labored as I walked the block to car - no one was around. Pulled off mask and sat in car - it subsided in 15 minutes. Body temp was 94.5 remainder of the day. 96.5 today. Awoke nauseated, headache, left foot and hand pain and very sore left arm. Nausea stopped about 3:00 pm, when body tremors started again. Cold all day with no energy
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| 70 | 2021-02-23 | rash |
flushing of face within 10 minutes, light rash arms, and trunk; flushing of face within 10 minutes, ...
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flushing of face within 10 minutes, light rash arms, and trunk; flushing of face within 10 minutes, light rash arms, and trunk; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 23Jan2021 01:00 PM at a single dose on the right arm for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to receiving bnt162b2. The patient was not diagnosed with covid prior to vaccination. The patient was not pregnant. Medical history included allergies to tree nuts, bees, penicillin, and sulfa. Concomitant medications were included hormones, fluticasone propionate, salmeterol xinafoate (ADVAIR), and esomeprazole sodium (NEXIUM). The patient experienced flushing of face within 10 minutes (as reported), light rash arms, and trunk on 23Jan2021 01:15 PM (as reported). The patient was not tested for covid post-vaccination. The patient received Benadryl as a corrective treatment. Outcome of the events was recovered on an unspecified date in Jan2021. Information on the lot/batch number has been requested.
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| 70 | 2021-02-24 | injection site pain |
After the vaccine my right arm was sore at the injection site. Later that night, after I went to bed...
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After the vaccine my right arm was sore at the injection site. Later that night, after I went to bed around 10:30 pm I started feeling nausea, followed by vomiting twice. Throughout the night I had body aches from head to toe. Also experienced body chills which continued the next morning.
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| 70 | 2021-02-24 | injection site pruritus, injection site redness | Redness and itching for 2 straight days at sight of injection- still ongoing. |
| 70 | 2021-02-24 | redness |
Within 30-minutes of vaccination, the patient returned to the vaccine clinic to report her face beco...
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Within 30-minutes of vaccination, the patient returned to the vaccine clinic to report her face becoming hot, her cheeks being red, and a headache. EMS evaluated patient on-site. Patient was hypertensive (206/96). EMS transported patient to Emergency Department for further evaluation. In ED, patient was still hypertensive, but in no acute distress. Per patient, she was taken off losartan by PCP in September secondary to hyperkalemia. ED physician administered losartan and Tylenol. Patient was discharged with HTN, HA, and vaccine reaction.
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| 70 | 2021-02-25 | skin warm, hardening |
Left breast generalized tenderness, warmth and mild swelling with focal area of induration to inferi...
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Left breast generalized tenderness, warmth and mild swelling with focal area of induration to inferior breast tissue. Warmth, tenderness and generalized swelling resolved after 5 days. Induration, ? mass persisted 1 week later prompting diagnostic work-up in clinic with imaging ordered
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| 70 | 2021-02-25 | rash | Lightheadedness; shortness of breath; rash below throat. Zyrtec; steroid pills. |
| 70 | 2021-02-25 | injection site redness, injection site pruritus, injection site swelling, injection site hardening, injection site warmth |
Shortly after the vaccine, I had a small, raised red bump around the injection site. As the day wen...
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Shortly after the vaccine, I had a small, raised red bump around the injection site. As the day went on, it grew larger and swelled a bit. By the next morning (2/25/21), it was swollen, red, and warm. It increased in size during the day and was still the same size this morning (2/26/21)..about 2" long by 1 1/2" wide. The big change today is that my arm became itchy. It has itched on and off through the day.
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| 70 | 2021-02-26 | skin warm |
EMT noticed client, (DOB 7/1/1950), was sitting in post-vaccine waiting area with flushed face withi...
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EMT noticed client, (DOB 7/1/1950), was sitting in post-vaccine waiting area with flushed face within 15 min of receiving the COVID vaccine (Pfizer, lot #EN6202, expiration date 6/30/2021, dose 1). EMT approached client, asked how she was feeling, client reported feeling fine. At 1337 EMT took oxygen saturation 98% and pulse 96. EMT informed PHN of client's condition and possible language barrier. EMT stayed with client as PHN called over client's family member who was waiting outside. Family member used FaceTime to call client's daughter for help with translation. Per client's daughter, client suffers from anxiety, asthma, hypertension and hyperlipidemia. EMT took vital signs: blood pressure 140/Palpated, respiratory rate 24, oxygen saturation 97%, pulse 96. Client's list of medications: diltiazem, clopidogrel, atorvastatin, Montelukast, albuterol sulfate, incruise Ellipta, flucatisone propionate, vitamin D, famotidine, benzonatate, losartan, gabapentin, duloxetine, prednisone, and vitamin C. Client's daughter translated and reported that client felt anxious, warm, and had difficulty breathing similar to her asthma flares. PHN noted client's arm was warm to touch, face flushed, anxious movement as noted by repeated touching chest and face, no use of accessory muscles noted. At 1346, vital signs: oxygen saturation 95%, pulse 92, blood pressure 138/70, respiratory rate 24. At 1350, PHN offered client benadryl, client consented and took 2 capsules of benadryl (50mg dose) orally. At 1352, client moved to chair outside on patio in front of CWS in the shade as offered by PHN, gait steady and assisted by family member. At 1352, client signaled to family member that she felt better, PHN noted decreased flushing, posture relaxed with arms at sides while sitting in chair outside. At 1402, PHN advised client and family member to have client follow up with PCP within 24hrs or as soon as possible thereafter. At 1413, vital signs: oxygen saturation 96%, pulse, 84, blood pressure 140/90, respiratory rate 16. PHN noted client yawning, no redness noted in face, no longer warm to touch at 1415. At 1427 vital signs: oxygen saturation 97%, pulse 85, blood pressure 140/100, respiratory rate 16; PHN advised to call 911 if adverse reaction occurs. At 1430, client left, gait steady, with family member to the car. Family member drove.
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| 70 | 2021-02-26 | redness, itchy skin |
Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweat...
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Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweating, tiredness, slight nausea, intermittent headaches, strong muscle and joint pains, slight swollen glands in neck
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| 70 | 2021-02-26 | injection site redness, injection site pruritus | Slight redness of upper left arm and mild itching |
| 70 | 2021-02-27 | rash, itchy rash |
Rash over mid section with mild itching. Cleaned rash area with cold damp towels to relieve itch De...
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Rash over mid section with mild itching. Cleaned rash area with cold damp towels to relieve itch Delayed visit to health care provider due to onset of winter storm from 2/14/2021 thru 2/18/2021. All facilities closed. Visit to clinic on 2/19/2021. Prescribed DIPHENHYDRAMINE HYDROCHOLORIDE, 25 mg. 2 X day. TRIAMCINOLONE 0.1%, Apply to affected area twice a day. Clearing of the rash and itching after 5 days of medications. Itching still occasionally. Still applying cream occasionally.
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| 70 | 2021-02-27 | itchy skin |
Weakness, vertigo, feeling unsteady, nausea, numbness in extremities, involuntary twitching in calf ...
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Weakness, vertigo, feeling unsteady, nausea, numbness in extremities, involuntary twitching in calf muscle and arms, itchy feeling under the skin, symptoms lasted 4-5 days, improved with Benadryl,
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| 70 | 2021-02-28 | rash |
2-22 6PM extremely sore left arm 2-22 9PM could not move left arm up but about 8" 2-23 10AM-...
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2-22 6PM extremely sore left arm 2-22 9PM could not move left arm up but about 8" 2-23 10AM-12PM Flushed hot to touch cheeks-normal temperature 2-24 9AM rash on left underarm....had scratched during the night & arm sore to touch in that area 2-25 9AM rash had subsided but arm still sore to touch
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| 70 | 2021-02-28 | rash macular |
eyelids became puffy; eyes became glassy; fever; body aches; chills; bad headaches; implanted breast...
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eyelids became puffy; eyes became glassy; fever; body aches; chills; bad headaches; implanted breast skin became blotchy; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E63247) , via an unspecified route of administration in the right arm on 01Feb2021 at 15:00 (at the age of 70-years-old) as a single dose for COVID-19 immunization. Medical history included Raynaud's syndrome, chronic lymphocytic leukaemia, irradiated thyroid gland, high cholesterol, previous breast cancer, allergy to latex and adhesives, and breast implants. Concomitant medications included levothyroxine sodium (SYNTHROID); rosuvastatin (MANUFACTURER UNKNOWN), and unspecified multivitamins. The patient previously took povidone/iodine (BETADINE) on unknown dates for an unknown indication and experienced drug allergy. On 05Feb2021 at 21:00, the patient experienced fever, body aches, chills, bad headaches, and implanted breast skin became blotchy. On 07Feb2021, the patient's eyelids became puffy and eyes became glassy,. All the events were reported as serious for disability. The peak temperature was 101 degrees Fahrenheit on an unknown date in Feb2021. The patient contacted the doctor, eye care professional and hematologist/oncologist for the events. On 08Feb2021, the patient had a COVID-19 nasal swab PCR which was negative. The patient was not treated for the events. The clinical outcome of the fever was recovered on 12Feb2021; while that of the body aches, chills, bad headaches, implanted breast skin became blotchy, eyelids became puffy, and eyes became glassy were recovering.
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| 70 | 2021-03-01 | skin laceration |
Lost consciousness for brief period; bleeding from small gash in head; broke my finger; feeling out ...
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Lost consciousness for brief period; bleeding from small gash in head; broke my finger; feeling out of sorts; feeling light headed; This is a spontaneous report from a contactable consumer (patient) who reported that a 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number:EL3246), via an unspecified route of administration into the right arm on 10Feb2021 07:45 at a single dose for COVID-19 immunisation. Medical history included known allergies to CT dye, COVID-19 from an unknown date prior to vaccination and known allergies to sulfa drugs. Patient was not pregnant. Patient had unspecified concomitant medications. On 11Feb2021 08:00, patient woke up feeling out of sorts and feeling light headed, patient sat down and the next thing she knew she was on the floor bleeding from a small gash in her head, she lost consciousness for a brief period and also broke her finger. The events required emergency room and physician office visit. The patient had 3 staples in her head and a finger splint for the events "bleeding from a small gash in her head" and "broke her finger". Outcome of events was recovering.
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| 70 | 2021-03-01 | rash | Severe systemic rash all body involved, random patches and striped . |
| 70 | 2021-03-01 | rash | lip swelling, rash |
| 70 | 2021-03-02 | itchy rash, rash with redness |
Diffuse erythematous pruritic rash primarily lower extremities and back, wax and wanes. Started on ...
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Diffuse erythematous pruritic rash primarily lower extremities and back, wax and wanes. Started on 2/21 and has persisted until seen today in clinic on 3/3/2021.
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| 70 | 2021-03-02 | hives, itchy skin, rash |
Itching skin - rash - hives around neck and on stomach, hips, lower back. Occurred about 4 hours aft...
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Itching skin - rash - hives around neck and on stomach, hips, lower back. Occurred about 4 hours after receiving vaccine. Hives continued to occur for almost 2 1/2 wks. Used oral benadryl, cortison cream and cold packs. Cool showers as warmth caused the hives to flare. Loose clothing as pressure caused hives to occur.
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| 70 | 2021-03-02 | itchy skin |
Pt c/o burning in nose area and pt reports pain, itching & burning down her left arm, which then rad...
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Pt c/o burning in nose area and pt reports pain, itching & burning down her left arm, which then radiated across her shoulders. Pt has wheezing which she reports is normal for her. BP is elevated, pt reporting not taking her meds this a.m. MD ordered breathing treatment of albuterol and metoprolol 50mg po for BP of 175/101. HR 68 SR 100%SpO2/RA,RR=21, No Respiratory Distress Noted
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| 70 | 2021-03-02 | vaccination site pain, itchy skin, redness, rash with redness, skin swelling |
all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size...
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all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; redness of the skin; whole body was in pain; severe allergic reaction; felt unwell; Joint muscle pain; flushed red; Tiredness; Injection site pain; joint and muscle pain; joint and muscle pain; white blood cell count on the lower side; possible damage to the kidneys; could have been possible that she had COVID and was asymptomatic, or she had it; cold; not feeling normal; This is a spontaneous report from a contactable consumer (patient) Medical information team. A 70-years-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 13Feb2021 at single dose for COVID-19 immunization. Medical history included dystonia and migraines from an unknown date and unknown if ongoing, COVID-19 antibody test positive from Nov2020 to an unknown date. The patient was taking unspecified concomitant medication for dystonia and migraines. The patient experienced a "severe allergic reaction" to her first dose of BNT162B2 in Feb2021. She had all-over body rash that was "very red, like a tomato" and showed up 35-40hours after her dose. She states her doctor does not recommend she get the second dose. The patient meant by allergic reaction, she had a number of things, she experienced tiredness, injection site pain, joint muscle pain, she felt unwell, this all happened on the Saturday, the same day she got the vaccine on 13Feb2021. Then on Sunday 14Feb2021, all the symptoms she spoke about were still there and so she rested all day. On 15Feb2021, she looked at her elbows, clarifying the inside of elbow, her elbow creases, and on both elbow creases the skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen down to her thigh, it was working it's way down to the knee, the color was like a beet red, tomato color, it was under the arms, started with elbow, was at her neck. The more down the redness spread, the more it red in color it also got. When she noticed this she called the doctor. When she called the doctor, the doctor said get over to the Emergency Room right away. Her husband and her were both on the phone and were telling the doctor that she doesn't want to go to hospital, she asked if she can just come into the doctors office. The doctor said No. He told her that needs to get special lab work done, and he needs to send her information over to the ER. He said this could do possible damage to the kidneys. The doctor said lets not forget the last time she did a blood test, which was in Nov2020, at that time she came up positive with COVID antibodies. It could have been possible that she had COVID and was asymptomatic, or she had it. The doctor said that they need to do another COVID test or it could be she had a COVID cold or a cold with antibodies, her doctor doesn't know. The fact that she had that test that came back with COVID antibodies test but not have COVID in Nov2020 was something to consider. He was concerned may be there is more to this, or just a rash. The doctor said that he is not equipped say what it should be. The doctor said he will speak with them at the hospital. Tiredness subsided yesterday afternoon on 15Feb2021, it subsided before she went to the ER visit. Right now, it's kind of like a lasting effect because she is not feeling normal. The injection site pain was still there but not as bad. The joint muscle pain subsided this afternoon around 1 o clock. It first began a half hour after leaving the stadium and she was experiencing it while driving back home, the pain continued and got worse. When she got up on Sunday morning her whole body was in pain, she was not getting better on Sunday and that's when she sat on couch rest of the day. For red skin, with the temperature of the skin, she didn't feel it to see if it was hot or anything, it was more this feeling that its just not going away getting worse, it didn't feel hot, there was no texture on the skin either. She just noticed she was flushed red. She called the doctor first, and he said that he was sending information to the emergency room. Then she went to (name of place withheld) ER. They took her temperature, there was no fever. She was then relieved from the ER in 2.5 hours and went home. She still has redness on the skin. In the hospital, they gave her 40 mg of prednisone and an injection or Benadryl, and prescription for prednisone to take for the next 4 days while tapering down. She did take Benadryl about 2 hours ago, she did notice all the sudden she was getting itchy. She is less itchy now. With the itchiness, she just observed this about 2 hours ago. She took Benadryl, she has somewhat improved, she is still itchy but not to the point that she will scratch heavily. She does not have her COVID CDC Card at the moment, her husband has that information but he is on a conference call with a client and she cant disturb him. The patient was scheduled for a second dose on 06Mar2021. That's where she has a question, the doctor is saying that he is not sure about getting second shot. They took lab work at the hospital and said everything was fine except for white blood cell count, it was on the lower side in Feb2021. She has had no vaccines on the same day or in the 4 weeks prior. She hasn't had any vaccines. She did have to visit the emergency room. She only called the doctors office, the doctor said not to come in and go tot he ER. She has No relevant family medical history that she would like to share. The severe allergic reaction, "skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen", injection site pain, redness of the skin, itchiness, joint muscle pain and whole body was in pain was recovering. The event tiredness recovered with sequelae on 15Feb2021 and the event joint and muscle pain was recovered on 16Feb2021. The outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-03-02 | injection site pain, injection site pruritus |
fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no uri...
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fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no urine output for 24 hrs, vertigo, fatigue, severe stabbing pains in face and head, stiff neck, no appetite, difficulty swallowing, pain in joints, chest pain, pain across upper back, stomach pain,. Symptoms lasted for 3 to 4 days. Severe head pain lasted 4 days. Could not raise left arm for 24 hrs after injection. After 6 days fatigue and general malaise still present. Stomach pain still comes and goes.
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| 70 | 2021-03-02 | redness, vaccination site pain |
pain at injection site; swelling; warmth; redness; This is a spontaneous report from a contactable n...
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pain at injection site; swelling; warmth; redness; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EM9810) via intramuscular in the left arm on 10Feb2021 13:15 at single dose for covid-19 immunisation. Medical history included hypothyroid. Known- allergies included sulfamethoxazole; trimethoprim (BACTRIM). Concomitant medication included levothyroxine, tramadol, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID). There was no other vaccine in four weeks. The patient had not COVID prior vaccination. The patient had not COVID tested post vaccination. The patient experienced pain at injection site, swelling, warmth, redness; all on 12Feb2021 08:00. The events resulted in physician office visit. The patient was hospitalized from Feb2021 for the events. Treatment received for the events included cefalexin (CEPHALEXIN) orally; methylprednisolone (MEDROL) dose pack; famotidine; and cetirizine hydrochloride (ZYRTEC). The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 70 | 2021-03-02 | rash |
rash on legs, arms, chest and stomach; headache; fever; chills; body ache; 3 days with out sleeping;...
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rash on legs, arms, chest and stomach; headache; fever; chills; body ache; 3 days with out sleeping; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information team. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included anaphylaxis with insect bites from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took codeine and diazepam (VALIUM) and experienced hyperkinetic reaction. The patient stated that she received the vaccine on 14Jan2021, and that day 6 hours later, she had headache, fever, chills and body ache; and the next day on 15Jan2021, when she woke up, she had rash on legs, arms, chest and stomach, and she still had the rash. On an unspecified date, the patient had 3 days with out sleeping. The patient assessed the events as non-serious. The patient further reported that she was hyperkinetic and she has had that reaction many years prior reporting, before when taking codeine or VALIUM, one of the ingredients in VALIUM. She went to the doctor the first day, who saw her rash and told her to report that. It was not itching. The patient had the appointment for the second dose of the Pfizer vaccine, this coming Thursday and wanted to know if there would be a problem to get the second dose. She was afraid to get the vaccine the first time, because she had a history of anaphylaxis with insect bites. She carried an epi pen, and the vaccine provider had one too and the paramedics was there, and everything was okay; they were nice with her. The patient didn't have any problem until later. The patient spoke to her health care professional and he thought it was okay for her to get the second dose and the health care professional just told her to put a cream on her rash. Therapeutic measures were taken as a result of rash on legs, arms, chest and stomach, which included putting a cream on her rash. The patient was not recovered from the rash on legs, arms, chest and stomach, while the outcome of the events "headache, fever, chills, body ache, and 3 days with out sleeping" was unknown. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-03-03 | injection site pain |
Pain in left arm within 30 minutes of administration. General tiredness/lethargy within10 hours (upo...
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Pain in left arm within 30 minutes of administration. General tiredness/lethargy within10 hours (upon waking next morning). Sore/stiff neck within 14 hours. Body aches, chills within 16 hours. Stomach/abdominal discomfort within 20 hours. Diarrhea at 36 hours. At 36+ hours - arm pain considerably less. Body aches and chills gone by 36 hours. Continued stomach/abdominal discomfort seems to be improving after 40 hours.
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| 70 | 2021-03-03 | shingles |
Patient woke up in the middle of the night the same day she received the vaccine and noticed pain an...
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Patient woke up in the middle of the night the same day she received the vaccine and noticed pain and burning on her upper left leg. She saw her doctor the next day who diagnosed her with shingles. The outbreak spread to the back of her knee in the meantime. She was prescribed ointment and medication to treat shingles.
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| 70 | 2021-03-03 | rash |
Severe fatigue and body aches and day 4 a severe rash on my back that lasted two weeks. Treated wit...
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Severe fatigue and body aches and day 4 a severe rash on my back that lasted two weeks. Treated with OTC steroid lotions.
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| 70 | 2021-03-03 | shingles | patient developed shingles |
| 70 | 2021-03-03 | vaccination site pain |
right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen ...
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right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
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| 70 | 2021-03-03 | vaccination site pain, redness |
severe asthma; trouble breathing; might have the coronavirus; My face is blood red; I am worried; Wh...
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severe asthma; trouble breathing; might have the coronavirus; My face is blood red; I am worried; Wheeze; she is also shaky; general malaise; heart attack; and last night she drank some water and choked on it then couldn't get her breath and; chest was hurting radiating to my arm down; fever; chills; exhausted/just felt very tired; her arm that was sore was the one where she had her injection; This is a spontaneous report from a contactable consumer (patient). A 70 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9810), via an unspecified route of administration (on left arm) on 15Feb2021 (at the age of 70 -years-old), single dose for COVID-19 immunization. Medical history included asthma, sleep apnea, thyroid problem, prediabetes, cpap use, all from an unknown date. There were no concomitant medications. Patient reported her face is blood red. Last night her chest was hurting radiating to my arm down. It felt like someone was strangling her with water. She noticed my symptoms were what people experience after receiving the second dose. She had fever, chills, exhausted and just felt very tired after receiving the first dose. She still have trouble breathing. She had severe asthma. She was not breathing normally. When she put the mask on it's even harder to breath. She was worried. She thinks, she might have the coronavirus. Consumer says that she is still not feeling well after receiving her first dose of the Pfizer COVID-19 vaccine on February 15th. She says that the first day after getting it, she had pain in her arm, it was achy, it was not really painful enough to where she had to take Tylenol for it. She says yesterday on the second day she had fever, chills, tiredness, general malaise, and today she is not feeling well. Caller says she was having trouble breathing, and did a treatment with her nebulizer which she has because she has real bad asthma. She says her breathing is labored and she wheezes every once in a while. She says she would like to see if there is anything that she needs to do, because she works with children, and if she is coming down with the corona virus she doesn't want to be around them with it. She says that her breathing is problematic today. She says she doesn't think that she is having a severe reaction, she has no rash or those kind of symptoms. She says it seems to be just the asthma, and last night she drank some water and choked on it then couldn't get her breath and her chest hurt and she had pain down her arm and thought oh gosh she was having a heart attack.Caller says she has done no treatments other than the nebulizer treatment. No further details provided about the nebulizer treatment. Caller says the provider said no Tylenol right away, so she didn't take any yesterday with her fever, and she didn't have a thermometer to take her temperature, but her face was really hot and she was having chills, which usually means she has a fever. She says that her arm that was sore was the one where she had her injection. She says that never really was that bad, everyone said their arm had ached, and she has a high pain threshold so it never bothered her. Her wheezing and little trouble breathing was better, after she did some breathing treatments with the nebulizer, she is not breathing well but she is breathing better. She says she is also shaky and doesn't know if that is just nerves, or if this is also something going on. Caller says that it has been a while since she had blood work, which was the last time she went to see physician, but she doesn't know the results for what they found out. The outcome of the events Breathing difficult,wheeze was recovering, other events was unknown.
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| 70 | 2021-03-04 | itchy skin |
About 10-15 min after shot pt reported itchy eyes and "itchy sensation" all over body. No rash appa...
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About 10-15 min after shot pt reported itchy eyes and "itchy sensation" all over body. No rash apparent. No dizziness, no SOB or breathing difficulty - gave 50mg oral Benadryl, pt waited another 20 min with no worsening symptoms - was with husband .
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| 70 | 2021-03-04 | injection site pain |
My last injection was on 1/28/21. That day and few days after I had no site pain. I did have aches...
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My last injection was on 1/28/21. That day and few days after I had no site pain. I did have aches and pains and bad headache and chest pressure for hours during the night which I reported and which disappeared next day. However, the site pain in my right arm continues and is pretty bad temporarily and also periodically. Not a big deal but decided to report it. Seems very odd since it's been so long.
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| 70 | 2021-03-04 | injection site redness, injection site rash |
Two days after the COVID19 vaccination I developed a red blotchy rash below the injection site. Ski...
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Two days after the COVID19 vaccination I developed a red blotchy rash below the injection site. Skin was also warm and swollen in this area.
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| 70 | 2021-03-04 | shingles |
diagnosed with shingles (on Scalp); This is a spontaneous report from a contactable consumer (patien...
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diagnosed with shingles (on Scalp); This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration on 25Jan2021 09:00 in left arm at single dose for covid-19 immunisation. Medical history included CAD (coronary artery disease), allergies: cosmetics, some topical meds, preservatives in eye drops and some perfume. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included atorvastatin (LIPITOR) at 40mg, acetylsalicylic acid (ASPIRIN) at 81mg and fexofenadine hydrochloride (ALLEGRA). The patient historical vaccine included varicella zoster vaccine rge (CHO) (SHINGRIX) and shingles vaccine (unspecified) for shingles, and previously took codeine and experienced allergies: Codeine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Feb2021 22:00, the patient experienced shingles (on scalp). The patient has received both the Shingrix Vaccine and the earlier Shingles Vaccine. So, it doesn't make sense. The seriousness criteria were considered as non-serious. Since the vaccination, the patient has been not tested for COVID-19. Therapeutic measures were taken as a result of diagnosed with shingles (on scalp) included valaciclovir 21 tablets. The outcome of the event shingles was not recovered.
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| 70 | 2021-03-05 | injection site rash | Rash at injection site |
| 70 | 2021-03-05 | rash, rash with redness, injection site reaction |
Red rash left arm towards the right of site of injection. Red rash forehead , nose and both sides o...
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Red rash left arm towards the right of site of injection. Red rash forehead , nose and both sides of nose , little red dots
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| 70 | 2021-03-06 | redness, injection site redness, injection site swelling, itchy skin |
Same onset of symptoms as first dose, but different symptoms this time ( 7-8 days after shot develop...
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Same onset of symptoms as first dose, but different symptoms this time ( 7-8 days after shot developed symptoms). Trunk itches and belly fat feels like someone is squeezing it, swollen hands and feet. This time had puffy eyes and lips,with neck and genitals itching. Over my body an erythema that turns white when stroked. On my right arm, where I received the shot, very large splotch approximately 3 inches by two inches (red and swollen.) Feeling of malaise and dizzy. Stiff neck and swollen joints in fingers. Visited outpatient clinic for check up. Given Hydroxysine HCL 25mg x 3 per day. When I was in my early 30s had an anaphylactic reaction to something I ate??? Went to ER for shot of epinephrine. We never discovered what it was I was allergic to.
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| 70 | 2021-03-07 | blister |
BROWN SPOTTING BLISTERS ON BOTH ARMS, THEN THEY DRY UP AND LEAVE SPOT AND DRY BLISTER FLAKS OFF. IT ...
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BROWN SPOTTING BLISTERS ON BOTH ARMS, THEN THEY DRY UP AND LEAVE SPOT AND DRY BLISTER FLAKS OFF. IT STARTED ON FIRST SHOT BUT I WAS NOT SURE UNTIL I GOT THE SECOND THAT WHENI REALIZED WHERE THEY WERE COMING FROM. PERM DAMAGE TO SKIN
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| 70 | 2021-03-07 | rash, redness, injection site rash |
Fever, chills, headache, nausea, body aches, redness and sore left arm, lack of appetite, couldn't s...
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Fever, chills, headache, nausea, body aches, redness and sore left arm, lack of appetite, couldn't sleep, fatigue, rash at injection site and down the arm and then several days post injection rash on thigh
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| 70 | 2021-03-07 | redness |
Pt reports received covid vaccine on 3/6/2021 to R deltoid. The next day (3/7) she woke up and R sid...
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Pt reports received covid vaccine on 3/6/2021 to R deltoid. The next day (3/7) she woke up and R side of cheek was bright red. No warmth/swelling. No bumps or sores. No difficulty breathing or swallowing. Feels completely fine, just the redness noted. She call PCP on 3/8 to report.
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| 70 | 2021-03-07 | blister, shingles |
Shingles; she can suffer with the pain; blisters; This is a spontaneous report from a contactable co...
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Shingles; she can suffer with the pain; blisters; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3249 and Expiration Date unknown) via an unspecified route of administration on 20Jan2021 at left arm (age at vaccine was 70-year-old) at single dose for COVID-19 immunisation. The patient's medical history included ongoing rheumatoid arthritis diagnosed about 8 years before unspecified date, ongoing hypertension diagnosed about 7 or 8 years before unspecified date. The ongoing concomitant medications was not reported Hydroxychloroquine from two years before unspecified date at 200mg tablet, one tablet twice daily, by mouth for Rheumatoid arthritis; Losartan from probably 7 or 8 years before unspecified date at 100mg tablet, one tablet, once daily by mouth for Hypertension; Chlorthalidone from about 7 to 8 years before unspecified date at 25mg tablet, one tablet, twice weekly, by mouth for Hypertension and other unspecified drug. There is no other vaccines on the same day as the COVID vaccine. Patient experienced Shingles on 26Jan2021. Patient can suffer with the pain in Jan2021. The blisters from Jan2021 had dried and they are scabs now, but patient still has pain. Patient is due for the second COVID vaccine this Wednesday, and she is a little hesitant to get it because she does not know if there is a connection between the vaccine and getting Shingles. Treatment was received for all events (taking medications). The outcome of shingles is recovering (Improved but also Persistent). The outcome of pain was recovering (so intense for about 4-5 days and now it has eased up). The outcome of blisters was unknown. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-03-07 | hives |
Within one hour after injection my left side of face started to swell. The swelling peaked within 2...
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Within one hour after injection my left side of face started to swell. The swelling peaked within 24-48 hours and eventually affected my right side as well. I continue to have a swollen face particularly on left side with whelps particularly near mouth. I went the an emergency care facility within the hour on the advice of my Dr. At that time the swelling was not as bad as it would get. I was told to take Benadryl the first night and it helped; I was told I could take Zyrtec or the equivalent generic following the first day. I continue to be on antihistamines and the swelling remains. It has been 12 days since the injection. I want to know if I can safely get my second shot.
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| 70 | 2021-03-08 | injection site inflammation, injection site bruising, injection site redness |
3/5/21 Restlessness, fatigue & arm soreness. 3/6/21 Arm fevered, inflamed and bruising at and aroun...
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3/5/21 Restlessness, fatigue & arm soreness. 3/6/21 Arm fevered, inflamed and bruising at and around injection area 3/7/21 Arm worsen with the bruising and redness 3/8/21 & 3/9/21 No improvement in arm Took Benadryl- no change
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| 70 | 2021-03-08 | rash |
After receiving vaccination patient stated a rash developed on arm and stomach. Facility called ambu...
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After receiving vaccination patient stated a rash developed on arm and stomach. Facility called ambulance and patient was taken to hospital for observation
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| 70 | 2021-03-08 | rash with redness | SWELLING AND RED RASH IN PALMS, SEVERE PAIN IN SHOULDER AND WRIST JOINT |
| 70 | 2021-03-09 | rash papular, rash |
After the first dose I developed a severe itchy maculopapular and vesicular rash on my back. It res...
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After the first dose I developed a severe itchy maculopapular and vesicular rash on my back. It resolved in two weeks. After second dose the rash broke out on my trunk and extremities. Different from first in that the papular. lesions developed into open and scabbed lesions. And persist almost three weeks later. No recent breakout but, very slowly resolving.
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| 70 | 2021-03-09 | injection site warmth, injection site hardening, injection site swelling, injection site pain |
I received my first dose (Pfizer EN6201) at 3-1-2021 on my left arm. I felt pain and observed swolle...
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I received my first dose (Pfizer EN6201) at 3-1-2021 on my left arm. I felt pain and observed swollen on the injection site for two days. Then I did not pay attention to the injection site until last night when I took a shower (3-8-2021, 8 days after first dose). The injection site became rigid, swollen, and a little warmer, but not painful.
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| 70 | 2021-03-09 | injection site pain | PRETTY BAD HEADACHE SUCCESSFULLY TREATED WITH TYLENOL; LETHARGY; MINOR SORENESS AT INJECTION SITE |
| 70 | 2021-03-09 | rash |
Seven or so hours after injection on Saturday, I developed a rash that quickly became hives on my lo...
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Seven or so hours after injection on Saturday, I developed a rash that quickly became hives on my lower back, which spread to my inner thighs. Took Benadryl OTC tablets, and used Benadryl topical gel on affected areas. Overnight, the rash spread to my outer thighs. By about 9am the next day, (Sunday) developed a headache which became more severe as the day wore on, a fever (102), and, body aches. Talked with my primary care manager on Sunday afternoon who advised me to continued with my benadryl treatment, but to go to the ER if I developed any breathing problems. This all persisted in varying stages of severity through Tuesday, when I started having breathing issues, and went to the ER, where I was given steroids and a breathing treatment, chest xray, blood tests, etc. Was also given a prescription for five days of prednizone, and, released.
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| 70 | 2021-03-09 | injection site pain |
injection site pain, tiredness, headache, joint pain in knees, chills, nausea , feeling unwell week ...
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injection site pain, tiredness, headache, joint pain in knees, chills, nausea , feeling unwell week and dizzy
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| 70 | 2021-03-11 | injection site pain, itchy skin |
Injection site pain Headache with ?brain zaps? for a period of 2+ hours Joint pain over entire body ...
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Injection site pain Headache with ?brain zaps? for a period of 2+ hours Joint pain over entire body Chills with severe trembling Fever Vomiting for a period of hours Severe itching on my back, shoulders and upper arms for two days
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| 70 | 2021-03-14 | rash |
Chills; fever; extreme fatigue; muscle achiness; headache; swollen arm; rash on arm; This is a spont...
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Chills; fever; extreme fatigue; muscle achiness; headache; swollen arm; rash on arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot#: EN6202, expiration date unknown) on 23Feb2021 at 12:15 AM at the age of 70-year-old at single dose via an unspecified route of administration at left arm for COVID-19 immunization. Patient was not pregnant at time of event and at the time of vaccination. Medical history included allergy to sulfa. Patient previously received 1st dose of BNT162B2 (Lot#: EL9264) on 02Feb2021 at 02:00 PM at the age of 70-year-old at left arm for COVID-19 immunization. Concomitant medications included raloxifene, fish oil, ergocalciferol (VIT D) and calcium. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced chills, fever, extreme fatigue, muscle achiness, headache, swollen arm, rash on arm; all on 23Feb2021 at 15:00. Outcome of the events was recovering. No treatment was received for the events. Events were reported as non-serious. Events didn't result in emergency room visit or physician office visit. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.
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| 70 | 2021-03-14 | rash with redness, rash papular, rash |
One week after second vaccination, rash started on the inside of my right arm(injection arm) and the...
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One week after second vaccination, rash started on the inside of my right arm(injection arm) and then gradually spread to inside of left arm, i went to doctor 8 days later and she thought it could be from the cleaning they gave my arm for the colonoscopy I had the day the rash appeared. I was prescribed a steroid .I am now 13 days out from the second vaccination and still have the rash but it is no longer raised nor as red.
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| 70 | 2021-03-14 | injection site pain, injection site swelling |
Pain and swelling at injection site - unable to raise arm above head Treated with Tylenol. Resolve...
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Pain and swelling at injection site - unable to raise arm above head Treated with Tylenol. Resolved in 36 hours. Severe generalized headache, myalgia, arthralgia, extreme fatigue, loss of appetite, but no fever. No analgesic helped symptoms. Required bedrest for three full days. Symptoms resolved after four days.
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| 70 | 2021-03-14 | rash with redness |
Reaction 48 hours after injection. Looked like a sunburn from head to toe. On 1/23/21 contracted co...
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Reaction 48 hours after injection. Looked like a sunburn from head to toe. On 1/23/21 contracted covid. This was confirmed on 1/25 Second injection on 2/4/25 had to be cancelled
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| 70 | 2021-03-14 | rash, itchy rash, hives |
Several hives on belly and left upper thigh. They were quite itchy. Took two Benedryl at 7pm, by 8p...
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Several hives on belly and left upper thigh. They were quite itchy. Took two Benedryl at 7pm, by 8pm the hives were beginning to go down .
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| 70 | 2021-03-14 | vaccination site pain, vaccination site redness |
syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; sor...
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syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; soreness, redness, and pain at injection site; her blood pressure was really high and kept going up and down like a roller coaster; She was taken to the ER and began feeling sick to stomach in ambulance; headache; felt her ears vibrating; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; She is anxious about getting the second vaccine; Enlargement of lymph nodes; increased heart rate; This is a spontaneous report from a contactable Nurse reported for self. This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 on Arm left at single dose (Lot # EL9262, Expiration: May2021) for covid-19 immunisation. Medical history included Atrial fibrillation from Jan2020. Had 2nd dose appointment scheduled but canceled appointment. Concomitant medications included apixaban (ELIQUIS) from 07Feb2021 at 5mg twice a day by mouth (provided SN100089537925, LOT 1771228, EXP: May2023, NDC: 0003-0894-21) for Atrial fibrillation. History vaccine included a Tetanus shot 40 years ago (1981) for immunisation and reacted terrible to it. She reports having and experienced soreness, redness, and pain at injection site. She reports getting a mammogram sometime after receiving the vaccine. They saw a spot they are going to recheck and saw swollen lymph nodes on the left side/ Enlargement of lymph nodes, which is the same side she received her vaccine. She was told it was most likely due to the vaccine. Six days later she suddenly felt sick, near syncope, couldn't catch her breath. It got so bad she thought she was dying and called EMS. Leads confirmed afib, her blood pressure was really high and kept going up and down like a roller coaster. She was taken to the ER and began feeling sick to stomach in ambulance. IN the ER she received 1000 ml of fluids and additional metoprolol in addition to dose she took that evening at home. She was sent home to follow up with her Cardiologist the following Monday. He wasn't sure if it was due to vaccine and started her on twice daily eliquis and increased her toprolol immediate release to twice daily. The following Friday night she got a headache and felt her ears vibrating. Her home EKG was fine, but blood pressure was high again and stayed up for hours. Took additional toprolol. Came down after 5 hours. Breast, arm and clavicle starting hurting two weeks and one day after the injection. She is anxious about getting the second vaccine. Asked PCP if she needed an antigen test to see if she needed a second dose of the vaccine. She says she got her first dose 01Feb, then on Wednesday, 03Feb she went and got a mammogram which had already been planned. She says that they saw enlarged lymph nodes to her left breast, under arm, and clavicle which they said are due to vaccine, but they also said they saw something else so they wanted to do a repeat mammogram three months later. She says it took two weeks, but suddenly her left breast and under arm were killing her, caller did not clarify this statement. She says she talked to her doctor who said don't worry it might take a while to go down. She says that the other thing is she has known atrial fibrillation that was diagnosed a year ago, and most of the time it is quick and doesn't last long, sometimes she doesn't know she is having it. She says 6 days after the first dose she started to feel ill, she had been in bed reading so she got up to get some water and suddenly felt like something was wrong and like she was going to pass out, she couldn't breathe, so she called EMS. She says her atrial fibrillation is not unusual, but she has never had it to where she couldn't breath. She says that the rate they estimated was 350, and her only other documented that was high like that was 150. She says that they treated her and she went home, and when she saw her cardiologist they said they don't know if the vaccine had to do with this, and to report it. She says a week later, on Friday a week ago, she started feeling funny standing while she was working on the computer in the middle of the afternoon, she felt like her ears were vibrating, which was very unusual, and she didn't know what was wrong so she looked at her Cardia app, and her heart was in normal sinus, and she checked her blood pressure which for her was sky high, up to 190/100 which her blood pressure is usually very low. She provided a second blood pressure that call handler was unable to capture and caller did not clarify as she no longer had her log with her. She says for hours her blood pressure (BP) went up and down, which was a similar or same thing as what happened that night she went to the ER with her atrial fibrillation, her BP would go up and down like riding a wave. She says needless to say, she has two questions: she says she doesn't know if there have been reports of that vaccine making A-fib worse, she is scared to get her second dose which she was supposed to get Monday a week ago, but put off primarily before the second thing with BP, she thought she would wait because she could hardly move her left arm so she put it off until the next Wednesday, She says that her second dose is now scheduled for 03Mar, so 4 weeks between doses, and she is a little afraid to get it because she doesn't know if her response was over the top or caused the other things, going to the ER with A-fib was terrifying, and she doesn't want that to happen again. She says people say that she has got to get her second dose because she won't be protected, so she would also like to know if it is possible for her to get antigens early on. She says that she had a tetanus shot 40 years ago, and had a horrible reaction after it, then years later they did a titer for tetanus and they said she would likely never need a tetanus shot again since she had built up such a high level and would never need it again. She says is it possible that she had enough immunity that she wouldn't need the second dose, or would there be an antigen test that could tell her if she would need a second dose, if so what is that test? She says she is afraid the next dose will kill her. AE treatment included says that when she went to the ER it was about 12:30AM when she arrived, they did not admit her. She says on the way to the ER in the EMS truck they gave her Cardiozyme to get her blood pressure going down and gave her 1000 cc fluids, and Metoprolol, another dose. She says that the Cardiozyme was IV push in the ambulance, she doesn't have the information to provide for all of the heart stuff they gave her, NDC/LOT/EXP: Unknown for Metoprolol or Cardiozyme. She clarifies that she takes Metoprolol normally every day that they have had her on that is extended release and she takes it at night. She says she had taken that at 09:30PM, and by the time she got there to the ER after midnight a little, they after gave her another to see if it would bring her heart rate down. She says that they kept her there a couple of hours, until her heart rate was normal, though her BP was up a bit. She says that they told her they could admit her but she said she would rather go home if they thought it was safe, and she went home. She says that her sister came home and stayed with her, whose husband is a cardiothoracic surgeon. Metoprolol: Caller says that the Metoprolol she is taking is in a pharmacy bottle that says use by 08Feb2022, it does not have an official label, the NDC or LOT are not on there. She says that they gave her 60 to take of regular Metoprolol, not extended release, which is 25mg to take twice a day by mouth, so 60 tabs and she would need to get refills as it is a months worth. Metoprolol extended release NDC/LOT/EXP not provided when queried. She clarifies that the not extended release is called Toprol/Metoprolol Tartrate 25mg. Caller says that her swelling lymph node limited the use of her arm, she can't pick up anything or lift her self up while moving in the bed, she is miserable, it hurts to put pressure on her arm and she can hold her arm up and move it around she can do anything with not holding anything, she feels a tightness there, even when she breathes or coughs. She says her left arm was sore initially for 3-4 days after getting the shot but the soreness left. She says she was told on 03Feb that she had swollen lymph nodes, which was two days after the shot, but she couldn't feel them then, she couldn't tell, and had no pain. She says it was two weeks later that happened, it was so odd that it was two weeks before it was hurting then got progressively worse. Caller says that Tuesday a week ago she thought she must have done weights with her arms since her muscles were sore, but it was only on one side and she hadn't done any exercise since after she went to the ER she was being careful what she did, and she thought she strained her arm and realized what it was, it has gotten progressively worse over the last week. She says last night she started looking up remedies, she has been putting ice on it, and the clinic said use warm, and she rubbed castor oil on it last night in the shower then this morning she massaged her arm with castor oil and put a warm wash cloth over it. She says that castor oil has anti inflammatory properties. She says she has not noticed a difference yet, but she has only done it two times. She says it also said she can take Aleve or Ibuprofen, they told her at the ER, they also started her on Eliquis the night she was there, which she had never been on, they didn't consider her A-f fib bad enough. She says that is what has her concerned, she got the shot then 6 days later A-fib made her feel like she couldn't breathe. She says also her BP and heart rate going back up made her sick to her stomach that subsided when her BP was coming down but then it started going back up again, when she went to the ER that Saturday night on the 6th but by the time she got there it was the 7th. Outcome of the events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 70 | 2021-03-15 | redness |
I woke up the morning after receiving the second Pfizer Covid-19 vaccine, and the ball joint and toe...
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I woke up the morning after receiving the second Pfizer Covid-19 vaccine, and the ball joint and toe of my left foot was swollen, red and painful. I ended up taking methylprednisolone (Medrol Dose Pac) for it. A few days after I completed that course of medication, I had another reaction where the left ankle did the same thing, got blood tests and the joint was aspirated; the doctor injected lidocaine and a corticosteroid into the joint, also the Medrol Pac meds again. Seems to be okay now. My doctor considers it a flare of inflammatory arthritis, auto-immune.
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| 70 | 2021-03-15 | injection site warmth, injection site pain |
Pain and warmth surrounding needle at time of FIRST injection. Subsequent: Fell soundly asleep 1 ho...
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Pain and warmth surrounding needle at time of FIRST injection. Subsequent: Fell soundly asleep 1 hour after shot for 8 hours. (4pm-midnite), woke for 3 hrs, slept again 'til noon. Each day for 3 weeks fell asleep 2ce/day (very unusual) 8 or 4 hours at a time, never being awake for more than 4-5 hours. (still occurring, but lessening a bit).
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| 70 | 2021-03-15 | injection site rash |
Patient presented to emergency department in afib RVR with heart rate in 180's. Patient has no known...
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Patient presented to emergency department in afib RVR with heart rate in 180's. Patient has no known history of afib, and stated that the heart rate of 180 started several days prior to arriving to emergency department. Patient was given IV push of 15mg cardizem, heart rate came down to 130. Patient then placed on cardizem drip at 10 mg/hr. Afib still present, but heart rate controlled in 120's. Patient underwent transesophageal echocardiography with cardioversion in order to convert patient back to normal sinus rhythm. Patient also stated that she slept for an extra 4 hrs/day for several days following vaccination and developed a scaly rash on injection site. Patient currently admitted in ICU under close monitoring.
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| 70 | 2021-03-15 | hives |
exacerbated the hives; exacerbated the hives; This is a spontaneous report from a contactable consum...
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exacerbated the hives; exacerbated the hives; This is a spontaneous report from a contactable consumer, the patient. A 70-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EM9809), via an unspecified route of administration in the right arm on 15Feb2021 at 08:00 (at the age of 70-years-old) as a single dose for COVID-19 immunization and ampicillin (AMPICILLIN), via an unspecified route of administration from an unspecified date at an unknown dose for an unspecified indication. Ampicillin was given within two weeks of BNT162b2. Medical history included penicillin allergy and sulfa drugs allergy; all from an unspecified date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks. The patient previously took nitrofurantoin (MACROBID) and prochlorperazine maleate (COMPAZINE); all from unknown dates to unknown dates for unknown indications and experienced allergy. The patient experienced exacerbated the hives on 15Feb2021 at 12:00. The patient had hives from ampicillin and believed that BNT162b2 exacerbated the hives. The patient went to the Emergency room/department or urgent care due to the event, exacerbated the hives. The patient received prednisone as the treatment for the event. The action taken in response to the event for ampicillin was unknown. The outcome of event, exacerbated the hives was recovering.
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| 70 | 2021-03-15 | rash vesicular, rash |
received vaccine on 3-11 and 2 hours later total body aches. on 3-13 she woke up with blisters and r...
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received vaccine on 3-11 and 2 hours later total body aches. on 3-13 she woke up with blisters and rash to both lips and sores in mouth, rash to right anterior chest and chills
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| 70 | 2021-03-15 | rash, itchy skin |
she started "itching on the right side of her ankle and leg" and it "was red"; she started "itching ...
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she started "itching on the right side of her ankle and leg" and it "was red"; she started "itching on the right side of her ankle and leg" and it "was red"/itching so bad all over; She also reported pain in the areas itching; Allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old female patient received first bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269), via an unspecified route of administration on 03Feb2021 10:31 at SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from 2020 to an unknown date, fall from Jan2021 to an unknown date (She went to orthopedic doctor on 10Jan2021 who gave her a Toradol shot and unknown injection in the knee; she thinks the unknown injection was a steroid or whatever they call it for the pain in her knee because she has bone on bone osteoarthritis) , ongoing Penicillin allergy while she was in her 20s , anxiety, diabetes mellitus, blood pressure abnormal. Concomitant medication included clonazepam (KLONOPIN, Tablet) 1/2 tablet taken as needed for Anxiety, duloxetine (DULOXETINE) for 60 mg, daily, metformin 500 mg, once daily for diabetes, hydrochlorothiazide/losartan potassium (LOSARTAN POTASSIUM AND HCTZ) 50mg/12.5mg tablet once daily for blood pressure, metoprolol succinate 50 mg, once daily. Patient previously took Flu vaccine on Arm was a little sore but that was it, went away in a few days. This was the first time she had ever gotten a flu vaccine on unspecified date in Nov2020 and experienced Arm was a little sore. Patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine last Wednesday. She added she was monitored for 15 minutes post injection but when back to work, at (Retail Company), where she started "itching on the right side of her ankle and leg" and it "was red". She called the ER that same day who recommended her to take "Benadryl 50mg", which "helped smooth it over and put [her] to sleep". She explained she went back to work yesterday, Thursday, and "last night [she] was itching". She specified applying some "hydrogen cortisone cream which eased it, but it is still itching and red". She asked if she should take the second dose of the vaccine given her reaction to the first dose. She said she will consult with HCP. She went to orthopedic doctor on 10Jan2021 who gave her a Toradol shot and unknown injection in the knee; she thinks the unknown injection was a steroid or whatever they call it for the pain in her knee because she has bone on bone osteoarthritis. This consumer was administered her first dose of Pfizer COVID-19 Vaccine 03Feb2021. She reported allergic reaction onset after that dose administered on 03Feb2021. She asked if she should still get the second dose of Pfizer COVID-19 related to this event. Onset same date as vaccine administration. Further described: they let her sit there in the (Facility name) for 15 minutes for monitoring and she had no reaction. She left there and went to work at (Retail Company). She got lunch while at work at (Retail Company) and sat in her truck eating lunch. That is when her right foot started itching right up by her ankle. She went on back into work. She told them she had to leave because she was itching so bad all over, her arms and stuff so she went back home. She also reported pain in the areas itching. She called the (Hospital name) and told the lady she was itching real bad and her ankle was turning red. The lady told her to take Benadryl, so she took 2 Benadryl tablets which helped the itching. After the Benadryl wore off the itching started again. She did not rest at all last night because of this event. She put some Hydrocortisone cream on the area because it is an anti-itch cream; the Hydrocortisone cream soothed it for a while, but then it started right back. She put a cold pack on the area because her daughter thought that might help, but the cold pack did not stop it, it just cooled it down. So she is seeing her Primary Care Physician today for this event. Outcome of the event pain was unknown. Outcome of the other events was not recovered.
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| 70 | 2021-03-16 | hives | Patient received full body hives shortly after receiving vaccine. Patient had hives for ~ 2 weeks. |
| 70 | 2021-03-16 | hives |
She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/p...
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She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/pain and tightness in both jaw lines was reported as worsened; I do have migraine; Hives; this is just a nightmare if this is not a normal problem; Can't think; pain and tightness in both jaw lines; pain and tightness in both jaw lines; thrush; proverbial headache/When I bend over I have a blinding headache; no coordination; Vomiting projectile/Throwing up right away; arm was hurting; swelling in arm; Chills; uncontrollable bladder gushing leaking; shaky arms; unable to eat anything; has been as sick as a dog; non stop coughing; Rib pain; This is a spontaneous report from a contactable consume. A 70-years-old female patient received bnt162b2 (BNT162B2) , via an unspecified route of administration on 2Feb2021 as a single dose, for covid-19 immunisation . Medical history included arthritis from 1992 and ongoing Verbatim: Arthritis , fibromyalgia from 1994 and ongoing Verbatim: Fibromyalgia , gastrooesophageal reflux disease from 1992 and ongoing Verbatim: GERD , lactose intolerance from 1992 and ongoing Verbatim: Lactose intolerance , depression from 1994 to an unknown date Verbatim: Anxiety depression , hypertension from 1992 to an unknown date Verbatim: Blood pressure high , MRSA , water pollution from an unknown date and unknown if ongoing She was unable to drink anything except sips of cold water and eat a few ice chips. She is unable to drink lukewarm water. This was prior to getting the vaccine , surgery from an unknown date and unknown if ongoing She had 22 surgeries in 4 years on her left eye. It started with pressure testing then infections. The patient reported she is legally blind in her good eye, has been as sick as a dog, non stop coughing, , non stop coughing , thrush on 23Feb2021, proverbial headache/when i bend over i have a blinding headache, , no coordination, vomiting projectile/throwing up right away arm was hurting, swelling in arm chills, uncontrollable bladder gushing leaking pain and tightness in both jaw lines unable to eat anything can't think felt like crap. The outcome of the events: Unknown: blindness, thrush, shaky arms, unable to eat anything, Can't think, Felt like crap, I do have migraine; Recovered, vomiting, swelling in arm; Recovoring illness, cough, rib pain, Not recovered headache, no coordination, uncontrollable bladder gushing leaking, pain and tightness in both jaw lines, pain and tightness in both jaw lines; Chills recovered with sequelae.
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| 70 | 2021-03-16 | hives, shingles |
Shingles outbreak involving dermatomes T10-12 on right side. Began two days after vaccination with d...
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Shingles outbreak involving dermatomes T10-12 on right side. Began two days after vaccination with deep pain and hives initially, resulting in typical herpes zoster rash about 6 days later. On the third day of the rash, began Valacyclovir 1gm PO TID. Is still symptomatic; rash has not yet resolved.
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| 70 | 2021-03-16 | rash macular, itchy skin |
Symptoms of maculopapular rash, mild fever (oral 100 degreed F), burning and itching sensation relat...
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Symptoms of maculopapular rash, mild fever (oral 100 degreed F), burning and itching sensation relative to rash. Rash location on arms, legs, chest, back, feet, hands, head. Rash was raised and red. Developed within 24h of COVID vaccine dose. Treated at home with scheduled diphenhydramine, Tylenol, hydrocortisone topical cream, and Pepcid. After two visits to PCP office, eventually treated with intramuscular steroid injection.
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| 70 | 2021-03-17 | injection site swelling, injection site redness, injection site pain |
Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swe...
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Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, feeling unwell, swollen lymph nodes Had these side effects for 24 hours, but the injection site swelling has lasted for a week. Took tylenol for the side effects and it helped.
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| 70 | 2021-03-17 | injection site bruising |
Several hours after receiving the Pfizer vaccine I noticed a very dark blue bruise at the injection ...
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Several hours after receiving the Pfizer vaccine I noticed a very dark blue bruise at the injection site. I still have this bruise, about the size of a Nickle, 12 days later. There is no pain or discomfort associated with this nor do I have any other side effects.
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| 70 | 2021-03-17 | vaccination site pain |
achy arm on the injection site; This is a spontaneous report from a contactable consumer (patient). ...
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achy arm on the injection site; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/ batch number: EN9810 and expiry date unknown), via an unspecified route of administration on 02Feb2021 (at 70 years old) at a SINGLE DOSE for COVID-19 immunization. The patient's medical history included blood pressure, blood thinner, and heart rate; all from an unknown date. Concomitant medications included atenolol, oral at 50mg, once daily for blood pressure; baby aspirin (acetylsalicylic acid) oral at 81mg, once daily as blood thinner; fish oil oral at 1000mg, once daily; hydrochlorothiazide, oral at 12.5mg, once daily for blood pressure; and levothyroxine, oral at 88mcg, once daily for heart rate; all the products were taken from an unspecified date for a long time and ongoing. It was also reported that patient takes blood thinners and other heart medications. The patient received the first dose of the vaccine today and noticed the information on the fact sheet after the shot. She is on baby aspirin and asked if she should still take it. Patient also asked what pain medication can she take; can she take Tylenol for her achy arm on the injection site? The patient further reported that when she got her shot, she didn't read the paper, but it says, "if you are on blood thinners" and does that affect this? She takes blood thinners and other heart medications. She asked if any of her medications affect her shot, she has not taken any today and she wanted to ask about that. Her only concern is the possible blood thinner interaction with the vaccine. With regards to the second dose, patient mentioned they didn't schedule her yet because she had to check and see where to get the second dose. She wanted to be more educated for the second dose. The outcome of "achy arm on the injection site" was unknown. No follow-up attempts are needed. No further information is expected.
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| 70 | 2021-03-18 | hives, redness | I experienced a red flushing and hives on my face as well as a tightening in my chest |
| 70 | 2021-03-18 | redness |
I immediately stated that the injection made me feel hot. Then my hands and face turned red. The c...
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I immediately stated that the injection made me feel hot. Then my hands and face turned red. The clinicians took my BP and it was over 170. They called the ER and took me directly there. The ER doctor administered Benadryl in IV. The redness started to go away and BP returned to normal. There was also a headache. Release from ER 2 hours after event. Subsequent fluctuations in BP and redness over the next 3 days. Saw PCP and he requested that I see allergist to determine cause of reaction in vaccine formula.
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| 70 | 2021-03-18 | rash, itchy skin | Tingling/Itching all over body. Rash starting to form |
| 70 | 2021-03-19 | rash macular, rash |
This was 2nd dose. Starting before I sat down in the observation area: Pressure and pain at back of ...
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This was 2nd dose. Starting before I sat down in the observation area: Pressure and pain at back of neck, dizziness, difficulty swallowing. This persisted until 3/17. I had a similar reaction to the first dose. 3/15: Rash on face and neck. 3/16 Rash spread to chest and upper arms. 3/17 face swollen; headache, scratchy throat. 3/18: Symptoms subside by end of day, although skin still a little blotchy. I did tell the person who gave me the injection about my reaction to the first dose and she looked for the rapid response team to watch me, but she didn't find them. I suggest a sign in the waiting area indicating which symptoms are of concern (hard to distinguish immune response from allergy and/or anxiety attack.
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| 70 | 2021-03-19 | rash, rash with redness, itchy rash |
on Friday 03/18/21 I woke at 6:00 AM with itching and upon inspecting my body found I had a red itch...
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on Friday 03/18/21 I woke at 6:00 AM with itching and upon inspecting my body found I had a red itchy rash on the trunk of my body front and back. Very, very little rash on my upper arms and upper thighs that didn't seem to present until Sat. morning 3/19/21. I did have allergy testing within the month prior which reaffirmed my cat allergy but saw improvement from testing 5 years ago. I also received my regular allergy shots 2/23/21 and 3/15/21. I was given ordansetron for nausea at the ER after gall stone diagnosis on 3/13/21 of which I took two tablets spaced according during the day 3/17/21. I was feeling well on 3/18/21 when I received my shot and was excited to get my Covid 19 vaccination.
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| 70 | 2021-03-20 | injection site swelling |
Left arm swollen at site of injection. Arm and finger swollen next morning. Tingling in toes. Ton...
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Left arm swollen at site of injection. Arm and finger swollen next morning. Tingling in toes. Tongue raw and sore and loss of taste. Very tired and achy. Low grade fever and chills. Unable to put two sentences together. Fill like my head is full of fog.
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| 70 | 2021-03-20 | injection site reaction |
lethargy; Chills; fever; muscle soreness; Major headache; nausea; Bad reaction at injection site; Th...
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lethargy; Chills; fever; muscle soreness; Major headache; nausea; Bad reaction at injection site; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered on the Left arm on 04Feb2021 14:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history was none. If other vaccine in four weeks: No. Other medications in two weeks: no. Other vaccine same date details: other vaccine same date dose number was 2. Facility type vaccine was Hospital. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. The patient experienced lethargy, chills, fever (pyrexia), muscle soreness (myalgia), major headache (headache), nausea and bad reaction at injection site (injection site reaction); all (non-serious) on 04Feb2021 17:30. Adverse event: Chills, fever, muscle soreness, major headache, nausea, lethargy, bad reaction at injection site. There was no treatment for AE. The outcome of events was recovered on an unspecified date in Feb2021..
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| 70 | 2021-03-20 | vaccination site redness, rash with redness |
nausea; low grade fever; chills; 4hrs after shot: redness at injection site; red rash about 3" in di...
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nausea; low grade fever; chills; 4hrs after shot: redness at injection site; red rash about 3" in diameter on non vaccinated arm. Rash is not itchy or raised; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unknown route of administration on 11Feb2021 at 16:00 (04:00 PM) in Left arm at single dose for COVID-19 immunisation at Pharmacy or Drug Store. Age at vaccination was 70 years. The patient wasn't pregnant at the time of vaccination. Patient had allergies to medications, food, or other products. Other medical history included asthma. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included fluticasone propionate, salmeterol xinafoate (ADVAIR) at 250/50; lisinopril (LISINOPRIL) at 40 mg dose; salbutamol sulfate (VENTOLIN) Inhaler. The patient experienced redness at injection site 4hrs (at 20:00) after shot on 11Feb2021. On 12Feb2021 at 18:00 (06:00 PM), she experienced nausea, low grade fever, chills 24hrs after shot; on Feb2021 experienced red rash about 3" in diameter on non vaccinated arm 40hrs after shot. Rash was not itchy or raised. Patient didn't received treatment for the adverse event. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Serious was reported as no. Outcome of all events was unknown. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-03-21 | rash |
First event - Rash on chest and torso 2 days after vaccination (3-10-21). Slight itchiness. Went awa...
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First event - Rash on chest and torso 2 days after vaccination (3-10-21). Slight itchiness. Went away after about 2 days. Second event - rash on beck and arms, aching in bones 2 weeks after vaccination (3-22-21). Went away after a few hours.
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| 70 | 2021-03-21 | rash |
Light colored rash down left side of neck and onto left shoulder area. Only lasted a few hours. No m...
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Light colored rash down left side of neck and onto left shoulder area. Only lasted a few hours. No meds or treatment needed.
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| 70 | 2021-03-21 | redness, itchy skin | Pt is experiencing swelling and redness in bilateral lips, tingling, itchiness. |
| 70 | 2021-03-21 | itchy skin | patient complained of itching on arms and legs 30 minutes post injection |
| 70 | 2021-03-22 | rash with redness, rash macular, rash, injection site warmth, injection site redness, injection site pruritus, injection site swelling |
About 70 hours after vaccination I developed a rash. It was a red blotchy rash that started on my ar...
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About 70 hours after vaccination I developed a rash. It was a red blotchy rash that started on my arms and it was everywhere. It stayed the same about ten days. It faded gradually over that time. It was not itchy or painful. The injection got puffy right around two inches which lasted about a week which started on the third day. It was itchy, red and hot. After the first dose I did not have any of these symptoms.
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| 70 | 2021-03-22 | hives | patient shortly broke out in hives after being administered dose 1 pfizer covid-19 |
| 70 | 2021-03-23 | injection site swelling, injection site reaction, rash macular |
Patient reported and sent picture of a egg shaped red blotch on left arm at injection site. Reports...
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Patient reported and sent picture of a egg shaped red blotch on left arm at injection site. Reports this developed 9 days after injection. She reported icing site. Redness and swelling did decrease after a few days.
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| 70 | 2021-03-23 | redness |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All ...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/24/2021 Date: 3/24/2021 Subjective is a 70 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience a change in her cough and felt nauseated. She felt better shortly after 5 minutes but then her husband noted some redness in skin color in her legs and on her abdomen. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension, rapid progression of symptoms, respiratory distress, skin changes and increased in HR. Upon arrival to bay, HR 180-190. Pt's husband states pt with hx of svt. Usually in high 200's or low 300's if it comes on. Hx of having HR in the 150s at times. Usually resolves on its own with elevation of feet above pt's head per pt's husband. He is not worried about it but wanted to know what her pressures were doing. PT with alz. Pt's husband is main caregiver. ALLERGY REVIEW OF SYSTEMS: Redness went away after sitting down.: CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Neuro negative Previous Reactions: none Objective Vitals Vitals: 03/24/21 1045 03/24/21 1101 03/24/21 1115 BP: (!) 141/86 124/80 124/82 Pulse: (!) 180 (!) 158 (!) 150 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is well-developed. Comments: Flushed appearance upon arrival to bay. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Regular rhythm. Tachycardia present. Heart sounds: Normal heart sounds. Comments: HR came down to 150-160's after Trendelenburg position. Ice pack placed on chest. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert. Mental status is at baseline. She is disoriented. Gait: Gait normal. Comments: Disoriented at baseline per pt's husband. Pt able to tell me who her husband is and their plans for cruise this summer. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Assessment/Plan Treatment included: water and Trendelenburg position Follow up response to treatment: fair. Patient discharge: AMA. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Discussed pt's HR despite of pt being stable here that they ought to seek further medical care in the ED. Pt husband declines as "she's done this before and I'm not worried. We will go to the hospital if she is not getting better. I think when we get home, in her normal environment, she will be fine." He voices appreciation for our evaluation and concerns. She was able to demonstrate assistance to standing position without reports of feeling dizzy or lightheaded. Pt color does look better. Redness is gone and she continues to report to feel well. Pt wheeled out in wheelchair. Husband is aware of our recommendations. APRN Electronically Signed 3/24/2021 10:59 AM Division of Health
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| 70 | 2021-03-23 | skin discolouration |
Severe pain in the upper arm in which she received the vaccine which started 8 days after administra...
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Severe pain in the upper arm in which she received the vaccine which started 8 days after administration. Associated symptoms include numbness and tingling in the right 1st and 2nd digits. fingers also turned white. Color change and pain improved with a medrol dosepak but pain has recurred off steroids.
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| 70 | 2021-03-23 | rash macular |
Swollen upper arm and tender for 2 days after the injection. The ringworm rash seemed to spread lik...
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Swollen upper arm and tender for 2 days after the injection. The ringworm rash seemed to spread like wildfire on the third day and within a couple of days, both my legs were covered with the blotches. I had continued using the tolnaftate but on Saturday the 13th of March I went to get medical advise at the local ER and was told to take Allegra and Clotrimazole-Betamethazone cream. The rash got worse and I called Dr. and he told me to contniue to take the Allegra but stop the cream and start with Lotrimin because the Betamethazone in the cream counteracts the positive effects of the Clotrimazole.
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| 70 | 2021-03-23 | pain of skin |
The vaccine was administered to this patient while in Skilled Nursing Care at this facility for Lumb...
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The vaccine was administered to this patient while in Skilled Nursing Care at this facility for Lumbar Spinal Stenosis. Following the injection the patient has experienced intermittent fever of unknown origin, severe skin pain to extremities, and paralysis to both upper and lower extremities. The symptoms are being investigated and the patient remains hospitalized.
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| 70 | 2021-03-24 | bruising |
Bruising of foot; foot was all messed up/it was all bruised and swollen, but it was not broken. She ...
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Bruising of foot; foot was all messed up/it was all bruised and swollen, but it was not broken. She says this was her right foot; Fatigue; had a low blood sugar episode she supposed; passed out/Unconsciousness; had muscle spasms almost to seizure amount of shaking/full body muscle spasms; had muscle spasms almost to seizure amount of shaking/full body muscle spasms; crashed unconscious to the floor/fell/fell backwards/caught her foot under the vanity; This is a spontaneous report from a contactable consumer (patient) reporting for herself A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 20Feb2021 11:00 (Lot Number: EN6201) as a SINGLE DOSE (at the age of 70 years old) for covid-19 immunisation. Medical history included breast cancer from 1988 to an unknown date , ovarian cancer from 2015 to an unknown date , she has had lymph nodes removed from her right arm "30 years ago" from 1988 to an unknown date, pass out from unknown date to unknown date. Concomitant medication included olaparib (LYNPARZA) taken for ovarian cancer from Feb2020 at 150mg, 2 tablets in the morning and 1-2 tablets at night by mouth.She says she is a little person and couldn't tolerate the side effects of that, so she varies how many she takes based on her side effects. She says she is supposed to take 300mg in the morning and 300mg at night. She says how she takes it is, she takes 150mg or one pill in the morning, then one or two at night depending on how she is doing. Historical vaccine information included BNT162B2 dose 1, lot no: EL9264, route left arm for Covid-19 immunisation. Past drug history included on days of intravenous (IV) chemo when she was being highly treated in the past sometimes she would pass out. The patient reported approximately 15 hours after the shot, on 21Feb2021 she had muscle spasms almost to seizure amount of shaking, full body muscle spasms. She clarifies that her side effects didn't kick in until 02:30AM on 21Feb2021. She says at 07:00AM on 21Feb2021 she got up and went into the bathroom and passed out, and had a low blood sugar episode she supposed. She crashed unconscious to the floor. She said that could be from the shot, but she is also a high risk patient, a cancer patient, and is on a maintenance chemo drug. She says on days of intravenous (IV) chemo when she was being highly treated in the past sometimes she would pass out, so she doesn't know if that was related to the COVID shot or not. No testing had been done on high risk patients, so she thought maybe this could be a good heads up for something someone else may experience. Her side effects were on and off for several hours, the shaking and spasms would subside and then start again. She says that they went away, and then she got up and passed out, and her foot was all messed up, she doesn't know what she did when she fell, but she had it checked and it was not broken, it was all bruised and swollen, but it was not broken. She says this was her right foot. She says she thinks she fell backwards, and she thinks she caught her foot under the vanity. On unknown date, she experienced bruising of foot, fatigue, foot was all messed up/it was all bruised and swollen, but it was not broken. She says this was her right foot. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-03-24 | skin warm |
Extreme fatigue, afternoon of 2/27 -- had to lie down; fatigue for the next two weeks -- often took ...
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Extreme fatigue, afternoon of 2/27 -- had to lie down; fatigue for the next two weeks -- often took an afternoon nap (which otherwise never do). Fatigue is better now. Right breast -- vague discomfort (also reported breast symptoms that started 3 days after first shot, VAERS report #380584). The breast discomfort (slight nipple tenderness; feeling of breast fullness, and sometimes warmth; slight fullness under arm) is off and on and continues even now, 03/24/2021.
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| 70 | 2021-03-24 | redness, rash | Red spots on upper right arm and below right breast. no pain no itch feels rough today |
| 70 | 2021-03-24 | itchy skin |
Right breast: nipple initially intensely itchy for about 12-24 hours; then tender; then breast feeli...
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Right breast: nipple initially intensely itchy for about 12-24 hours; then tender; then breast feeling a little full; didn't feel tender exactly, just different. Bra felt slightly tighter fitting. Seemed to get better, then right breast tenderness again after second COVID shot, also in right arm on 27 Feb 2021, lot # EN 6202. Very mild discomfort diffuse through breast; 25 days after second shot (and after mammogram) nipple tender again, breast mild discomfort, including vague sensation of warmth in breast.
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| 70 | 2021-03-24 | injection site warmth, injection site pain |
She reports she had a COVID-19 vaccine 2 weeks ago in her RUA. She just noticed the area on her arm...
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She reports she had a COVID-19 vaccine 2 weeks ago in her RUA. She just noticed the area on her arm yesterday because it was feeling tender to the touch. There is currently an approximate 2 in x 2 in circular area on her RUA deltoid. It is warm to the touch. It is not painful, other than just tender to the touch. She denies: chest pain, dizziness, headache, hives, any other new symptoms or concerns since the injection
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| 70 | 2021-03-24 | hives, itchy skin |
hives, tingling in lips, no SOB or nausea, had similar reaction with 1st vaccine , improved signific...
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hives, tingling in lips, no SOB or nausea, had similar reaction with 1st vaccine , improved significantly after Benadryl but hives persist although itchiness much better
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| 70 | 2021-03-25 | itchy rash, hives, itchy skin, rash |
70 y/o female of Asian descent developed a mild, pruritic, hive-like rash on her left arm and leg ab...
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70 y/o female of Asian descent developed a mild, pruritic, hive-like rash on her left arm and leg about 2 days (21 Jan 2021) after receipt of her 2nd BioNTech vaccine (injected in her left arm; no other vaccines given on that day). Patient did not self-treat. Rash continued on 26 Jan when patient was evaluated in Medical Center ER – described as "3 small wheals located on left upper and lower extremity with excoriations"; she was treated with Benadryl 25 mg orally and the itching decreased and the rash significantly diminished. No other signs or symptoms concerning for allergic reaction. Patient also reports onset of muscle aches, starting within 48 hours of vaccine receipt; also reports onset of fatigue, headache, and feeling hot. The headache and feeling hot resolved within 72 hours, but fatigue and muscle aches continued. Reports muscles hurt in her arms legs, and chest. Around 22 Jan, patient began having diffuse joint pain in her extremities. The pain became significantly worse on Sun, 24 Jan. Patient self-treated with Ibuprofen with some relief. By 26 Jan, when patient sought evaluation at ER, she described the joint pain as "unbearable" and rated pain intensity as 9/10. In the ER, patient was afebrile and her exam noted: bilateral hand and wrist swelling (left>right), but no redness or warmth at joints; full ROM, but pain increased with movements. Diagnosed as reactive arthritis and prescribed Tiger Balm and Lidocaine patches, with continued Ibuprofen recommended. At follow-up appointment with patient's PCM on 29 Jan, she reported continued muscle and joint pains. She reported some relief with topical analgesics and Ibuprofen, but Ibuprofen upset her stomach, so was changed to Celecoxib 200 mg twice daily as needed. Topicals and Benadryl were renewed. (Benadryl helped rash, but patient ran out and had recurrence of pruritic rash.) Muscle pain continued in her extremities. Reported fair control of muscle pain with topical analgesics and Celecoxib. Reported having "muscle spasms" in her hands. Patient reported increased sensitivity – painful sensation when she touched something cold. Reported using a pot holder to hold a cold can of soda to reduce pain. Joint pain primarily in hands, wrists, shoulders, feet, ankles, and knees. Reported swelling of hands and wrists resolved after about 2 weeks. She also had swelling of her left foot, which resolved. Reported some relief of joint pain with topical analgesics and Celecoxib, but joint pain interfering with sleep. Patient's fatigue continued. Spouse describes as decreased stamina. An example: they used to go out to do errands over a 2-hour period and it would not impact patient's energy level; now, after 2 hours of minimal-to-moderate activity, patient is exhausted. Follow-up with PCM on 8 and 18 Mar 2021 – rash resolved, but generalized muscle aches and joint pains continue. No localized joint swelling. Full ROM. Labs ordered (see below) – patient's Rheumatoid Factor was elevated; she is pending a Rheumatology evaluation (appointment on 17 April). No history of recent trauma or injury. No previous history of similar joint pain. No history of arthritis or Rheumatic disease. Not previously diagnosed with COVID and never tested positive for COVID; was quarantined in 2020 after returning from being on a cruise ship. After 1st COVID vaccine in Dec, she experienced a headache and local redness and tenderness at vaccination site, lasting less than 3 days.
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| 70 | 2021-03-25 | redness | Localized erythema without sorenss, itching or other pain |
| 70 | 2021-03-25 | injection site redness |
Pt received Pfizer COVID vaccine in left arm at 0828 at our high-risk anaphylaxis clinic. After rece...
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Pt received Pfizer COVID vaccine in left arm at 0828 at our high-risk anaphylaxis clinic. After receiving the shot she then proceeded to our monitoring area for 30 minutes. At 0836 pt c/o of mild pain in her left deltoid. RN observed the injection area to be slightly red. Pt no c/o of itchiness or SOB. RN provided the pt with an ice pack. VS 162/110 and pulse ox of 97-99%. At 0855 left arm redness notably decreased. At 0905 pt c/o of feeling SOB. O2 sat of 99% with HR of 114. Pt taken into exam area in back of clinic and put on a stretcher. Now c/o of left shoulder and neck pain. Area tender to touch. Pt placed in 2 liters nasal O2. Rapid response was called at 0915. Team arrived, evaluated pt, and then transported pt to ER for further eval and tx.
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| 70 | 2021-03-26 | shingles, injection site pain |
Very sore at injection site. Diagnosed with shingles on arm, extremely painful arm. As of this date...
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Very sore at injection site. Diagnosed with shingles on arm, extremely painful arm. As of this date, arm still very sore and seems lumpy!
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| 70 | 2021-03-27 | vaccination site pain, injection site pruritus |
Mild coughing about a half hour after vaccination administered Mid-afternoon, achiness and chills Ab...
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Mild coughing about a half hour after vaccination administered Mid-afternoon, achiness and chills About 7 pm, intense itching and tenderness at vaccination site Took aspirin, slept all night, some symptoms in the morning, but they were gone by about 10 am
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| 70 | 2021-03-28 | skin warm |
neck and face, and her face was warm, swollen, she didn't experience any fever spoke to the pharmac...
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neck and face, and her face was warm, swollen, she didn't experience any fever spoke to the pharmacist who expressed they are side effects to the vaccine it could have been an allergic reaction
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| 70 | 2021-03-29 | hives, itchy skin |
I got hives on my neck and on the top of my chest; Itching; This is a spontaneous report from a cont...
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I got hives on my neck and on the top of my chest; Itching; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200, Expiry Date: Jun2021) via unknown route of administration on 13Feb2021 at single dose for COVID-19 immunisation. Medical history and Concomitant medication were not reported. Patient stated, "I recently had my shot (clarified as Covid 19 vaccine Pfizer) yesterday, my first one where I go to the site. On the way home I got hives on my neck and on the top of my chest, that was the only place on 13Feb2021. I had no trouble breathing but I was itching on 13Feb2021. Anyway, my concern now was I was trying to find out if I should even think about getting the second shot of the possible, more severe side effects? Treatment was reported as No. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-03-29 | hives |
does not feel good; hives on her neck that itched; This is a spontaneous report from a contactable c...
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does not feel good; hives on her neck that itched; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 25Feb2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated right after she had the shot she had just a couple hives on her neck that itched but they went right away. She stated she took a Benadryl the night before so she thinks this is why it went away. She did not feel good for probably two weeks. The outcome of the event hives on her neck that itched was recovered and the outcome of the other event was unknown. Follow-up attempts are needed. Information on the lot/batch number has been requested.
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| 70 | 2021-03-30 | redness, itchy skin |
Facial puffiness; Redness; Itching; This is a spontaneous report from a contactable consumer. A 70-y...
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Facial puffiness; Redness; Itching; This is a spontaneous report from a contactable consumer. A 70-years-old female patient received First dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Formulation: solution for injection, Lot number and Expiry date was not reported) via unspecified route of administration on 15Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 22Mar2021, the patient experienced facial puffiness, redness and itching. Symptoms continue today with some improvement. The patient was asking if its possible to develop reaction on week later. The outcome of the events was recovering. No follow-up attempts are possible, information about batch/lot number cannot be obtained.
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| 70 | 2021-03-30 | vaccination site mass, vaccination site swelling, vaccination site pain, vaccination site redness, cellulitis |
cellulitis; her reaction went from the injection site all the way up to the top of her shoulder. It ...
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cellulitis; her reaction went from the injection site all the way up to the top of her shoulder. It was red, the size of a tennis ball and it was swollen; her reaction went from the injection site all the way up to the top of her shoulder. It was red, the size of a tennis ball and it was swollen; her reaction went from the injection site all the way up to the top of her shoulder. It was red, the size of a tennis ball and it was swollen; It does still hurt a little bit; she had noticed a reaction that evening; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206, expiry date not reported), via an unspecified route of administration, administered in the left arm on 10Mar2021 as single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included allergy to bees and spider. There were no concomitant medications. The patient previously took tetanus vaccine in 1974 and experienced pharyngeal swelling. The patient said that she wanted to report that she has had a reaction to the COVID vaccine. She received the COVID vaccine on 10Mar2021, that morning, and she had noticed a reaction that evening around 8:00 PM. It started out about the size of a quarter. She took Benadryl and then she went to bed. When she woke up the next morning, her reaction went from the injection site all the way up to the top of her shoulder. It was red, the size of a tennis ball and it was swollen. It is still a little bit red, but not near like it was. It does still hurt a little bit. She got her daughter to take her to the emergency room and from there she was placed on a medication and she has been on that medication ever since. She has no intention of taking the second COVID vaccine. Clinical outcome of cellulitis and vaccination site reaction was unknown while for the other events was recovering.
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| 70 | 2021-03-30 | hair loss |
losing her hair; This is a spontaneous report from a contactable consumer (patient reported herself)...
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losing her hair; This is a spontaneous report from a contactable consumer (patient reported herself). A 70-year-old female patient received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, NDC number: Unknown, Expiry Date: Unknown) intramuscularly first dose (Batch/lot number: EK5730) on 15Jan2021 09:00 at single dose injected in left arm muscle and second dose (Batch/lot number: EL3249) on 05Feb2021 at single dose for prevention. Vaccination facility type was Hospital, not a military facility. Time the vaccination was given: 09:00 and second dose 09:30-10:00. The patient's medical history included ongoing diabetic diagnosed in 1989 or 1998, ongoing high blood pressure (took medication), inflammation (took a vitamin and pro-biotic every once in a while) and took heart medication because she had a stent. She had some surgeries in Oct2020. Family medical history included parents are deceased. Siblings have high blood pressure and diabetes. Concomitant medications were not reported. Prior vaccinations (within 4 weeks) were none. On 18Jan2021, she experienced losing her hair every day. It was reported that the patient was experiencing hair loss everyday. Caller asked if that was a side effect and what can she do to make it stop. Caller had been "losing her hair" since she received the first dose of the vaccine (on 15Jan2021) and since the second dose as well (on 05Feb2021). She spoke with safety agent (she was not given a reference/reportum). She had an appointment with her HCP next week. Losing her hair every day was reported as worsened. Received call from consumer regarding the Pfizer Covid vaccine. She took both doses of the vaccine. She was a little worried because she was losing her hair every day. She would like to know what she should do. She just had second dose last Friday. She needed to make it stop. There was no prescriber. IT was part of an initiative in her area for her age group. She spoke with a nurse when she got the second dose to let her know about the hair loss and she suggested she speak with her doctor. She took first dose on 15Jan2021, and 3 days later was when she noticed she was combing out excessive amounts of hair. Since then, she can just rub her hand through her hair and it was coming out. She combed out 3 combs full and a brushful since this morning. Second dose was given on 05Feb2021. That lot number was EL3249, and expiration unknown. It was also given in the left arm muscle at same facility. She was a diabetic and she took heart medication because she had a stent and took high blood pressure medication. She took a vitamin and pro-biotic every once in a while for inflammation. She was taking all prior to getting the vaccination. She had some surgeries in Oct2020, but other than that, no other medical conditions. First dose of Pfizer COVID vaccine on 15Jan2021, and 3 days later was when she noticed she was combing out excessive amounts of hair. Additional vaccines administered on same date of the Pfizer suspect reported as none. AE Details and time of onset included losing hair every day - before she went to bed, she saw excessive amount of hair and the next day more and more. Unknown time. She still could not comb her hair without having it come out. No ER or physician's office required. AE following prior vaccinations were none. Outcome of the event was not recovered. No PQC present. No further details provided.
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| 70 | 2021-04-02 | vaccination site pain |
light headache; site pain morning after; This is a spontaneous report from a contactable other healt...
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light headache; site pain morning after; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), at 70 years of age, via an unspecified route of administration on 07Feb2021 03:45 at single dose, in left arm for COVID-19 immunization. The patient medical history included Multiple sclerosis and unknown if ongoing. Patient had an statins allergy. Concomitant medication included gabapentin, Prozac, gemfibrozil, losartan and coq10. On 07Feb2021: 07:00 PM, the patient experienced light headache and site pain. The events were considered as non-serious. No treatment was given for the events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on an unknown date.
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| 70 | 2021-04-06 | vaccination site pain |
Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, h...
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Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, her eyes are weak; Difficulty breathing; thought she was having a heart attack; dehydrated; fast heart beat that felt like her chest was full; fast heart beat that felt like her chest was full; Injection Site Pain; blood pressure fluctuated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 27Feb2021 12:00 (lot number: EN6202; expiration date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure and stroke from 2012 to an unknown date. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN) taken for stroke from 2012 and ongoing; clopidogrel bisulfate (CLOPIDA) and simvastatin both taken for high blood pressure from 2012 and ongoing; ongoing amlodipine, lisinopril, and metoprolol all taken for high blood pressure. On 27Feb2021, she took the first vaccine. From that day, for 2 days, she had injection site pain. On 07Mar2021, she started having tiredness, headaches, chills, fever, felt nauseated, had a fast heart beat that felt like her chest was full and thought she was having a heart attack, dizziness, weakness, felt sick, and difficulty breathing. The patient added that she can't see as good, her eyes are weak. She was going to make an appointment to get her eyes checked. For dizziness event, she has to sit on the side of her bed for 10 minutes and she was still dizzy. She has to hold on to something because she feels like she is going to fall. She was given meclizine three times a day for this event. For tiredness event, she stated that it fluctuates during day. After she takes a paracetamol (EXTRA STRENGTH TYLENOL) and lays down for a while, she feels ok and then she feels tired again. For fast heart beat that felt like her chest was full and thought she was having a heart attack event, it comes and goes, she had it yesterday (21Mar2021) but hasn't had it today (22Mar2021) but she doesn't know if it is gone. Her symptoms were usually in the morning when she first gets up. She has been to the emergency room (ER) on 07Mar2021 and on 13Mar2021 and they say that nothing is wrong. On 07Mar2021, they gave her an IV because they thought she was dehydrated. On 13Mar2021, she went back to another hospital ER. She felt worse and her son came and got her and took her to the ER. They did a whole workup MRI of her head, x rays, blood work and everything. They didn't know what was causing it because it had it been over a week since her vaccine and they sent her home. She has been laying down and staying hydrated. She couldn't hardly get up and they asked her what has she done different and the only thing different was the vaccine. Everything listed on the risk factors [side effects] is how she is feeling. She was not hospitalized, they gave her medicine and told her to stay hydrated and sent her home and was told to follow up with her physician. She finally got an appointment for tomorrow (23Mar2021) with her physician. She can't drive because of the dizziness. All of her tests came back normal. They said her blood pressure fluctuated on 2021 but that is normal. Outcome of the injection site pain was recovered on 01Mar2021, of the difficulty breathing was recovering, of the headache, chills, fever, dizziness, weakness, and felt sick was not recovered, while of the remaining events was unknown.
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| 70 | 2021-04-15 | shingles |
I came down with shingles, right side fr. It is ongoing and may not be related to the Covid-19 vacc...
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I came down with shingles, right side fr. It is ongoing and may not be related to the Covid-19 vaccine I received, however I report it for your information. I was vaccinated with Zostavax on 11/02/2012.
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| 70 | 2021-04-16 | itchy skin |
swollen upper and lower lips; horrendous itching; I broke out in large hives, (palm sized); had swol...
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swollen upper and lower lips; horrendous itching; I broke out in large hives, (palm sized); had swollen earlobes; swollen palm on my right hand; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 18Feb2021, 12:00 pm at a single dose for covid-19 immunisation (age at vaccination was 70 years). The patient was not pregnant. Medical history included colon polyps and diverticulosis. Allergies to medications, food, or other products included premarin, ambien and many seasonal allergies. Co-suspect medication included amoxicillin sodium, clavulanate potassium (AUGMENTIN) for diverticulitis. Concomitant medication patient received within 2 weeks of vaccination included acebutolol hydrochloride (SECTRAL), allopurinol, rosuvastatin calcium (CRESTOR) and amitriptyline. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 28Jan2021, 13:00 pm at a single dose for covid-19 immunisation (age at vaccination was 70 years). No other vaccine was received within 4 weeks prior to the COVID vaccine. On 18 Mar2021, 4 weeks after second vaccine, the patient took Augmentin for recurring diverticulitis. For the last few years, the patient has taken the Augmentin once or twice a year to treat the problem (alternative to the flagyl/cipro regimine) and she have never had any problems. This time, on the 3rd day of the Augmentin, the patient broke out in large hives, (palm sized) and had swollen earlobes and a swollen palm on her right hand. The next day on 19Mar2021 she had swollen upper and lower lips. The patient took lots of Benadryl and Zyrtec, and by the 5th day her hives and horrendous itching went away. The patient does not know if the vaccine played any role in this at all. She just thought she should report since prior to the vaccine she never had a problem with Augmentin. The patient had absolutely no reaction at all to the Pfizer Covid vaccine itself after either of the doses. No covid prior vaccination and no covid tested post vaccination was reported. The outcome of all the events was recovered on an unknown date in Mar2021. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-04-17 | redness |
Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both...
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Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both upper and lower parts collapsed); Lower chest partial atelectasis or scarring in the lung bases bilateral; Beneath this area was a red circle where blood clotted or something; Wheezing; Shortness of breath; Swelling of the face; underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red; underneath the arm where the injection site was, a big red circle was noted and it was swollen; I would get hot and cold; I was sweating; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Fatigue; Pain in left elbow; goes to bathroom and bowel was not emptying the way it should; rib cage is going on the side of body noticed this thumping; Her lips were red; Throat was red; Been sick and just laying around; Her eyes were red; Cramp in left arm where site of injection; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; This is a spontaneous report received from contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 15Mar2021 (at the age of 70 years) at a single dose in the left arm for COVID-19 immunization. Medical history included lung issues and allergic asthma. Family history included brothers and sisters who died of lung issues and third sibling sister died many years ago due to allergic asthma. The patient previously took flu vaccine for immunization and experienced severe pain throughout her whole body. On 15Mar2021, patient received the first dose of Pfizer COVID-19 vaccine. Later on, that day when she got home after receiving the vaccine, underneath the arm where the injection site was, a big red circle was noted and it was swollen, beneath this area was a red circle where blood clotted or something, she would get hot and cold and take her clothes off because she was sweating but did not have fever, there was pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow. She goes to bathroom and bowel was not emptying the way it should. She also noted that her rib cage is going on the side of body noticed this thumping, lips and throat were red. She's been sick and just laying around, her eyes, under her nose and left elbow were red, had cramp in left arm where site of injection, and sharp pains were hitting her in her eye, thigh, chest, head, and the arm. Patient clarified that these symptoms began on 15Mar2021, the same day she received the Pfizer COVID-19 vaccine. On 23Mar2021, patient went to the ER and the findings were lower chest partial atelectasis or scarring in the lung bases bilateral and partial lung collapse (both upper and lower parts collapsed). At the hospital her temperature was 98.9 F on 23Mar2021, but 97.1F - 97.7F is her normal temperature. She went to the Pulmonary doctor also, but was getting a second opinion because she knew it could be life threatening. The pulmonary doctor made light of it saying they were just creases, like creases in pants. Patient said crease was a far cry from partial lung collapse on both bases and the Pulmonary doctor also said that it is in the upper part of the lung also. This scared her and made her think nobody cared. She did not know if she should provide the information because the doctor did not seem to believe that that her symptoms were coming from receiving the Pfizer COVID-19 vaccine. She guessed she should provide the information because Pfizer does research. She wanted to know how long do the side effects last and if she should take the second dose. The outcome of the events underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red, pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow, goes to bathroom and bowel was not emptying the way it should, rib cage is going on the side of body noticed this thumping, lips were red, throat was red, been sick and just laying around, eyes were red was not recovered; while unknown for the other events. Information on the lot/batch number has been requested.
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| 70 | 2021-04-17 | rash |
she ended up in the hospital her blood pressure was way up, it was at 188; pain in chest; feeling si...
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she ended up in the hospital her blood pressure was way up, it was at 188; pain in chest; feeling sick and stuff; on her right arm she has a hidden rash between her hand and her elbow; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EP6955), via an unspecified route of administration, administered in the left arm on 22Mar2021 at 16:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EN6198) on 25Feb2021 at 15:00 on the left arm for COVID-19 immunization and reported that her blood pressure went sky high and it continued to be high and her heart rate was up and caused her to go to urgent care. The patient also previously received a flu vaccine on an unspecified date and her arm was sore for 3 weeks and she felt like she had the flu for 3 days. The patient reported that after she got her second vaccine she had the normal, what people call normal reaction, of feeling sick and stuff on 27Mar2021 then she ended up in the hospital her blood pressure was way up, it was at 188 and she forgets what the bottom number was. She went in because she felt like she was having a heart attack there was a pain in chest like right where the middle of a bra would be. It lasted about 15 or 20 minutes. That is her experience with the vaccine, it is raised blood pressure and she is still dealing with it her blood pressure is still high. She tries not to be scared but the doctors at the hospital made her a little nervous that is why she spent the night but that is a definite side effect. The patient was admitted to the hospital on 27Mar2021 and was discharged on 28Mar2021. They wanted to keep her for 2 nights and do a stress test and she said no way she is not staying for 3 nights in that hospital, the nurses were outstanding they were the most efficient nurses but the hospital food sucked and she got no sleep. Also, on her right arm she has a hidden rash between her hand and her elbow under the skin there is a rash that popped up with the vaccine on an unspecified date in Mar2021. The patient also stated that her blood type is O negative and she does not know she heard that O neg people weren't going to get COVID and she has never got COVID before. The patient also reported that they drew blood 6 times in the hospital to see if she had a heart attack and everything came back negative. it just so happens she had a echocardiogram the day after the first dose was given and her blood pressure was elevated that day but everything was fine. She says it is not relevant but she tested for that out of precaution, her doctor asked her to do that every 2 years and just so happened to fall on the day after the first dose. The patient received treatment for the events she ended up in the hospital her blood pressure was way up, it was at 188, felt like she was having a heart attack and pain in chest. The outcome of the event she ended up in the hospital her blood pressure was way up, it was at 188 was not recovered while the outcome of the other events was unknown.
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| 70 | 2021-04-18 | injection site pain |
On the morning of Friday 4/16/21, patient came to vaccine clinic to let us know that his wife passed...
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On the morning of Friday 4/16/21, patient came to vaccine clinic to let us know that his wife passed away the night of her second dose of her Pfizer covid vaccine. He states that she complained of arm pain at the injection site that evening (4/14/21) and went to bed around 9:30pm because the pain was excruciating. He said around 2:00am, she woke up stating she couldn't breathe. This has happened before, so she went and sat up in the living room which helped her last time. For whatever reason, she then went into her bedroom where he said she fell out. He noticed foam coming from her mouth and called 911. EMS was unable to revive her. She passed away at home.
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| 70 | 2021-04-24 | rash |
My entire body experienced extremely severe body pain; I couldn't walk; rash; Very weak and tired; V...
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My entire body experienced extremely severe body pain; I couldn't walk; rash; Very weak and tired; Very weak and tired; This is a spontaneous report from a contactable consumer (reporting for herself). This 70-year-old female patient received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318) via an unspecified route of administration on left arm at a single dose on 04Feb2021 09:45 AM, for Covid-19 immunization. She Received second dose BNT162B2 (Pfizer Covid 19 vaccination, lot number EN6200) via an unspecified route of administration, on left arm at an single dose on 25Mar2021 for Covid-19 immunization. She was not pregnant at the time of vaccination. She had not received any other vaccine in four weeks. Medical history included type II diabetes, high blood pressure and pneumoconiosis. She was allergic to Chlorol Hydrate and Thimerasol. Concomitant medications included Metformin, Losartan HCTZ, Amlodipine, Zyrtec. On 09Mar2021 07:00 AM, the patient experienced a rash above her right knee, up my thigh, and knee pit, felt very weak and tired, her entire body experienced extremely severe body pain from upper neck down to feet. It got so bad that she could not walk, only took baby steps. It was stated that she would cry with hand on the wall with each baby step. On 12Mar2021, the patient went to the hospital emergency room and the patient was tested for Covid-19, blood test came out to be negative, results of SARS CoV-2, diagnostic radiologic EC EKG were unknown. She was treated with intravenous and pain medication. The outcome of the events of rash, felt very weak and tired, extremely severe body pain and could not walk was recovering. No follow-up attempts are needed. No further information is expected.
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| 70 | 2021-04-27 | vaccination site itchiness, vaccination site redness, rash |
feel strange; rash; throat is not closing; and it was itchy on her arm at the injection site; hard a...
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feel strange; rash; throat is not closing; and it was itchy on her arm at the injection site; hard and hot beside the site of injection; woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site; General malaise; Nausea; Headache; This is a spontaneous report from a contactable consumer (Patient). This 70-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZERBIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262; Expiry date: unknown) via intramuscular route, administered in right arm as a single dose (at the age of 70-year-old) for COVID-19 immunization. The patients past medical history included Cesarean section (Had 3 of them. Caller said that did well with anesthesia and had no reactions), cataract removal (First was on 24Nov2020 and the second 01Dec2020. Caller said that did well with anesthesia and had no reactions), Hysterectomy (Caller said that did well with anesthesia and had no reactions), Foot surgery (Caller said that did well with anesthesia and had no reactions), cataract removal on 01Dec2020. The patient was allergic to Penicillin and tetracycline. The patient allergic to Keflex and had a rash. Tetracycline she had in her 30's got a shooting pain in her left arm and got another shooting pain in her left arm when she took tetracycline again. She had no other allergies aside from ragweed. She said that she had the Penicillin when she was a kid and Keflex as a young adult. Caller does not have the NDC, Lot, or expiration dates for the Penicillin, tetracycline, or Keflex. Lot: SBF021, exp:Aug2021. The only other time that this happened was 2 years ago when she got her flu shot and the year before that. The first year it was mild reaction and 2 years ago it was the size of a golf ball. This year she had nothing from the flu shot. She took Benadryl last night and was surprised when she saw that this morning. It usually wards off any allergy attack. She did not take a whole one and stated that it knocks her out so she only took a half. The patient said that she took a Advil every 4-6 hours and attributed the well being to that. The patients concomitant medications was not reported. The patient was calling about the COVID-19 Vaccine and said that she received the first shot on 20Jan2021. She said that everything had been fine until this morning and it had been 2 weeks. She had no sore arm. On 20Jan2021, patient experienced a headache for a minute for like 2 days. On 21Jan2021, she had nausea lasted a few minutes then it was gone. Caller said that her headache and nausea symptoms were so fleeting that she did not even report it. She said that it was so mild that it was almost insignificant it was so mild. She said that she did report it at the safety reporting system and at the (Website name) for the vaccination check in. One day on an unspecified date, she did feel strange and on 22Jan2021 she had general malaise, she just felt something was wrong and it lasted about 30 minutes. She said that it was a general feeling that she was not well. She said she took a Advil and ignored it. The patient clarified that last night she started scratching underneath her ear, thought she was going to have a break out, but on 04Feb2021, she woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site. She said that it is no where else, no else on her body. On an unknown date, she felt fine and her throat was not closing and she was not having any trouble breathing or anything. She stated that the spot under her ear was gone. She put Neosporin on it. It was gone this morning. She said that this place on her arm was more of a hard place and a rash now on an unspecified date. She knows the body remembers and years down the road you could get a pain from a injury or surgery. Last night she felt a sharp pain in her right arm. She ignored it and this morning she woke up with this. It is not as hot or red, but it is still raised. The clinical outcome for the events headache recovered on 21Jan2021, nausea recovered on 22Jan2021, general malaise was recovered on 23Jan2021. The outcome for woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site was recovering. The clinical outcome for the other events was unknown.
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| 70 | 2021-04-30 | rash with redness, itchy rash, rash papular, rash |
1st dose developed a red, raised, itchy rash on RUQ of abdomen/ after 2nd dose aggravates; 1st dose ...
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1st dose developed a red, raised, itchy rash on RUQ of abdomen/ after 2nd dose aggravates; 1st dose developed a red, raised, itchy rash on RUQ of abdomen/ after 2nd dose aggravates; 1st dose developed a red, raised, itchy rash on RUQ of abdomen/ after 2nd dose aggravates; 1st dose developed a red, raised, itchy rash on RUQ of abdomen/ after 2nd dose aggravates; This is a spontaneous report from a contactable other health care professional (Nurse- patient herself), report received from a Pfizer-sponsored program. A 71-year-old female (non-pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3249, Expiration date and NDC number: Unknown), via an unspecified route of administration in left arm on 29Jan2021 at 11:15 (at the age 70-year-old) for COVID-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6202, Expiration date and NDC number: Unknown), via an unspecified route of administration in left arm on 26Feb2021 at 11:15 (at the age 71-year-old) for COVID-19 immunisation. Medical history included diabetes possibly diagnosed in 1998 and ongoing, obesity from an unspecified date and ongoing, anemia diagnosed about probably in the past 5-6 years and ongoing, allergies diagnosed around 2000 and ongoing, sleep apnea diagnosed around 2000 and ongoing, and reaction to the small pox vaccine when patient was a small child. The patient had anaphylaxis to cephalosporin, Keflex and rocuronium and allergic to food. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Feb2021 20:00, the patient developed a red, raised, itchy rash on RUQ of abdomen. By time of 2nd dose of vaccine, rash was still present but seemed to be fading. Approximately 4-5 days after the 2nd dose a red, raised, itchy rash developed on chest, upper abdomen, across lower back, up the middle of back and on buttocks and upper outer thighs. The patient reported that no investigations were done. The treatment received for the events were Benadryl, Zyrtec, and OTC cortisone creams and over the next 30 days rash did not improve, and medical treatment was sought. The patient tried triamcinolone (KENALOG) cream, pepcid twice a day, for two weeks and the rash was still spreading down her abdomen and up her back, so patient started on prednisone, 20 mg for 7 days and 10 mg 7 days, along with pepcid, zyrtec and benadryl, rash is still profuse. The patient was also treated with xzyal. The event was reported as serious (medically significant). Outcome of the events was reported as not recovered; Sender's Comments: Based on temporal relation, the association between BNT162B2 and the events, erythematous, papular, pruritic rash cannot be excluded.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
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| 70 | 2021-05-13 | shingles |
lost hearing in her right ear; mouth sores diagnosed as oral shingles; This is a spontaneous report ...
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lost hearing in her right ear; mouth sores diagnosed as oral shingles; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Feb2021 (Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Medical history included surgery from 22Sep2020 (had lab work on Sep2020 because of surgery) and blood pressure. The patient had shingle's vaccine. Concomitant medication(s) included irbesartan (IRBESARTAN) taken for blood pressure, start and stop date were not reported. Five days after the first vaccine the patient got severe sores in her mouth and then she went to the doctor, they call it she could possibly have shingles or shingles in her mouth it appeared to be canker sore (later reported mouth sores diagnosed as oral shingles). Then five days later she woke up in the night and could not hear. She lost hearing in her right ear. Actually loss of hearing 2 days before the got her second vaccine and she talked to her doctor and doctor thought the patient still went ahead and had the second vaccine but she didn't want to put the patient on the Prednisone because that will weaken her immunity but then it didn't get better and she sent the patient to Ear, Nose and throat he told the patient if she has any hope to getting her hearing back she had to start this medicine but that's what the patient was concerned about. The patient took Prednisone on 12Mar2021 for the ear treatment. For the first 2 week she was taking 60 mg and then after 3 weeks, she took 2 tablets 40 mg and then the next week she took 10 mg for 2 days. The outcome of event mouth sores diagnosed as oral shingles was recovering, others was unknown.
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| 71 | 2021-01-07 | injection site tingling |
TINGLING TO LEFT DELTOID Narrative: C/O TINGLING TO LEFT DELTOID AFTER ADMINISTRATION OF VACCINE - N...
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TINGLING TO LEFT DELTOID Narrative: C/O TINGLING TO LEFT DELTOID AFTER ADMINISTRATION OF VACCINE - NOTIFIED OCCUPATIONAL HEALTH PROVIDER DENIES, PA PT DECLINED ASSESSEMENT BY ER.
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| 71 | 2021-01-07 | hives, itchy skin, rash |
hives; face swelling; itching; rash; This is a spontaneous report from a contactable nurse (patient)...
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hives; face swelling; itching; rash; This is a spontaneous report from a contactable nurse (patient). A 71-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), intramuscular in left arm on 22Dec2020 11:08 at single dose for COVID-19 vaccination. Medical history included ongoing blood pressure high, ongoing cholesterol, ongoing depression. Concomitant medication included atenolol (tablet, strength 50 mg) from an unknown date and ongoing for blood pressure high, simvastatin (tablet, strength 20 mg) from an unknown date and ongoing for cholesterol, paroxetine hydrochloride (PAXIL, tablet, strength 40 mg) from an unknown date and ongoing for depression. The patient experienced hives, face swelling, itching and rash on 27Dec2020. No additional vaccines administered on same date of the Pfizer suspect. Prior vaccination within 4 weeks was none. She got the first Covid 19 dose on 22Dec2020 and was fine, then on 27Dec2020 she had hives, itching, and face swelling for several days. Caller stated her lungs were clear and she was okay other than the extreme itching. The face swelling was what worried her. The hives and itching went away within about 36 hours. The face swelling kind of got worse for a couple of days before it went away. Caller verifies she recovered from the hives/rash/itching within 36 hours. She got a steroid shot and things like that and it went away pretty quickly. The face swelling was completely gone but did last for a good 5 days. She didn't know if this reaction was related to the vaccine. She wanted to call and let Pfizer know and see if there was any reports of anything else like that or similar to that type of reaction. She was not sure if that really matters or not except she was not sure about taking the booster. She was kind of leaning towards taking the second vaccine. She didn't have any breathing issues. She asked as far as the second dose after those side affects, was it recommended? Her doctor said she could get the second one and prescribed her an Epi pen and would give a dose of Benadryl at the time of the second vaccine. She may take some Benadryl before getting the second vaccine and have her EpiPen with her just in case. She hadn't seen her doctor about this experience with the COVID-19 vaccine. She only went to an urgent care. The caller stated she went to urgent care twice. She received a steroid shot but doesn't have any name, NDC/UPC, Lot number or expiration date for any of the medication she received. She probably threw that paperwork out. She knew she wasn't given anything the second time she went to the urgent care. The second time she went back was because the face swelling was getting worse. She was prescribed an EpiPen and was told to take Zyrtec which did help. Everything had gone away. She would consider these events to be medically significant because of the face swelling, it kind of scared her. She made the comment she was taking high blood pressure medicine and cholesterol medicine, but other than that she was very healthy. She was not really an allergic person. She had not had any testing done since she received the vaccine. She did have bloodwork done prior but not since the vaccine. The patient underwent lab tests and procedures which included blood work prior vaccine with unknown result. The outcome of hives, rash and itching was recovered on an unspecified date of Dec2020 (within about 36 hours); face swelling was recovered on 01Jan2021.; Sender's Comments: Based on the time gap between the vaccine and the events there is not a reasonable possibility that the reported events were related to the suspect product, events are most likely due to patient underlying contributory factors The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
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| 71 | 2021-01-09 | itchy rash, rash vesicular |
Three itchy vesicular lesions on upper left three days after vaccine lasting three days thus far. H...
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Three itchy vesicular lesions on upper left three days after vaccine lasting three days thus far. Headache first twenty four hours. Tylenol, Neosporin ointment, Cortisone cream, Anti-itch cream
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| 71 | 2021-01-14 | cellulitis | mild superficial cellulitis left upper arm. Ordered Keflex, TMC ointment 0.1% and cool compresses |
| 71 | 2021-01-16 | injection site redness | Ci urlar redness at the site if injection,not warmth tontouch |
| 71 | 2021-01-16 | injection site redness, injection site pain |
injection site redness and soreness, severe migraine headache, severe myalgia (even the tendons in m...
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injection site redness and soreness, severe migraine headache, severe myalgia (even the tendons in my hands and feet hurt), arthralgia, chills, rigors, swollen lymph nodes lasted two and a half days, mostly spent in bed
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| 71 | 2021-01-18 | injection site rash, rash, injection site redness, injection site pain |
Left upper arm pain and redness Rash left upper arm to left mid forearm Swelling and tenderness lef...
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Left upper arm pain and redness Rash left upper arm to left mid forearm Swelling and tenderness left axilla Swelling and tenderness left breast
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| 71 | 2021-01-20 | injection site bruising, injection site pruritus, injection site redness, injection site swelling |
1 Day after injection (January 13) - bruising (no pain). Bruising has not gone away 8 Days after in...
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1 Day after injection (January 13) - bruising (no pain). Bruising has not gone away 8 Days after injection (January 20) - circle of redness, swelling and some itching below bruise. No or little pain. No lack of mobility in arm.
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| 71 | 2021-01-20 | injection site swelling, injection site swelling, injection site pain | 1/20/21 HA, fever, chills, fatigue, pain and swelling at site, nausea and diarrhea |
| 71 | 2021-01-20 | rash | COMPLAINT OF A LOCALIZED RASH TO LEFT LEG STARTED 1/21/2021 |
| 71 | 2021-01-20 | rash | LOCALIZED RASH NOTED ON LEFT LEG ON 1/21/2021 RECEIVED VACCINE ON 1/14/2021 |
| 71 | 2021-01-20 | hives | Tightness in chest , Hives, weakness, required visit to E.R. Given IV Benadryl Pepcid, prednisone |
| 71 | 2021-01-24 | rash macular |
Chills, aches, high blood pressure, heart racing, tired, flu sick feel, asthma Jan 14th, 2nd day: fa...
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Chills, aches, high blood pressure, heart racing, tired, flu sick feel, asthma Jan 14th, 2nd day: face swollen, blotchy, numb eyes swollen, sore sockets, upper lip puffed out, burning face feel, asthma
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| 71 | 2021-01-24 | injection site pain |
Extremely unusual pain at injection site, (compared to any other past injections) generally achey, ...
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Extremely unusual pain at injection site, (compared to any other past injections) generally achey, headache, occasional waves of nausea, fever 100.4, fatigue (stayed in bed most of the day). There was one occasion where my left hand had a strange involuntary "twitch". I only mention that because on Saturday (1/23/21) i had a few episodes of speech difficulty (words "not coming out right")
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| 71 | 2021-01-24 | hives, redness |
Triggered severe urticaria which had been controlled. Palm and inside of fingers turned bright red...
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Triggered severe urticaria which had been controlled. Palm and inside of fingers turned bright red.
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| 71 | 2021-01-25 | skin warm |
1:45 warmth of entire left arm and felt anxious, felt elevated heart rate and shakey b\p 190/90 hea...
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1:45 warmth of entire left arm and felt anxious, felt elevated heart rate and shakey b\p 190/90 heart rate 90 2pm 176/72 heart rate 90 sat up 160/90 gave OJ to drink released 2:30 178/88 heart rate 80 Instructed to seek medical attention if further problems. Was walked to car
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| 71 | 2021-01-25 | itchy skin |
Pt. reports 20 minutes post vaccine itching of (R) and (L) lower extremities. No other symptoms EMS ...
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Pt. reports 20 minutes post vaccine itching of (R) and (L) lower extremities. No other symptoms EMS notified of reaction. and pt. was to go to local hospital ER for evaluation.
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| 71 | 2021-01-25 | injection site pain | Sore at injection site, body aches after getting vaccine |
| 71 | 2021-01-25 | injection site pruritus, injection site hives, injection site rash |
Within 15-minutes of vaccination, the patient reported a rash, hives, and pruritus at the injection ...
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Within 15-minutes of vaccination, the patient reported a rash, hives, and pruritus at the injection site. Managed on-site.
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| 71 | 2021-01-25 | vaccination site pain |
persistent headache; even touching her head hurts/hurts to the touch; with this shot her arm really ...
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persistent headache; even touching her head hurts/hurts to the touch; with this shot her arm really hurt when getting it/pain in the arm the shot was given/uncomfortable pain/in their arm after receiving the injection; insist on giving the next dose in 4 weeks; insist on giving the next dose in 4 weeks; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1283) via an unspecified route of administration in the left upper arm on 06Jan2021 09:40 at a single dose as COVID vaccine. The patient had no medical history. Concomitant medications noted as on other medications but nothing new. She previously got the shingle shot for immunization then her arm hurt a few days. She had no other reaction to vaccines in the past. She received no vaccine on the day of or in the prior 4 weeks. Last Wednesday on 06Jan2021, the patient took the vaccine and has had a headache since; even touching her head hurts. She had a persistent headache that started the day after the vaccine and has continued since. The next day on 07Jan2021 was when the headache started. She took regular Motrin (lot OFE3249A, expiry: May2022) and Tylenol extra strength (lot: LMA051, expiry: Jul2019, perhaps not working anymore) sometimes but they didn't really seem to help. She felt the best when she was standing up or laying down, and she would rather be laying down. She asked "Is this a normal side effect, am I dying? I am not a headache kind of person, I take a Motrin, it goes away and I do not have one for months. It actually hurts to the touch." Should she be worried? She did call the clinic about the headache and was told if it got serious to go to the emergency room, she didn't think it was that serious. It was just persistent. She could leave with the pain if it kept her from getting COVID but the fact it was persistent worried her. It was also reported that on 06Jan2021 with this shot her arm really hurt when getting it and that day but that was all (pain in the arm the shot was given), the next night there was no pain. Her and her husband both oooo'd and ahhhh'd with the pain in the arm but that was it (a very uncomfortable pain they experienced in their arm after receiving the injection). She asked how long a side effect lasts after the vaccine? She also stated that on Jan2021, they insist on giving the next dose in 4 weeks. Asked if the vaccine was given a week later would the efficacy be lower? The outcome of persistent headache was not recovered; of vaccination site pain was recovered on 07Jan2021; and of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021036651 same reporter and drug, different patient and AE
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| 71 | 2021-01-26 | injection site tingling |
Periodic Tingling sensation like electric impulses shooting from injection area in a line up arm, ac...
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Periodic Tingling sensation like electric impulses shooting from injection area in a line up arm, across shoulder and up neck about ear level; Low back/ hip pain I haven?t had before, especially at night turning over in bed. Self-massage, change position
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| 71 | 2021-01-27 | vaccination site pain |
Flu like symptoms; feeling achy; Left arm sore after second dose injection administered initially de...
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Flu like symptoms; feeling achy; Left arm sore after second dose injection administered initially described as at the injection site; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second single dose of BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, lot number: EK9231, exp date: Apr2021), via an unspecified route of administration (Injection to left upper arm ) on 13Jan2021 09:00 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first single dose of BNT162B2 (lot number: EK5730) on 23Dec2020 for COVID-19 immunization wherein she reported left arm sore after first dose injection administered which she recovered completely from after about 4 days (from 23Dec2020 to 27Dec2020). The patient called to ask if it was ok to take something like Ibuprofen or paracetamol (TYLENOL) after having been administered Pfizer COVID-19 Vaccine. She reported left arm sore after second dose injection administered on 13Jan2021 and flu like symptoms on an unspecified date. The left arm sore after first dose injection administered was same reaction she had following the second dose: Left arm sore after second dose injection administered initially described as at the injection site; very sore; her arm being much better since she slept all last night with ice pack on her left arm; but then specified that outcome of that event and flu like symptoms have remained persistent with on and off pattern; The flu like symptoms include feeling achy which started on 14Jan2021 (day of reporting). The outcome of events was not recovered.
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| 71 | 2021-01-27 | itchy skin, hives |
Resident began with all over itching, progressing into hives, that then ended with facial swelling. ...
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Resident began with all over itching, progressing into hives, that then ended with facial swelling. She required an initial dose of Prednisone, then began a Medrol dose pack, with PRN Benadryl ordered. She proceeded to experience episodic hives over her arms and torso for almost a week.
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| 71 | 2021-01-27 | injection site pain |
tenderness on the left arm where she received the vaccine dose.; severe pain in right shoulder joint...
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tenderness on the left arm where she received the vaccine dose.; severe pain in right shoulder joint and right hip joint/It was so severe she could hardly get out of bed; Headache; This is a spontaneous report from a contactable nurse (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686, expiration date unspecified), via an unspecified route of administration on 31Dec2020 11:00 at single dose (left arm) for COVID-19 immunization. Medical history included arm soreness from flu shot 2-3 months ago. There were no concomitant medications. It was reported that she received her 1st dose of the vaccine on her left arm on 31Dec2020 as she works with elderly at nursing home and she was of age. Two days after her shot, on 02Jan2021, she experienced little headache which lasted all day but was gone by the following day. On 12Jan2021, 2 days ago, when she woke up and got of bed with severe pain in right shoulder joint and right hip joint which lasted for maybe 10 minutes. It was so severe she could hardly get out of bed. Currently, she had no joint pain. The right shoulder and right hip pain were so odd she thought, but it has also improved since. It's been 2 weeks and she never had this happen before. This lasted a little while, but thought it was from the cold weather since it's been 2 weeks since having the vaccine. She still has a bit of tenderness on the left arm where she received the vaccine dose on an unspecified date. She mentioned this to her supervisor and was encouraged to call and she wants to know if this could be a side effect. The patient had no vaccines the same day or 4 weeks prior. She had the flu shot before in past and the area would be sore for a few days, but now with this Covid vaccine this arm was still tender. Also, she had gotten the shingles shot the same day as the flu shot but that was about 2-3 months ago, at least 2 months ago. The patient had no additional vaccines administered on same date of the Covid vaccine. The patient had no prior vaccinations within 4 weeks prior to the first administration. Outcome of event headache was recovered on 03Jan2021; severe pain in right shoulder joint and right hip joint/it was so severe she could hardly get out of bed was recovered in Jan2021; and outcome of tenderness on the left arm where she received the vaccine dose was not recovered.
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| 71 | 2021-01-28 | vaccination site pain |
Intestinal cramps; urgency to go to the bathroom/the urgency is almost like diarrhea; nausea; sore a...
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Intestinal cramps; urgency to go to the bathroom/the urgency is almost like diarrhea; nausea; sore arm; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored Program. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231, expiration date 30Apr2021) on her left deltoid, intramuscular on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that she is having intestinal cramps since last night. The patient also said that she is also experiencing nausea, urgency to go to the bathroom (the urgency is most likely diarrhea), and she has a sore arm; all on 14Jan2021. The outcome of the events was not recovered.
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| 71 | 2021-01-28 | itchy skin |
developed a cluster type headache that lasted all night/severe cluster headache; developed pinpoint ...
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developed a cluster type headache that lasted all night/severe cluster headache; developed pinpoint itching all over her body/mild itching today 'like when a nerve lights up'; she felt her left outer ear was burning until around 22:00 at night; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EL0142 and expiry date:Mar2021) , via an unspecified route of administration on 13Jan2021 16:15 at a single dose in left arm for covid-19 immunization. There were no medical history and concomitant medications reported. She states that she had the first dose of the vaccine on Wed 13Jan2021 at 16:15 together with her husband, right after receiving the dose on left arm she felt her left outer ear was burning until around 22:00 at night and was milder the next day. She states that last night 14Jan2021 around 20:00, she developed a cluster type headache that lasted all night, she took ibuprofen (ADVIL) and around 22:00 the same night she developed pinpoint itching all over her body. She reported she still has some mild itching today 'like when a nerve lights up' and still has a 'little bit of a headache.' She wants to know if these were common side effects. The outcome of the event burning sensation recovered on 14Jan2021, while cluster headache and itching were recovering.
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| 71 | 2021-01-28 | rash | severe headache, rash on arms, face,neckline, throat, and hands |
| 71 | 2021-01-29 | redness |
Pt received Covid-19 vaccine at 4:50 pm. patient's daughter, informed observer that her mother has...
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Pt received Covid-19 vaccine at 4:50 pm. patient's daughter, informed observer that her mother has complaints of her face feeling warm and itchy and a scratchy throat. Assessment completed by Dr., daughter to translate due to patient speaking limited English . 50 mg of Benadryl administered orally at 5:05pm. Reassessment completed at , 5:18 PM, face appears to be more reddened and facial swelling noted. Daughter also stated that her mother's voice is becoming hoarse. 125 mg of solumedrol given IM by, RN. at 5:20pm. Patient reassessed at 5:40PM, facial swelling and redness improving. Daughter states that mother 's voice is returning back to normal. and stated that the patient has informed her that she is feeling better. Patient discharged by Dr. at 5:43 PM at daughters request, stating that she will be monitoring her all night and will take her to the ER if symptoms return or worsen.
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| 71 | 2021-01-30 | injection site pain, itchy skin, rash with redness |
Initial soreness following the injection resolved within 24 hours, but 9 days after receiving inject...
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Initial soreness following the injection resolved within 24 hours, but 9 days after receiving injection, I noticed a red, slightly raised area around and mostly below the injection site, along with a small red dot which I assume was the actual site. I have not yet recovered because I just noticed it earlier today. For a couple of days prior, I had some mild itching which may have been due to contact dermatitis.
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| 71 | 2021-01-30 | injection site redness, redness |
had mild redness at injection site initially, day 8 post vaccine, woke up with left arm throbbing pa...
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had mild redness at injection site initially, day 8 post vaccine, woke up with left arm throbbing pain, erythema, difficulty lifting arm secondary to pain. treated with supportive therapy: warm compresses, NSAIDS and is slowly improving. no fever or secondary bacterial infection suspected. no other flu like symptoms.
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| 71 | 2021-01-31 | injection site pruritus, injection site pain | My left arm at the injection site is extremely itchy and my arm hurts and does not feel right. |
| 71 | 2021-01-31 | injection site redness, rash macular, injection site rash, injection site swelling |
Site of injection and arm become blotchy, red, rash, swollen 1 hour after injection.she reports she ...
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Site of injection and arm become blotchy, red, rash, swollen 1 hour after injection.she reports she got a sensation ?like she was going to have shingles-tingling? shortly after her arm that she received the vaccine in was blotchy/rash from site down to wrist and entire extremity became swollen. It went away by itself by the next day. No other issues. She proceeded to call the CDC and her PCP.
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| 71 | 2021-02-01 | injection site bruising |
Burning sensation in abdomen & upper track lasted for approx 3 hours. Bruise (black & blue) on t...
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Burning sensation in abdomen & upper track lasted for approx 3 hours. Bruise (black & blue) on the injection site (right arm).
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| 71 | 2021-02-01 | injection site pruritus, skin discolouration, injection site swelling, injection site redness |
Itching, followed by swelling and redness that spread over days until it reached from the shoulder t...
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Itching, followed by swelling and redness that spread over days until it reached from the shoulder to the elbow. The redness and swelling took about 9 days to disappear. It still itches. Some pin point scabs appeared near to the injection site. Also have dark splotches appearing on other arm.
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| 71 | 2021-02-01 | itchy skin |
right side of her face was swollen and was itching; eyes swollen/puffy; puffy underneath eyes/ like ...
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right side of her face was swollen and was itching; eyes swollen/puffy; puffy underneath eyes/ like bags; swelling of right side of face/ right side of her face was swollen; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date: 30Apr2021) intramuscular on the right arm on 15Jan2021 at 30 ug, single for COVID-19 prophylaxis. Medical history included high cholesterol, high blood pressure, cancer survivor and allergic to walnuts. Concomitant medication included ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE) for supplementation therapy, HCTZ for high blood pressure, vitamins nos (MULTIVITAMIN [VITAMINS NOS]) for supplementation therapy, rosuvastatin for high cholesterol. The patient received 1st dose of vaccine on Friday and on 17Jan2021 evening, experienced the following: "swelling of right side of face, eyes swollen/puffy." She spoke with HCP office and was told to take Benadryl and Tylenol. She took the medication and the "swelling went down". She said she woke up this morning and had "puffy underneath eyes", "like bags", and "slight facial swelling." The patient ate at an Indian restaurant on 17Jan2021 at about 6:30-7:00pm and was unsure if her reaction was to the vaccine or food, since the food she ate could have been cooked with nut oil. She said that her eyes were still puffy and her face was still a little swollen. She went to see her doctor today 19Jan2021 and he was trying to figure out what could have caused this on his end. The patient said that the right side of her face was swollen and was itching. The left side did not appear to be swollen at all. Outcome of the event pruritus facial was unknown while recovering for the other events.
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| 71 | 2021-02-02 | injection site pain |
about 30 minutes after shot was having extreme fatigued to the point i had to go home and lay down....
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about 30 minutes after shot was having extreme fatigued to the point i had to go home and lay down. Bad head ache, chills, upset stomach, Fever of 100.0, extreme soreness at the shot site. A little bit of a cough and stuffy nose. lasted about 3 days. the headache is still lingering.
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| 71 | 2021-02-03 | itchy skin, rash macular, redness |
2/2/21 Slight arm discomfort - went away after an hour. Face became red, blotchy and itchy in afte...
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2/2/21 Slight arm discomfort - went away after an hour. Face became red, blotchy and itchy in afternoon. Took benedry tablets and allegra cream. 2/3/21 woke up with puffy face. Still had redness and itchy. Contacted nurse association suggested fill out this form and contact my doctor. my doctor said go to urgent care clinic. I decided to call my dermatologist who I will meet with today. Note: Not sure if this is reaction to vaccination - I have never had an adverse reaction to taking any type of vaccine.
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| 71 | 2021-02-03 | vaccination site redness, vaccination site swelling, vaccination site pain |
I am kind of tired; Redness and little bit of swelling, a patch that is getting bigger just below th...
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I am kind of tired; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was; Pain; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: GL1283, on 15Jan2021 at 10 AM at single dose for COVID-19 immunization. The patient had some medical history, but not reported. Concomitant medications were not reported. Patient stated, she received her second dose of the COVID Pfizer vaccine (COVID 19 Vaccine) on Friday at 10 AM and usual it pained next day (16Jan2021) but they went away by the end of the day. However, she noticed that yesterday (17Jan2021) and today (18Jan2021) there was redness and little bit of swelling, a patch that was getting bigger just below the site where the injection was made. Yesterday it was smaller. Today the part was larger and little bit swollen So she thought she better see what's going on. Patient stated she was kind of tired. She was old. For treatment, the patient went to the drug store today and got some Benadryl. So, she took two Benadryl tablets at about three hours prior to the report and it hadn't effected it one way or the other. The patient didn't have any lab test. Patient's height was 5'5 and three quarters. The outcome of the events "Pain" and "Redness and little bit of swelling, a patch that is getting bigger just below the site where the injection was" was not recovered at the time of report. The outcome of tired was unknown.
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| 71 | 2021-02-03 | rash with redness, rash papular, itchy rash | Red, raised, itchy rash 2?x2? Appeared 8 days after 1st shot Lasted 5 days |
| 71 | 2021-02-03 | itchy skin |
Swollen lymph nodes; Lymph nodes are really itchy/The itching is worse/worsened; This is a spontaneo...
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Swollen lymph nodes; Lymph nodes are really itchy/The itching is worse/worsened; This is a spontaneous report from a contactable consumer via medical information team. A 71-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly on the left arm on 09Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history included ongoing diabetes: diagnosed before 2000, the condition was controlled; ongoing blood pressure high: diagnosed about the same time as the diabetes (before 2000), the condition was controlled; breast cancer twice: first time she had breast cancer was in 2008, the second time was in 2017; and had surgery and lymph nodes were removed: four lymph nodes were removed on the side where the shot was done (left). There patient had no concomitant medications. On 19Jan2021, the patient experienced swollen lymph nodes, lymph nodes were really itchy and the itching is worse/worsened in Jan2021. The patient received the COVID vaccine 10 days ago (also reported as almost 2 weeks ago) and experienced swollen lymph nodes. The vaccine was given to her in the same arm where she had her lymph nodes removed. She added that within the last 2 days, her lymph nodes on one side were swelling and really itchy. She added that "it's itchy to the point she would like to rip her arm off". The patient was scheduled to have her second dose on the 30th. It was explained to her that she shouldn't have a problem with getting the second dose, but the vaccine was injected into her left arm and that was the side where her lymph nodes were removed and now it was itchy. The swelling and itching started first thing in the morning on the 19Jan2021, she woke up with it. The itching was worse, or she doesn't know actually. She doesn't know if it's worse or its just annoying because it has now been 2 days of it. The itching and swelling hasn't gotten any better. Initially she was thinking it was a bug bite. She was thinking it would be better today, but its not. She wanted to make sure it had nothing to do with her breast cancer. The consumer wanted to know how long it took for the swollen lymph nodes to go down and should she take the second dose of the vaccine. She also wanted to know if she should take BENADRYL or apply any ointment on the swollen lymph nodes. The adverse event did not require a visit to the emergency room or the physician office. No relevant tests were done. The patient has not recovered from the events.
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| 71 | 2021-02-03 | rash | Systemic: Rash (other than injection site); symptoms lasted 3 days |
| 71 | 2021-02-03 | vaccination site pain |
Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaki...
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Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaking really hard; feeling unwell; still cold; Just like when one catches the flu, all the symptoms came at one time; It was so stiff one time; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EK01231), via intramuscular route on the left arm on 19Jan2021 12:11 as a single dose for COVID-19 immunization. Medical history included stomach issues, two stents, pacemaker, asthma that turned into bronchitis. Historical vaccine data included the pneumococcal 13-valent conjugate vaccine (PREVNAR 13) first dose in "September" and the second Pneumonia shot on 11Jan2021, second dose, on the right arm within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing prasugrel for blood thinner. On 20Jan2021 03:00, the patient experienced really heavy chills, she was shaking really hard, she had muscle pain like the flu, joint pain, fever that started at 100.6 degrees Fahrenheit and worsened to 101.6 degrees Fahrenheit, nauseated, feeling unwell. The caller clarifies that all of the symptoms came on at once, around 3am. Just like when one catches the flu, all the symptoms came at one time. The patient reported that it felt like she had the virus (not specified) all over again. The chills had calmed down, but she was still cold. Where the injection was given it was real sore. She had been doing arm circles and such to keep her muscles loosened up. It was so stiff at one time last night (20Jan2021) that she thought, she could not move it. The clinical outcome of events chills was recovering; muscle pain, fever, nauseated, still cold was not recovered; joint pain, shaking really hard, feeling unwell, vaccination site pain, stiff, flu like symptoms was unknown.
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| 71 | 2021-02-04 | injection site pain |
Headache, tiredness, muscle pain, chills, joint pain, soreness at injection site and nausea caused ...
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Headache, tiredness, muscle pain, chills, joint pain, soreness at injection site and nausea caused from the really bad headache.
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| 71 | 2021-02-04 | injection site pain, injection site redness | Injection site pain and redness |
| 71 | 2021-02-04 | skin warm |
Patient felt warm, flushing from waist to feet; BP, pulse, respiratory rate, and O2 sat: 132/69, 78,...
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Patient felt warm, flushing from waist to feet; BP, pulse, respiratory rate, and O2 sat: 132/69, 78, 20, 99%. Felt better after 15 minutes.
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| 71 | 2021-02-04 | rash | Rash on left arm where shot was given |
| 71 | 2021-02-04 | vaccination site pain |
cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea;...
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cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea; feeling freezing cold; chills; ache; cold; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration at left arm on 19Jan2021 08:15 at a single dose for COVID-19 immunization. She was sick (COVID symptoms) all Dec2020 when she was with her sister who had COVID-19. She does not know for sure that she had COVID 19 because she was never tested. She recovered from that illness about two weeks before getting the Pfizer COVID 19 vaccine first dose. The cough was all gone before she had the Pfizer COVID 19 vaccine. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient had the vaccine on 19Jan2021, two days ago and had not had a problem. She left there and went to the gym for 1 hour afterwards. Then yesterday morning she woke up and has been sick ever since with a cough and chills. She never tested positive for COVID but she was with her sister who had it during Dec2020. She had a cough similar to the one she had in Dec2020 when she was quarantined for COVID symptoms. She was not expecting anything, but it says you can have side effects if you have had COVID-19 so she was calling in about that. On 20Jan2021 she woke up at 02:00 in the morning with a cough; injection site pain which was not sore before; headache; muscle pains, chills; joint pain; fever, but not a high fever; feeling freezing cold; and nausea. She reported 'cold, chills, fever, ache'. She felt a little bit better today on 21Jan2021. She was scheduled to receive the second dose on 15Feb2021 at 08:15. The patient would like to know whether her history of COVID symptoms from Dec2020 may have aggravated her post-vaccination symptoms. The patient would like to know whether there have been other reports of similar post-vaccination as hers. The outcome of the events cough, injection site pain, headache, fever and feeling freezing cold was recovering; event muscle pain, joint pain and nausea was not recovered; event chills was recovered on 21Jan2021; and unknown for the other events.
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| 71 | 2021-02-05 | skin reaction |
Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red ...
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Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red flushing to the skin on the face and left neck, shoulder & hip pain. BP initially was 182/98 which is elevated for me. Felt disoriented & very unwell. Over the next few days, low BP was noted @90/62, pulse 58. This occurred intermittently.
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| 71 | 2021-02-06 | injection site pain | Mild site pain, headache, joint pain and fever |
| 71 | 2021-02-06 | blister |
Pfizer-BioNTech COVID-19 Vaccine EUA Cold sore on upper lip-first a bump then large blister today. I...
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Pfizer-BioNTech COVID-19 Vaccine EUA Cold sore on upper lip-first a bump then large blister today. If I hadone before, it must have been many years ago. Have not had sex in decades or kissed anyone since the pandemic started. Have no idea how I could have gotten this unless the vaccine triggered it.
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| 71 | 2021-02-07 | itchy skin |
Immediately after shot, strange head sensations--lightheaded, confused. A minute after that, a tight...
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Immediately after shot, strange head sensations--lightheaded, confused. A minute after that, a tight throat. After 30 minutes, I was released, though still had those symptoms the rest of that day. The EMT at the site thought I'd had a mild allergic response. 36 hours after the shot, I woke up itching a lot on my head, trunk, and arms. I saw no obvious rash (maybe a little mottling) or hives. I used a small dab of Benadryl cream on the itchiest spot. The symptoms disappeared pretty soon.
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| 71 | 2021-02-07 | injection site redness, injection site pain, injection site swelling |
Slight swelling , tenderness and redness at site. Fever of 102.9, severe chills, severe aching from ...
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Slight swelling , tenderness and redness at site. Fever of 102.9, severe chills, severe aching from top of legs down, headache but not quite as severe as when hospitalized last year. All symptoms resolved within approx. 20 hours except for the arm site.
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| 71 | 2021-02-07 | vaccination site pain |
Stomach hurt/stomach pain; feels like throwing up/Nausea/feels nauseous/sick to her stomach; some pa...
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Stomach hurt/stomach pain; feels like throwing up/Nausea/feels nauseous/sick to her stomach; some pain after inoculation in her arm at the site; dizzy; This is a spontaneous report received from a contactable consumer. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: 31May2021), intramuscular in the left arm, on 21Jan2021 13:00, at 0.3 mL, single, for COVID-19 immunization. Medical history included "kashi disease" which the reporter further explained as a rare disease that affects shape of red blood cells and has to do with spleen; and brittle bones (pending clarification). Concomitant medications included an unspecified infusion which the patient has to go to every other week (also reported as every two weeks) for "kashi disease" and unspecified medications for brittle bones (pending clarification). The patient did not have any other recent vaccinations. On 21Jan2021, the patient had some pain after inoculation in her arm at the site, was a bit dizzy and had stomach issues which started at night. The patient started feeling "stomach hurt"/stomach pain or sick to her stomach on 21Jan2021 at around 23:00 (reported as "11:00PM-12:00PM"), experienced nausea/felt nauseous, stomach pain, and felt like throwing up. The patient still has that in the morning of 22Jan2021. It was reported that they were not treating the stomach pain with anything. The patient's dizziness went away. The reporter wanted to know if the patient would get the same side effects after the second shot. It was also reported that they check the patient's blood once a month doing labs, results were unknown. The outcome of dizziness was resolved on an unspecified date; "stomach hurt/stomach pain" and nausea were not recovered; and vaccination site pain was unknown.
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| 71 | 2021-02-07 | injection site swelling |
Swelling at site of shot, tiredness, headache, muscle pain, chills, joint pain, fever, swollen lym...
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Swelling at site of shot, tiredness, headache, muscle pain, chills, joint pain, fever, swollen lymph nodes. Gout flare up. Began 29 hours after injection with chills and fatigue followed by fever, etc. Lasted until next morning (47 hours after shot) with just a remaining headache.
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| 71 | 2021-02-07 | itchy skin |
itchy on face and other parts of body; This is a spontaneous report from a contactable consumer (pat...
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itchy on face and other parts of body; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 3247, expiration date: 31May2021), via unspecified route of administration on right arm on 21Jan2021 at 13:30PM at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient mentioned she didn't have any of the side effects they mentioned on the paper. Stated about two hours later she started to feel itchy on her face and then it became itchy on other parts of her body including her back. Added she had no rash or welts. This continued to midnight. Added she woke up about a quarter to twelve and then fell back to sleep so she thought it was better. She still felt slightly itchy this morning, so she took Zyrtec this morning at 08:00AM and now she felt perfectly fine. Mentioned she would have taken the Zyrtec last night but she took Amitriptyline 10mg at night and didn't want to take them together. She was scheduled for the second dose of the vaccine on 11Feb2021. None of adverse events required a visit to physician or ER. None prior vaccinations within 4 weeks. The outcome of the event was recovered on 22Jan2021.
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| 71 | 2021-02-07 | redness | redness extending to upper arm and back |
| 71 | 2021-02-08 | itchy rash, rash, dry skin, hives |
Experienced a delayed type hypersensitivity reaction. She first noticed the onset of a rash and hive...
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Experienced a delayed type hypersensitivity reaction. She first noticed the onset of a rash and hives on her bilateral hands and wrists anywhere from 1/29/21- 2/01/21. The rash did move up her arms and she noticed it had moved to her abdomen and thighs on 2/06/21. The rash is very itchy, not painful, and was dry. She noticed a similar reaction when she got the zostavax immunization in October of 2014.
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| 71 | 2021-02-08 | redness |
Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is h...
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Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is high for her; Felt heart palpitations and pressure in her chest; Felt heart palpitations and pressure in her chest; Facial flushing, redness; Facial flushing, redness; Lips swollen and numb; Lips swollen and numb; Left arm stiffness; This is a spontaneous report from a contactable consumer reported for self. This 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 12:30 on Arm left at single dose (lot number: EL8982) for Protection from COVID. Medical history included diabetes, slightly elevated blood pressure, taking drops under her tongue for her 21 environmental allergies, clarified product as sublingual immunotherapy, had a reaction to some kind of steroid shot recently. Had bad hives from it. Believes the steroid shot started with "met." And allergy to antibiotic. Concomitant drug included Sublingual immunotherapy, metformin at 500 mg and cetirizine hydrochloride (ZYRTEC). Past drug history included had Drug hypersensitivity to Neurontin, Detrol, Sulfur, and Neuropherntin. The patient experienced facial flushing, redness, and her lips felt like she had a Novocain shot on 22Jan2021. Her lips are still kind of numb. Can't feel her lips when she bites down on them. Believes reaction was fairly immediate. Sitting there for 15-20 min. Could feel a little facial flushing. Went home because (name withheld) is 45 minutes away from her house. By the time she got home was very flushed. Lips were getting more swollen and numb on 22Jan2021. Had an Epinephrine injection UPS Auto injector 0.3 mg, NDC: 49502 10201,Lot: 9FM783, Exp: Jun2021, Dose: injected one time in the middle of her right thigh and used it. Went to the ER. Had blood work and an EKG done. Was kept for five hours in ER. Had a chest x-ray. Blood pressure was 183 over something, which is high for her on 22Jan2021 that is controlled with medication. Experienced Hands shaking and looked like she has Parkinson's on 22Jan2021. Only lasted for a short time. Put on Prednisone for five days and told to see primary physician. Can't get into primary physician until Wednesday. Felt heart palpitations and pressure in her chest. Can't separate if it was the COVID-19 Vaccine or her nerves. She experienced Left arm stiffness on 22Jan2021. AEs require a visit to ER, was discharged from ER. Lab data on 22Jan2021 included Two sets of blood work separated by 3-4 hours: Unknown Results, Chest X-ray: Unknown Results, EKG: normal; on unknown date had a colonoscopy the day before the COVID-19 Vaccine: Unknown Results; Treatments were received for the events. Outcome of the events was unknown.
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| 71 | 2021-02-08 | rash, injection site pain |
She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both ar...
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She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both arms, the crown of her head, and on her scalp; Pfizer covid vaccine: nausea; Pfizer covid vaccine: chills; Pfizer covid vaccine: hurting at the injection site; Pfizer covid vaccine: headaches/on and off headaches; She cannot speak this morning; Pfizer covid vaccine: vomiting; This is a spontaneous report from a contactable Nurse (patient). A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL8982, expiry date: 31May2021) intramuscular injection in right upper arm on 19Jan2021 10:00 at single dose for COVID-19 immunisation. Her second dose is scheduled on 10Feb2021. Medical history included stage 4 metastatic breast cancer. There were no concomitant medications. The patient previously took Ibrance for stage 4 metastatic breast cancer and experienced broken out in terrible rash. She is taking Ibrance for cancer, she has been taking it for a while. The past few weeks she has broken out in terrible rash. She went to a dermatologist that stated the rash was from Ibrance. She cannot speak this morning (Jan2021). Her doctors are speaking to each other and she is being told not take Ibrance by the dermatologist and to continue taking from her oncologist. Reports she had a pathology report and it showed her skin eruptions she is having is from Ibrance. She clarifies that her terrible rash is up and down both arms, the crown of her head, and on her scalp. She took the first dose of the COVID-19 vaccine a couple of weeks ago. She is having quite a bunch of side effects from the injection. The side effects she is experiencing after the COVID vaccine are nausea, vomiting, chills, hurting at the injection site which is not terrible, and on and off headaches. Events did not require a visit to emergency room or physician office. Nausea started 3 days after the receiving the vaccine on 22Jan2021. Vomiting is still ongoing on and off and started about a week and half after receiving the vaccine (Jan2021). Chills started right away and she still has the chills. It has not changed. The chills started maybe a day after receiving the vaccine (20Jan2021). Hurting at the injection site started the day after (20Jan2021) and lasted for two or three days and is still ongoing, reports it goes on and off. Reports the hurting at the injection site is not terrible. Headaches started a day or so after receiving the vaccine (20Jan2021) and is still ongoing, on and off. Reporter seriousness for events nausea, vomiting, chills, hurting at the injection site, headaches were reported as medically significant. She is currently taking Ibrance since her oncologist told her not to stop taking Ibrance. The dermatologist said her rash is related to Ibrance. When querying causality she reported that she is not sure because she has been taking Ibrance for a while. She confirms the rash started after receiving the COVID vaccine. Events outcome of nausea, vomiting, chills, hurting at the injection site, headaches was not recovered (nausea and vomiting was reported as worsened), while for others was unknown. Relatedness of drug Pfizer COVID vaccine to events for nausea, vomiting, chills, hurting at the injection site, headaches were reported as related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 71 | 2021-02-08 | shingles | Shingles outbreak developed <48 hrs after vaccination |
| 71 | 2021-02-08 | injection site pain, rash, itchy skin |
tiredness, injection site pain, headache, itchey, chills, nausea, feeling unwell, swelling of throat...
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tiredness, injection site pain, headache, itchey, chills, nausea, feeling unwell, swelling of throat, slight rash
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| 71 | 2021-02-09 | rash, itchy rash, rash with redness |
PATIENT EXPERIENCED RED ITCHY RASH ON HER CHEST AND NECK WHEN SHE RECEIVED VACCINE. BENADRYL RESOLVE...
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PATIENT EXPERIENCED RED ITCHY RASH ON HER CHEST AND NECK WHEN SHE RECEIVED VACCINE. BENADRYL RESOLVED 3 HRS LATER
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| 71 | 2021-02-09 | injection site pain |
following the vaccination shot on same day 2/6/21 complaints of injection site pain and headache she...
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following the vaccination shot on same day 2/6/21 complaints of injection site pain and headache she was found deceased in her residence 2/8/21 8:00 am
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| 71 | 2021-02-09 | vaccination site pain, vaccination site redness |
soreness and redness where given the injection; soreness and redness where given the injection; Feve...
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soreness and redness where given the injection; soreness and redness where given the injection; Fever; Headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date not reported), via an unspecified route of administration at the left arm on 20Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, thyroid disorder and COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications (unspecified) in two weeks were given. On 21Jan2021 15:00, the patient experienced soreness and redness where given the injection, fever, headache, and chills. No treatment was received for the adverse events. Clinical outcome of the events was recovering.
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| 71 | 2021-02-10 | injection site pain |
After getting vaccine and driving home I had tingling in right leg from calf to toes, lasted about 2...
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After getting vaccine and driving home I had tingling in right leg from calf to toes, lasted about 20 minutes. From 7:00 thru 9:00pm had tightness in middle of chest and upper back discomfort. Next morning no reactions other than sore injection site.
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| 71 | 2021-02-10 | rash | Rash on back and chest |
| 71 | 2021-02-11 | itchy skin |
Cluster of pustular, typical H. Zoster lesions over left scapula. causing itching and local pain. ...
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Cluster of pustular, typical H. Zoster lesions over left scapula. causing itching and local pain. Treated within 24 hours with Valcyclovir 1 gm every 8 hours for 7 days. Lesions gradually resolved over the next seven days.
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| 71 | 2021-02-11 | shingles |
I presented at ER with burning, throbbing right leg pains at upper calf and upper thigh area. The E...
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I presented at ER with burning, throbbing right leg pains at upper calf and upper thigh area. The ER doctor said it was not a blood clot, but was the beginning of Shingles on the back of my right thigh, buttock and downward just below the back of my knee. I was prescribed Acyclovir, Hydrocode with Tylenol and suggested topical creams. I was unable to find the Zostrix suggested so began with Caladryl and Terrasil cream as well as baking soda/water soaks a couple times a day. As of today, February 12, I still have leg pain, markings from the lesions and am unable to sleep more than a couple of hours a night without throbbing, burning pain especially at 2 lesion sites. Now taking Tylenol alternating with Tramadol for the pain.
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| 71 | 2021-02-14 | rash, rash papular, itchy skin |
The rash now is getting little bumps; itching and a rash on his right arm up to her shoulder and bet...
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The rash now is getting little bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; itching and a rash on his right arm up to her shoulder and between her legs and small bumps; next day she felt fine, cold but it's cold; chills; headache; First dose was on 05Jan2021/ Received the second dose on 22Jan2021; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration in left arm (by injection) on 22Jan2021 17:00 (also reported as 16:30) at a single dose for COVID-19 immunization. Medical history included allergic to yellowjacket (anaphylaxis) and bee venom. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient experienced chills and headache on 23Jan2021, next day she felt fine, cold but it's cold on 24Jan2021, itching and a rash on his right arm up to her shoulder and between her legs and small bumps on 25Jan2021, the rash now is getting little bumps on an unspecified date. Patient received Pfizer-BioNtech Covid-19 vaccine on Friday 22Jan2021 around 4:30PM (as reported). On Saturday she experienced chills and headache, next day she felt fine, cold but it's cold in the city, she didn't take anything (Tylenol). Last night she started to get itching and a rash on his right arm up to her shoulder and between her legs and small bumps. She would like to know if this side effects have been reported for the vaccine. The patient reported she is getting a little concerned. She had her 2nd dose of the Pfizer COVID vaccine on Friday, 22Jan2021. She had the side effects that Pfizer submitted in the brochure. She had them starting on Saturday. She had chills and a headache. The headache left her by Sunday morning. She now she has a rash that started last night in her thighs between her legs. Then this morning it is on her arms in the folds. She does not know if that is normal. She is wondering if this is a normal side effect and what to do about it. She has had anaphylaxis from yellow jackets before. She hopes she does not go that direction. Received the second dose on 22Jan2021 at 5 pm. The chills is hard to tell if she still has it as it is cold in the city. She took Tylenol for her headache. She used anti itch cream after she showered. The rash now is getting little bumps. First dose was on 05Jan2021 (LOT: EL0142). No expiration date or NDC for first or second dose is written on her vaccination card. She thought maybe it was her detergent, or bleach, but that is not it. Therapeutic measures were taken as a result of headache which included Tylenol and itching which included anti itch cream. The outcome of the event headache was recovered on 24Jan2021, of event itching and a rash on his right arm up to her shoulder and between her legs and small bumps was not recovered, while for the other events was unknown.
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| 71 | 2021-02-18 | rash | Extremely cold, migraines, nausea, tightness in chest, face rash, joint pains, extremely tired |
| 71 | 2021-02-18 | redness | Hands turned bright red. Went to Emergency room Blood pressure was high. |
| 71 | 2021-02-18 | itchy skin, rash | No sign of reaction for four days, then itching, swelling, rash on body started. |
| 71 | 2021-02-19 | injection site redness, injection site swelling | Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe |
| 71 | 2021-02-19 | rash, itchy rash |
Very itchy rash on insides of arms and legs and on torso. It started in the evening and was gone by...
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Very itchy rash on insides of arms and legs and on torso. It started in the evening and was gone by the next morning. When it started i took an antihistamine, Claritin D, and used triamcinolone acetonide ointment. About 10 days later the same thing happened again 2 more times with the same treatment and results. I have had no symptoms in the last 3 days.
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| 71 | 2021-02-21 | itchy skin, rash with redness | Itching, red rash on upper left arm 37 hours after vaccine and still present |
| 71 | 2021-02-21 | rash | Small bumps on both hand and both ankles. Like little pimples. They don't itch. |
| 71 | 2021-02-21 | injection site redness, injection site pruritus, injection site swelling | injection site swelling injection site redness injection site itching |
| 71 | 2021-02-22 | cellulitis, injection site redness, injection site pain, injection site swelling, injection site warmth, skin reaction |
2-18-21: no adverse reactions to this date / none. . I am 9 days out. Site now red, tender, swoll...
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2-18-21: no adverse reactions to this date / none. . I am 9 days out. Site now red, tender, swollen and HOT. Red area in a circle around injection site. Measures 2.1/4" in diameter. Went to MD. He said could be a very delayed reaction or cellulitis.. Said I was the 3rd person in 2 weeks who had come to see him with this type of what he presumed was a delayed reaction. Said he looked at CDC articles and could not find any reference to this type of reaction. As a precaution I was prescribed Keflex for possible cellulitis. MD said wait it for a few days and take ATB if site gets bigger. Also mark with a pen on my arm the current size of red area so could determine if it gets larger. 1 day later site was much bigger but slightly less red: now looked like a cloud shape, size now measured 2 1/2 " by 31/2 " at the largest point. still hot and red. I never took the ATB. Eventually all subsided by today 2-23-21. Just minimal red area left.
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| 71 | 2021-02-22 | redness | FACIAL REDNESS TOOK ORAL BENADRYL AT HOME 1 HOUR LATER PT FELT IMPROVED |
| 71 | 2021-02-22 | injection site swelling, injection site discomfort, injection site redness, injection site pain |
Initially, post vaccination on 2/12/21, patient experienced pain, and swelling at the injection site...
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Initially, post vaccination on 2/12/21, patient experienced pain, and swelling at the injection site which then resolved. Yesterday on 2/20/21, patient started experiencing discomfort, redness and swelling at injection site (left deltoid). referred patient to primary provider if symptoms worsen
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| 71 | 2021-02-22 | injection site pain, injection site inflammation, injection site pruritus |
Moderna - 19 Vaccine EUA - tender, itching and inflammation in an oval 3 - 4 inches around injectio...
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Moderna - 19 Vaccine EUA - tender, itching and inflammation in an oval 3 - 4 inches around injection site. Covid Arm ?
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| 71 | 2021-02-22 | injection site redness, redness |
Patient reports experiencing fever and chills that began about 7-8 hours after receiving the 2nd dos...
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Patient reports experiencing fever and chills that began about 7-8 hours after receiving the 2nd dose. This lasted for about 36 hours. Patient also reports having nausea and vomiting that began about 12 hours after receiving the vaccine. This also lasted for about 36 hours total after receiving the vaccine. Patient also reports increased local pain, redness, erythema 36 hours after receiving the vaccine and states that this lasted for about 96 hours. The skin redness started locally to the injection site and then spread to covering the entire upper arm.
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| 71 | 2021-02-22 | shingles, rash |
Per patient: " I received my 2nd vaccine on Friday, February 12, 2021 and started breaking out on S...
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Per patient: " I received my 2nd vaccine on Friday, February 12, 2021 and started breaking out on Saturday, February 13, 2021 around my forehead and into my eyebrow. I developed body aches as well as a headache and arm soreness. I went to the dermatologist on Wednesday, February 17, 2021 and they cultured the lesions and results came back positive for shingles on February 22, 2021. I called the health department to let you know. "
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| 71 | 2021-02-22 | rash | Rash on both wrist area. Pimples on each armpit/breast area and left forearm. |
| 71 | 2021-02-22 | redness, itchy skin |
arm swollen, red, itchy, . Spreading around to underside of arm. Face " feels funny" though no visi...
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arm swollen, red, itchy, . Spreading around to underside of arm. Face " feels funny" though no visible swelling or redness noted
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| 71 | 2021-02-23 | redness |
10 days later arm got red; soreness to her arm; This is a spontaneous report from a contactable cons...
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10 days later arm got red; soreness to her arm; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 16Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has a question about the COVID-19 vaccine. She stated that she thought she had a simple question, and she called the COVID hotline, and the CDC and they just keep bouncing her around. She said she had her first dose of the vaccine on 16Jan2021, and wasn't bothered by it, she had just a bit of soreness when she touched her arm (unspecified date in Jan2021), but 10 days later, on 26Jan2021, her arm got red, so she is wondering if this could be a delayed reaction. She stated that she is not having bad effects, she is just wondering why it would pop up after so many days. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 71 | 2021-02-23 | bruising, rash |
Chills with violent shivering starting second night after vaccine and continued for 3 nights. Dren...
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Chills with violent shivering starting second night after vaccine and continued for 3 nights. Drenching night sweats overnight began the 3rd night and is continuing now but lessening slightly in degree. Headaches. Muscles ache and stiffness particularly in legs. Slight loss of balance from time to time. Loss of appetite. Rash on chest possibly caused by sweating at night. Increased severity when bruised.
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| 71 | 2021-02-23 | injection site pruritus, injection site reaction, injection site warmth, rash with redness |
Red rash approximately 1 1/2 inch circle at injection site 10 days after receiving vaccine. It itch...
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Red rash approximately 1 1/2 inch circle at injection site 10 days after receiving vaccine. It itched and was hot to touch. Today is fourth day of rash and it seems to be getting lighter in color and does not itch as much. I read an article about this symptom and it is reported as "Covid Arm" 8th day delayed cutaneous hypersensitivity reaction. Should go away.
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| 71 | 2021-02-23 | hives | Very severe chills, flushing, hives, nausea |
| 71 | 2021-02-24 | injection site redness | - erythema diffuse body, hot flashes, headache and ecchymotic areas |
| 71 | 2021-02-24 | itchy skin |
Blood pressure roller coaster over 3 days: highest 148/84 down to lowest 105/85; chills, pain in upp...
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Blood pressure roller coaster over 3 days: highest 148/84 down to lowest 105/85; chills, pain in upper left quadrant chest on 3rd day, vision issue and pressure behind left eye after 5 minutes--pressure lasted for 3 days with different levels of pressure; chills, dripping nose on day 1, and itchiness on both arms especially around elbows--has continued
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| 71 | 2021-02-24 | injection site pain | Chills, fever, body aches, pain at injection site |
| 71 | 2021-02-24 | injection site pain |
Side effects, not anaphylactic adverse reaction. Chills, fever, muscle aches, bad headache, joint pa...
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Side effects, not anaphylactic adverse reaction. Chills, fever, muscle aches, bad headache, joint pain, injection site pain.
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| 71 | 2021-02-24 | skin peeling |
Skin peeling off arms(less so?mostly flaking) and legs. Enough sloughing off to create a snow mound....
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Skin peeling off arms(less so?mostly flaking) and legs. Enough sloughing off to create a snow mound. Trunk not affected. Noticed 48 hours after shot but did not think anything of it. Peeling skin increased. Purchased Nivea intensive healing lotion on Saturday and started applying liberally. Peeling/flaking gradually declined. Minor flaking on legs currently.
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| 71 | 2021-02-25 | rash |
Patient is being seen today due to a rash that developed after receiving first dose of her Pfizer va...
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Patient is being seen today due to a rash that developed after receiving first dose of her Pfizer vaccine 2/18/21. Rash appeared on 2/22/21, mostly on the tops of her feet and her face. A few very mild patches on her body. She has been taking Benadryl and has used Cortisone 10 on the itchy areas. She says what alarmed her was that her eyes felt dry and tight. Nose was also puffed up and felt a slight sensation in her ears and teeth. No tightness in throat or difficulty breathing. No swelling in lips or tongue or throat. She has no redness at the injection site.
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| 71 | 2021-02-26 | injection site redness, itchy skin, injection site swelling |
I had a sore arm a few hours after the injection as well as swelling and redness at the site. It con...
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I had a sore arm a few hours after the injection as well as swelling and redness at the site. It continued for a day or two. No problem until my arm started itching Thursday and I noticed the redness and itching as well as a little swelling.
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| 71 | 2021-02-26 | rash |
Left and right arms sore and achy for 3 days; felt tired and ill the night of the shot and all the n...
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Left and right arms sore and achy for 3 days; felt tired and ill the night of the shot and all the next day; general malaise feeling; loss of appetite; headache; slight swelling of sinuses and rash on face. Took Benadryl the first and second nights, used hydrocortisone cream on rash, took Tylenol. End of day three feeling better, almost normal.
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| 71 | 2021-02-26 | itchy skin | Throat tight; itching on arms. |
| 71 | 2021-02-26 | itchy skin, rash papular, hardening |
large elevated (swollen) round rash on left arm with hardness in middle. Noticed it day after injec...
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large elevated (swollen) round rash on left arm with hardness in middle. Noticed it day after injection (2/25). Became itchy on 2/26. Faint inner circle inside larger rash. Mildly annoying but strange looking. This did not occur after 1st injection on 2/21 Pfizer EL9265.
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| 71 | 2021-02-28 | itchy skin | Itching from neck into arm pit. Lasted until 2/18/2020 |
| 71 | 2021-02-28 | shingles, itchy skin, rash |
She started experiencing burning; Rash; Shingles; itching; Headache; Malaise; very tired; This is a ...
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She started experiencing burning; Rash; Shingles; itching; Headache; Malaise; very tired; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: E13247) via an unspecified route of administration on 19Jan2021 11:30 at a single dose for COVID-19 immunization. Medical history included A-fib. Concomitant medication included apixaban (ELIQUIS). Had COVID-19 Vaccine on 19Jan2021 and everything was fine. Had a headache and a little bit of malaise on 20Jan2021. After two days was ok. On 21Jan2021, broke out in what she thinks was shingles. Not 100% sure if it was a major rash or shingles. Wanted to know if that was a possible side effect. Patient was taking Valaciclovir (VALTREX) for Shingles. Doctor suspected it was shingles, but it was possible she had shingles brewing before the COVID-19 Vaccine or the COVID-19 Vaccine brought the shingles out. Second COVID-19 Vaccine is scheduled for 09Feb2021, patient was scared and afraid of it. Doesn't know what to do. On 20Jan2021 she was very tired and had a headache. Next day was ok. On 21Jan2021 thought she had bug bites. Started itching. Then it began traveling and she realized it was not bug bites. She started experiencing burning. Went to two Urgent Care and her Internist. Was told it was basically shingles. Her internist was on the fence because she just had the COVID-19 Vaccine and wasn't certain. Caller stated it was ironic that she broke out after the vaccine. Caller's internist stated for any rash it would be treated the same with Valtrex. Internist stated chances were the rash was viral so if it's not shingles, would be treated with Valtrex. Rash and Itching: Wasn't very bad on Saturday, 23Jan2021, which was the first time she had someone look at it. On Sunday, 24Jan2021 it was full blown and really blossomed. Was initially treating rash as if it was bug bites. Was applying Benadryl tropical. On Sunday, 24Jan2021, started taking Valtrex. Outcome of the events headache, malaise, fatigue was recovered on n unspecified date, while unknown for the other events.
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| 71 | 2021-02-28 | vaccination site warmth |
With the first dose she felt the little warmth or gush of the medication going in; This is a spontan...
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With the first dose she felt the little warmth or gush of the medication going in; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration at the upper left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. With the first dose she felt the little warmth or gush of the medication going in on 06Jan2021, not pain but she could feel it going in but with this second shot there was nothing and no blood. The outcome of the event was unknown.
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| 71 | 2021-02-28 | redness, itchy skin |
Within first 30hrs of receiving vaccine: chills (twice), body aches, diarrhea (twice); fatigue, fev...
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Within first 30hrs of receiving vaccine: chills (twice), body aches, diarrhea (twice); fatigue, fever (did not exceed 100 degrees). Underarm pain, enlarged lymph node began within 2 days post 2nd vaccine. ( Friday-Sat. Feb. 26-27) Within four days (Sunday Feb. 28) redness, swelling, pain and itching began in upper arm. ....neck pain reduced. By Monday, March 1, I contacted my family practice clinic and received a video consult with Dr.
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| 71 | 2021-02-28 | vaccination site pain |
headache; nauseous; soreness at the site; extreme fatigue; This is a spontaneous report from a conta...
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headache; nauseous; soreness at the site; extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN5318, expiration date was unknown), via an unspecified route of administration in the left arm on 24Jan2021 at 12:15 at a single dose for COVID-19 immunization. The vaccine facility type was reported as "other." Relevant medical history included hyperactive thyroid; known allergies to penicillin, eggs, and cashews; and severe allergy to all dairy products; all from an unknown date and unknown if ongoing. Concomitant medications included fluvastatin, ezetimibe (ZETIA), acetylsalicylic acid (BABY ASPIRIN), and unspecified multivitamins. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She had not tested for COVID post vaccination. On 24Jan2021, after 2-3 hours of receiving the vaccine, the patient became very nauseous, which lasted for three days. It had eased at the time of the report. On 24Jan2021, the patient also had soreness at the site, extreme fatigue, and headache. The patient had headache for about one day; however, she managed to deal with it without pain killer. The patient drank a lot of warm water with fresh ginger and lemon (with peel) to control the nausea. The patient was very fatigued for three days following the vaccine. Therapeutic measures were taken as a result of nauseous. The patient did not receive treatment for the events "soreness at the site, extreme fatigue, and headache." The patient was recovering from the events "nauseous, soreness at the site, extreme fatigue, and headache."
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| 71 | 2021-02-28 | itchy skin |
severe glaucoma; Intermittent itching, numbness around my left eye & down cheek; Intermittent itchin...
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severe glaucoma; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; Visual field defect; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; This is a spontaneous report from a contactable consumer. A non-pregnant 71-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EM9810), via an unspecified route of administration in the right arm on 05Feb2021 at 15:30 at 71-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the bnt162b2 administration. Medical history included controlled blood pressure high (HBP) from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing; "known allergies: comparing." Concomitant medications included unspecified medications taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of the vaccination. On 08Feb2021 at 07:30, the patient experienced: severe glaucoma (medically significant), intermittent itching, numbness around my left eye & down cheek (non-serious), visual field defect (non-serious); with no treatment received. The clinical outcome of the events was not recovered. The patient was not tested for COVID prior to the vaccination and post vaccination.
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| 71 | 2021-03-01 | hives | Hives at various locations around my body, swollen hands, knees, lips - ongoing problem |
| 71 | 2021-03-01 | hives, redness, itchy skin |
I developed hives between my breasts and on my chest within 10 days after receiving the second dose ...
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I developed hives between my breasts and on my chest within 10 days after receiving the second dose of the COVID 19 vaccine from Pfizer. It was very itchy and red and uncomfortable. Anytime clothing touched it, it was itchy.
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| 71 | 2021-03-01 | injection site pruritus, injection site redness |
Not a terribly adverse reaction, but wanted to report that I had read only Moderna gives some women ...
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Not a terribly adverse reaction, but wanted to report that I had read only Moderna gives some women a "covid arm" or delayed cutaneous hypersensitivity. I have had an itchy injection spot for the last 6 days (each day getting less itchy), and slight redness around the injection site. All is much better now, but since I had read only Moderna and I had Pfizer I wanted to let you know.
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| 71 | 2021-03-01 | rash with redness |
Red rash around middle of my body from below my bra line to below my panties and on my back, it does...
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Red rash around middle of my body from below my bra line to below my panties and on my back, it doesn't itch or hurt, just lots of red spots everywhere. Leg and foot cramps.
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| 71 | 2021-03-01 | injection site pruritus, redness |
erythema, itching to injection site that began few hours after injection. pt daughter states area ha...
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erythema, itching to injection site that began few hours after injection. pt daughter states area has lessened. no further reactions, rashes, shortness of breath
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| 71 | 2021-03-01 | injection site numbness |
patient reported numbness in her upper deltoid muscle on the side of vaccination initially. After 5 ...
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patient reported numbness in her upper deltoid muscle on the side of vaccination initially. After 5 minutes the patient reported feeling a little short of breath and that her heart rate felt fast. Patient remained alert and oriented throughout. Patient was given water and instructed to perform pursed lip breathing. When attempting to move patient to a private space, she reported weakness in her legs and required assistance to transfer to a wheel chair. 911 was called when patient reported trouble breathing that was not improving. Patient also reported a history of anxiety and congestive heart failure. Patient was transported to a local emergency department via ambulance for further evaluation. Patient was transported away from our clinic at 10:15am.
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| 71 | 2021-03-02 | injection site redness, injection site pruritus, vaccination site swelling |
Headache, cold, hot, nausea, swelling at vaccination site, red and itchy at vaccination site too, fa...
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Headache, cold, hot, nausea, swelling at vaccination site, red and itchy at vaccination site too, fatigue Was sick for 17 days. Dr. prescribed steroids and nausea medication.
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| 71 | 2021-03-02 | itchy skin | pruritis, transient HTN 173/94 Given Benadryl 25mg IM x 1 Send to ED for further observation |
| 71 | 2021-03-03 | itchy rash, rash with redness | Itchy Red Rash, roughly 2.5 inch diameter. duration-in progress. |
| 71 | 2021-03-03 | injection site rash, itchy skin |
Received shot on 2/27 2/28 & 2/29 fever , chills, joint aches, headaches, took Tylenol for fever 2/3...
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Received shot on 2/27 2/28 & 2/29 fever , chills, joint aches, headaches, took Tylenol for fever 2/30 rash started at injection site. I took Benadryl but rash spread and got worse 3/4 went Emergency center for worsening rash, sever itching, and unable to sleep. I was given a Benadryl 25mg injection and a steroid shot. I was to continue taking Benadryl and set up an appointment with my PCP.
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| 71 | 2021-03-03 | rash papular, itchy skin, hives |
Severe welts on both arms torso breasts legs. These lesions are extremely itchy and lumpy. They have...
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Severe welts on both arms torso breasts legs. These lesions are extremely itchy and lumpy. They have spread to cover most of my body.
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| 71 | 2021-03-03 | itchy skin, hives |
states that she received her second Covid vaccine on Monday 03/01/21, and that yesterday she had sid...
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states that she received her second Covid vaccine on Monday 03/01/21, and that yesterday she had side effects of body aches, and just feeling yucky. 3/3/21, she woke up with Hives covering her body. No difficulty breathing, or swelling of Face at this time, per NP, pt to take Benadryl OTC and if Sxs worsen or do not improve she will need to come into to be seen, and if any difficulty breathing, swelling of face/tongue/throat patient is to call 911. 3/4/2021 11:52 AM 71 yo female seen today with c/o hive like rash,, first onset noted on both forearms yesterday 3/3/21 associated with severe itching, she took some benadryl last night, this may have helped for a while, however notes spreading of hive like rash to the entire body including the face starting this morning, bodyaches and chills with extreme fatigue Pt had her 2nd pfizer covid shot 48 hours ago, she denies any other new medications or products.
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| 71 | 2021-03-04 | redness |
Blood pressure at 4 pm on 3 March was 150. By 8 pm that evening it was 197. Had slight head ache and...
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Blood pressure at 4 pm on 3 March was 150. By 8 pm that evening it was 197. Had slight head ache and face was red. Went to the ER. That night I experienced moderate chills.
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| 71 | 2021-03-04 | rash, skin peeling |
Got a rash on Sunday night, the day after the vaccine. Rash was mostly gone within a few days. No...
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Got a rash on Sunday night, the day after the vaccine. Rash was mostly gone within a few days. Now peeling skin.
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| 71 | 2021-03-05 | injection site pruritus, hives, injection site pain |
Friday: Before I left facility I started tingling around my mouth but ignored. When I got home my ar...
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Friday: Before I left facility I started tingling around my mouth but ignored. When I got home my arthritic places that always hurt started intensifying more than usual but not my injection arm. Started itching on my head and went down in different spots on my body. Never had hives except from scratching. Took 1 otc Benadryl when continued itching then again at bedtime. They helped but not 100%. Saturday: Woke up in the morning with more itching, headache, fatigue.Eyes burning for three days, Continued Benadryl and Tylenol for headache and joint aches. No fevers. Monday: went to urgent care. They first gave me a Zyrtec, then 30 minutes later gave me a steroid IM. Did urine test. Prescribed: dexamethazone 4mg. 1 in the morn for 5 days, singular 10 mg. Daily, Zyrtec 10 mg. Daily. Drink lots of water. Each morning after I went to urgent care I?d wake up itching until Friday morning. Itching has improved. Took my last script this morn on Saturday. First day not fatigued and very sleep was Thursday. The other days before I slept a lot. I?m just concerned if it will be okay to take the second dose. I have it on March 19.
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| 71 | 2021-03-05 | skin warm |
This is my second vaccine. Same results as the first one, They are now calling this covid arm or ...
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This is my second vaccine. Same results as the first one, They are now calling this covid arm or Maderna arm per on-line news, but I got the pfizer vaccine (not Maderna). First dose this reaction started 9 days post injection.. You have my report. This time it is in the other arm and the reaction started 5 days post shot (today) . The area is hot and raised. Area is larger than my first reaction: now 4 x 4 inches in a pyramid shape. It does not itch but it is painful. I have no other discomfort.
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| 71 | 2021-03-05 | injection site pain, pain of skin |
This was the second shot in series of 2. First shot only gave me a sore arm at site & was administer...
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This was the second shot in series of 2. First shot only gave me a sore arm at site & was administered on February 6, 2021. Second shot was administered on March 3, 2021. Started feeling these adverse effects about 9 or 10 am the following morning, 3/4/2021. Symptoms were soreness at site, in muscle that goes to the neck, headache, soreness across upper back/shoulder to shoulder. By 4 pm on 3/4, my entire body was reacting with extreme joint pain in all joints, extreme joint stiffness, skin was tender to the touch, temperature of 100.1, sore/stiff neck, and continuing headache. Temperature ceased around 11:30 pm but all other symptoms remained upon going to bed at 1 a.m., 3/5/2021. Upon waking at about 7:30 am 3/5/2021, all symptoms had diminished enough for me to go to an appointment at 10:45 am. However, by the time I headed back home at about 1:30 pm, I was so sleepy I could hardly keep my eyes open. More stiffness and achiness had returned too, especially a sore left underarm. Not the extent of night before, but enough to be uncomfortable. Today, 3/6/2021, I have noticed a sore muscle traveling from my left underarm down to my waist.
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| 71 | 2021-03-05 | redness, injection site redness, skin burning sensation |
Within 5 minutes, I became hot and flushed face, red arms below the vaccination site, red legs. Tre...
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Within 5 minutes, I became hot and flushed face, red arms below the vaccination site, red legs. Treated immediately with benadyl and extra water, followed by benadryl and tylenol 6 hours later and again 6 hours later. After approx 18 hours, my skin looked and acted like a sunburn reaction. After 24 hours I had chills. After 36 hours all symptoms were gone.
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| 71 | 2021-03-06 | injection site rash, injection site pruritus | Large red spot at site of injection a few days after vaccine. Very itchy. |
| 71 | 2021-03-06 | rash, itchy skin |
Rash on entire torso, arms, and fingers, especially dominant under both arms. This occurred about 40...
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Rash on entire torso, arms, and fingers, especially dominant under both arms. This occurred about 40 hours after vaccine. The rash lasted for at least 48 hours and was itchy. The itchiness lasted an additional 24 hours after the rash dissipated. I took Benadryl.
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| 71 | 2021-03-06 | injection site pain, injection site swelling |
Site pain, swelling, chills, body aches 6hrs and by next day. 4 days later- bellyache, cramps, burn...
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Site pain, swelling, chills, body aches 6hrs and by next day. 4 days later- bellyache, cramps, burning diarrhea, nausea, lack of appetite, more fatigue. Last symptoms hard to shake. Better and then back.
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| 71 | 2021-03-06 | rash |
Woke up approximately 12 hours after vaccination, with severe chills causing my teeth to chatter and...
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Woke up approximately 12 hours after vaccination, with severe chills causing my teeth to chatter and shaking all over. Chills dissipated within about 4 hours. Had a very bad headache which also began about same time as chills and lasted for approximately another 12 hours, even though I took tylenol and advil alternating every 4 hours. Had a slight fever, approximately 1 degree over what I normally register for about 8 hours. I showered about 36 hours after vaccination and immediately broke out in a rash (not hives)...more like prickly heat all over my stomach, neck, chest, stomach, inside arms. This lasted until the next day; did not itch or cause any discomfort.
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| 71 | 2021-03-06 | shingles |
approximately 24 hours after the shot i got sharp electric shock like pains under my right arm down ...
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approximately 24 hours after the shot i got sharp electric shock like pains under my right arm down near my ribs and towards my back. the pain became so bad i couldn?t move my arm. it was like that for 2-3 days and then got so i could move it but still had pain. a few days later i got a rash where the pain was and went to the dr the next afternoon and was told that i had shingles
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| 71 | 2021-03-07 | skin warm |
About 30 min after injection, tendon in my neck, left side began to warm, then, the warmth rose to ...
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About 30 min after injection, tendon in my neck, left side began to warm, then, the warmth rose to the base of scull. I started rotating neck, but continued for about 30 minutes. My neck on that side became stiff and painful. I continued throughout the pm to exercise my neck . By bedtime, it was no longer warm. Still slightly stiff, next morning, a bit stiff. By 36 hr, totally back to normhe, I am an RN, retired & daughter is RN, active, didn't see reason to contact Dr.
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| 71 | 2021-03-07 | skin discolouration |
About 6 min after tongue,top of mouthnumb,repoeted Bendryl 25 given per mouth 6 min after tong...
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About 6 min after tongue,top of mouthnumb,repoeted Bendryl 25 given per mouth 6 min after tongue,top of mouth numb repoeted and Bendrly 25mg given by mouth later that day above L eyebrow pain, then over next few days up to now blue around eye now blue around eye r side DONE
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| 71 | 2021-03-07 | skin warm, redness |
After receiving the first dose of vaccine at 5:30 pm noticed swelling around and below elbow with re...
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After receiving the first dose of vaccine at 5:30 pm noticed swelling around and below elbow with resdness and warmth to touch. Denies pain
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| 71 | 2021-03-07 | rash | Covid arm, Chills and slight fever. Day 2 rash on torso |
| 71 | 2021-03-07 | redness |
Face and arms were reddened. Pt reported feeling "a little winded" when she ambulated to the bathr...
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Face and arms were reddened. Pt reported feeling "a little winded" when she ambulated to the bathroom. Pt states she has had this reaction previously with a shingles vaccine. Pt did not report previous reaction to administering nurse.
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| 71 | 2021-03-07 | skin warm, hives |
Hives on both arms, wrists to shoulder. Hives on chest and upper back. Treatment...benadryl and OTC ...
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Hives on both arms, wrists to shoulder. Hives on chest and upper back. Treatment...benadryl and OTC hydrocortizone. Hives started on arms and spread to chest and upper back, under arms. Skin very warm to the touch and chills. I am still dealing with hives and chills...little, if any improvement 03/08/2021.
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| 71 | 2021-03-07 | injection site redness, injection site swelling, injection site pruritus | Itchy, red, swollen from just below elbow to armpit |
| 71 | 2021-03-07 | injection site pain |
Low grade fever, chills, flu-type aching, loss of appetite, extreme fatigue, pain at injection site,...
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Low grade fever, chills, flu-type aching, loss of appetite, extreme fatigue, pain at injection site, joint and muscle pain. The worst of it was the Wednesday after late Monday afternoon vaccination; ie on day two post-vax. Felt like a case of bad flu. Lasted about 2 to 3 days, with tapering severity. A week later, energy level is still down; sleeping more than usual.
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| 71 | 2021-03-07 | skin tightness |
My symptoms from the gadolinium worsened after the vaccine. Increased neuropathy in extremities, lo...
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My symptoms from the gadolinium worsened after the vaccine. Increased neuropathy in extremities, loss of short term memory, tightness of skin on face, nose numb, sympathetic nervous system engaged, no ability to get out of fight or flight.
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| 71 | 2021-03-07 | rash |
Rash; Fast heart beat; This is a spontaneous report from a contactable consumer. A 71-year-old femal...
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Rash; Fast heart beat; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 20Feb2021 (at the age of 71 years old) at a single dose for covid-19 immunisation; and paracetamol (TYLENOL), via an unspecified route of administration from an unspecified date at unknown dose and frequency for an unspecified indication. Medical history included high blood pressure, rheumatoid arthritis, tinnitus, vertigo, blood cholesterol. Concomitant medications included amlodipine for high blood pressure, lovastatin for blood cholesterol, meclizine [MECLOZINE] for vertigo, dipyridamole for tinnitus, prednisone for rheumatoid arthritis, and folic acid. On 21Feb2021, the patient experienced rash (hospitalization) and fast heart beat. "If this is the reaction, I guess I shouldn't take the second dose, right? I just think that I am not going to take second dose." Both the events required emergency room visit. The patient underwent lab tests and procedures which included blood work, electrocardiogram (EKG) and x-ray and everything came back normal on 21Feb2021. Therapeutic measure was taken as a result of the rash which included hydrocortisone. The action taken in response to the events with paracetamol was unknown. Outcome of both events was recovering. Information on the batch/lot number has been requested.
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| 71 | 2021-03-07 | shingles |
Shingles on torso after 2nd dose. Started at navel, then around right side to spine, then back. Pain...
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Shingles on torso after 2nd dose. Started at navel, then around right side to spine, then back. Painful. No headache/fever, SOB. Backache prior to shingles
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| 71 | 2021-03-08 | rash | Chills, Headache, Myalgia, Arthralgia, Fatigue, Rash on forearms |
| 71 | 2021-03-08 | injection site mass, injection site swelling, injection site redness |
Injection site swollen, with hard ball under skin. Skin is red ar needle site spreading to pink (abo...
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Injection site swollen, with hard ball under skin. Skin is red ar needle site spreading to pink (about 2.5? wide
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| 71 | 2021-03-08 | itchy skin, injection site rash |
Received injection on 3-3-2021. On 3-7-2021 I noticed a large red blotch at the injection site that ...
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Received injection on 3-3-2021. On 3-7-2021 I noticed a large red blotch at the injection site that was not there previously. It's size is 3 1/2" by 1 1/2". No pain at site. Slight itching. Skin is not raised nor are there any blisters. No other side effects associated with vaccine.
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| 71 | 2021-03-08 | redness |
Swelling; redness; soreness down to the elbow; This is a spontaneous report from a contactable consu...
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Swelling; redness; soreness down to the elbow; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 25Jan2021 11:00, at single dose, for covid-19 immunization. The patient has no medical history. Concomitant medications included estradiol (VAGIFEM) and, vitamins. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The vaccine was administered in the hospital. The patient experienced swelling; redness; and soreness down to the elbow - all on 01Feb2021. The patient had not recovered from these adverse events and; no treatment was received for them. The patient has not been tested for COVID-19 since the vaccination. Information about the lot/batch number has been requested.
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| 71 | 2021-03-08 | injection site bruising, injection site pain |
The shot was given to me (Sat) in the upper (L) arm about 2 -1/2 inches down from top of shoulder. ...
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The shot was given to me (Sat) in the upper (L) arm about 2 -1/2 inches down from top of shoulder. It was a simple prick however I thought it seemed an odd location. About 24 hours later (Sun) I felt first signs of tenderness at the site but didn't think much of it as that is what I had heard from others about the vaccine. Later in the day it became achy. On Monday morning I noticed my whole arm was achy in addition to the top of my shoulder and the left side of my neck and upper shoulder blade. At 9:30 am I felt very tired and laid down and awoke 4 hours later! My aches were still all there as though I had slept wrong. Again I was not too concerned except that my friends all said their discomfort was gone within 24 hrs. Today is Tuesday and evening and as I sit here I have a very tender, sore, achy upper left arm and a small black and blue spot at the site. It's strange because it doesn't hurt when I touch it, instead it is just an ache/pain that I feel and especially when I move the arm. The tightness and ache in my neck and back and shoulder has lessened. I am reporting as I was not expecting this type of reaction especially to last 3-1/2 days so far. I feel this adverse reaction probably has more to do with the location that the technician chose to give me the vaccine. I am thinking the muscles are reacting to injection.
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| 71 | 2021-03-08 | pain of skin |
fever of 101.9 for 2 full days- lessened on 3rd day-, headache, nausea, chills, muscle aches includ...
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fever of 101.9 for 2 full days- lessened on 3rd day-, headache, nausea, chills, muscle aches including my fingers, runny nose, sore skin to the touch on left lower arm. Sore skin did not occur until 4th day. very fatigued throughout. All symptoms gone by end of 4th day.
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| 71 | 2021-03-09 | pain of skin |
About 6 hours after the vaccine she felt really, really sleepy. Then she laid down and then her lef...
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About 6 hours after the vaccine she felt really, really sleepy. Then she laid down and then her left hand started stinging all over. Both legs started getting a strange warm sensation, the size of a pea that kept getting warmer. She was not able to get up or open her eyes, doesn't know if she passed out but apparently went to sleep and slept for 3 hours and woke up and went to bed. She then had toe cramps on her left foot, then got up and walked around the bed and laid down again and fell asleep until the morning. She did not feel normal until 3/5/21. On Sunday, 3/7/21 had nausea, took something for that and the next day she was fine.
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| 71 | 2021-03-09 | itchy skin |
Patient experienced mild reaction following first dose of Pfizer COVID-19 vaccine, so she pre-medica...
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Patient experienced mild reaction following first dose of Pfizer COVID-19 vaccine, so she pre-medicated with 25 mg of oral Benadryl before coming for 2nd dose. Provider authorized administration with 30-minute observation to follow. Shortly after administration, patient experienced facial flushing, itching hands and tongue swelling. No difficulty breathing reported. Patient took second oral dose of 25 mg Benadryl (her own medication from home) with resolution of itching and significant improvement of flushing and tongue swelling. Patient stated 'much improved' prior to discharge. Follow-up call attempted next day to check on patient with no answer--message left to contact PCP office if any ongoing concerns. Second follow-up call: patient symptoms improved evening of immunization.
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| 71 | 2021-03-09 | shingles, itchy skin |
Pfizer-BioNTech COVID 19 Vaccine The day after receiving the vaccine, I had a slight headache and ...
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Pfizer-BioNTech COVID 19 Vaccine The day after receiving the vaccine, I had a slight headache and later that morning I had a site on my rump that was itchy. Later I took a shower and I broke out with shingles rash, now two days later feeling achy. It has been 2 yrs since I had an outbreak of shingles. I tried to call Pfizer to see if I could safely take the Valtrex dosage for the outbreak and after an hour and a half the call dropped and I was not able to call them. I did send them a report via the computer to their web address.
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| 71 | 2021-03-10 | dry skin, injection site pain |
20 minutes after injection, I began feeling progressively warmer as if I had beads of sweat on my fo...
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20 minutes after injection, I began feeling progressively warmer as if I had beads of sweat on my forehead. I began to feel light as if my body was light. The Lead Monitor came over and had my blood pressure and oxygen levels checked over the next 40 minutes before I felt actually fine and able to walk out. At no point did I have trouble breathing although that question was repeatedly put to me. Then at home I took it easy but noted anything out of the ordinary. 1.5 hrs after the injection and lasting only 2 minutes, I felt like a band was being tightened around my head to the point of discomfort but not pain. 24 hrs after the injection, for less than one minute, my left temple felt pressure as if I had a head cold. I haven't had a headache in a decade so this was unusual for me. 10 hrs after the injection, I was awakened to by cramping from lower Achilles to foot in my right leg only. This lasted painfully for 12 minutes. My right foot itself felt numb. I would stand to stretch the muscle/ tendon but then immediately felt nauseous. I hate feeling nauseous so I would lay back down only to have to stand again due to the pain of the persistent cramping. This was 12 minutes of excruciating leg cramps. When usually I might have only one or two very brief leg cramps per year. 14.5 hours after injection, I awoke very thirsty adn my skin felt very dry. I drank water and applied hand lotion. Thereafter the vaccine site felt sore but the injection site would have been invisible but for the bandaid outline that narrowed down where the injection had to have been located. The vaccine site was never red or pink or raised at all. Just a pin prick if you really looked for it. As a follow-up, the second Pfizer dose was Lot EM9809 on Feb. 26, 2021, and I had no reaction at all. No visible injection site in right arm, no warmness, no light-headedness, no cramps, nothing at all happened.
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| 71 | 2021-03-10 | injection site pain | Headache, fatigue,fever, muscle ache at injection site, naysea |
| 71 | 2021-03-10 | rash |
Progress Notes Date: 3/8/2021 ...
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Progress Notes Date: 3/8/2021 Subjective Patient is a 71 y.o. female who was seen at the clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied difficulty breathing, difficulty swallowing, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and respiratory distress. PMH: htn, hld, eczema, hypothyroidism, prediabetes ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness ("lightheaded") Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives and itching of skin Previous Reactions: none Objective Vitals Vitals: 03/08/21 0929 03/08/21 0937 03/08/21 0950 BP: (!) 153/53 (!) 154/60 (!) 153/54 BP Location: Left arm Patient Position: Sitting Pulse: 58 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is well-developed. She is not diaphoretic. Comments: Appeared to not feel well upon arrival. After water and snacks, improved. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Lightheadedness. Pt observed in the medical bay for approx 20 minutes. She was able to stand from wheelchair w/o lightheadedness/dizziness. She states she feels much better and is ready to go home. Pt provided handwritten instructions on monitoring her bp at home and when to follow up with pcp. She was taken out to the front accompanied by her husband by RN. She and husband both voice appreciation of today's care. 3/8/2021 9:36 AM
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| 71 | 2021-03-10 | injection site swelling | quarter size swelling at site of injection, no other symptoms |
| 71 | 2021-03-11 | injection site redness, injection site pain | Joint pain over entire body, chills, nausea, bad headaches, site redness and tenderness,. |
| 71 | 2021-03-11 | rash |
This patient developed a severe, multisystem inflammatory syndrome after covid vaccination that nece...
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This patient developed a severe, multisystem inflammatory syndrome after covid vaccination that necessitated hospitalization for 6 days. It involved skin (rash), liver (elevated bilirubin and asT/alt), bone marrow (leukopenia, thrombocytopenia), cns (hallucinations, visual disturbance), and musculoskeletal system (synovitis). Inflammatory markers were markedly elevated with ferritin over 1000 and CRP over 100. COVID infection was definitively excluded.
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| 71 | 2021-03-14 | redness, itchy skin, hives, injection site pain |
Received vaccine about 12:30pm 3/10/21. When I woke up next morning, besides arm being sore, there ...
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Received vaccine about 12:30pm 3/10/21. When I woke up next morning, besides arm being sore, there were hard welts about 1 inch from injection site. They were itchy and red. Over the past few days itching stopped, but the separate welts turned into one long 2 inch raised hard area. Still there 3/15/21
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| 71 | 2021-03-15 | rash |
Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to conce...
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Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to concentrate , extreme weakness & fatigue, extreme focused joint pain, headache, coughing and difficulty breathing requiring multiple nebulizer uses every 2 hours over 2 weeks, headache. Face & body rash, . Persistent exhaustion continues requiring 2-3 hour daily naps & non Fibro brain fog continues at 3 weeks.
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| 71 | 2021-03-15 | injection site pain |
I am having increasingly bad pain in both arms, wrists, hands, knees, neck. My pain in especially ba...
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I am having increasingly bad pain in both arms, wrists, hands, knees, neck. My pain in especially bad at the injection site. The first shot on Jan 11 caused a terrible sore arm that only lasted a day, the second shot on Feb 1 caused a sore arm that lastsd 3 days, then this full body pain began and has not abated (45 days). The pain is spreading now to my quadriceps and my calf muscles and the pain seems to be mostly in muscles or tendons. Someone suggested I had RA but my joints (except wrists) are good. I'm taking Ibuprofen every 4 hours. I did a 5 day blast of 50MG prednisone about 3 weeks ago and that helped a lot, but pain is back and worse.
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| 71 | 2021-03-15 | shingles |
Shingles; This is a spontaneous report from a contactable consumer reported for herself. A 71-years-...
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Shingles; This is a spontaneous report from a contactable consumer reported for herself. A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number Batch/Lot number was not reported, via an unspecified route of administration on 24Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and Concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient experienced shingles (herpes zoster) on 26Jan2021. Outcome of the event was recovered. The reporter considered the events as non-serious. Information on the lot/batch number has been requested.
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| 71 | 2021-03-15 | rash papular, injection site pruritus, injection site redness, injection site rash, injection site discomfort |
originally after the shot I had slight discomfort at the injection site. A week later, I had a red,...
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originally after the shot I had slight discomfort at the injection site. A week later, I had a red, raised, inflamed area--an 8 inch band around my upper left arm, over the injection site. It itched. I also had severe muscle aches in my neck and shoulders. It lasted 2 days.
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| 71 | 2021-03-16 | injection site pain, itchy skin, skin warm |
3/10/2021-Shot given at 9:30 AM. in the afternoon was very tired and achy. Had a headache and gland...
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3/10/2021-Shot given at 9:30 AM. in the afternoon was very tired and achy. Had a headache and glands felt swollen.Took a 2 1/2 hour nap. 3/11/2021- Flu like feeling. Pounding headache, tired, sore muscles, injection site was sore, low grade temperature.( 99.9, 99.5, 100) 3/12/2021- Headache,feeling tried and unwell. Injection site very itchy and staring to swell 3/13/2021-two areas on the left arm are swollen and very itchy. Top swelling in arm near the injection site. Lower swelling is 2 inches by2 inches large 3/14/2021-Swelling in arm increased to 3 inches x 3 inches at the widest spots. Arm was red, hot to the touch and very itchy. 3/15/2021-Swelling in arm was the same. Call Dr. Was told I had " COVID arm"
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| 71 | 2021-03-16 | injection site redness, injection site swelling |
Numbing and tingling around mouth area, lightheadedness, dizziness, slight chills sore throat, tired...
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Numbing and tingling around mouth area, lightheadedness, dizziness, slight chills sore throat, tiredness, slight headache, injection site swelling and redness slight fast heartbeat,Light weakness
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| 71 | 2021-03-18 | itchy skin, hives |
3/8 Red welt with mild itching . Slight arm muscle soreness. Still bothersome 3/19! 3/9 Day after sh...
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3/8 Red welt with mild itching . Slight arm muscle soreness. Still bothersome 3/19! 3/9 Day after shot felt like I'd been hit by a truck. Everything joint & muscle hurt! Better on 3/10.
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| 71 | 2021-03-18 | bruising |
Four days after the first dose of Pfizer on 2/24/2021, got blisters in mouth bleeding, bruises on th...
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Four days after the first dose of Pfizer on 2/24/2021, got blisters in mouth bleeding, bruises on the legs, arms, hands, and shoulder, sore legs, very weak, difficult to sleep.
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| 71 | 2021-03-19 | injection site pruritus, injection site redness, itchy skin, injection site swelling |
A few days after injection low grade fever - 99-100 degrees F, fatigue, severe aching neck and back...
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A few days after injection low grade fever - 99-100 degrees F, fatigue, severe aching neck and back After about 7-8 days intense itching arm, raised red area, swelling at injection site. Still with me today
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| 71 | 2021-03-20 | itchy rash, rash with redness | Itchy red rash about the size of a half dollar on underside of inner left elbow. |
| 71 | 2021-03-20 | injection site pain |
Moderate pain at injection site in right arm. Pain also began in non-injection left arm (site of the...
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Moderate pain at injection site in right arm. Pain also began in non-injection left arm (site of the first injection) about the same time and worsened over about 8 hours. The pain subsided in the left arm, the first injection site, but continued for about 24 hours in current injection site - right arm. Severe body aches, mild headache, chills, fever (101 F), fatigue, no appetite: began about 6 hours after injection and continued for about 30 hours. Temperature normal and symptoms subsided about 48 hours after injection.
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| 71 | 2021-03-20 | hives, injection site mass, injection site rash, itchy skin |
Next day lump and rash at injection site Rash on upper right arm Rash on right wrist Itchy neck. All...
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Next day lump and rash at injection site Rash on upper right arm Rash on right wrist Itchy neck. All but wrist and some neck itchiness gone by day 5. Day 8 lump and rash at site returned. Hives on neck started day 10.
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| 71 | 2021-03-20 | itchy rash |
full body pruritic rash requiring benadryl 25 mg PRN for more than 2 weeks after the vaccine. No new...
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full body pruritic rash requiring benadryl 25 mg PRN for more than 2 weeks after the vaccine. No new laundry detergents, soaps, fabric softeners, deodorant, new medications, new foods. As of today, still present but markedly improved. Nearly resolved.
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| 71 | 2021-03-21 | injection site pain |
Awakened by very loud roaring , tinnitus, in right ear only. Approximate time 0300. Loud noise, ro...
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Awakened by very loud roaring , tinnitus, in right ear only. Approximate time 0300. Loud noise, roaring subsided at approximately 0600. No other side effects other than pain at the site of injection,, left arm. Pain in left arm eased up after two days. FYI:: Patient had contacted COVID-19 in November and had recovered.
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| 71 | 2021-03-21 | injection site hardening, injection site swelling |
Shaking chills, Fever (102.2), nausea, vomiting, mlalaise, head pressure, hard red rash at injection...
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Shaking chills, Fever (102.2), nausea, vomiting, mlalaise, head pressure, hard red rash at injection site, swollen nodes at injection site arm axilla
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| 71 | 2021-03-21 | rash, itchy rash | Tongue irritated, Throat irritated Rash appearing on stomach back upper legs very itchy |
| 71 | 2021-03-21 | rash, itchy skin |
Within 10 minutes I became nauseous. I left the vaccination center and drove home becoming increasin...
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Within 10 minutes I became nauseous. I left the vaccination center and drove home becoming increasing ill. When I got home I went to bed and slept for two days, nauseous, weak, body aches, a rash under the vaccinated arm and on my back left side, headaches, fever, sleep interruption, vivid dreams. The left arm which had been vaccinated was extremely sore and remained so, just recently lessening. I believe I had Covid 19 in February of 2020 and while I got ill, did not experience the severity of illness that I experienced after vaccination. Now, 17 days later I continue to experience weakness, headaches and recently have had difficulty breathing after exercise. Although the rash has gone away, the left side is still itchy, but less so. I have discussed this with my Doctor and he informed me that my response to second shot may be stronger, although he did not tell me to avoid the second dose.
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| 71 | 2021-03-22 | injection site pruritus, vaccination site warmth, injection site redness, vaccination site rash |
A large red, warm, slightly itchy rash appeared around the vaccination site one week after my vacci...
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A large red, warm, slightly itchy rash appeared around the vaccination site one week after my vaccination.
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| 71 | 2021-03-22 | itchy skin, hives, rash | First Itching and later rash and then hives and extreme tireness |
| 71 | 2021-03-22 | injection site redness, injection site pruritus | Headache, chills, fever 100.7, fatigue, itchy redness below injection site. |
| 71 | 2021-03-23 | redness, hives |
First shot didn't feel it. Second shot I have a huge welt, red arm and swollen. Had migraine next d...
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First shot didn't feel it. Second shot I have a huge welt, red arm and swollen. Had migraine next day, low fever, nauseous. Today, March 24, 2021, I have a bump under my left arm - swollen lymph node. Arm is still very red. , I was very fatigue d next day.
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| 71 | 2021-03-24 | vaccination site swelling |
Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk o...
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Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk or get out of a chair); Severe weakness (could not walk or get out of a chair); Nausea; Diarrhea; Mild headache; Blurred vision; Significant swelling at injection site which spread to full upper arm; Significant swelling at injection site which spread to full upper arm; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 05Mar2021 08:00 (lot number: EN6199) as single dose for COVID-19 immunisation. Medical history included osteoporosis (not bothersome), known allergies to some antibiotics, and felt dehydrated. The patient was not pregnant at the time of vaccination. The patient was taking other medications like grapefruit juice. The patient previously received first dose of bnt162b2 on 12Feb2021 (dose number 1, lot number: EL9267, administration time: 08:00 AM, vaccine location: left arm). No other vaccines received four weeks prior to COVID vaccination. On 05Mar2021 12:30, the patient experienced severe weakness (could not walk or get out of a chair), delirium (was convinced that (name) had taken over her body and was the cause of her illness), nausea, diarrhea, mild headache, blurred vision, significant swelling at injection site which spread to full upper arm over next three days and remains troublesome. Other symptoms (unspecified) lessened within two to three days and are no longer of concern. The AEs resulted in doctor or other healthcare professional office/clinic visit. Event 'significant swelling at injection site which spread to full upper arm' were treated with application of steroid cream (for arm only). Outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination.
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| 71 | 2021-03-24 | hives |
chills; hives; headache; extreme fatigue/became very tired/exhausted; Couldn't stay awake; cannot fu...
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chills; hives; headache; extreme fatigue/became very tired/exhausted; Couldn't stay awake; cannot function; This is a spontaneous report from contactable nurse (patient) via medical information team. A 71-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via an unknown route of administration on 12Mar2021 at 11:30 at single dose for COVID-19 immunization in airfield where they build airplanes. Medical history included spleen removed many years ago due to enlargement from the blood disorder. Also had ongoing spherocytosis (States takes B12 and Folic Acid for this condition), ongoing sleep disorder, ongoing narcolepsy, chronic fatigue syndrome. She got pneumonia and respiratory failure after pneumonia vaccine and was hospitalized for 6 weeks. This happened years ago. She was almost died. So she avoids vaccines. Concomitant medications included ongoing methylphenidate hydrochloride (RITALIN) for sleep disorder and narcolepsy (20 years), folic acid for spherocytosis, cyanocobalamin (B12-VITAMIIN) for spherocytosis. No prior vaccinations (within 4 weeks). Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 12Mar2021 at 11:30 (Friday as reported). In the evening she started experiencing some reactions (caller states she got the paper with the side effects and it mentions that they are usually worse after the second dose of the vaccine); chills, hives, headache and extreme fatigue on 12Mar2021. She is still very tired (crippling fatigue) and her headache is not so bad. She felt fine until around 1700 of the same day, when she experienced chills, hives, headache, became very tired, couldn't stay awake and went to bed. The next day she still had a headache, was still tired, hives were gone. At this time, just the extreme fatigue is continuing. States that today she is so tired she cannot function. Also mentions that she did not get a vaccine card from the facility that administered the vaccination. States that she is sorry that she got the product because she has a history of chronic fatigue syndrome and wondered if this would trigger it; but that her doctor said it would not. Caller feels that it has, because she can't function and this is terrible. She was afraid to get the second dose if she felt this crappy after the first one. She had no soreness or anything from the injection. With this amount of fatigue, she is just exhausted. States she has not been seen by her doctor, did not expect her doctor to do anything. A visit to emergency room or physician office was not required for events. Events were reported as medically significant. Specific causality was not provided for each event by the reporter. The outcome of event hives recovered on 13Mar2021; for events headache and fatigue was not recovered; for other events was unknown. Information on lot/batch number has been requested.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the events,chills, hives, headache, extreme fatigue ,somnolence and cannot function cannot be completely ruled out.
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| 71 | 2021-03-25 | skin warm |
About 1 min after Pfizer injection, pt. c/o "heat" across her chest. BP was 140/100, pulse ox 95%, ...
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About 1 min after Pfizer injection, pt. c/o "heat" across her chest. BP was 140/100, pulse ox 95%, pulse 59. Denied SOB. Within 20 mins. all sx had abated. She contacted her doctor that afternoon and was instructed to take BP 3x the next day which she did and reported back to her doctor. Her doctor "doubled" her metoprolol. She has done well since, plans to take the second dose on 3/31/21.
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| 71 | 2021-03-25 | hardening |
Patient states right arm became hard after receiving first dose of Pfizer and is still feels hard wh...
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Patient states right arm became hard after receiving first dose of Pfizer and is still feels hard when she came in for her second dose. She states no pain.
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| 71 | 2021-03-25 | rash |
rash all over; This is a spontaneous report from a contactable consumer. A 71-year-old female pati...
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rash all over; This is a spontaneous report from a contactable consumer. A 71-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 10Feb2021, at 09:45 as single dose for covid-19 immunization. The patient medical history was not reported. There were unspecified concomitant medications. On 18Feb2021, at 08:00 patient experienced rash all over ( this occurred eight days the vaccine was given) and described as terrible rash all over her body. Therapeutic measures were taken as a result of rash all over in the form of prednisone cream. The patient did not have COVID prior to vaccination, and no COVID test post vaccination. The outcome of rash all over was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 71 | 2021-03-26 | injection site pain |
Please note that I have had Covid-19 2 months prior and have since tested negative. Event: Low gr...
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Please note that I have had Covid-19 2 months prior and have since tested negative. Event: Low grade fever 100.5, extreme fatigue, body aches, sore arm at injection site.
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| 71 | 2021-03-26 | injection site pain | Slight nausea, pain at injection site, fever, fatigue, headache |
| 71 | 2021-03-27 | rash, hives, itchy skin |
On March 10th: - Patient woke up with swelling on the lower right side of her lip. - Usual foods eat...
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On March 10th: - Patient woke up with swelling on the lower right side of her lip. - Usual foods eaten that morning: mashed potatoes, milk, cream of wheat - Throughout the day, patient notes she was not feeling well. At 6 PM, she developed rashes on her hip, groin, and abdomen. At 7 PM, she took diphenhydramine 25 mg. By then, her mouth was swollen. Her tongue also started to swell. At 9:30 PM, she had increase itching, burning sensation, and hives worsened. Developed a large rash on her butt. At 10 pm, took a second diphenhydramine; notes she had tongue swelling voice changes (gravel-like quality), and bilateral facial swelling. She was also breathing rapidly. Went into the ER, was checked in after ~3 minutes. She was administered epinephrine IM, IV diphenhydramine, solumedrol 125 mg, and IV famotidine. Patient was also intubated for respiratory distress and airway swelling, and admitted to the ICU. Was intubated until the afternoon of the following day.
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| 71 | 2021-03-28 | redness |
Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swel...
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Anaphylaxis; Respiratory distress; Sensation of throat closure; trouble breathing; Upper airway swelling; Tachycardia; Her tongue started symptomatic; sweating; Generalized erythema; general feeling of unwellness; energy is still very low; Generalized prickle sensation; Nausea; This is a spontaneous report from a contactable consumer (Patient) via telephone. A 71-year-old female patient (non-pregnant) received second dose BNT162B2 (Pfizer, Formulation: Solution for injection, Lot Number: EN9808) administered in Left Arm via an unspecified route of administration on 12Mar2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included Cancer survivor, High BP, Allergies: Shell fish, Allergies: Latex, Allergies: Iodine, urticaria and insect bite/sting allergy, GI sensitivity to all antibiotic, Allergy: surgical scrubs, intestinal reaction to Pneumonia In 2017, (patient had intestinal reaction to Pneumonia Vaccine by (Name) for which she was administered antihistamine, IV Benadryl and Oral Benadryl). On 19Feb2021, patient took historical vaccine BNT162B2 (COVID 19, brand=Pfizer, Lot Number: EN6201) as 1st dose at 12:30 PM on left arm for Covid-19 Immunization and not received any vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. Concomitant medication included hydrochlorothiazide taken for BP medication. The patient was not received any vaccine in four weeks. On 12Mar2021, patient experienced anaphylaxis 5 minutes after the vaccine 2nd dose which resulted to visit emergency room and was treated with EPI, Benadryl, Zophyin, DEX and Pepcid. Started with general feeling of unwellness. Her tongue started symptomatic, sweating, trouble breathing, they took BP they injected 1st dose of Epipen which had no improvement, however after 5 minutes given the 2nd dose and body reacted to Epinephrine. Then given Benadryl injection and transported to a different hospital. Corticosteriod DEX was administered. Patient was under ER observation for 5-6 Hours. On an unknown date in Mar2021, patient also experienced upper airway swelling, respiratory distress, difficulty breathing (without wheeze or stridor), energy was still very low, general feeling of unwellness, sensation of throat closure, her tongue started symptomatic, sweating, trouble breathing, tachycardia, generalized erythema, generalized prickle sensation and nausea. Therapeutic measures were taken as a result of anaphylaxis, respiratory distress, general feeling of unwellness, her tongue started symptomatic, sweating, trouble breathing. The outcome of all the events reported as recovering.
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| 71 | 2021-03-28 | injection site pruritus, injection site redness, injection site swelling |
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at In...
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Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium
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| 71 | 2021-03-30 | itchy skin, dry skin, bruising |
Eye floaters/ doesn't have eye floaters before but now she does/ now she sees it more and it is pret...
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Eye floaters/ doesn't have eye floaters before but now she does/ now she sees it more and it is pretty much every day; Eye floaters/ doesn't have eye floaters before but now she does/ now she sees it more and it is pretty much every day; did the CRP and it was elevated. C reactive protein- elevated; small bruises; Itching; Difficulty chewing; Joint pain; having difficulty walking; Dry skin; This is a spontaneous report from a contactable physician. A 71-year-old female patient received second dose of bnt162b2 (BNT162B2; batch/Lot Number: EN5318; expiration date not provided), intramuscular on 05Feb2021 as SINGLE DOSE for COVID-19 immunisation. Patient's medical history included ongoing 'Diabetes/High sugar/ Diabetes', lymphoma (reported as in remission now) from 2010 and ongoing, 'General wellbeing' from an unspecified date and unknown if ongoing; eye floaters from an unspecified date and ongoing. Concomitant medications included glipizide from Jan2021 and ongoing for 'High sugar'; metformin from an unspecified date (taking for a long time) and ongoing for 'High sugar/ Diabetes', colecalciferol (VITAMIN D [COLECALCIFEROL]) from an unspecified date (taking for a long time) and ongoing; calcium from an unspecified date (taking for a long time) and ongoing; and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) from an unspecified date (taking for a long time) and ongoing for 'General wellbeing'. Patient previously took bnt162b2 (BNT162B2; batch/Lot Number: EL1283; expiration date not provided) on 17Jan2021 for COVID-19 immunisation. The patient experienced joint pain and 'having difficulty walking' (both serious, disabling) and dry skin (medically significant) on 19Feb2021; itching, difficulty chewing, and small bruises (all serious, medically significant) on Mar2021; eye floaters on an unspecified date; and 'did the CRP and it was elevated/C reactive protein- elevated' (non-serious) on 08Mar2021. Patient's clinical course is as follows: a physician reporting on behalf of his wife (patient). It was reported that patient received both doses of the COVID-19 vaccine. Reporter stated that they have side effects to report and wanted to find out how common these side effects are and how long they are going to last. Patient received first dose on 17Jan2021 and second on 05Feb2021. It was reported that the patient has been having joint pain starting from 19Feb2021 and it fluctuates from one joint to another so if the patient's shoulder is affected, the joint pain goes to the other side and then to a different joint such as her knee joint. The pain was continuous, and it doesn't disappear. Reporter mentioned that it gets better with medication but it's still not going away. Regarding patient's treatment, it was reported that in the beginning, patient was taking ibuprofen but now the doctor switched it to naproxen (ALEVE) and also added hydrocodone bitartrate and acetaminophen (NORCO). Reporter mentioned that sometimes not only the patient's joints gets affected, patient also experienced difficulty chewing, but it goes away and then comes back. Patient also had dry skin, itching, and sees eye floaters sometimes. Initially, reporter mentioned that patient doesn't have eye floaters before but now she does, then clarified she has seen it before the vaccine, but now she sees it more and it is pretty much every day. Patient also had small bruises. Reporter just wanted to know if someone can tell him if it's related to vaccine and how long this might last. Seriousness criteria for joint was reported that this is disabling as the patient was having difficulty walking, getting up from the bed from the chair, patient has to use a walker to walk and needs help going to bathroom and taking a shower. It was reported that joint pain has definitely affected patient's normal walking. Reporter also mentioned that he was not exactly sure when the dry skin started but it was around the time the joint pain started. Seriousness criteria for dry skin and itching was reported as medically significant because it does bother the patient. Patient was scratching even in her sleep, even though they use the moisturizer and cream. Reporter clarified it was not debilitating but it does bother the patient. Reporter mentioned that difficulty chewing started over the last few days, on Friday or Saturday. It comes and goes, one day patient might have it in the afternoon, but it goes away in the evening. Reporter added that the eye floaters started more in the last one week. They do not know why this is happening, if it was vaccine related or not. The medicines the patient takes shouldn't be causing these, but they don't know if it was the medicine causing it or if it's the vaccine. Causality for was reported as 'didn't have these issues before, thinks it's related, this is for all the events'. It was further reported that the doctor did the CRP and it was elevated also reported as C reactive protein- elevated on Monday 08Mar2021. Outcome of the events 'small bruises' and 'did the CRP and it was elevated. C reactive protein- elevated' was unknown; outcome of the remaining events was not recovered.; Sender's Comments: Based on temporal association and known drug profile, a contributory role of bnt162b2 to the reported events cannot be totally excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 71 | 2021-03-30 | vaccination site pain |
Headache; fatigue; sore arm; This is a spontaneous report from a contactable consumer (patient herse...
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Headache; fatigue; sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: EL3302), via intramuscular in right arm on 05Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included Migraines and aortic valve insufficiency. Concomitant medications included acetyl carnitine hydrochloride (NEUROTIN), candesartan cilexetil (ATACAND), rosuvastatin calcium (CRESTOR), allopurinol (ELAVIL), topiramate (TOPAMAX) and calcium on unknown date. On 06Feb2021, the patient experienced headache, fatigue and sore arm. Treatment information was reported no. The outcome of the events was recovered on Mar2021. No follow up attempts are possible. No further information is expected.
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| 71 | 2021-03-30 | injection site bruising |
Next morning, bruising (1.5 inches long) on one side of injection site; This is a spontaneous report...
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Next morning, bruising (1.5 inches long) on one side of injection site; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 06Feb2021 16:00 as single dose for covid-19 immunisation. Medical history included none. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]), vitamin d nos (VITAMIN D NOS), ascorbic acid (VIT C) from unspecified date to unspecified date for unknown indication. On 07Feb2021 08:00, The patient experienced next morning, bruising (1.5 inches long) on one side of injection site. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was recovering. Information on the Lot/Batch Number has been requested.
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| 71 | 2021-03-30 | vaccination site redness, vaccination site swelling |
Redness and swelling at injection site; Redness and swelling at injection site; Red bump at the inje...
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Redness and swelling at injection site; Redness and swelling at injection site; Red bump at the injection site; This is a spontaneous report from a contactable pharmacist. A 71-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL3302), first dose administered intramuscularly in the left arm on 27Jan2021 at 09:00am (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and coronary artery disease (CAD). The patient has no allergies to medications, food, or other products. Concomitant medications were not reported. The COVID-19 vaccine was administered at the pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, the patient got redness and swelling at the injection site, and also a red bump at the injection site. It has decreased some but still visible 4 weeks later. The red bump is in the middle of the deltoid, but there was no shoulder involvement. The outcome of events redness, swelling and red bump at the injection site was reported as not recovered.
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| 71 | 2021-03-30 | rash |
Severe rash all over body, admitted to hospital; This is a spontaneous report from a contactable oth...
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Severe rash all over body, admitted to hospital; This is a spontaneous report from a contactable other health professional (HCP). A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via intramuscular route in left arm on 09Mar2021 at 12:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021 for COVID-19 immunization. On an unspecified date, the patient experienced severe rash all over body, admitted to hospital. The patient underwent lab tests and procedures which included computerized tomogram: unknown result on an unspecified date, and sars-cov-2 test: negative on 09Mar2021. The patient received an unspecified treatment for the event. The outcome of the event was unknown.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product, a possible contributory role of the suspect product BNT162B2 to the development of event Rash generalised cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 71 | 2021-04-01 | bruising, redness |
Fever; Headache; Redness; Stiffness; Bruising; Neck pain; pain Swelling/Throbbing; pain Swelling; Th...
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Fever; Headache; Redness; Stiffness; Bruising; Neck pain; pain Swelling/Throbbing; pain Swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER; Solution for injection; Lot number: EL3302, COVID 19) administered in left arm via an unspecified route of administration on 25Feb2021 at 11:30 AM at single dose for COVID-19 immunization. Medical history included Sarcoma cancer (amputated hand), heart failure, patient was allergic to Morphine, nitroglycerin, pertussis, walnuts, corn and bees. Concomitant medications were not reported. On 04Feb2021 at 12:30 PM, patient received first dose of BNT162B2 (PFIZER; Solution for injection; Lot number: EL0142) administered in left arm for covid-19 immunization. No other vaccine was given in four weeks. It was reported that patient was given other medications in two weeks: 15 meds too many to list. On 25Feb2021 at 22:00, patient experienced fever, headache, redness, stiffness, bruising, neck pain, pain swelling and throbbing which resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient received treatment with Meloxicam for 10 days for the events. The patient not had covid prior to vaccination. The patient not tested for covid post vaccination. The outcome of all events was reported as not recovered.
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| 71 | 2021-04-02 | redness, itchy skin |
Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and tur...
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Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and turned bright red; chest congestion with coughing; chest congestion with coughing; Brain fog; fatigue; muscle weakness; nausea; slight diarrhea; Extremely sore arm up into neck; Extremely sore arm up into neck; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 11:00 at a single dose for COVID-19 immunization. Medical history included arthritis and patient was 17 years post endometrial, ovarian cancer, stage 1; she had no known allergies. Concomitant medication included ibuprofen (ADVIL) taken for arthritis. The patient did not have COVID prior vaccination, had no other vaccines in four weeks and was not pregnant. She received the vaccine at a Public Health Clinic. On 15Feb2021 11:45, the patient experienced chest congestion with coughing lasting 45 minutes, brain fog, fatigue, muscle weakness, nausea, slight diarrhea and extremely sore arm up into neck. Twice after the first dose; first onset was 45 minutes after first injection. She also experienced palms of hands itched tremendously and turned bright red, lasting 20-25 minutes. Three days after first dose (18Feb2021). The day of the first injection plus three days after, something happened every day. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified dose in left arm on 11Mar2021 11:00 at a single dose for COVID-19 immunization. The patient has not been tested for COVID post-vaccination. Outcome of the events chest congestion with coughing was recovered on 15Feb2021 12:30, palms of hands itched tremendously and turned bright red was recovered on 18Feb2021 and of the remaining events was recovering.
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| 71 | 2021-04-02 | rash |
Swollen clavicle; small rash; This is a spontaneous report from a contactable consumer (for herself)...
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Swollen clavicle; small rash; This is a spontaneous report from a contactable consumer (for herself). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in left arm on 20Feb2021 14:30 as a SINGLE DOSE for covid-19 immunisation. Medical history included drug Allergies to: Penicillin (Allergies to medications, food, or other products: Penicillin). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Facility where the most recent COVID-19 vaccine was administered was Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced swollen clavicle (non-serious) on 21Feb2021, small rash (non-serious) on 21Feb2021. The patient underwent lab tests and procedures which included X-ray: unknown results on unspecified date in 2021. Therapeutic measures were taken as a result of swollen clavicle (bone swelling), small rash (rash). treatment received for the adverse event: Yes: Methylprednisolone. For events, outcome was not recovered. Information on the lot/batch number has been requested.
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| 71 | 2021-04-09 | skin peeling, rash with redness, redness |
2 or 3 minutes after the vaccine I started feeling really hot. When the nurse came to ask me if I wa...
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2 or 3 minutes after the vaccine I started feeling really hot. When the nurse came to ask me if I was ok I told her that I needed some water. When I was drinking the water I was having problems swallowing. Then I started having problems breathing. I then broke down on a rash my skin was so red it looked like I was sun burned. My skin also peeled. Then I was taken into the emergency room by ambulance. They put an IV on me when I got to the hospital. They put a steroid & pepcid famotidine. They told me if I was not better by the next day to go back. My voice also goes occasionally & I still don't have energy.
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| 71 | 2021-04-11 | itchy skin |
About 4-5 hours after her first shot she started getting and itchy feeling. This carried on for th...
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About 4-5 hours after her first shot she started getting and itchy feeling. This carried on for the next several weeks. She felt like the itching feeling may have improved a little just a couple days prior to her second vaccine, but then the symptoms came back even worse after her second vaccination. She saw her primary care and was noted to be very jaundiced. She was sent to the emergency department where her bilirubin was greater than 12. She ultimately was admitted to the hospital. She had no abdominal pain, nausea, or vomiting. She had persistent elevation of her bilirubin. Workup was done during the hospitalization including lab work, MRI of the liver, liver biopsy. She was also found to have choledocholithiasis on the MRI. ERCP was done with stone extraction. Bilirubin trended down several days later to around seven. She followed up with me in the office where repeat lab work was unchanged.
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| 71 | 2021-04-11 | skin burning sensation | Constant urination, constant dizziness, N/V, burning up all over |
| 71 | 2021-04-17 | cellulitis |
cellulitis; fallen; This is a spontaneous report from a contactable consumer. A 71-year-old female p...
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cellulitis; fallen; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 27Feb2021 (Lot:EN6198, expiry:30Jun2021) as a single dose for covid-19 immunisation; and potassium, via an unspecified route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included ongoing non-ischemic cardiomyopathy. Concomitant medications included atenolol taken for cardiomyopathy, magnesium (MAGNESIUM) taken for an unspecified indication, and furosemide, potassium chloride (LASIX + K) taken for an unspecified indication. The patient was diagnosed cellulitis and was prescribed with cortisone and antibiotics, she was taking 2 antibiotics, named one as Bactrim and unable to name second one, possibly Cefaxin. She was prescribed with prednisone now. She was wondering if the prednisone would interact with the vaccine. Patient had blood work and everything was normal, including new blood tests yesterday. Went off a particular medication, had been on a high dose of Magnesium because she was taking Lasix and Potassium so this test was checking all of that. She hasn't heard back regarding the test yet but is not anticipating any problems. Patient wanted to know if she should take an antibody test to determine if she already gained immunity then she could take her prednisone. It was also reported that about 5 or 6 days before her second shot, which was this past Saturday, she went to her orthopedic doctor and got 2 shots of Cortisone, 1 in each shoulder. Patient had fallen a week before her doctor thought there was a hairline fracture not picked up on the first X-ray. Stated she was supposed to start prednisone and was reading the pamphlet. Patient wanted to know if this would interfere and if taking steroids after the vaccine will interfere with the efficacy of the vaccine. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
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| 71 | 2021-04-23 | vaccination site pain |
Arm felt like lead and could not raise it; Stinging sensation at injection site; felt like it stung ...
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Arm felt like lead and could not raise it; Stinging sensation at injection site; felt like it stung when she received the first dose. She felt it running into her vein.; When she took the band aid off, instead of a spot, there was an area of blood; muscle pain; This is a spontaneous report from a contactable consumer (Patient) self-reported. A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247 and expiry date: unknown), Injected via an intramuscularly route of administration in left arm on 06Feb2021 at 16:15, as a single dose for COVID-19 immunization. Patient medical history included high blood pressure, diminished kidney and family history like her mother had a breast cancer and father had massive heart attack. Patient concomitant medications included as amlodipine (5mg) daily for high blood pressure start date and stop date was unspecified. Patient did not take it prior to getting the vaccine. Patient did not receive other vaccine in four weeks of vaccination. Patient did not get the adverse events prior vaccinations. Patient experienced felt like it was stung" when received the first dose. Patient could feel warm fluid running through vein on 06Feb2021, and stinging sensation at vaccination site on 06Feb2021 at 16:15 and arm felt like lead and could not raise it on 06Feb2021 at 18:00. When she took the band aid off, instead of a spot, there was an area of blood in Feb2021. And experienced muscle pain in feb2021. Patient took an extra strength Tylenol. The outcome of the event felt like it stung and felt it running into vein and Arm felt like lead and could not raise it was recovering and outcome of the event Stinging sensation at injection site, band aid off, instead of a spot and muscle pain was unknown.
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| 71 | 2021-04-24 | redness, shingles |
She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said th...
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She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said this what she has, almost like a fibromyalgia; Shingles became aggravated; she had had broken toe on the other foot that was killing her; total fatigue, no energy at all; total fatigue, no energy at all; abscess on tooth that will be pulled tomorrow; She doesn't have the strength that she had before; This is a spontaneous report received from a contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiration date: UNKNOWN), dose 2 via an unspecified route of administration on 11Mar2021 12:00 as SINGLE DOSE, dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EN620) as SINGLE DOSE for covid-19 immunisation. The patients medical history included ongoing asthma since she was 4 years old, ongoing herpes zoster (Shingles) since Nov2019, Raynaud's phenomenon for 20 years, High anxiety, gastroesophageal reflux disease from 4 years. Concomitant medications included amoxicillin at an unspecified dose taken for an unspecified indication for 7.5 days from 29Mar2021 to 05Apr2021; Advair Disc at an unspecified dose taken for an unspecified indication for maybe 30 years she is prescribed twice a day but takes it only once day, fluticasone propionate, salmeterol xinafoate (PROAIR BRONQUIAL) taken for an unspecified indication from an unspecified start date and ongoing; she had been on this for maybe 30 years, as needed, montelukast sodium (SINGULAIR) taken for asthma from an unspecified start date and ongoing for 30 years, multivitamin, sambucus nigra, sodium, zinc (MULTIVITAMIN, SAMBUCUS NIGRA, SODIUM, ZINC) taken for an unspecified indication from an unspecified start date and ongoing, she says she has been taking this forever because she never ate vegetables, magnesium sulfate (MAGNESIUM SULFATE) taken for bowels from an unspecified start date and ongoing from around 4-5 years as it helps with her bowels, felodipine (FELODIPINE ACTAVIS) taken for an unspecified indication from an unspecified start date and ongoing, for 30-40 years; rosuvastatin calcium (ROSUVASTATIN CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing; calcium, colecalciferol (CALCIUM PLUS D3) taken for bones from an unspecified start date and ongoing for 30 years once menopause started, for bones, famotidine (FAMOTIDINE) taken for an unspecified indication from an unspecified start date and ongoing, says she has been on this for maybe 4 years because she was eating a lot of Rolaids. The patient was also taking for concomitant Products Hair, nail, skin vitamin for hair, nail, and skin health and says her nails are nice and strong, she still has wrinkles, but she says that was part of being old. The patient also said flu shot in Sep2020, pneumonia shot, shingles shot on an unspecified date and had nothing. patient says the first shot was nothing, everything was fine, the second shot she was thinking this is good, everything is good, it was on 11MAR2021 but by 14Mar2021 she was in total fatigue, started to get an abscess on tooth, she doesn't think this was because of shot, she has a prostheses, fake hip, her hip was killing her where the actual bone joint was, she had had broken toe on the other foot, that was killing her, she had no energy at all. She says normally, she is 71 years old, she was very active. She says her doctor takes care of everything, in her case she is asthmatic, everything, he does all of her bloodwork. she has to get this tooth pulled, she had some cadaver teeth put in, she went to the gym, everything was great, all the sudden she has an abscess, she went to her periodontist who says it is bad, it needs to be pulled. She says she was going to get her tooth pulled tomorrow. She reports her shingles seemed to get aggravated, her doctor said she will always have this, when she gets upset, aggravated or anxious it flares up, she is now back on the gabapentin, it is like pins and needles under rib cage where the actual shingles were. She says she was asthmatic but it did not bother her lungs one bit, she did not have any lung issues. She says everything happened on 14MAR2021. She reports that she does find she gets tired, she cooked all day Saturday, she stood over the stove all day, she did nothing but that all day. She says her tooth was bright red, her whole cheek and still, she took the last antibiotics, a heavy dose, last dose this morning too. She reports her foot is not bothering her anymore, her hip is still a little sore. She says she can do 2 miles in the gym, it was hard to exercise with mask on, it is always cold, she can't walk, she's limited to what she can do right now. she said this what she has, almost like a fibromyalgia, she diagnosed herself as having this condition, she Googles it and it says its muscle pain, she doesn't have the strength that she had before, she doesn't have hand strength, stamina, to walk a mile killed her, now she can do 2 miles, she is not 100% of what she was, she's coming along though. prior Vaccinations (within 4 weeks); she got her flu shot in SEP2020; AE(s) following prior vaccinations: She says flu shot, pneumonia shot, shingles shot, and had nothing. The patient was recovering from fatigue and asthenia, not recovered from tooth abscess and shingles and rets of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 71 | 2021-04-24 | shingles |
severe pain across the front of her stomach/ rash/ shingles; severe pain in her head/it hurt to touc...
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severe pain across the front of her stomach/ rash/ shingles; severe pain in her head/it hurt to touch; severe pain in her head, it hurt to touch and had shocks and her whole body would cramp up; her whole body would cramp up; Tourette's; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198, expiration date: 30Jun2021) at the age of 71-years-old, via an unspecified route of administration in right shoulder on 05Mar2021 at 10:30 at single dose for COVID-19 immunization. Medical history included neuropathy in feet caused Tamoxifen (chemotherapy), anal cancer stage IV, breast cancer, double mastectomy, chemotherapy, and lymph node in left arm. Concomitant medications included gabapentin, meloxicam, and vitamins. There were no additional vaccines administered on the same date with the COVID-19 vaccine as well as within 4 weeks. The patient previously took tamoxifen as chemotherapy and experienced neuropathy in feet. The patient received her first COVID-19 vaccine on 05Mar2021 and on 13Mar2021, she experienced severe pain across the front of her stomach. On 19Mar2021, she said she has something, and it was a rash. She went to care facility on 20Mar2021 and was told she has shingles. The patient stated that the doctor just looked at her and said she has shingles, no testing was done. They told her it was ok for her to get the second shot, but she was worried about that. She experienced shingles since 13Mar2021, she still has it. She was supposed to have the shingles vaccine 4 years ago, but it was expensive. Her son heard on the radio that the shot may cause shingles, it may or may not be related but she wanted to let Pfizer know. The rash was starting to go away, and the pain was not, but the pain was far better. She ended up going to the doctor on 24Mar2021 with severe pain in her head since Mar2021, and she didn't know why. It hurt to touch and had shocks and her whole body would cramp up. Her daughter told her she looked like she had Tourette's, it was happening every 2-5 minutes. The doctor couldn't do anything and told her what she could take. It was an additional thing and the doctor said it was probably from shingles but she did not have a rash there. It was completely gone now. She received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiration date: 31Jul2021), via an unspecified route of administration in right shoulder on 26Mar2021 at noon and stated that it was getting better then, and by 27Mar2021 it was gone completely. She was petrified this was going to happen while she was there to get the second vaccine and they would say she couldn't do it. The outcome of the event shingles was recovering and recovered on 27Mar2021 for all other events.
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| 71 | 2021-04-26 | hives, redness, itchy skin |
Blood was coming through; Slight bee stings all over and thigh; Scabs on me; my eyelids have been a ...
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Blood was coming through; Slight bee stings all over and thigh; Scabs on me; my eyelids have been a little itchy too; that was the only way that I am able to get some sleep; was miserable; consumer was in pain; hives; the same day I started to itch, it was mild across my breast and my stomach but my thighs and my bottom legs were turning red, swelling; but my thighs and my bottom legs were turning red/Thighs/Legs turned red; but my thighs and my bottom legs were turning red, swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 71-year-old, via an unspecified route of administration on 10Apr2021 13:30 (Lot Number: EN6207) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included apixaban (ELIQUIS), tamsulosin, and iron. The patient got her first injection on Saturday, 10Apr2021 at 1:30 pm in the afternoon around 7 o'clock the same day she started to itch, it was mild across her breast and stomach but her thighs and bottom legs were turning red, swelling, hives there too, and she rubbed alcohol (treatment) on this to stop the itch, that seems to helped a little bit, but the swelling was not that bad today but the redness was still there. She has scabs on her, blood was coming through, and slight bee stings all over and thigh on an unspecified date, she used hydrocortisone cream (treatment), she was lucky she have some of that here because she keep that when going or here but she rubbed that on last night and that was the only way that she was able to get some sleep. The patient doesn't think that she was going to get the second shot, she doesn't want to experience that again. It feels like that today it was not that bad itching today but at 71 that was miserable yesterday so probably she would not get the second shot. She hopes that the first one can protect her to a point, but she cannot subject herself to that again, that would be senseless for her to experience that again and get a second shot. The patient also stated that her eyelids have been a little itchy too so hopefully you all understand it was 71 years old was suffering from that kind of misery second time. The patient was unable to probe the more question, patient was in pain and not willing to proceed. The outcome of the events was unknown.
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| 71 | 2021-04-28 | vaccination site redness, vaccination site pain, itchy skin |
muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain...
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muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain in left arm; pain in the joints; Red circle around injection site; Weak feeling in arms and legs; body feels heavy; dizziness; Very exhausted; Nausea; Diarrhea; Some cramping in stomach; Brain Fog; Body aches; headache; itchiness; Left arm sore at injection site; anxiety; not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Feb2021 at 15:00 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes diagnosed 15 years ago, obesity, asthma with bronchitis as a child, allergy to other medications, anaphylactic reaction to sulfas twenty years ago (also reported as 50 years ago), muscle hurt/sore arm usually when she got a flu vaccine (unspecified) once a year, allergies to makeup and clothes (diagnosed at least 50 years ago), heart beats fast, low thyroid and borderline high cholesterol. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for 30 years for low thyroid, nebivolol hydrochloride (BYSTOLIC) taken for 25 years, rosuvastatin calcium, (CRESTOR OD) taken for 2 years for borderline high cholesterol and insulin (unspecified). The patient did not receive any other vaccinations on the same day or within 4 weeks of the vaccine. The patient previously took paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as pre-medication since she had allergic reactions to some things and would get this before the flu shot; as well as salbutamol sulfate (PROAIR HFA) for runny nose and coughing. The patient had the first dose of the vaccine on 28Feb2021, and "they" wanted to give her diphenhydramine (BENADRYL) after the vaccine but could not since she was driving. After the vaccination, the patient was not feeling well for 2 days (as of an unspecified date) and thought she was getting better. On 28Feb2021, the patient experienced anxiety. She was more anxious when "that stuff" appeared on the news on day 4 and 5 after the vaccine. She took a small dose of clonazepam 0.5 mg, dividing the pill in 4 pieces as she never took the whole thing. She took it when she got extremely anxious and tried not to take it because it can be habit forming. She may take it 3 times a week or in the middle of the night. It helped a little bit, but she still felt panicky and upset. She woke up feeling anxious. She did not normally take these medications. The patient reported that she experienced headache (constantly several times a week) and left arm sore at injection site, itchiness/ itching all over body (not constant but still happening) from 28Feb2021. On Mar2021 (day 4), the patient experienced dizziness (comes and goes and was not constant like it was), was very exhausted, nausea (tapered off after 2 weeks), diarrhea, some cramping in stomach, brain fog (still struggling and forgets to take her insulin, not as bad as when she first noticed), body aches. At first, the body aches were a pain in the left knee and left elbow and then moved to various joints and muscles. The left knee and elbow pain persisted without ever going away, but also moved to different areas. The calf muscle in left leg pain is also constant. The patient experienced pain in the joints and stinging pain in left leg (below knee down to ankle) from 04Mar2021, runny nose (tapered off) from 07Mar2021, and on an unspecified date muscle pain, back pain, fever, neck pain, pain in left arm. On Mar2021 (two weeks after vaccination), the patient had a red circle around injection site not all the way filled in, but rim around where she got shot. On Mar2021 (3 weeks after vaccination), the patient experienced a weak feeling in arms and legs and other times when she stood up her body felt heavy (persistent but not every day). The patient spoke with her physician who did not believe the patient about the symptoms and recommended she seek psychiatric help. The patient had not received the second dose of the vaccine because her physician did not recommend it. She was upset because her physician told her she could not get the second shot. She was having worsening anxiety because she had not been feeling well for so long, going on 7 weeks. She visited her physician's office 6,7, or 8 times. The patient underwent lab tests and procedures on unspecified dates which included an ultrasound of the leg (did not have a blood clot), an X-Ray of the back (unknown results) and an MRI of the back (did not find anything) to determine the pain. The physician thought it might be a compression fracture, but the MRI did not show anything. The patient was tested for antibodies on 05Apr2021 and had zero antibodies. The clinical outcome of anxiety, felt panicky, neck pain was unknown; dizziness, headache, runny nose, itchiness, pain in the joints, muscle pain, back pain, fever, very exhausted, nausea, diarrhea, some cramping in stomach, brain fog, body aches, stinging pain in left leg / pain in left arm, weak feelings in arms and legs, body feels heavy, left arm sore at injection site, red circle around injection site, not feeling well, was resolving. No follow-up attempts are needed. Information on lot/batch cannot be obtained.; Sender's Comments: Linked Report(s): same patient, different vaccine dose/event
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| 71 | 2021-04-30 | hives |
noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remem...
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noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; Large brown circle surround site of shot; bruising surrounding it; some welting. Some tenderness; some welting. Some tenderness; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:30 (at the age of 71-years-old) (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunisation. Medical history included, neuropathy peripheral, drug hypersensitivity, diarrhoea, vision blurred blurred/double vision since Feb, hypertension Mild high blood pressure. Drop in blood pressure and increase in blood pressure month after Covid, chills, MGUS, non symptomatic ascending aorta aneurysm, pronounced cough, fever, sore throat, flu symptom. I had the virus on 30Nov after being unknowingly infected with virus by someone unknowingly with virus, some 8 feet away, with no direct interaction. Experienced fever 4 days later. tested. Virus positive. Excessive flu symptom-pronounced cough, fever, sore throat. treated w/antibodies some 8 days later. The patient received first dose of BNT162B2 for COVID-19 immunization on 10Mar2021 ({Product=COVID 19, brand=Pfizer, Lot number=EN6199, Lot unknown=False, Administration date=10Mar2021, Administration time=12:30 PM, Vaccine location=Left arm, Dose number=1}]. Concomitant medication included hydrochlorothiazide, lisinopril (ZESTORETIC); bupropion hydrochloride (WELLBUTRIN); naproxen (NAPROXEN). Large brown circle surround site of shot, with additional bruising surrounding it. Not noticed until 18 days after 2nd shot, some welting. Some tenderness. Don't know when first appeared, does not appear to be fading. No reaction after first shot. (There was sudden unexpected loss of consciousness after sudden slumping. Wednesday eve before noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes. Mild concussion with symptoms. Amnesia at time of loss of consciousness. Do not know if two are related. Deep brown circle on left arm noted 2 day later. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Nov2020. The outcome of the events was not recovered.
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| 71 | 2021-05-12 | skin burning sensation |
Continued skin burning sensation/ she felt like she was on fire/ she felt like she has the worse sun...
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Continued skin burning sensation/ she felt like she was on fire/ she felt like she has the worse sunburn but can't see it; This is a spontaneous report from a contactable consumer. A 71-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL9269; expiration date: 31May2021), via an unspecified route of administration on 17Feb2021 at 13:45 in left arm as single dose for covid-19 immunization. The patient's medical history included hypertension, elevated cholesterol and allergies to medications, food, or other products like sulfa, cipro and macrodantin. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's historical drug included ciprofloxacin from Mar2018 to Mar2018 for which she had a similar experience (she had a fever and checked her temperature several times. She feels like she has the worse sunburn but can't see it. She does not have a rash). After she stopped taking it, the symptoms disappeared. Unless she takes Benadryl, she feels this way. Her doctor didn't want her to stay on Benadryl. In Mar2018, she took Cipro for 3 days straight before she noticed it. She called her doctor and was told to stop taking it immediately. The patient's concomitant medications included losartan, amlodipine and atorvastatin: all has been taking for several years and was ongoing. As per the context, it was reported that all was well until she woke Friday night. On 19Feb2021 at 02:00 AM the patient experienced continued skin burning sensation with no fever or rash for one week, only temporary relief with benadryl, she felt like she was on fire. She felt like she has the worse sunburn but can't see it. She thought she had a fever and checked her temperature several times. Her temperature was normal. She felt like she had the worse sunburn but can't see it. She does not have a rash. There was no emergency room or physician office visit. She was concerned about taking the second dose on of the Covid-19 vaccine which was due on 10Mar2021. She found in her research from a Dr with the Coronavirus Task Force where he talked about allergic reactions. This was listed as an allergic reaction versus a side effect. It mentioned that there was a higher risk for the same thing happening with the second dose. They don't think that it is related to the vaccine but instead to an additive to help stabilize the vaccine. The outcome for all the events was not recovered/not resolved. Follow-up attempts are needed. Further information is expected.
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| 71 | 2021-05-12 | shingles |
Shingles; This is a spontaneous report from a contactable Nurse (Patient). A 71-year-old female pati...
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Shingles; This is a spontaneous report from a contactable Nurse (Patient). A 71-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection; Lot Number: EL9264, Expiration date: 05May2021), via an unspecified route of administration, on 05Feb2021 (at the age of 71 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no other products, patient history and investigation assessment. Caller was due for her second dose on Friday. Caller had been diagnosed with shingles and was taking Valtrex. Caller wanted to know what to do about the second dose in regards to her shingles diagnosis. Caller wanted to know what to do about getting the second shot of the covid 19 vaccine because she was taking Valtrex. She received her first injection Friday 05Feb and then last week she came down with shingles which was adult chicken pox. She was currently taking Valacyclovir which was generic Valtrex, 3000 mg per day and she was finishing that on next Wednesday the 24Feb. Her question was and she asked, neither her PCP nor pharmacist was able to answer this. She wanted to know was she still able to get the second dose this coming Friday. Her shingles began last Wednesday (17Feb2021). She told it was still ongoing, she was still on the medication until this coming Wednesday. It was improved. No further information provided. Regarding product details she told the card had little, tiny writing. She did not see an NDC Number and dose was unknown to the patient. The patient received treatment for the event Shingles with Valtrex. The outcome of the events was recovering. The reporter assessed event as serious and told the shingles was not directly related to the vaccine.; Sender's Comments: Based on the information provided, the reported shingles is likely an intercurrent condition that is unrelated to BNT162B2.
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| 72 | 2021-01-06 | itchy skin, rash, itchy rash |
extremely stiff neck for 4 days; itching on back and shoulder area for 2-3 days, swelling of the eye...
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extremely stiff neck for 4 days; itching on back and shoulder area for 2-3 days, swelling of the eyes for 2-3 days; itchy rash on medial aspect of vaccinated arm for 2-3 days
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| 72 | 2021-01-07 | injection site pain |
Day of injection - sore injection site Day 1 post injection - headache, nausea Day 2 post injection ...
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Day of injection - sore injection site Day 1 post injection - headache, nausea Day 2 post injection - nausea Day 3 post injection - increasing nausea, gas Day 4 post injection - Loose stool x 7, gas, nausea
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| 72 | 2021-01-13 | vaccination site pain |
Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to...
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Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to her elbow; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; Nausea; total loss of appetite; stated that she gained 10lbs, but she is very physically active.; either not making blood or there was an interference; she was freezing/she woke up cold and could not get warm/ felt cold; she had a little headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: Mar2021), intramuscular at left arm on 31Dec2020 at single dose for covid-19 prophylaxis. Medical history included low sodium, Covid-19 in Nov2020 (She had felt sick for a week and on 13Nov2020 she went to the ER and they did blood tests and she could not eat or drink for 3 days. She stated that she had 4 different IV fluids going and one of them was sodium and the other was for nausea), blood did not clot properly, broke her back. There were no concomitant medications.The patient had a unique reaction after receiving the Covid-19mRNA Vaccine. She clarified that she never had a reaction to a shot before. She received the vaccine on 31Dec2020 and was fine for the first 20 hours. She said that the next morning on 01Jan2021 at 0600 she woke up cold and could not get warm. She said that she spent the next 24 hours to where she kept adding clothes and blankets to keep warm. She stated that she was freezing and the she felt like the interior of her body was freezing even down to her toes felt cold. She also had injection site pain and the arm felt heavy and stated that the pain extended from her shoulder down to her elbow. She stated that the injection site pain was kind of delayed. She had aches and pains. She said that some of the pain went from the injection shoulder and spread to the middle of her spine. She had nausea and total loss of appetite and could not even eat. Her aches and pains after the vaccine were similar aches like she had with the Covid. She said that she had a terrible headache when she had Covid though. She stated that after the 24 hours of receiving the vaccine she had a little headache, but she took a migraine pill for it. She said that she was able to shed clothes, but she could not take a shower, but within 24-36 hours she was back to normal like it all never happened. She said that was when she figured out it was like her hemorrhaging with one of her childbirths. She explained that she had 3 children and hemorrhaged with each of her child births and was going into shock with one of them and felt this freezing sensation due to blood loss. She thought that her reaction to the vaccine was so bad that she was either not making blood or there was an interference. There was some kind of weird interruption. She said that her blood clots break down from minutes to hours after her child birth or with dental procedures. She had a PAI-1 deficiency or Plasminogen Activator Inhibitor-1 deficiency. She said that there was also something deeper that her doctors had not figured out yet too. She said that her blood did not clot properly. She said that she did not bruise or anything, but she was not allowed to have internal surgery without a transfusion. She said that her doctor's started to figure this all out after she broke her back before. She went to a hematologist and had her counts checked regularly. She said that she was being studied by 127 different clinics. She gained 10lbs, but she was very physically active. This was her first dose of teh vaccine. She said that her doctors told her that she needs to be under 48 hours of observation if she gets the second vaccine. Her primary care physician recommended that she did not take another mRNA vaccine. She said that she was taking their advice and canceled her second dose appointment. She said that when she had Covid-19 they did a Chest x-ray on 13Nov2020 and she had low sodium. She said that they gave her tramadol at the hospital for her headache, but she had already taken 3 migraine pills that day. She had already had her flu shot and read somewhere on a website, that mRNA vaccines might cause unstable anticoagulation. She wondered if it could be possible that Covid-19 antibodies interfered with her injection? The outcome of events was unknown.
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| 72 | 2021-01-13 | rash | Large pink circle (2.5 inch diameter) developed 6 or 7 days post injection. |
| 72 | 2021-01-13 | injection site pain | Moderate pain at injection site lasting 2 days |
| 72 | 2021-01-13 | skin discolouration |
No reactions immediately after vaccine was given. Resident has dementia, has had multiple hospitaliz...
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No reactions immediately after vaccine was given. Resident has dementia, has had multiple hospitalizations related to a renal stone recently. Had a tooth that was bothering her, went to see her dentist and it was extracted on 1/6/21. On 1/10 they noted feet and ankles are dark purple with white splotches appears to be mottling. Minimally responsive to voice and touch. Not eating. Compassionate visit with family. Family did not want hospice, did not feel it was needed, said, what more could they do for her than you're already doing? On 1/11 at 1950 was determined to be deceased.
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| 72 | 2021-01-14 | rash, itchy skin |
2:15PM headache 10:30PM. Rash and itch on face trunk and under arms ...
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2:15PM headache 10:30PM. Rash and itch on face trunk and under arms Dry scratchy eyes , hazy vision Took Benadryl 25 mg at 10:45PM 1/15/2021. 9AM Rash subsided itch persists and eyes remain dry, scratchy and hazy vision gone 10 AM went to Dr
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| 72 | 2021-01-14 | injection site swelling, injection site pain |
The text phone contacts to me have not worked for past two days. My symptoms now are fatigue, genera...
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The text phone contacts to me have not worked for past two days. My symptoms now are fatigue, general achy joints and muscles, slight swelling and pain at the injection site. I am fine but need help with the survey sent via text does not work. Unable to "Do your weekly post-vaccination check in".
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| 72 | 2021-01-14 | hives | in about 30 minutes after shot, hives began. They continue for 3 days - stopped now |
| 72 | 2021-01-17 | injection site mass |
After waking in the AM of the following morning after vaccination, felt total exhaustion and weakne...
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After waking in the AM of the following morning after vaccination, felt total exhaustion and weakness, unable to function with morning duties, left arm sore with a notable lump approximately 2 inches wide. Able to lie down and sleep for about an hour; awoke and felt better. Took two 200mg ibuprofen and laid down again. Within an hour of rest, felt awake with no weakness or exhaustion. Arm was less sore; however placed a warm heating pad on arm throughout the day which improved the lump and soreness.
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| 72 | 2021-01-17 | skin warm, redness |
Patient received her shot at 9:36am. She walked out to her car and got hot in the face and noticed i...
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Patient received her shot at 9:36am. She walked out to her car and got hot in the face and noticed it was red. She came back in. She stated her lips were tingling. Dr gave her 25mg of benadryl. She stated she had a past reaction of steroids with flushing/redness. Her blood pressure was 176/106 and a pulse of 91. The patient stated after 15 minutes of the benadryl that she felt better. Her husband was going to drive her home since she took a benadryl, and she stated she was already getting sleepy.
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| 72 | 2021-01-19 | itchy skin |
Per RN, patient reported tingling fingers and itchy palm on R arm during 15-minute observation perio...
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Per RN, patient reported tingling fingers and itchy palm on R arm during 15-minute observation period post-Pfizer COVID-19 vaccine (Lot # EL1283). Diphenhydramine 25 mg PO administered. No additional symptoms observed. Patient discharged ambulatory in NAD.
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| 72 | 2021-01-20 | injection site discolouration |
3" diameter black mark approx. 180 degrees from the vaccination site. No pain, or swelling experien...
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3" diameter black mark approx. 180 degrees from the vaccination site. No pain, or swelling experienced.
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| 72 | 2021-01-20 | itchy skin |
Community member receiving covid vaccine c/o abd discomfort and urge to defecate with left arm itchi...
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Community member receiving covid vaccine c/o abd discomfort and urge to defecate with left arm itching (vaccine receive in right arm). Escorted to bathroom without incident, no rash noted to either arm. Escorted back to monitoring area where approx 15 min later she continued to c/o abd discomfort and "crumminess." ED Charge RN contacted, ED staff transported patient via wheelchair to ED.
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| 72 | 2021-01-22 | rash, itchy skin, hives | Rapid heartbeat, rash, hives, itching, felt flushed, no fever. I still have mild symptoms. |
| 72 | 2021-01-24 | itchy skin |
1 week after the shot, I started itching from head to foot. No outward rash, just non-stop itching....
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1 week after the shot, I started itching from head to foot. No outward rash, just non-stop itching. A little nausea at times. I took benadryl which helped a little for a short time.
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| 72 | 2021-01-24 | injection site pain | Chills Body Aches Soreness at Injection Site |
| 72 | 2021-01-24 | injection site pain | Injection site pain, tiredness, muscle ache, chills, fever 100.1 |
| 72 | 2021-01-24 | rash | Localized rash 1 day after vaccine on 1/22/21. |
| 72 | 2021-01-25 | vaccination site itchiness, vaccination site redness |
redness and itching at the injection site; redness and itching at the injection site; The vaccine ad...
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redness and itching at the injection site; redness and itching at the injection site; The vaccine administrator missed the main deltoid muscle. maybe it was a SQ injection; This is a spontaneous report from a contactable Nurse reporting for herself. A 72-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine , subcutaneous in the right arm on 11Jan2021 09:00 at single dose for covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient stated that the vaccine administrator missed the main deltoid muscle. maybe it was a sq injection on 11Jan2021 09:00. The patient reported she experienced redness and itching at the vaccination site on 13Jan2021 with outcome of not recovered. Further information has been requested.
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| 72 | 2021-01-26 | skin warm |
Severe Headache - for 2 days and took Tylenol, Face Swelling - for 1 day and took Benadryl, ...
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Severe Headache - for 2 days and took Tylenol, Face Swelling - for 1 day and took Benadryl, Diarrhea - for 1 day, Arm swollen and hot, - for 1 day, Body muscle pain - for 3 days
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| 72 | 2021-01-26 | itchy skin, vaccination site pain |
extreme chills; neck is aching; right arm pain; the pain prevented her from sleeping; Itching; This ...
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extreme chills; neck is aching; right arm pain; the pain prevented her from sleeping; Itching; This is a spontaneous report from a contactable consumer report self. This 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at right arm on 12Jan2021 15:30 at single dose for covid-19 immunisation. Medical history included had COVID back in Nov2020, blood cholesterol abnormal. Concomitant medication included Pravastatin for blood cholesterol and unspecified water pill. No prior vaccinations within 4 weeks. No additional vaccines administered on same date. Patient received Pfizer covid vaccine on 12Jan2021 around 15:30. Her right arms started getting in pain about 11pm and the pain prevented her from sleeping most of the night till she took an Aleve around 6am. She took another Aleve on 13Jan2021. She can barely raise her right arm and it is ok if she does not try to use it but if she tried to use her right arm then it is inoperable. At 12Jan2021 night after she got the vaccine she experienced itching, she never got a rash, the itching never got bad and it went away. She has not taken her temperature. She was having extreme chills that started around 13Jan2021 3:00 pm and she cannot get warm, she has blankets piled on her. Her neck is aching (started 13Jan2021 afternoon) and she thought this may be from tensing up since she is cold. No emergency room or physician office visit. The outcome of "Itching" was recovered, of else events was unknown. Information on the lot/batch number has been requested.
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| 72 | 2021-01-27 | injection site pain, rash macular, hives, redness |
1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day he...
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1st day after Vaccine, soreness on injection sight. 3rd day Fatigue and light headiness, 4th day headache, nausea, mind fog and imbalance, 6th day ulcers on my tongue, very painful for 3 days, severe crippling muscle cramps in my toes on my right foot during the night while sleeping. hives and red blotches. I didn't feel like myself for at least 12 days after the vaccine. I'm a little nervous about today, 01/28/2021, I took my 2nd dose this morning. Hope I don't have to report anything on the 2nd.
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| 72 | 2021-01-27 | bruising |
Bruise; Pain; Have horrific pain in back of my neck and head into my neck and not a headache; I can'...
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Bruise; Pain; Have horrific pain in back of my neck and head into my neck and not a headache; I can't turn my neck; Have horrific pain in back of my neck and head into my neck and not a headache; I can't turn my neck; wondering hurts to open my mouth and swallow; wondering hurts to open my mouth and swallow; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 23Dec2020 at a single dose on upper left arm for COVID-19 immunization. Medical history included Heart stents, Lupus, Type II Diabetes, rheumatoid arthritis (Autoimmune disease), anticoagulant therapy, cardiac disorder. Concomitant medication included clopidogrel for "My heart, it's a blood thinner", carvedilol, lisinopril, and amlodipine besilate all for heart related, hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for rheumatoid arthritis, rosuvastatin, semaglutide (OZEMPIC) for type II diabetes, citalopram, cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), moringa oleifera (MORINGA [MORINGA OLEIFERA]), and unspecified blood thinners. The patient stated, "I received the Pfizer immunization for COVID-19 on 23Dec2019 (later confirmed), and I am due to have my second dose this week and I was fine and I had just some size a small bruise. But I'm on blood thinners (further clarified and captured in medical history, hence not captured as suspect product in the tab), so I didn't think anything of it and a little pain but it went away. And then, this past Monday, which is into my third week, I have a horrific pain in the back of my neck and head into my neck and it's not a headache. It's pain and it's in the back of my head and into my neck and I can't turn my neck, right or left or up or down. It hurts to open my mouth, and it almost hurts to swallow and I am wondering if this is a reaction, so they have a delayed reaction. Is this swollen lymph nodes?" The patient stated, "I had lab work done this past Monday. I have no results yet." Therapeutic measures were taken as a result of bruise, pain, have horrific pain in back of my neck and head into my neck and not a headache; I can't turn my neck, wondering hurts to open my mouth and swallow which included ice packs and Aspirin. The outcome of the events was unknown.
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| 72 | 2021-01-27 | rash macular, hives, itchy skin, redness, skin burning sensation |
Woke up at 6 am to the trunk of my body, mostly left side and spinal area very itchy. It was complet...
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Woke up at 6 am to the trunk of my body, mostly left side and spinal area very itchy. It was completely RED, burning & itchy. All Red. I waited 2 hours and it was not diminishing, took 2 Benadryl tablets. After 7 hours, the redness was disapating but I could see blotches of red hives (again mostly left side) which are mostly still there at 7:45 tonight. Still itchy but not AS itchy. Through all of this my temperature remained between 97.4 and 97.7 which is my normal body temperature. The highest my temperature reached after the 2nd vaccine was 99.3 on 1/26/21.
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| 72 | 2021-01-29 | hives, rash, itchy skin | HIVES, RASH, AND INCHING |
| 72 | 2021-01-29 | vaccination site rash, itchy skin, rash with redness, vaccination site warmth, vaccination site pain |
Itchy red rash developed around vaccine site five days after vaccine; c. 4 in. diameter Also, feve...
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Itchy red rash developed around vaccine site five days after vaccine; c. 4 in. diameter Also, fever and redness and soreness at vaccine site 1-2 days after vaccine
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| 72 | 2021-01-31 | bruising |
Bruising on my face, it is visibly notable they are so many around and above the eye also; Bruising ...
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Bruising on my face, it is visibly notable they are so many around and above the eye also; Bruising on my face, it is visibly notable they are so many around and above the eye also; This is a spontaneous report from a contactable consumer (Patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 18Jan2021 at single dose for Covid-19 Vaccination. Medical history included had major concussion in May2020. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN). The patient was noticing some what looks like bruising on her face, it was visibly notable they were so many around and above the eye also on 18Jan2021. The patient was going to put ice on it. The bruising was appearing where she had major concussion in May2020. The patient was breathing ok, didn't have racing heart, didn't have fever nothing on the big one. No lab work done. The outcome of the events was unknown.
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| 72 | 2021-01-31 | redness |
Headache, upset stomach, nausea and diarrhea, and her face was sunburn red and started Friday the 29...
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Headache, upset stomach, nausea and diarrhea, and her face was sunburn red and started Friday the 29th and still sick. throwing up every 15 to 20 mins. Called Dr. on Sunday and was told to take aspirin and Tylenol
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| 72 | 2021-01-31 | vaccination site redness, skin burning sensation, itchy skin |
Itching/itchy/back was itching like crazy; her shoulder and it was red and it looked like a hive/lik...
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Itching/itchy/back was itching like crazy; her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine; her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine; Slight, dull headache; son sprayed her back with a fragranced alcohol and and it started burning; she thought it was a mosquito bite; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), intramuscularly on 06Jan2021 at about 13:00 at single dose in Left arm for COVID-19. There were no medical history and no concomitant medications. She was not allergic to anything. The patient previously took shingles vaccine for immunization before. The patient reported that in the middle of the week (in Jan2021) she started feeling itchy. She said that she did not take anything and never took the flu shot. She was itching so bad last night (on 17Jan2021) she was going nuts. Her doctor told her get BENADRYL. She looked at her shoulder and it was red and it looked like a hive. She said that 5 minutes later and it went away without her taking her BENADRYL. She took the BENADRYL dose that she picked up from and that put her out. She stated that she took 10ml. She was a little itchy. She stated that if you look at the area on her shoulder, it was like pinpoint little dots now and you can barely see it. She said that this happened in the same shoulder where she received the vaccine. She said that she w supposed to get the next one next Wednesday. The patient asked if this was a side effect or just a coincidence. She stated that her symptoms started about a week after the shot sometime, but she did not know the exact day. It was around 13Jan2021 or 14Jan2021. It happened in a matter of seconds and she thought she was seeing things, then it went away. It was red and raised and was gone within 5 minutes at the most. It was weird. She said that she thought it was a mosquito bite. The patient stated that her back was itching like crazy. She stated that she put alcohol on it and it went away. Her son sprayed her back with a fragranced alcohol and it started burning. She also had a slight dull headache in Jan2021 and she had never had that in her life. The outcome of events her shoulder and it was red and it looked like a hive/like pinpoint little dots/this happened in the same shoulder where she received the vaccine was recovered in Jan2021. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 72 | 2021-01-31 | rash |
On day following shot, I became achy all over, had a headache and slight fever. I went home from my ...
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On day following shot, I became achy all over, had a headache and slight fever. I went home from my shopping trip, took a 3 hour nap. I felt worse so I went to bed and slept 14 hours. I felt better Saturday morning. That evening I noticed a rash on both legs, from ankles to my knees. It is still there, though it doesn't itch or make me feel sick.
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| 72 | 2021-01-31 | rash papular, itchy skin |
it hurts a little bit if she touches it; arm got red and it was little bump and then it spread and g...
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it hurts a little bit if she touches it; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen/It is a big red mark, probably the size of a lemon; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen; felt like she was going to come down with something, she didn't feel right; This is a spontaneous report from a contactable consumer (patient) reported that a 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at a single dose as the patient don't want to have COVID. Medical history included arrhythmia, mitral valve prolapse, acid reflux, high cholesterol, and heart murmur; all from an unknown date. Concomitant medications included verapamil, rosuvastatin, pantoprazole, estradiol (ESTRACE), and acetylsalicylic acid; all were taken from an unspecified date for an unspecified indication. The patient had the first dose of the vaccine 3 days ago (13Jan2021) and stated that her arm got red and it was little bump and then it spread and got itchy, and it was a little swollen on 14Jan2021. She also felt like she was going to come down with something, she didn't feel right. It is not swollen today (16Jan2021) but it hurts a little bit if she touches it. It is a big red mark, probably the size of a lemon. The patient took Tylenol, Zyrtec, and put ice on it all last night (15Jan2021), and it became little itchy and this morning (16Jan2021) it's little itchy, still red but the bump is gone. The patient was asked if she still experiencing the events and she stated that the bump was gone, but now it's like red and a little itchy, the red got bigger, it was also like she was coming down with something but so far today she feel okay. The patient underwent lab test with an unknown results on an unspecified date. The outcome of the event 'it hurts a little bit if she touches it' was unknown; event 'it was a little swollen' was recovered and not recovered for the rest of the events. Information on the batch number/lot number has been requested.
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| 72 | 2021-01-31 | vaccination site pain, vaccination site itchiness, vaccination site swelling |
left arm where the injection was, was swollen and itchy and painful most of the night; left arm wher...
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left arm where the injection was, was swollen and itchy and painful most of the night; left arm where the injection was, was swollen and itchy and painful most of the night; left arm where the injection was, was swollen and itchy and painful most of the night; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on left arm on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of Pfizer-Biontech Covid19 vaccine yesterday (15Jan2021). She was reporting symptoms that started yesterday evening at 21:00. On her left arm where the injection was, was swollen, itchy and painful most of the night and hurts even when she's not moving it. She wanted to know if this is normal, how long does it last and what she can do to treat it. She doesn't know if she can put icepack on it or take a shower. She asked if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 72 | 2021-02-01 | vaccination site pain |
dizziness; aches; fever; sniffles; pain at injection site; This is a spontaneous report from a conta...
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dizziness; aches; fever; sniffles; pain at injection site; This is a spontaneous report from a contactable health care professional (patient). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested) via an unspecified route of administration on 13Jan2021 at 07:00 PM on the left arm at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergies to eggs both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not have COVID-19 prior to vaccination. It was reported that on 14Jan2021 at 07:00 AM, 12 hours after the vaccine, the patient experienced dizziness, aches, fever, sniffles and pain at injection site. The outcome of the events was recovered on an unspecified date in Jan2021. The patient did not receive any treatment for the events. The patient has not been tested for COVID-19 post vaccination. Information on the lot/batch number has been requested.
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| 72 | 2021-02-01 | itchy skin, skin warm, redness |
right after shot, month/lips tingling , fast heart beat, lasted about 4 hours, next day starting itc...
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right after shot, month/lips tingling , fast heart beat, lasted about 4 hours, next day starting itching but no rashes, still have some fast heart beat but not like first day. Still itching and every day my face gets real red and hot for about an hour maybe twice a day
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| 72 | 2021-02-01 | itchy skin, itchy rash, hives |
she got it Thursday and that night she noticed a little itching/itching a little again in the palm o...
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she got it Thursday and that night she noticed a little itching/itching a little again in the palm of her hands; some face soreness; her BP was 152/85 that was high; she has to got the rash on her behind where she has been scratching; having an allergic reaction; a little puffiness on her lip; the cellulitis part of her skin; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3247), via an unspecified route of administration on 14-JAN-2021 at the 72 years old at single dose for COVID-19 immunization. The medical history included COPD so sometimes she would cough, kidney stent, rheumatoid ("two" Tylenol and 20 mg prednisone for "her rheumatoid"). The concomitant medication was clarithromycin (MACROBID) from an unspecified date to 12Jan2021. The patient got it on the 14Jan2021. She says she had been doing fine she didn't know now. She was a retired paramedic so she usually felt things out, she got it Thursday and that night she noticed a little itching on 14Jan2021 but she did not think anything of it. Friday evening she had a good time eating some walnuts and she woke up about 2:30 itching that was Saturday morning before day, she took Benadryl and went back to sleep later then later on she was itching a little again in the palm of her hands and she just took a Benadryl and it went away. Then Sunday night, last night, she was okay so she decided to go to the pharmacy to get some Benadryl, they had no Benadryl and she only had old Benadry. Then about 12:30 she started itching on her bottom, itching on her arms and she was scratching. She noticed she was having some face soreness in Jan2021 but she was using some expired facial cream so she thought that was why her face was sore so she put some hydrocortisone cream on it. Since she was itching she decided to take a little of her nieces Benadryl, it is pediatric Benadryl. She was itching so she called her doctor and she heard him in the ER say they had too many people in there to tell her to go to the ER so she said okay. She hung up and called the pharmacy and they said it sounds like having an allergic reaction in Jan2021 and she told him she had the COVID vaccine but she doesn't think she was short of breath and she gave them her vitals her BP was 152/85(BP 157/85) that was high for her in Jan2021, but it came down, she took some Tylenol then it was 146/77, her pulse rate was 77 and her respirations were good she did not have shortness of breath or cough well she has COPD so sometimes she would cough. Then she got up and said let me go one over and get some Benadryl so she went by there got some good Benadryl and she thought she would call and see what they think about all this. She took the Benadryl at 10:25 and she is doing okay right now but she had whelps, she has to got the rash on her behind where she has been scratching in Jan2021, it is on the left side of her hip, the cellulitis part of her skin that is mostly where she is itching in Jan2021. She remembers when she worked at the health department they would give Benadryl and Prednisone. She thought if the Benadryl does not help then she would call, then she decided she would go ahead and call to see what information they have. She says Pfizer is giving her alerts that she has been answering but she did not have the itching at that time. She retired from being a paramedic in 2009. She says she is 72 now but she woke up in 1985 and her lip was swollen like not totally swollen but her top lip was swollen more than the bottom in Jan2021. They gave her an Epinephrine shot and Benadryl and she is just wondering if this itching is related to the vaccine or if it is just an allergy that she may have come up on or something like to the walnuts or something. She says they went there and they gave the shot and they gave Benadryl but they are not sure. She said the doctor never figured our what it was that cause it and it never happened again until she did notice a little puffiness on her lip again this morning. She said the itching first started around 2:34 AM in the morning before light. It had improved since taking up to date Benadryl. She was supposed to get her second dose 04Feb2021. She didn't want COVID 19. She knew she just came off, she had a kidney stent and she had stopped taking 2 days before, she was taking Macrobid. She was not taking that right now. She took a lot of other medications but the Macrobid she was just on and it was stopped on Tuesday 12Jan2021, 2 days before the vaccine. She didn't know if the Macrobid would interfere with getting vaccine. The outcome of the event itching was recovering, the other events was unknown.
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| 72 | 2021-02-02 | rash with redness |
I woke up in the middle of night with extreme body heat and the next morning I had a beer red rash f...
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I woke up in the middle of night with extreme body heat and the next morning I had a beer red rash from my upper chest through the top of my face with itching along my jaw lines. This did not require any visit to ER although a call was made. The event lasted 24 hrs.
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| 72 | 2021-02-02 | injection site pain | Muscle aches, soreness at site of vaccine, diarrhea |
| 72 | 2021-02-03 | itchy skin |
itching and burning sensation around the face, ears and arms and continued down the back, legs to th...
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itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet; itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet; This is a spontaneous report from a contactable health professional, the patient. A 72-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3246), via an unspecified route of administration in the left arm on 20Jan2021 at 11:45 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no known allergies. The patient was not diagnosed with COVID prior to the vaccination. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 20Jan2021 at 23:30 (the evening after receiving the first dose), the patient experienced an itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet. The patient was treated for the events with 1 tablet of expired diphenhydramine (BENADRYL), one to one and a half hours after which the symptoms started to improve and by 02:00 the patient was able to get some sleep. Since the vaccination, the patient was not tested for COVID. The clinical outcome of "itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet" was resolved on 21Jan2021.
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| 72 | 2021-02-03 | vaccination site pain |
pain at the injection site, left arm; so stressed; This is a spontaneous report from a contactable c...
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pain at the injection site, left arm; so stressed; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection intramuscular in the left arm on 18Jan2021 at 15:00 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. Medical history included allergic to sulfa. Concomitant medications were not reported. Past drug history included drug allergy: ciprofloxacin (CIPRO) and codeine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Jan2021, the patient experienced pain at the injection site, left arm and so stressed. There was no emergency room or physician office visit. No treatment was provided for event pain at the injection site. The outcome of the event pain at the injection site was not recovered. The outcome of the event stressed was unknown.
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| 72 | 2021-02-04 | injection site irritation | Chills, severe muscle aches, injection site irritation. |
| 72 | 2021-02-04 | redness |
Five minutes after taking the vaccine, patient c/o facial burning, face turning red, facial tingling...
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Five minutes after taking the vaccine, patient c/o facial burning, face turning red, facial tingling, and feeling shaky. Admin Benadryl 25 mg PO. Patient c/o tongue numbness. B/P 180/94. HR 70;. EMS arrived for transport but patient declined. Symptoms resolved. F/U with patient confirmed that she went to ER. Admin Decadron
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| 72 | 2021-02-04 | injection site pruritus, injection site redness, injection site rash, injection site swelling |
Injection site is red, a little raised, itchy with a little rash around site. This did not happen u...
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Injection site is red, a little raised, itchy with a little rash around site. This did not happen until Wednesday, 2/3/2021. Size of redness is a silver dollar. It is better today, worse on 2/4/2021. Rubbed alcohol and cortisone cream to ease itching at home.
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| 72 | 2021-02-04 | itchy skin |
Itchiness, tingling around lower lip. Bilateral arm tingling and lightheadedness. BP 125/74, pulse 6...
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Itchiness, tingling around lower lip. Bilateral arm tingling and lightheadedness. BP 125/74, pulse 64; refused Benadryl.
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| 72 | 2021-02-04 | redness, itchy skin |
Patient stated that her right hand started itching and turned red at 12pm after receiving the vaccin...
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Patient stated that her right hand started itching and turned red at 12pm after receiving the vaccine at 11:40am.
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| 72 | 2021-02-05 | injection site warmth, injection site redness, injection site hardening, injection site pruritus, injection site swelling | 11 days after shot site itched and discovered red swollen bump with knot under it and fever in it. |
| 72 | 2021-02-05 | skin warm, itchy skin, redness | 8 days after injection, my left arm started to itch is red, warm and swollen |
| 72 | 2021-02-06 | injection site tingling |
About five minutes after receiving the injection, I had tingling at the injection site; then strange...
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About five minutes after receiving the injection, I had tingling at the injection site; then strange taste in my mouth along with tingling; then there was tightness in my throat. The RNs took me another area, gave me ice water and put ice on injection site. After about 45 minutes the tightness in my throat was still there and I was transported to ER for treatment.
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| 72 | 2021-02-06 | itchy skin, rash with redness |
Erythematous patches on face, ears, neck, knees, dorsal aspect of ankles Tingling perioral area an...
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Erythematous patches on face, ears, neck, knees, dorsal aspect of ankles Tingling perioral area and face. No swelling, no dyspnea, no wheezing, no fever. No diaphoresis, no dizziness. Mild pruritus. Benadryl 50 mgm taken po
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| 72 | 2021-02-06 | injection site pain |
Fever the evening of the shot and the next night, sore are at the site of injection for two day Lymp...
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Fever the evening of the shot and the next night, sore are at the site of injection for two day Lymph node swelling the next night after the shot in the left arm pit and has subsided as of today but still tender
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| 72 | 2021-02-06 | injection site rash, injection site reaction, redness, injection site pain |
allergic reaction on skin around injection site, large red breakout, in addition to pain there, last...
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allergic reaction on skin around injection site, large red breakout, in addition to pain there, lasting for several days
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| 72 | 2021-02-07 | redness, vaccination site swelling, itchy skin | Vaccination site is a bit swollen, red, and itchy |
| 72 | 2021-02-07 | injection site pain |
pt stated that her left arm was very sore and then she woke up in a hot sweat, had chills, headache,...
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pt stated that her left arm was very sore and then she woke up in a hot sweat, had chills, headache, and was nauseated. She took medicine for nausea but then she felt even more sick and then vomited. Pt stated she is still nauseated and will contact her PCP if she doesnt get to feeling any better.
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| 72 | 2021-02-07 | injection site pain | site pain, tiredness headache, chills, feeling unwell |
| 72 | 2021-02-08 | injection site swelling, injection site redness, injection site pain, injection site bleeding, injection site bruising |
The day of the injection my arm was mildly tender for a couple days but I did have a quarter-sized d...
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The day of the injection my arm was mildly tender for a couple days but I did have a quarter-sized dark bruise at the injection site and it had bled. About a week later the bruise started to lighten and the arm around the bruise became reddened, swollen and tender. Each day the bruise got lighter and the other symptoms were reduced. It was almost like some of the vaccine was in the bruise area and as it was released it affected the arm. It is improving on its own with no other side effects.
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| 72 | 2021-02-09 | injection site pain |
Burning sensation when vaccine was injected & the shot hurt. During the rest of evening my left arm...
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Burning sensation when vaccine was injected & the shot hurt. During the rest of evening my left arm was sore. During the night, I couldn't get comfortable because my left arm pit started to hurt and could tell it was somewhat swollen. Woke up next morning and I had a low grade fever and my lymph nodes were tender and hurt to touch. Fever lasted all day & into the late night day after vaccine, but the arm pit lymph nodes lasted three and a half days. They are still a bit tender but not swollen today (02/10/2021). I had NO body aches but a little chills.
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| 72 | 2021-02-09 | rash, redness |
On my drive home, my face started burning. When I arrived at home the burning increased with redness...
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On my drive home, my face started burning. When I arrived at home the burning increased with redness I reported this information on Tuesday 1/26/21 to the provider of the vaccine. I was told to take Benadryl which I did immediately. On Wednesday, I continued to take Benadryl every 4 hours. On Thursday, my face continued to burn with redness and a rash. I then started to get a low grade fever and it appeared my face was swelling and then we decided to go to Urgent Care. The Doctor said my face was swollen and gave me a 1/2 dose of a steroid shot and a prescription for steroid pills. I saw my Primary Care Doctor 2/8/21 and he said I should not get the second dose of the vaccine.
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| 72 | 2021-02-09 | itchy skin |
Within 20 minute of receiving the shot my face was very flushed and hot; Within 20 minute of receivi...
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Within 20 minute of receiving the shot my face was very flushed and hot; Within 20 minute of receiving the shot my face was very flushed and hot; lips slightly swollen; Mild itching on face continues 20 hours later; This is a spontaneous report from a contactable consumer reporting for herself. A 72-years-old non-pregnant female patient received BNT162B2 lot number unknown, via an unspecified route of administration on 22Jan2021 15:45 (at the age of 72-years-old) as a SINGLE DOSE in the right arm for covid-19 immunisation. Medical history was none. It was unknown if the patient had allergies to medications, food, or other products. Concomitant medications were none. The facility where the most recent COVID-19 vaccine was administered was provided as other. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Within 20 minutes of receiving the shot, the patient's face was very flushed and hot, lips slightly swollen on 22Jan2021 16:00. Mild itching on face from unspecified date in Jan2021 continues 20 hours later. No treatment was received for the events. The clinical outcome of within 20 minute of receiving the shot my face was very flushed and hot was not recovered It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 72 | 2021-02-09 | hives, itchy skin, rash |
raised welts if is scratched; felt very warm; itching; developed a rash all over the trunk; I took m...
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raised welts if is scratched; felt very warm; itching; developed a rash all over the trunk; I took my temperature and it was 97.4; My heart rate jumped to 93bpm; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via an unspecified route of administration on 22Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. The patient medical history included hypothyroidism, inflammation and sensitive to grains. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient was not pregnant at the time of vaccination. Approximately 4 hours after patient received the vaccination (22Jan2021 21:45), she felt very warm, and she started itching. Patient developed a rash all over the trunk. Patient took her temperature and it was 97.4. Patient heart rate jumped to 93bpm. Patient took a diphenhydramine hydrochloride (BENADRYL). As soon as the diphenhydramine hydrochloride took effect, her heart lowered pretty quickly. When patient woke up this morning (23Jan2021), she was still itching mildly and raised welts if is scratched. More diphenhydramine hydrochloride four hours ago. Treatment received for the adverse event included diphenhydramine hydrochloride (self administered). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was recovering. The events were reported as non-serious.
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| 72 | 2021-02-10 | injection site pain |
Date and time of vaccination: (list both if they received both shots): 1st: 1/18/2021, 2/8/2021 at 0...
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Date and time of vaccination: (list both if they received both shots): 1st: 1/18/2021, 2/8/2021 at 0900 Brand and lot of vaccine: Pfizer 1st#: el1283, 2nd#: el9263 Starting feeling chills in the afternoon, become worse in the evening. Fever of 101.5. C/o muscle weakness, fatigue. Feels like "covid symptoms". Taking Acetaminophen as needed. Site injection pain as well. Denies dizziness/neuro changes, SOB, chest pain or DIB.
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| 72 | 2021-02-10 | injection site pain, redness |
Injection site pain, tiredness, headache, joint pain, swelling, redness, feeling unwell, fast heart ...
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Injection site pain, tiredness, headache, joint pain, swelling, redness, feeling unwell, fast heart beat, dizziness and weakness. nausea.
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| 72 | 2021-02-10 | itchy skin, hives |
Patient reported extreme itchiness and hives all over body starting about 4 days after her second do...
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Patient reported extreme itchiness and hives all over body starting about 4 days after her second dose of the Pfizer BioNTech COVID vaccine. Symptoms did not subside with OTC anti-histamines and lotion so she went to her primary doctor on 2/11/21 and was prescribed oral steroids (prednisone), a different anti-histamine, and topical creams. Patient said she's never had an allergic reaction before. This is being reported when the treatment first started so outcomes are unknown.
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| 72 | 2021-02-10 | redness, itchy skin |
Patient reports redness 3 inches long and about an inch wide on back of R side and tender in one spo...
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Patient reports redness 3 inches long and about an inch wide on back of R side and tender in one spot. Patient reports some itching that improves with ice. Patient discussed with PCP and recommended direct follow-up with a provider if the site continues to expand and/or concerns for an abscess arise.
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| 72 | 2021-02-10 | injection site pain | foggy feeling, dizzy, pain from injection site up neck |
| 72 | 2021-02-11 | redness, itchy skin, skin warm | It started to itch and I realized it was red and swollen and hot to the touch |
| 72 | 2021-02-14 | itchy rash, rash with redness | Pain for 2 days. On second day red rash and swollen and a bit itchy |
| 72 | 2021-02-14 | itchy skin |
Pt. reported itching on back and bilateral arms. Pt. did not complain of shortness of breath, GI ups...
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Pt. reported itching on back and bilateral arms. Pt. did not complain of shortness of breath, GI upset, difficulty breathing; redness to bilateral upper arms and scapular region. Pt. stated she does have an allergy to penicillin but does not carry emergency medication for treatment. Pt. declined EpiPen and shared with pt and husband, the driver, that it was protocol to call EMS at this time due to reaction. Pt and husband upset and concerned about cost of EMS ride. Driver (husband) stated he would take pt to ED if emergency care was needed. Called 911 to have EMS dispatched and while on line with dispatcher, husband stated he was leaving and proceeded to exit the vaccination site.
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| 72 | 2021-02-15 | injection site redness, injection site pruritus |
On 2/10/21, intense itching started, on 2/11/21 redness developed in area. Intense itching stopped o...
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On 2/10/21, intense itching started, on 2/11/21 redness developed in area. Intense itching stopped on 2/11/21 in PM but minor itching continued through 2/14/21
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| 72 | 2021-02-15 | injection site pruritus, injection site redness |
Redness at the site of the injection on Saturday, 02/13. Redness improved on Monday, 02/15. Woke up ...
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Redness at the site of the injection on Saturday, 02/13. Redness improved on Monday, 02/15. Woke up on Tuesday, 02/16 with increased redness and itchiness.
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| 72 | 2021-02-15 | redness | T 102 on yesterday+chills this morning with red (right and neck) and swelling |
| 72 | 2021-02-16 | itchy skin | Extreme itching about 10 days after |
| 72 | 2021-02-16 | hives |
HIVES near injection site. Started evening of day after shot. Gone by following morning. No big...
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HIVES near injection site. Started evening of day after shot. Gone by following morning. No biggie just thought I'd let you know.
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| 72 | 2021-02-16 | injection site pain |
Pfizer-BioNTech Covid-19 Vaccine EUA Headache all night, achy, chills, fatigue, injection site pain,...
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Pfizer-BioNTech Covid-19 Vaccine EUA Headache all night, achy, chills, fatigue, injection site pain, Feeling a little better by 8am next morning. Taking Tylenol and it helps
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| 72 | 2021-02-16 | itchy skin |
SOB, sweating, dizziness, itching. After the 2nd dose of vaccine I had itching in arms and neck . Th...
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SOB, sweating, dizziness, itching. After the 2nd dose of vaccine I had itching in arms and neck . This was followed by dizziness, high BP, SOB, and nausea. The 2nd shot triggered post itching my neurocardiogenic syncope.
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| 72 | 2021-02-16 | itchy rash, rash |
on 01/09/2021 I had an immediate reaction with an itchy rash all over my body that lasted 3 days. I ...
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on 01/09/2021 I had an immediate reaction with an itchy rash all over my body that lasted 3 days. I controlled it with Benadryl and ranitidine. on 01/30/2021 I took Benadryl before getting this dose and I had a lenticular rash from the chest up for 1 days.
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| 72 | 2021-02-17 | vaccination site redness, vaccination site swelling |
This is a spontaneous report from a contactable unspecified healthcare professional (patient). A 72...
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This is a spontaneous report from a contactable unspecified healthcare professional (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: 1284, via an unspecified route of administration in the right arm on 16Jan2021 15:00 at SINGLE DOSE for covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included sulfur allergy. Patient was taking unspecified blood pressure medication/s concomitantly. Patient previously took codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 17Jan2021 08:00, the patient experienced just redness and swelling at injection site, no other side effects. Patient did not receive treatment for the events. The outcome of events was recovered. the events were considered as non-serious. Follow-up attempts are completed. No further information is expected. Information on the batch/lot number has been obtained.
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| 72 | 2021-02-18 | rash, redness, rash macular | Rash on face and neck blotchy and red spots. |
| 72 | 2021-02-18 | skin burning sensation |
Tingling in groin area, tongue, neck, chin and finger right after injection. Went away in about 15 m...
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Tingling in groin area, tongue, neck, chin and finger right after injection. Went away in about 15 min. 6 hrs later got hot spot burning under my skin in my chest, under my left arm pit to elbow and neck and lower legs. This continues when I get anxious. Like a sunburn just under the skin
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| 72 | 2021-02-21 | rash |
Patient received Pfizer Covid vaccine # 1 02/05/2021. She developed the bumps on scalp (15 raised no...
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Patient received Pfizer Covid vaccine # 1 02/05/2021. She developed the bumps on scalp (15 raised nodules and sores around her mouth). She states the bumps wer not itchy and were no where else but on scalp. The sores around mouth were non vessicular. She did not present until 02/13/2021 and had taken steroids at home as she has so many reactions. 1 day she took 20 mg and the next 10 mg. several days later another 10 mg pill. On 02/13/2021 the scalp bumps not the lip sores were non visible. The was 1 raised area on the side of left face that appeared to be a stuck on lesion. She states the steroids took car of the rest. She was instructed to follow up with PCP and Dr to see if she should take second vaccine. Er for any s/s of distress. I dod not give her any additional therapy as the symptoms had abated.
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| 72 | 2021-02-21 | redness |
Patient received vaccine at 10:23 am and parked and instructed to wait 30 min due to prior reaction ...
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Patient received vaccine at 10:23 am and parked and instructed to wait 30 min due to prior reaction to bee stings. At 10:47am patient reported feeling a flushed and reddened face, "blurry eyes", and lightheadedness. Assessment VS as follows BP 150/70 HR 70 - SR skin- warm and dry SpOx-99 % This reaction was not like a typical bee string reaction. She denies restricted airway and throat tightness. Talking in a normal rate and rhythm. Advised patient that we will call EMS for transport to a higher level of care, however patient refused. This patient was instructed to remain onsite for further observation and she agreed. She was accompanied by her spouse who was the driver. She reported that she will return home and take benadryl or the epi-pen if condition worsens. She will contact her doctor and report her experience today. Patient felt recovered and decided to leave after 30 additional minutes.
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| 72 | 2021-02-21 | shingles |
shingles; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-preg...
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shingles; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EN5318; expiration date: unknown), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunisation . The patient 's medical history was none. Concomitant medication included NP [pending clarification]. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she did not have side effects from the shot. The patient added that 2 days after the shot (01Feb2021 08:00 AM), she got shingles. The patient reported that the event as non-serious. She received treatment for the event (medicine) and the adverse event result in doctor or other healthcare professional office/clinic visit. The patient has not been for COVID-19 since the vaccination. The outcome of the event was recovering.
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| 72 | 2021-02-21 | redness, vaccination site pain |
the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredne...
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the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.
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| 72 | 2021-02-22 | vaccination site rash, rash | Rash on vaccine site and neck |
| 72 | 2021-02-23 | injection site pruritus, injection site rash |
4am I developed a rash and itchiness around injection site on right arm At 7:20pm it?s still red and...
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4am I developed a rash and itchiness around injection site on right arm At 7:20pm it?s still red and itchy I?m going to take a Benadryl 25 mg
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| 72 | 2021-02-23 | rash |
Chills 24 hrs after vaccine. Sporadic during day for up to 48 hrs. Total body rash noticed 36 hrs ...
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Chills 24 hrs after vaccine. Sporadic during day for up to 48 hrs. Total body rash noticed 36 hrs after vaccine, no raised areas or itching.. No difficulty breathing. Cetirizine HCL 10mg no change in rash after 1 hr.
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| 72 | 2021-02-23 | vaccination site pain |
feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; he...
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feeling weak; shaky; fever, 100.4; her eyes start feeling funny and burning when she has a fever; her eyes start feeling funny and burning when she has a fever; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is the first of 2 reports. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at the right upper arm close to the shoulder on 02Feb2021 07:30 at single dose as she doesn't want to get COVID again or give COVID to anyone else. Medical history included metabolic syndrome from 1994 and ongoing, it all started when she was 46 and it runs in her family and it was a genetic thing; ongoing diabetes mellitus, was diagnosed when she was 65, so 7 years ago; she had COVID in Nov2020 but it was just a very mild case and she just had a cough; and cardio artery problems. She takes a lot of medications and she has metabolic syndrome which includes cardio artery problems and diabetes, but she has taken all of those medications for a long time. The patient says she was calling to report a couple little concerns she has. She received her shot on Tuesday, 02Feb2021 at about 7:30 in morning and her arm started at about 2 to 3 in the afternoon and she noticed it was getting sore, but it was no big deal, she did not think anything of it, and on the second day she thought that was it and she was over it on 03Feb2021. She states her husband also mentioned that he had soreness in his arm after his vaccination. She says at three in the afternoon on 03Feb2021, she started feeling weak and shaky, but she didn't think much of that. She says this began around 3 to 4 when yesterday afternoon, 03Feb2021, she had a fever. She says she took her temperature and it was 100.4 and that all kind of was gone by the evening but when she woke up this morning, she was weak and shaky again. Today she got up and was weak and shaky and it never left, she was still weak and shaky. The patient mentions that she was diabetic so she can get weak and shaky when she needs to eat something, but she had just eaten, and she ate yesterday so she doesn't think it was caused by that. The patient says she thinks we should know that she was diabetic. She says then she could tell that she had a fever, so she took her temperature and it was 100.4 which for her was high. She states she didn't even have a fever when she had COVID. The fever began yesterday afternoon (03Feb2021). She says her eyes start feeling funny and burning when she has a fever and they felt that way so that's why she took her temperature. This was the highest it has been in years. She says last night she took her temperature again and the fever had gone away in 30 to 40 minutes, so she thought it was over. She took her temperature again before she called this morning, 04Feb2021 and it was 99.2, which was still a little hot for her. She says for her that's a fever. She was 96 and 97 usually. The patient says she still feels like she has a little fever. She was not someone who usually has a fever and it can be just a little bit of a fever for instance like this morning when she was 99.2. Her eyes were still feeling funny and burning this morning and that was why she took her temperature this morning. The outcome of the event arm was a little sore was recovered on 03Feb2021; feeling weak and shaky was not recovered; fever and her eyes start feeling funny and burning when she has a fever was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162089 Same reporter/drug, similar event, different patient
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| 72 | 2021-02-23 | injection site pain |
pt states that the next day after her vax she had weakness, chills, fatigue and she still has these ...
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pt states that the next day after her vax she had weakness, chills, fatigue and she still has these symptoms. Pt states that the injection site hurt for just a few days. Pt contacted her PCP regarding her symptoms and was told not worry about them at this time but has an appt next week for an annual check up and will FU w/ her about this at that time.
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| 72 | 2021-02-24 | injection site rash, rash, injection site warmth, injection site pruritus |
PATIENT STATES: "I HAD MY VACCINE ON 2/23/2021 AND A SMALL BUMP APPEARED LATER ON. ON 2/24/2021 I N...
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PATIENT STATES: "I HAD MY VACCINE ON 2/23/2021 AND A SMALL BUMP APPEARED LATER ON. ON 2/24/2021 I NOTICED THE BUMP BECAME LARGER LIKE WHEN I PLACE MY THUMB AND INDEX FINGER SPREAD OUT. THE SITE IS PINK, WARM, ITCHES AND WHEN I RAISE MY ARM I CAN FEEL IT PULSATING. I TOOK AN ADVIL AND LAID DOWN BUT IT DIDN'T HELP."
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| 72 | 2021-02-24 | itchy rash |
Received 2nd vaccine on 2/20/21. Started having some tightness in her throat and tingling on her ton...
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Received 2nd vaccine on 2/20/21. Started having some tightness in her throat and tingling on her tongue the next day. Two days later started having dizziness, and itchy rash and SOB, chills, and nonproductive cough. Went to ER on 2/24/21
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| 72 | 2021-02-24 | hives |
patient developed hives to shoulder, face and scalp 10 minutes after receiving covid vaccine. Treate...
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patient developed hives to shoulder, face and scalp 10 minutes after receiving covid vaccine. Treated with Benadryl 50 mg by mouth. Doctor in to examine patient.
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| 72 | 2021-02-25 | hair loss |
Hair loss starting February 6, 2021 and continuing. Approximately 40% of the hair on my head has fa...
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Hair loss starting February 6, 2021 and continuing. Approximately 40% of the hair on my head has fallen out. I am taking Biotin and Hair, skin, & nails pills to help correct this.
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| 72 | 2021-02-25 | redness |
LYMPH NODE IN LEFT ARM ON THE PATH OF THE LYPHATIC VESSEL IS RED SWOLLEN AND PAINFUL. ( ABOUT 2 INCH...
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LYMPH NODE IN LEFT ARM ON THE PATH OF THE LYPHATIC VESSEL IS RED SWOLLEN AND PAINFUL. ( ABOUT 2 INCHES IN DIAMETER) NOT SEVERE BUT NOTICEALBE
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| 72 | 2021-02-25 | rash | delayed arm rash about 6 inches by 3. Not itchy 'delayed cutaneous hypersensitivity |
| 72 | 2021-02-25 | vaccination site warmth, vaccination site redness, vaccination site swelling, vaccination site pain |
injection site area was red; injection site was swollen; injection site area was painful; injection ...
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injection site area was red; injection site was swollen; injection site area was painful; injection site area was warm to touch; This is a spontaneous report from a contactable nurse and consumer. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL9265, intramuscular on 29Jan2021 11:30 at a single dose in the left arm for COVID-19 immunization. Medical history included asthma from 2010, hypothyroidism diagnosed in 2000, obesity from 1995, hypertension from 2000. She has allergies to medications and environmental, allergic to Gadolinium dye. She had an anaphylactic reaction in a hospital, mostly due to food and environmental. No additional vaccines administered on the same date and no prior vaccinations within 4 weeks. Concomitant medication included benralizumab (FASENRA PEN) for asthma (taking for a couple of years). The patient previously took hydrochlorothiazide and experienced allergy. The patient received the first covid vaccine dose on 29Jan2021 and was fine until this morning (11Feb2021 at 9:00) when she woke up and the left arm injection site area was red, swollen, painful and warm to touch. Her height was under 5 feet. The outcome of the events was not recovered. The events Left arm injection site area is red, swollen, painful and warm to touch were assessed as serious-medically significant. Causality of the events to the suspect drug was related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "the left arm injection site area was red, swollen, painful and warm to touch" and the administration of the COVID-19vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 72 | 2021-02-25 | vaccination site redness, vaccination site warmth, vaccination site swelling |
shot site was red and swollen; shot site was red and swollen; Area felt warm; This is a spontaneous ...
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shot site was red and swollen; shot site was red and swollen; Area felt warm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Right arm (at age of 72-year-old) on 03Feb2021 at 03:15 PM as a single dose for COVID-19 immunisation, lot number: EN5318. Medical history included breast cancer from Dec1995. Patient previously received prochlorperazine (COMPAZINE) and experienced allergy. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Concomitant medications in two weeks prior to the vaccination included sumatriptan nasal spray and Vitamin D NOS. Prior to vaccination the patient was not diagnosed with COVID-19. On 11Feb2021 (also reported as on day 8) at 05:00 PM after vaccine shot site was red and swollen. Area felt warm, no previous discomfort. Symptoms have continued for 48 hours. No treatment was received for the events. Since the vaccination patient had not been tested for COVID-19. Patient had not recovered from the events, at the time of the report.
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| 72 | 2021-02-26 | injection site hardening, injection site redness, injection site swelling |
Had low grade fever of 99 degrees. Extreme fatigue. Shot site is bright red, swollen. Area around...
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Had low grade fever of 99 degrees. Extreme fatigue. Shot site is bright red, swollen. Area around site is swollen, red, and hard to the touch. Swelling, redness, and hard to the touch continues. Hurts to touch or bump entire area.
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| 72 | 2021-02-26 | hives |
On Feb 26th - approximately 45 minutes after vaccination and departing site, symptoms began. Swelli...
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On Feb 26th - approximately 45 minutes after vaccination and departing site, symptoms began. Swelling tongue and throat. Wheezing and difficulty swallowing. Proceeded to ER and taken in at 2pm. Treated at ER with IV of Benadryl, Famotidine, MethlyPredeniSolone, Medrol with little effect. Then did Epipen at 2:40pm. Observed and discharged from ER at 4:50pm . On Feb 27th - skin hives, headache, nausea, chills and overall body pain. Taking Benadryl. Have Rx with 2 EPIPEN kit.
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| 72 | 2021-02-27 | itchy skin, rash macular |
Mild upper arm splotchy redness (not itchy) Skin overall itchy mainly upper calves, mid-back, Clavic...
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Mild upper arm splotchy redness (not itchy) Skin overall itchy mainly upper calves, mid-back, Clavicle bone area. used cortisone cream. Thought it was dry winter skin but gone 2 days. I do get mild itch by clavicle after Keytruda.
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| 72 | 2021-02-27 | redness |
Pt noticed increased reddness to palms of hands and fingers, VS taken q 15 minutes (WNL) and monitor...
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Pt noticed increased reddness to palms of hands and fingers, VS taken q 15 minutes (WNL) and monitored for 1 hour. Redness decreased but still visable. Pt stable and ok to go home. pt called while at home at 3:30 pm and was resting with decreased symptoms.
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| 72 | 2021-02-28 | rash |
Neck rash and left eye redness and itching two days after 1st shot on 1/26/21. Neck rash and both ey...
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Neck rash and left eye redness and itching two days after 1st shot on 1/26/21. Neck rash and both eyes swelling, black, itching and burning by 2nd day after second shot on 2/17/21.
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| 72 | 2021-02-28 | shingles |
Shingles; This is a spontaneous report from a non-contactable non-healthcare professional reporting ...
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Shingles; This is a spontaneous report from a non-contactable non-healthcare professional reporting for a patient. A 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 post vaccination by nasal swab on 09Feb2021 which had negative results. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 10Feb2021, the patient experienced shingles. The patient was hospitalized for the event on an unknown date for 2 days. It was unknown if the patient received treatment. The clinical outcome of the event shingles was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 72 | 2021-02-28 | vaccination site pain |
Too long to have muscle pain from a shot; Migraine headache; severe arm pain where the shot was inje...
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Too long to have muscle pain from a shot; Migraine headache; severe arm pain where the shot was injected; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261; expiration date not provided), via an unspecified route of administration from 21Jan2021 to 21Jan2021 at SINGLE DOSE for an unspecified indication. Medical history included 'thyroid' from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine from an unspecified date and unknown if ongoing at 100 ug, 1x/day for 'thyroid'. Patient stated that she spoke with her physician's assistant. Patient received vaccine on the 21st of January, the first shot at her local place. The following morning at 4 in the morning, patient had severe arm pain where the shot was injected. So patient put a hot compress on it and took some paracetamol (TYLENOL). Patient mentioned that it didn't relieve for about an hour and a half. Patient meant the pain was really severe but finally it went away. The next day, it came back again and then the patient did it again and the pain keep coming back. Patient stated "And now it's been tomorrow will be a week. And that's too long to have muscle pain from my shot". Patient also mentioned that second day after the shot, migraine headache started. Patient stated, "Now I get them, but I only get them in the spring and I get them in the Fall. I don't get the migraine headaches in the winter time. I could only take Excedrin Migraine for the migraine, it's just over the counter medicine. And so I took that for the headache but those have not gone away either. When patient contacted her physician's assistant just now, it was reported that patient the physician's assistant is going to write a prescription for a muscle relaxer. Patient also reported that she is not going to take that second shot as she didn't know where to go to cancel it but she is not taking it. Patient mentioned she can't have pains like this. Patient stated that she can't tolerate pain to begin with, let alone have excess pain in her system. Patient added that she doesn't take medications. She is only on a thyroid medication (later confirmed the name as levothyroxine). Patient confirmed that the vaccine was Pfizer COVID-19 vaccine. When probed for the due date of the next shot, patient stated 'February 11th at 12 o' clock'. Patient also stated 'I am not getting it, I am not taking the second shot. I didn't get you, I don't know what you said. I am not understanding you. I am not getting what you are saying. I am not taking the second shot, it is scheduled for February 11th of 2021, I am not taking it. Because they called and asked if I wanted to receive it and my age is almost 73. So, I thought I probably should give it a chance. But now with the reaction I don't want the second one' and 'I don't know if there is something wrong with this phone or something wrong with the connection, I don't understand, I get part of it but I don't understand the other part. It blanks out, I don't know what's wrong, you are asking me something, but I don't know what it is'. Patient also reported that the pain started the day after she got the shot, 22Jan2021. Patient is still having pain. Patient also confirmed that TYLENOL was the treatment for pain but it was not working. Medication for migraine was reported as EXCEDRIN migraine. Patient further confirmed EXCEDRIN Migraine did not help with the migraine and stated 'No, I still have it, it gives me some relief but then after wears off it comes back, the migraine comes back'. Patient further added "Okay, I am just going to rely on my physician assistant, she has got some medication ordered for me, a muscle relaxer. And I am going to try that and see if that will make everything go away". Outcome of the events 'severe arm pain where the shot was injected' and 'migraine headache' was not recovered; outcome of the remaining event was unknown.
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| 72 | 2021-02-28 | injection site pain |
fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain o...
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fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain onset 12 hours after receiving the vaccine ongoing at this point
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| 72 | 2021-03-01 | redness, itchy skin, rash macular |
Swollen, blotchy, red, itchy face, eyelids, ears. General feeling of being warm and itchy all over...
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Swollen, blotchy, red, itchy face, eyelids, ears. General feeling of being warm and itchy all over.
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| 72 | 2021-03-02 | vaccination site mass |
Has a small, walnut sized lump on her left arm where the injection was; having increased arthritis p...
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Has a small, walnut sized lump on her left arm where the injection was; having increased arthritis pain; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (lot EL3247) via an unspecified route of administration in the left arm on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included Covid prior to getting the first shot (has had Covid). Concomitant medications were not reported. It was reported that the patient has a small, walnut sized lump on her left arm where the injection was on Jan2021 that has been there for about a week. She wanted to know what to do about the lump and if she should get the second shot. It was also reported that she's having increased arthritis pain on 2021. She's going to a state on 28Feb2021 and would have second shot on 23Feb2021 and she needed a negative Covid test 72 hours prior to going. She wanted to know how would she get a negative Covid test. The outcome of the events was unknown.
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| 72 | 2021-03-02 | injection site swelling, injection site pain, injection site rash |
Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash ...
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Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash appeared day after injection as well as burning. Day of injection tired, arm very sore, didn't sleep well followed by feeling really sick nausea, just a little, then fever started terrible headache continued until next evening. Now arm sore also realized I have neck pain yesterday and now, still have rash the burning has subsided
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| 72 | 2021-03-02 | injection site pain |
Headaches began later in the afternoon after getting vaccine. Loss of sleep that is abnormal and wor...
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Headaches began later in the afternoon after getting vaccine. Loss of sleep that is abnormal and worrisome due to seizure condition. Sore arm at injection site and general body aches present.
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| 72 | 2021-03-02 | itchy skin |
In observation patient noticed a new onset of tingling and itching on her upper extremities. Admini...
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In observation patient noticed a new onset of tingling and itching on her upper extremities. Administered benadryl with no relief and subsequently given epi pen. Patient has prior allergy to flu and pneumonia vaccine. Advised by PCP to take benadryl prior to COVID vaccine which patient took. Patient presented to ED subsequent day as itching continued. No lip swelling or tongue swelling or difficulty breathing.
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| 72 | 2021-03-02 | injection site redness, injection site pain |
Pfizer Covid-19 Vaccine second dose on 02/28/2021 at 1:00 P.M. Very chilly all day next day on 03/...
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Pfizer Covid-19 Vaccine second dose on 02/28/2021 at 1:00 P.M. Very chilly all day next day on 03/01/2021. Redness and pain on the arm at the vaccine site on 03/03/2021 at 9:00 A.M.
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| 72 | 2021-03-02 | rash |
She has started developing rash all over her neck and now coming on to arm, it's a very bad rash; Ri...
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She has started developing rash all over her neck and now coming on to arm, it's a very bad rash; Right now it is getting kind of worse; She is feeling very bad after the vaccine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient started to receive bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot ENS318), via an unspecified route of administration from 30Jan2021 to 30Jan2021 at SINGLE DOSE for an unspecified indication. The patient's medical history was not reported. Concomitant medications included diclofenac, gabapentin, losartan, levothyroxine sodium (SYNTHROID), vitamin C (ASCORBIC ACID) and ergocalciferol (VITAMIN D). On 31Jan2021, she was feeling very bad after the vaccine administration and started developing rash all over her neck and now coming on to arm. Reported that it's a very bad rash and right now it was getting kind of worse (no treatment). The outcome of rash aggravated was not recovered; for other event was unknown.
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| 72 | 2021-03-02 | bruising |
while she was on the top step of a 2-step stool, her left leg went out from her, and she fell straig...
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while she was on the top step of a 2-step stool, her left leg went out from her, and she fell straight back, landing on the floor; her left knee keeps wanting to go out/ left leg kept wanting to buckle under her; she has 2 big bruises on arm, 1 bruise at her elbow and 1 bruise on her upper arm.; horrible pain in her left back/ pain was above her left kidney, and the pain ran from the bottom of her left rib cage to the bottom of her left butt cheek; pain ran from the bottom of her left rib cage; caller experienced pain from her kidney to her butt cheek; her arm was mildly sore; her left leg muscle is sore from above her left knee; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 22Jan2021 10:00AM at a single dose on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history included COVID-19 in Nov2020 and lost taste and smell. Reported she tested positive for the COVID-19 Virus in Nov2020. She said she was never sick during the time she had the COVID-19 Virus, though she lost her sense of taste and smell. She said she may have had a headache during that time, but she doesn't know if the headache was from the COVID-19 Virus or something else. She said anything she was experiencing during the time she had the COVID-19 Virus was kind of normal for her. Concomitant medications were none. Reported she got her first dose of the COVID-19 Vaccine on Friday, 22Jan2021, and thinks she may be having an adverse reaction. She said after she received her COVID-19 Vaccine, she was OK for the remainder of Friday, 22Jan2021, as well as, Saturday morning, 23Jan2021. Reported she was working outside the day before she had her first COVID-19 Vaccine dose (21Jan2021). She clarified she had a tree cut down in her yard, and she moved all the 3 foot length cut-up pieces of tree by herself. She had been moving tree cuttings. Her arm was mildly sore. Reported on Saturday (23Jan2021) in the middle of supper, she experienced a horrible pain in her left back. She clarified that the pain was above her left kidney, and the pain ran from the bottom of her left rib cage to the bottom of her left butt cheek. She said the pain was so bad she didn't think she was going to be able to finish eating supper. She said after supper she got on a heating pad and walked around the kitchen to see if that would help with the pain. She said she sat on the heating pad and walked around the kitchen 4 times that night. She said by Sunday (24Jan2021), the pain started to go away, and by Sunday night, she was OK. Reported this past Thursday, 28Jan2021, she was going to her mailbox. She said while she was walking out to her mailbox, she was holding onto her front porch post to go down the front porch stairs, and her left leg collapsed out from under her. She said she would have fallen if she wasn't holding on to the front porch post. She said she tried to continuing walking to the mailbox, and her left knee went out from under her again. She said her left leg kept wanting to buckle under her. She said after she got back inside her house, she sat down in a chair to read a book. She said she was making soup at the time and grabbed her husband's cane to walk to the kitchen. She said she is short and got on her 2-step stool to look in the freezer for vegetables. She said while she was on the top step of the stool, her left knee buckled and her left leg went out from under her. She said she fell straight back, landing on the floor. She said she has 2 big bruises on arm, 1 bruise at her elbow and 1 bruise on her upper arm. She said her left leg went out from under her again, yesterday (31Jan2021), while she was going to church. She said everything she has experienced since getting her COVID-19 Vaccine shot is only happening on her left side. Reported her left knee keeps wanting to go out and she has to be really careful when she walks. She said her left knee feels like it is wanting to buckle, like when someone runs up behind you and hits the backside of your knee. She said her left leg muscle is sore from above her left knee. She said she doesn't know if what she is experiencing is from getting her first COVID-19 Vaccine dose, and she wanted to know if anyone else has reported a similar experience since receiving the COVID-19 Vaccine. For fall treatment, she took a couple of Aleve 220mg tablets (UPC Number: 325866555090, Lot Number: NAA6W3T, Expiration Date: Jun2021) on 28Jan2021, after she fell off her stool. Reported she took another 2 Aleve 200mg tablets last night (31Jan2021) at 11:00PM. Reported she is pretty darn healthy and only takes 3 pills. No other details provided. Reported she is trying to lock her left knee when she walks, saying she can feel her left knee giving away. She said she while she was walking down a small ramp at church on Sunday (31Jan2021) her left knee wanted to buckle from under her. She said she had to hold onto a railing while she was walking down the ramp, so she wouldn't fall. She said she is not used to her left knee trying to go out from under her. The reported adverse events did not require a visit to the emergency room or physician office. Outcome of events "horrible pain in her left back/ pain was above her left kidney, and the pain ran from the bottom of her left rib cage to the bottom of her left butt cheek" (back pain, rib pain, and buttocks pain) was recovered on 24Jan2021. Outcome of "her left knee keeps wanting to go out/ left knee kept wanting to buckle under her" (joint instability), and "her left leg muscle is sore from above her left knee" (myalgia) was not recovered. Outcome of the remaining events was unknown.
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| 72 | 2021-03-03 | itchy skin, redness |
2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, ...
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2nd day I had extreme tiredness, chills, upset stomach, sore shoulder, bad headache. 3rd day same, with fever & brain fog, & felt very weak, & I had a swollen & sore lymph node under my arm. On day 6 my upper are (& underneath) turned red & swollen. I also had been suffering random itching. On day 8 I went ER, & was given steroid cream. That night most of my back turned red. I put the cream on & it was gone next day, but my arm stayed red & itching. All this has made me weaker, & My stomach hasn?t felt good.
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| 72 | 2021-03-03 | redness | Left big toe swollen/painful and foot and toes were red |
| 72 | 2021-03-03 | rash, skin discolouration, injection site pain, injection site bruising |
Numbness and slight swelling on entire left side of face within half hour following shot, accompanie...
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Numbness and slight swelling on entire left side of face within half hour following shot, accompanied by severe stiff neck (left side). Headache and slight transient facial rash with skin discoloration under eyes about two hours later. Mostly subsided by 10:30 PM- about eight hours later, although some numbness remained l through the night. Symptoms were mostly gone the next morning, replaced by arm soreness and bruising at the injection site. Black and blue remains (3 days later).
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| 72 | 2021-03-03 | injection site rash, injection site bruising |
Rash (almost blister) on upper arm on either side of injection site. Still mark and small bruise t...
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Rash (almost blister) on upper arm on either side of injection site. Still mark and small bruise today March 4, 20121
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| 72 | 2021-03-03 | itchy skin |
aches; itching; kind of tired; This is a spontaneous report from a contactable consumer (patient). ...
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aches; itching; kind of tired; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262, expiry date unknown) in the doctor's office, via an unspecified route of administration on 27Jan2021 at a single dose on the right arm as she was over 65, for COVID-19 immunization. Medical history included ongoing diabetes mellitus a long time ago since she was in her 60's, ongoing blood pressure, ongoing high cholesterol and cyst. Concomitant medication included ongoing losartan (manufacturer unknown) for blood pressure, ongoing pravastatin (manufacturer unknown) for high cholesterol, metformin (manufacturer unknown) for diabetes mellitus from an unspecified date to an unspecified date and ongoing sitagliptin (JANUVIA) for diabetes mellitus. The patient was also prescribed an unspecified antibiotic for a cyst which was taken 2 weeks before the vaccination. The patient did not have prior vaccinations within 4 weeks of the COVID vaccine. The patient experienced itching on 27Jan2021, the same day as the Covid 19 shot later in the day, after she got home. She didn't pay attention to it. The next evening she called her doctor and told him about it and he said it was one of the side effects of the Covid 19 shot and prescribed Benadryl. She started the Benadryl that same night, 28Jan2021. She should not have waited, she should have called the doctor the same day. She called the pharmacy and got the prescription, it's not that far for her. The patient stated that the the itching lasted a couple of days, it is gone, as of an unspecified date. She took Benadryl for the itching, it is the best thing for her. In all, she thinks she went through 2 to 3 days of the whole situation. The patient also stated that she took Tylenol for the aches and that got better. She had aches but the aches from the Covid 19 shot started on 28Jan2021. On the day of the report, she was a lot better. The aches went away but does not recall what day they went away. She feels much better that day. The aches were not severe. She added that the aches and itching lasted for 2-3 days and are totally improved, that they stopped on an unspecified date. State she was able to go outside that day. She added that she was kind of tired. She had to lay down one day because the itching and aches were bad. The outcome of the event kind of tired was recovering while the outcome of the other events was recovered on an unspecified date in 2021.
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| 72 | 2021-03-03 | skin burning sensation, skin warm, hives |
left eye felt tight and felt itchy/severe tightness in her left eye; intense itching in inner ear wh...
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left eye felt tight and felt itchy/severe tightness in her left eye; intense itching in inner ear where you cannot scratch; severe tightness in her left eye that felt like it was going to swell up; hot skin for several hours; hot flashes; She has itching in ears and throat; Onset of burning and itching; Skin had feeling of about to break out in hives/full blown body hives all over; This is a spontaneous report from a contactable nurse. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3249), intramuscular on the right arm, at the age of 72 years, on 13Jan2021 09:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient would like to know if the vaccine was derived from or does it have any products from Acacia. One of the reason's she was asking was because she knows it has Polyethylene Glycol in it. Her resources are limited. She was a retired healthcare provider and she taught graduate level nursing and has background in epidemiology and public health. The Polyethylene Glycol was in the vaccine, according to the prescribing information. Some forms of Polyethylene Glycol in some type of way are derived from gum acacia and she does not know if this is the case for the COVID vaccine. She did have 1st dose and waited 15 minutes. When her left eye felt tight and felt itchy, she took 2 Benadryl and then waited in car a little longer. She felt like she was going to go into what she has had in past 3-4 times relating to fish. She has had full blown facial swelling, intense itching in inner ear where you cannot scratch. Those times, if she had chopsticks, she would want to scratch inside her ear. She never had that with the COVID vaccine. They told her when she got the vaccine that if this develops further, she should go to her doctor or ER, but should not come back there. She did not want to go to the ER and sit there for 12 hours waiting to see if she was going to have a worse reaction, so she went home, took 2 more Benadryl, and went to bed. Eight hours later, she was fine and did not have hives. She then stated she completed report with Pfizer online and did not have a reference number for previous report. For those time when she had these episodes with the fish, she had extreme itching and hives. The worst allergy she had, her fingers looked like they were webbed. She was treated with Adrenaline, Cortisone and Benadryl by injection and that would usually stop the reaction, but it usually takes 3-4 days for the swelling to go down. In later years, if there is a piece of fish mixed in with fried shrimp and she inadvertently eats it, she knows it immediately. She will take Benadryl immediately. She will have facial swelling and swelling around her eyes. The Benadryl will contain it. She will be disfigured for 2 weeks, with bags of fluid in her cheeks. She is going for her second shot tomorrow. She can self treat with Benadryl. In 1994, she had a very positive wheels from an intradermal scratch testing for Acacia and codfish. The patient had an onset of burning and itching, periorbital. She took 2 25 mg Benadryl tablets. She has itching in ears and throat. After my 15 minutes waiting, she left. She had various hot spots of burning skin, legs and arms. Left eye felt like past episodes of itching, about to swell. Her skin had feeling of about to break out in hives. Facility said to go to provider or ER if got worse. She chose not to go to ER, and wait and be miserable for hours on end, while waiting for full blown body hives all over. She took two more 25 mg Benadryl and went to bed. She had intermittent burning skin, various areas, for several hours. About 8 hours later, was resolved. The patient was about to receive 2nd dose of the Covid vaccine. After the 1st dose she experienced an itchy feeling in throat, rotating heat in arms and legs, slight bag fluid under left eye and it felt to her like she was going to have an allergic reaction but did not. She took some Benadryl and after 8 hours she was fine. The patient stated after the first dose of the vaccine she had itching, severe tightness in her left eye that felt like it was going to swell up, and hot skin for several hours. She took two Benadryl while she was still in the waiting period and perhaps that blunted the reaction. She had hot flashes on the drive home. She took two more Benadryl at her daughter house (100mg total after taking 4 that day). She didn't feel good and felt she was on the verge of getting hives. She had episodes of hot skin and itching and after 8 hours it was over and done with and she was fine. She stated she is nervous about the second dose but stated they have what they need if she has an immediate reaction and it is worth the risk of getting vaccinated. Therapeutic measures were taken as a result of left eye felt tight and felt itchy/severe tightness in her left eye (eye pruritus), intense itching in inner ear where you cannot scratch (ear pruritus), onset of burning and itching (skin burning sensation), skin had feeling of about to break out in hives/full blown body hives all over (urticaria). The outcome of the event onset of burning and itching and skin had feeling of about to break out in hives/full blown body hives all over was recovered on an unspecified date while other events were unknown.
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| 72 | 2021-03-03 | rash |
rash developed on arm opposite of injection immediately after getting vaccine, denies resp sxs, any ...
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rash developed on arm opposite of injection immediately after getting vaccine, denies resp sxs, any facial edema. was monitored for 30 additional minutes after getting vaccine and released home. reports no increase in rash size since it appeared.
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| 72 | 2021-03-04 | redness |
Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and...
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Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and then blacked out woke up laying on floor, couldn't move arms or legs, not sure if hit head, laid on floor close to 1 hour, difficulty getting back into bed, extreme nausea, dry heaves, weak, headache, dizzy, chills, dizzy x 1 week, dizzy 3/3/21, got into bed 6:30 PM, face flushed and reddened, called daughter who is nurse, daughter checked temperature and blood pressure, no fever, B/P 156/102 (normally 120/82), B/P came down to when retaken to 140/90), was "upset" at time of first B/P reading, causing elevation. Continues to have weakness and fatigue, headache comes and goes.
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| 72 | 2021-03-04 | itchy skin, injection site redness, injection site swelling |
Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: redness o...
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Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: redness on arm-Mild, Additional Details: redness and swelling of injection arm
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| 72 | 2021-03-05 | rash | Diffuse rash over trunk, back and front |
| 72 | 2021-03-05 | itchy skin | Facial swelling/ itching |
| 72 | 2021-03-05 | shingles | Raging outbreak of shingles |
| 72 | 2021-03-05 | redness, itchy rash |
Skin red, swollen everywhere with tiny itchy hard bumps. Eyelids were red and swollen, hot and hard ...
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Skin red, swollen everywhere with tiny itchy hard bumps. Eyelids were red and swollen, hot and hard to open. Body aches and fingers partially numb.
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| 72 | 2021-03-06 | dry skin |
Both hands & fingers swollen & VERY PAINFUL on 03-05-2021 -- cracked open more on fingers, tha...
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Both hands & fingers swollen & VERY PAINFUL on 03-05-2021 -- cracked open more on fingers, than hands- but all fingers & both hands feel like SAND PAPER--Had to use Cera/Ve Crm and wear cotton gloves to keep "moisture in"- and I have to wear gloves to wash anything by hand--Have made appt. with dermatologist for 03-11-2021 to check this condition .
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| 72 | 2021-03-06 | redness |
Patient had redness in both her cheeks after vaccine. Similar incident after the first vaccine. Sta...
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Patient had redness in both her cheeks after vaccine. Similar incident after the first vaccine. States she took claritin before getting this second shot. Patient feels fine otherwise. Denies chest pain, throat/tongue swelling/tingling or itching.
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| 72 | 2021-03-07 | cellulitis |
Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; C...
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Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; Questioned if she might have a blood clot in left leg; Might have an infection in area of cellulitis in left leg; pain in the left leg; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, expiration date 31May2021), via an unspecified route of administration on 01Feb2021 at left upper arm around 19:00 or a little later at single dose (at the age of 72-years-old) for covid-19 immunization. Medical history included bad knees and got injections for this and recurrent cellulitis of legs (cellulitis was not active at time of vaccine; but anytime her leg swells with bad knees she had a little episode with the cellulitis down around her ankles on both legs but left leg was more predominant. She had been keeping it at bay), mineral supplementation, bad knee pain, blood pressure medication (abnormal), urine output control (abnormal), dehydrated and dizzy. Concomitant medication included lisinopril as blood pressure medication, potassium for Mineral supplement, solifenacin succinate for urine output control, paracetamol (TYLENOL 4) for bad knee pain. She had taken potassium before and it calmed it down: she was little dehydrated, little dizzy, so was drinking some Pedialyte, water, and taking potassium. The patient had it once before but it kind of snuck up on her again. The patient called to ask if anyone had reported any type of blood clot on the same side of the body that the Pfizer COVID-19 Vaccine was administered. She questioned if she might have a blood clot in her left leg after having been administered the Pfizer COVID-19 Vaccine. She had recurrent cellulitis in both legs prior to Pfizer COVID-19 Vaccine. The doctor thought the cellulitis in left leg may be acting up and that she might have an infection in that area of cellulitis. She reported pain in the left leg when she rested her leg on a pillow; but did not feel any pain when she was standing and walking. The pain became a little too hard for her to bear so the doctor prescribed her Cephalexin 500m capsule every 12 hours-she was on the 3rd capsule now. Onset date for the events was approximately 03Feb2021 or 04Feb2021. The events were better since started Cephalexin. Second dose date scheduled for 22Feb2021 but did not give her time. The outcome of the events was recovering. Follow-up (23Feb2021): New information received from the product quality complaint group includes confirmation of lot number (EL9262) and new expiry date.
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| 72 | 2021-03-07 | hives | Hives spreading over body |
| 72 | 2021-03-07 | injection site redness, injection site pruritus |
Red, intermittent itching, about 1 1/2 inches from injection site about 2 inches long, 3/4 inch wide...
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Red, intermittent itching, about 1 1/2 inches from injection site about 2 inches long, 3/4 inch wide.
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| 72 | 2021-03-07 | rash |
That evening client began to have swelling hand. The following day client noticed swelling in her fa...
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That evening client began to have swelling hand. The following day client noticed swelling in her face and tongue. Rash on chest, neck and face. No difficulty breathing.
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| 72 | 2021-03-07 | itchy rash, injection site pruritus |
itchy rash that started on my stomach, then to thighs, then to back. Site of shot was also very itc...
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itchy rash that started on my stomach, then to thighs, then to back. Site of shot was also very itchy. Rash began receding on Sunday, March 7, 2021 --itching pretty much stopped, except for site of shot. Rash pretty much gone by Monday, March 8.
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| 72 | 2021-03-08 | redness |
I got swollen, red, burning, painful toes, but only the big toes. Numbness in my toes and ankles....
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I got swollen, red, burning, painful toes, but only the big toes. Numbness in my toes and ankles. Is this known as Corona Toe?
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| 72 | 2021-03-08 | injection site redness, injection site pain, injection site pruritus | Painful, itchy, red arm at injection site |
| 72 | 2021-03-08 | injection site pain |
Received 02.14.21: Pain at left arm injection site - duration 2 days. 0n 02.17.21, sudden onset of ...
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Received 02.14.21: Pain at left arm injection site - duration 2 days. 0n 02.17.21, sudden onset of headache (moderate severity); overwhelming fatigue; difficulty lifting left arm. Took ibuprofen and slept for approx. 20 hours.
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| 72 | 2021-03-09 | itchy rash, hives, rash with redness, hair loss, rash |
Four hours post injection I became flushed and broke out in hives and a red itchy rash on my body an...
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Four hours post injection I became flushed and broke out in hives and a red itchy rash on my body and legs. My heart rate jumped at the same time. I took Benadryl immediately, and for the next 24 hours. The itchy rash has persisted on and off ever since ( 6.5 weeks). In addition I have had many other symptoms. Excessive hair loss, a severe metallic taste in my mouth that is getting worse over time. At the suggestion I was scratch tested for PEG (negative), but I have since learned that test is not reliable. I tried to go on a sustained course of antihistamines but got allergic reactions to both 24 hour Allegra and 24 hour Claritin. My primary care doc has me on a course f very high dose vitamin C and I am getting some relief, but if i don't take the vitamin the itching returns.
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| 72 | 2021-03-09 | vaccination site pain, skin peeling, vaccination site redness |
peeling like sunburn; slight inject site soreness; 2 circles appeared just above and below like a ri...
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peeling like sunburn; slight inject site soreness; 2 circles appeared just above and below like a ringworm; dark rimmed, scaly, non itchy or painful red raised centers, above and below the inject site; This is a spontaneous report from a contactable nurse (reporting for herself). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN5318), via an unspecified route of administration on 02Feb2021 09:00 (at the age of 72) single dose left arm for covid-19 immunisation. Medical history included septicemia x2 15yr ago with hospitalizations (full recovery x2), oxygen therapy (full recovery x2), renal impairment and liver compromised (full recovery x2). Concomitant medication included oxybutynin hydrochloride (OXYBUTININ). No other vaccine was received in four weeks. The patient experienced slight injection site soreness, 2 circles appeared just above and below like a ringworm, dark rimmed, scaly, non itchy or painful red raised centers, above and below the inject site, all on 06Feb2021, peeling like sunburn on an unspecified date. No treatment received. The outcome of peeling like sunburn was unknown, of the other events was recovered.
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| 72 | 2021-03-10 | skin warm |
Adverse Event: sore arm, could not raise right arm above should height, fever 100.4; onset at 4-5 h...
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Adverse Event: sore arm, could not raise right arm above should height, fever 100.4; onset at 4-5 hours after injection. Very tired; achy especially painful in knees and lower back. Took one Tylenol every 4 hours on Tuesday and Wednesday. Felt fine at 4:30 a.m on the 11th of March. Slept most of Tuesday from 5 p.m until next day. Wednesday, again achy, fever, exhausted, pain in joints, arm warm to the touch. Slept thru most of the day.
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| 72 | 2021-03-10 | injection site pruritus, injection site redness, injection site rash |
Approximately 8 days after receiving the vaccine in the deltoid area the patient states that she dev...
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Approximately 8 days after receiving the vaccine in the deltoid area the patient states that she developed a large (3" diameter) red, itchy area at the site of the injection. This eventually cleared. without incident. She received her second dose today of lot #EN 6204 in the same arm.
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| 72 | 2021-03-10 | hardening, skin warm |
Starting 24 hours after her second dose (Wed), patient experienced fever, chills, body aches, and he...
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Starting 24 hours after her second dose (Wed), patient experienced fever, chills, body aches, and headaches throughout Thursday and Friday On Saturday she noticed a little 'movable lump' on her lower right jaw (opposite side from vaccine site). By Monday the lump had grown to 3.5cm. That day she saw a doctor who examined her and was uncertain if the lump was due to the vaccine. She had a CBC taken that day that came back normal. Nothing was prescribed. Since Monday, the lump is still hard, slightly tender, and sometimes warm to the touch, but it has been getting smaller. Pt notes her temperature has been slightly higher than normal for her (~98.3') but otherwise she feels fine and the lump does not impede her swallowing, breathing, or talking.
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| 72 | 2021-03-10 | skin mass, skin warm, hardening |
Starting 24 hours after second dose, patient experienced fever, chills, body aches, headaches throug...
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Starting 24 hours after second dose, patient experienced fever, chills, body aches, headaches throughout Thursday and Friday. On Saturday, she noticed a little 'movable lump' on her lower right jaw (opposite side from vaccine site). By Monday the lump had grown to 3.5cm. That day she saw a doctor who examined her and was uncertain if it was due to a vaccine. A CBC taken that day was completely normal. Nothing was prescribed. Since Monday, the lump is hard but slightly tender and sometimes warm to the touch, but it has been getting smaller. Patient notes her temperature has been slightly higher than normal for her (~98.3') but otherwise she feels fine and the lump does not impede her swallowing, breathing, or talking.
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| 72 | 2021-03-10 | injection site pain |
slept for most of 2 days, no energy, achy all day, balance was off, shot site was sore, was not able...
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slept for most of 2 days, no energy, achy all day, balance was off, shot site was sore, was not able to lay on it or rub it
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| 72 | 2021-03-11 | hives, rash |
Covid vaccine was administered on March 3 without any reactions or side effects afterwards. On 3/8 ...
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Covid vaccine was administered on March 3 without any reactions or side effects afterwards. On 3/8 she underwent a left molar extraction. Afterwards she had persistent left-sided pain and was taking NSAIDs at the recommended doses. She was also having intermittent nausea. On 3/11 she developed a rash which appeared like erythema multiforme versus urticaria on her chest, back and extremities. She also had very minimal swelling of her upper and lower lip. She presented to the ED. No fever or leukocytosis. Noted to have AST of 10,133, ALT of 8717, T bili 2.2, ALP 143. PTT 17. We suspect NSAID induced drug injury and rash.
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| 72 | 2021-03-11 | injection site pain | Sore arm at injection site Headache Chills Fatigue |
| 72 | 2021-03-12 | shingles | I developed shingles 19 days after the vaccine |
| 72 | 2021-03-12 | redness, rash |
I was fine when getting the injection and my ½ hour wait. I was fine during dinner and after dinner...
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I was fine when getting the injection and my ½ hour wait. I was fine during dinner and after dinner and until about 9 hours after the injection when my arm felt exceedingly sore. I had been watching a free Amazon Prime cute movie while knitting a blanket for my grandson. When the movie was over and I was clearing my knitting, I noticed my super sore arm. I got up to check my face in the mirror to be sure that I was not having a reaction. But I did have a reaction with a rash on my chest and face 9 hours after the injection. My arm really hurt for three days but is fine now. When I saw my red face and chest, I took a Zyrtex D and a Benadryl. It did not seem to help the redness to go away. When I felt some tightening of my throat and started to feel that I might be starting to lose some clarity of thought, I quickly watched a minute video on how to use my new kind of generic epipen and jabbed myself in the leg and called 911. I felt much better after the epipen in terms of my thinking and throat. Basically, the medics that came to the house and said that I had taken what they would give me at the hospital and it was up to me if I wanted to go to the emergency room or not; they would take me but I would need a ride home. With the pandemic and 48 new cases, I decided to stay home and I went to bed; the rash on my face was gone in the morning. The next days I just felt muscle soreness all through my body (day 2) and felt tired (next two days) but had no fever at any time. I am fine today. I appear to have two very small areas on my chest that probably related to the reaction.
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| 72 | 2021-03-12 | injection site hardening, injection site redness |
Redness in the shot given area (small red area -somewhat hard to the touch) acey body, low grade fev...
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Redness in the shot given area (small red area -somewhat hard to the touch) acey body, low grade fever, chills and diarrhea.
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| 72 | 2021-03-13 | itchy skin, injection site pruritus, injection site rash |
On day 12 after first dose itching began. On day 13 a raised, red 2.5-inch circle around the inject...
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On day 12 after first dose itching began. On day 13 a raised, red 2.5-inch circle around the injection site appeared and the itching became severe. Hydrocortisone Ointment (2.5%) was applied, but afforded little relief. The rash and itching continued for about three weeks, only lessening the last several days. Also on day 12 after the first dose, my lower lip began to feel as if it were sunburned (which it was not) and swelled slightly. Lip balm was applied. The strong burning feeling lasted burning lasted for about three weeks, only lessening the last several days. On the day following the second dose, a smaller red circle appeared around the injection site which itched moderately. It did not continue to itch or appear red after 3 days post injection.
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| 72 | 2021-03-14 | vaccination site pain |
03.11.21 Thursday Day 1: Arm sore and swollen by bedtime, c. 2:00 am Friday. 03.12.21 Friday ...
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03.11.21 Thursday Day 1: Arm sore and swollen by bedtime, c. 2:00 am Friday. 03.12.21 Friday Day 2: Arm remains sore and more swollen than yesterday. Mild nausea all day. Moderate ?acidity? all day. Mild muscle aches all day but now seem to be lessening (8:43 pm). Started feeling unusually tired around 6 pm. 03.13.21 Saturday Day 3: Arm sore at vaccine site only. Nausea stronger. Acidity stronger ? feels like undilute sulfuric acid is burning a hole in my stomach. Extremely unpleasant. Less fatigued than yesterday. Very mild muscle aches. 03.14.21 Sunday Day 4: Nausea mild. Acidity mild. Unpleasant. More energy than any day since vaccine. 03.15.21 Monday Day 5: Very mild nausea and acidity, but still unpleasant. Slept too late but good energy level otherwise.
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| 72 | 2021-03-14 | injection site pain |
Bedridden for 48 hours+ with overwhelming fatigue, fever, chills, severe headache, overall severe j...
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Bedridden for 48 hours+ with overwhelming fatigue, fever, chills, severe headache, overall severe joint pain, sensation of swelling in L axilla although no actual swelling noted, pain at injection site, leg cramping, mouth pain (gums & teeth)
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| 72 | 2021-03-14 | redness |
I stayed in the parking lot for 15 minutes with no reaction. I drove to get gasoline, but within fiv...
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I stayed in the parking lot for 15 minutes with no reaction. I drove to get gasoline, but within five minutes, my face became flushed, a little puffy, and very hot. I put cold compresses on it for about 10 minutes. When it was less red, I left to return to home. I had no fever. I had only a sore arm and extremely tired for 36 hours. No breathing difficulties -- during the flush or afterwards.
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| 72 | 2021-03-14 | skin warm |
Nausea. Fatigue, pressure back of head, dizzy, jittery, sleeplessness, hot feeling top portion if...
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Nausea. Fatigue, pressure back of head, dizzy, jittery, sleeplessness, hot feeling top portion if stomach.
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| 72 | 2021-03-15 | skin burning sensation | Fever 101.9, headache, nausea, burning sensation in spine, chills |
| 72 | 2021-03-15 | injection site discomfort, injection site redness |
I am reporting the below as everything written has NEVER happened to me before in my 72 years of liv...
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I am reporting the below as everything written has NEVER happened to me before in my 72 years of living. This has all taken place since I have had the Vaccine Injection on Wednesday, February 24th. I am attributing all of this as a possible reaction to the vaccine or maybe coincidence. I wanted to report what has taken place so you all can assess if this is a possible adverse reaction, a direct effect from the vaccine or just coincidence. Please let me know if anything like this has been reported and what your thoughts about the matter. Wednesday, February 24th 11:15am Pfizer Vaccine right arm ?about an hour later discomfort on shot side that went from the shoulder up the right side of the neck. Was gone by next day. Thursday, February 25th Day seemed to be normal. When I went to bed that evening a pressure and pounding on the left top side of the head, on the part line. Lasted 5-6 hours and then went away for that episode. Friday, February 26th Day started off OK, walked 2 miles and then ran some errands. *3:00pm I bent down to pick up something and when I came up I had extreme light headedness like I have never had before. I was able to get myself collected and then continued to get ready to go out. *6:00pm I just sat in a chair in the restaurant and BAM the room started spinning at about 500 miles (that is the speed that it felt like) an hour. My arms were flailing as I was trying to grab something to old onto. Just when I was about to fall off of the chair my husband walked up and grabbed me as he could see that something was going on and he said that I was white as a sheet. Once I got somewhat collected, I knew immediately that I had to throw up. My husband took me to the restroom. I had severe dry heaves that just would not stop. I wasn?t breathing properly so my hands and feet were numb, tingly and very white in color. Then I had to have a bowel movement. We phoned for the ambulance to take me to the hospital jus to make sure that I did not have a stroke, or it was my heart, or a vessel had burst in the head. The Paramedic tested me for a stroke and I passed the test. *8:00pm or so I had another episode with room going around at top speed and I started having dry heaves. Nurse gave me medicine in the IV for nausea. My Doctor said that everything was Benign. He said that the CT patient scan was negative and all other tests were OK. Saturday, February 27th I was released from the hospital and went home. I did very little that day. I slept that night from 10:00pm until 10:00am the next day. Sunday, February 28th I was lightheaded, had a headache, and ears ringing all day. I just did not feel myself at all. Tuesday, March 9th Around noon I had a severe lightheadedness/spinning episode, eyes felt like they were spinning. Laid down for about 2 hours and when I got up I was able to function and the spinning had gotten better. Headache all night long, ears ringing, feeling of lightheadedness. Wednesday, March 10th Not quite as dizzy, headache all day, back of neck and left side of head sore to touch. Pounding on left top side of head ? along the part line, where I had the same discomfort the 2nd day after the vaccine. Thursday, March 11th Having discomfort on left side of head. To the right of the left ear, going down to the neck. I can touch those areas and add to the discomfort. Friday, March 12th On Monday, March 7th I noticed a red spot on the right side behind where I was given the injection. I tried to treat it myself but my remedies were not helping. Contacted my Dermatologist on Thursday, March 11th. She saw me today, Friday, March 12th. She is not sure if it is a possible aftermath of the vaccine or something else. Had some bloodwork run to rule how Shingles. Prescribed some medication for Shingles to take until Monday when the bloodwork report is due for review. Blood work was negative for Shingles. Ever since the episode on February 26th I have NOT felt myself at all. Lightheaded, nausea, headache, pressure in head and feels heavy, not steady on my feet, discomfort in back of head near neckline, on/off discomfort in the top of the head with a pounding force. BLOOD PRESSURE IS NOW HIGHER THAN NORMAL ESPECIALLY WITH BOTTOM NUMBER BEING HIGH. I have never had a Blood Pressure problem, although as I have aged the top number has elevated but not enough to take medicine. However, the lower number is now elevated (high 80-?s, low mid range 90?s) and Cardiologist is going to make a decision on whether I should start on a low dose medicine. I am to take my 2nd Pfizer shot tomorrow ? Wednesday, March 17th at 11:00am. Thank You for reviewing the above writings. I look forward to the conclusion VAERS makes on my situation.
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| 72 | 2021-03-15 | itchy skin |
Itching terribly; This is a spontaneous report from a contactable consumer (patient). This 72-year-o...
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Itching terribly; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 (lot number: EL3249 and expiry date unknown) at a single dose and then the second dose via an unspecified route of administration on 09Feb2021 13:30 (lot number: EL9261 and expiry date unknown) at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. She got the first shot on 19Jan2021 and about a week and half later, she started itching terribly for about 48 hours and was off and on, mostly at night. She got her second dose of the vaccine Tuesday, 09Feb2021 13:30, and she started itching terribly Tuesday night, around 19:00-19:-30 and she had been itching since. It is ongoing but has gotten better because she has been taking Benadryl. She called the place where she got the shot done and they said it was not a side effect, to call her internal medicine, doctor and she called them and they told to call Pfizer because they do believe it is a side effect. She is trying to clarify if itching is associated with the product. Outcome of the event was recovering.
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| 72 | 2021-03-15 | itchy skin, redness, skin warm | Large red, swollen, hot, itchy, circle about 5 /2inches in diameter |
| 72 | 2021-03-15 | itchy skin, rash with redness, itchy rash, rash |
Severe rash started on my hips and became beet red, burning and itching intensely. Over the next 2 ...
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Severe rash started on my hips and became beet red, burning and itching intensely. Over the next 2 days the rash spread up my back, and to the top of my thighs. The second day it spread down my legs to my feet (but not as severe) and on my arms down to my hands. My head also began itching. This lasted for about 10 days and has now cleared up. I experienced extreme exhaustion and dry mouth. I still feel tired and have a dry mouth when arising.
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| 72 | 2021-03-15 | redness |
The day after second vaccine I awoke with left underarm and neck lymph nodes swollen, tender, uncomf...
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The day after second vaccine I awoke with left underarm and neck lymph nodes swollen, tender, uncomfortable, with slight redness to area. Over course of next 5 days I felt more tired than usual as swelling subsided. After first vaccine I only experienced left arm soreness at injection site, mild headache and some tiredness for first 24-36 hrs.
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| 72 | 2021-03-16 | hives | Urticaria over most of body - occurred about 2 - 3 days after vaccine administration. |
| 72 | 2021-03-17 | injection site pain |
Arm started to hurt at injection site in the evening , then feeling somewhat achy & headachy. Progr...
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Arm started to hurt at injection site in the evening , then feeling somewhat achy & headachy. Progressed to chills, body aches, fever, joint pain, and minor nausea through a good part of the night. This morning I still feel headachy and have a low fever. Have not taken any pain reducers.
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| 72 | 2021-03-17 | itchy skin |
Itching all over body, Foggy, eyes rollingback in head, unable to articulate information, fingers...
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Itching all over body, Foggy, eyes rollingback in head, unable to articulate information, fingers tingling.
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| 72 | 2021-03-17 | injection site pain |
Just lots of symptoms for 48 hours after: injection site pain, tiredness, headache, muscle aches, ch...
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Just lots of symptoms for 48 hours after: injection site pain, tiredness, headache, muscle aches, chills, nausea, feeling unwell, feeling hot (but no actual temperature). I did NOT have a severe allergic reaction, just
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| 72 | 2021-03-17 | itchy skin |
Pt received vaccine at 09:52. 10:22 pt started to itching on arms and back. No visible rash. No ches...
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Pt received vaccine at 09:52. 10:22 pt started to itching on arms and back. No visible rash. No chest pain, stridor, sob, tongue or lip swelling. Hx of allergies to pcn, iodine, sulfa, latex. Hx of rash and itching with pneumonia shot. No hx of anaphalxis to vaccines or meds - just itching and rash. VSS . 98 % RA 68. BP 177/84 (pt did not take her BP medication as of this mornig). Pt states she feels well but still itching as of 10:41. Pt appears to have the ability to make her own decisions and would like to talk to husband about going to ER. If pt still itching, recommend pt be evaluated. Pt would like d/w husband and physician prior to going to ER. EMS crew on standby. Note from ED: This is a well-appearing and pleasant 72-year-old female who presented via ambulance for itching response after receiving the Pfizer COVID-19 vaccine today. Patient is very well-appearing. Skin is normal and well-appearing there is no rash or erythema. Patient is speaking in complete sentences with normal work of breathing. Respirations are even and nonlabored. Lung fields are clear to auscultation bilaterally throughout patient denies any shortness of breath or breathing issues, cough or itchy throat. Airway is clear with no tongue or mouth swelling, floor mouth is soft and not elevated mandible is easily palpated, throat is nontender, neck is supple. Heart rate is within normal limits with regular rhythm. She was provided with Benadryl and famotidine as treatment for her itching. Patient was observed for greater than 2-1/2 hours in the emergency department. Patient noted that itching markedly reduced with use of Benadryl I felt patient was appropriate and stable for discharge. I had an in-depth discussion with her regarding she monitor her symptoms closely at home we discussed all symptoms that she should look for that would be concerning and she should make sure to seek emergent care. She was given the opportunity ask questions. All question concerns were thoroughly addressed. Patient indicated she felt good with her care here today with discharge and would monitor herself at home. She was picked up by her husband would also be home to monitor her. Advised her to follow-up with her primary care provider regarding recommendations for whether she should receive her second dose of the vaccine. Provided her with CDC printed out recommendations for vaccine allergic reaction. She was given the opportunity ask questions. All questions and concerns were addressed and answered to the best of my ability. No evidence of Stevens-Johnson syndrome, anaphylaxis, cellulitis, or systemic compromise Feel supportive care and symptomatic treatment reasonable. Urged dermatologic follow up. At time of discharge patient remained well-appearing not in any type of acute distress. She ambulated out of the emergency department with a steady gait. I reviewed recent and relevant Chart Entries, Previous Notes, Previous Labs, Previous Radiology studies.
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| 72 | 2021-03-17 | itchy skin |
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lighthead...
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Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
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| 72 | 2021-03-18 | injection site swelling |
Fatigue, shaky, crooked, ache all over, chills. Vaccine was Sunday pm, reaction started after 4-mile...
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Fatigue, shaky, crooked, ache all over, chills. Vaccine was Sunday pm, reaction started after 4-mile walk Monday pm, missed meeting. Took 2 Tylenol, slept. Tues-Thurs: fatigue, chills, aches, diminished over the days. I rested and slept. Today=Friday, declared myself cured, took shorter walk, got tired, normally don?t get tired. *Today I discovered why I felt crooked: right shoulder higher because it?s swollen, down to mid-way between elbow & wrist, down to waist, some of side of body.* Treatment still only rest, but still I'm not so fatigued, aching easy to ignore. Never had fever (temp around 96.8 which is normal for me). I never felt too bad. Except for overpowering fatigue, I felt like doing things.
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| 72 | 2021-03-18 | injection site pain, rash with redness |
Injection site soreness for 3 days, extreme tiredness, severe headaches, and red rash around armpit ...
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Injection site soreness for 3 days, extreme tiredness, severe headaches, and red rash around armpit area, not itchy but under both arms.
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| 72 | 2021-03-18 | injection site pain |
Pain at inoculation site at vaccination. Development severe muscle pain R arm and R shoulder within...
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Pain at inoculation site at vaccination. Development severe muscle pain R arm and R shoulder within 4 hours. Self treatment with ice pack and sleep. Pain 90% subsided within 48 hours.
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| 72 | 2021-03-18 | injection site pain |
head ache chills fatigue loss of appetite pain at location of injection gradually t spread to overal...
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head ache chills fatigue loss of appetite pain at location of injection gradually t spread to overall pain dizzy symptoms are resolving still noticing dizziness by day 2
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| 72 | 2021-03-21 | injection site pruritus |
After injection pt states a "funny feeling like itchy" on the injection side LD. Vitals stable pt a...
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After injection pt states a "funny feeling like itchy" on the injection side LD. Vitals stable pt assess for 30 minutes. D/C arm feels normal.
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| 72 | 2021-03-21 | injection site pain |
Extreme pain in upper arm where vaccinated made worse by any movement. OTC pain med minimally helpf...
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Extreme pain in upper arm where vaccinated made worse by any movement. OTC pain med minimally helpful. I?ve not at all. Ten days later pain lessened but ache remains especially upon movement.
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| 72 | 2021-03-21 | injection site pain | Headache, body aches, arm pain injection site, tiredness, nausea |
| 72 | 2021-03-21 | shingles, blister, rash |
I felt fatigue even the day of the second vaccine. Then about 2 days after I had a severe and sudde...
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I felt fatigue even the day of the second vaccine. Then about 2 days after I had a severe and sudden bout of plantar facsitis, then increase in other arthritis symptoms. Then a week after I suffered a stomach virus. Then latter that same week for two days I experienced severe right leg pain. Then developed cluster rashes on the whole right leg. Went to Urgent care since we are wintering out of state. Was diagnosed with Shingles which I have never had and hope to never have again. The blisters are improving but the pain remains. I very strongly feel this is ALL due to the second dose of this vaccine. I certainly feel the second dose of this vaccine should not be given for at least 6 months.
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| 72 | 2021-03-21 | skin warm, redness |
I received the Moderna COVID shot for my 1st injection. Now I received the Pfizer COVID shot for my ...
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I received the Moderna COVID shot for my 1st injection. Now I received the Pfizer COVID shot for my 2nd injection. Two days after my 2nd injection I have developed swelling and redness and painful reaction in my left arm. Left arm is also very warm to the touch. The CDC website says Moderna should be used for 2nd injection if used for 1st injection.
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| 72 | 2021-03-22 | injection site redness, injection site pain |
Shaking, joint pain, fever of 101, loss of appetite, headache, tiredness, nausea, pain and redness a...
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Shaking, joint pain, fever of 101, loss of appetite, headache, tiredness, nausea, pain and redness at injection site. These symptoms persisted for 48 hours.
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| 72 | 2021-03-22 | itchy skin, redness |
Swelling, itching, burning, redness, blocked ears (I needed to hold my nose and blow) itching - most...
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Swelling, itching, burning, redness, blocked ears (I needed to hold my nose and blow) itching - mostly hands, face, torso. Redness - hands, arms, torso, crotch. Called primary MD, called Healthcare facility clinic, went to pharmacy and spoke to pharmacist. Took Benadryl.
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| 72 | 2021-03-23 | injection site pain, rash, rash with redness |
Fever of over 101 degrees developed during the night, approximately 12 - 15 hours after receiving se...
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Fever of over 101 degrees developed during the night, approximately 12 - 15 hours after receiving second dose. Fever lasted for nearly 24 hours and did not respond to Extra Strength Tylenol. Allergic red rash appeared over trunk of body overnight following injection, within 12 - 18 hours. Rash continued to spread to inside of arms, thighs, across back and abdomen, and neck. Treating with Benadryl oral and topical. Pain and soreness in arm where injection was received began a few hours after injection, lasting about 24 hours.
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| 72 | 2021-03-23 | hives, itchy skin, skin peeling, rash |
Got the vaccine, got very dizzy immediately after and kept her for 30 minutes and gave her water. ...
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Got the vaccine, got very dizzy immediately after and kept her for 30 minutes and gave her water. Then driving home she started feeling itchy, and could feel little hives in each ear. She was then very lethargic that night and all the next day Sunday, and then first thing Monday morning was covered with a large hives and a rash. She was covered from one end of her body to the other and into her joints where she was not able to bend her joints. She tried to use cortisone, but that made it worse. Also tried Benadryl lotion and Calamine lotion, which also did not help. She then went to the doctor and he prescribed steroids. She has had pain as if somebody was sticking needles in her. In the past 2 days her lips are numb and swelled, and on the right cheek plus her two eyes there is a big swollen area and her eyes are burning. Now her entire body is peeling as if she had a bad sunburn. Now her blood sugar due to the steroids is from 250-475. The site of the vaccine itself was ok.
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| 72 | 2021-03-23 | hives |
Hives beginning with small sports like bug bites to almost covering my thighs, on my legs, arms and ...
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Hives beginning with small sports like bug bites to almost covering my thighs, on my legs, arms and torso
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| 72 | 2021-03-23 | redness |
my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started ...
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my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started feeling stuffy; felt flushed; my face was red; what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain; what feels like my heart quivering for several seconds; This is a spontaneous report received from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at left arm on 08Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included gastroesophageal reflux disease, osteoarthritis, nodules on thyroids and allergy to Aspartsme. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. Concomitant medication included pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40). the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took Sulfanomide (Sulfa drugs) and had allergy (swelling), codeine and had allergy (nausea). The symptom that has made patient concerned enough to report the possibility of a side effect is: she had her shot this morning and between about 8:55 and 9:15 this evening she had 9 or 10 episodes of what feels like her heart quivering for several seconds followed 3 or 4 times by very slight pain, just below her right breast, she has never experienced such a thing before. (she took baby aspirin around 9:20 in case she was having some kind of heart thing). It's 9:45 pm, and the quivering episodes haven't happened for the last 30 minutes, so maybe they're all cleared up. Earlier, within 30 min of getting the vaccine, her ears started feeling like they were stopped up and her nose started feeling stuffy. Then as she was driving home she felt flushed and looked in the mirror and her face was red, she took one Sudafed in case it was allergies, and those symptoms improved quite a lot. Adverse event start date was 08Mar2021 10:00 AM. Since the vaccination, the patient has not been tested for COVID-19. Unknown if treatment received for ears started feeling like they were stopped up and nose started feeling stuffy. Outcome of what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain was recovered. Outcome of felt flushed and face was red was recovering and outcome of other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 72 | 2021-03-24 | itchy skin |
Date and time adverse event started: 3-7-21 low grade fever X3 days,sore throat, itching to inside o...
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Date and time adverse event started: 3-7-21 low grade fever X3 days,sore throat, itching to inside of ear, congestion, runny nose, wheezing- asthma. Benadryl Recommended antihistamine (benadrly,claritin, zyretec), decongestion, analgesic (tylenol, ibuprofen, naproxen), lots of fluids; caller verbalized understanding. informed her to get covid tested due to expressing covid like symptoms & if + to wait until after her quarantine period to receive the 2nd dose; caller verbalized understanding.
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| 72 | 2021-03-24 | hives, itchy skin, rash |
I woke up the next morning around 4am itching all over and started breaking out in red spots all ove...
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I woke up the next morning around 4am itching all over and started breaking out in red spots all over my body . This has not lessened, but has become worse over time. My eyes are swollen, I'm still itching all over and breaking out in hives.
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| 72 | 2021-03-24 | injection site pain |
Injection site pain, feeling unwell Tiredness, swollen lymph nodes Headache, light headedness Chills...
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Injection site pain, feeling unwell Tiredness, swollen lymph nodes Headache, light headedness Chills Fever
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| 72 | 2021-03-25 | rash |
After 1st shot had 8 days of a migraine and vertigo every day. Then after second shot 3 weeks later...
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After 1st shot had 8 days of a migraine and vertigo every day. Then after second shot 3 weeks later, had 11 out of 12 days of migraine and after 8.5 days after shot had a whole body rash for 4.5 days . I have had vertigo most every day since the last shot on 2/20 and have had 27 migraines since the 1st shot Jan 30th I used Hydrocortisone on the itchy, blistery rash. Not much sleep for 3 nights. The night before the rash popped out I experienced chest pain that I thought was heartburn but was not relieved with baking soda and water and charcoal pills. It didn't go away until the hours into the next day and the rash was there at 3am. I have had Migraines for many years but this is 4 times more migraines.
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| 72 | 2021-03-26 | redness |
Concern about unusual swelling at night in left leg and one night in which half moon shaped redness ...
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Concern about unusual swelling at night in left leg and one night in which half moon shaped redness and swelling on from of my left leg from knee to ankle.
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| 72 | 2021-03-26 | redness |
Received second Covid shot at noon, by 5pm beet red from neck to waist, even all the way down both a...
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Received second Covid shot at noon, by 5pm beet red from neck to waist, even all the way down both arms. At 11 pm went to bed with large lump in my throat, felt like I was breathing thru a straw plus whole body freezing from inside out. Could not get warm. Added layers of clothes and blankets and laid like that all nite, no sleep. 7am called nurse, advised to remove some of the layers, drink hot liquids and Tylenol every four hours. By mid afternoon the cold was gone but severe achy bones, even the bottom of my feet hurt. Next day hot and cold and ache. Fourth day dripping sweat all day and flu like symptoms. Took three showers to get sweats down plus the entire time had been taking Tylenol every four hours. Day five just drained, felt like I'd been through the wringer.
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| 72 | 2021-03-27 | skin spots, rash |
I received my vaccine at 10:15 am on March 18, 2021, and was fine until 6 pm that evening.After eati...
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I received my vaccine at 10:15 am on March 18, 2021, and was fine until 6 pm that evening.After eating dinner, I took my omesartan and pravastatin, as usual, and within 10 minutes, my heart rate became erratic. I have tachycardia (SVT) but control it with atenolol. I went to the ER at where I had an EKG, ches xray, and blood work. My heartbeat reached 143. While waiting on the test results, I noticed a rash forming below both my knees. The ER doctor returned with the news that all tests came back normal with no accounting for the rapid heart beat other than the Pfizer vaccine. He checked the rash saying it was likely another reaction from the vaccine. He gave me medication to reduce my heart rate, prescribed hydrocortisone for the "rash" and released me. By the next morning, my heart rate was back to normal but the "rash" had spread all over both legs. On Saturday, March 20,, 2021, I went to a medical clinic to see if I could Triamcinolone Acetonide on the rash as the hydrocortisone wasn't helping. The NP identified the rash as petechiae and prescribed Triamcinolone. She could not prescribe an oral steroid xplaining that not enough info is known about the Covid vaccines and possible interactions with steroids. I then followed up on Monday, March 22, 2021, with my PCP who said I had a bad case of petechiae and did more blood work to rule out vasculitis. The day before getting the vaccine, I competed a 7-day course of the antibiotic Nitrofurintoin for a UTI and suggested to her that perhaps I had a delayed reaction to it. However, she ruled that out saying I would likely have had a reaction before the day after completing the medication. She called me back the next evening on Tuesday, March 23 advising that all blood work came back negative, that the Pfizer vaccine is likely the cause of the petechiae, and that I should probably not get the 2nd vaccine. I asked her if she thought I would be okay getting the Johnson & Johnson vaccine and she said yes, if they will give it to you. I could not get directed to anyone to answer that question, but I need to know. Can you help me?
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| 72 | 2021-03-27 | hives |
Pfizer-BioNTech cOVID-19 vaccine EUA Swelling of hands, swelling of lips, hives from neck to knees. ...
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Pfizer-BioNTech cOVID-19 vaccine EUA Swelling of hands, swelling of lips, hives from neck to knees. 3-6 days after injection Resolved using Benadryl, ice, cortisone cream, ibuprofen.
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| 72 | 2021-03-30 | injection site redness |
Headache; Nausea; localized, large red spot where she received the injection; This is a spontaneous ...
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Headache; Nausea; localized, large red spot where she received the injection; This is a spontaneous report from a contactable consumer. A 72-year-old female consumer(patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL9264, Expiration date: unknown) via an intramuscular route of administration in left arm on 28Jan2021 at 9:30 am as single dose for COVID-19 Immunization. The patient's medical history included Osteopenia(ongoing) diagnosed 20 years ago, patient had allergies with grasses, trees, and dust. The patient also allergic to penicillin and Succinylcholine, which is a muscle relaxer. The patient clarified she shouldn't say allergic, but more so hypersensitive. The patient reported that she took nothing but over-the-counter supplements. On 06Feb2021 patient experienced localized, large red spot where she received the injection, Headache and Nausea. The patient also stated that 9 days after vaccination she developed "COVID arm", she clarified it was a localized, large red spot where she had received the injection, she had no reaction or redness or anything else when she received the injection on 28Jan2021. After 9 days of vaccination, on 06Feb2021 (Saturday)the patient first noticed the spot at the injection site she also had a headache and nausea. She was actually awakened at 2am on 06Feb2021 by the headache. She did not notice the spot at the injection site at this time, but she wasn't looking for it. Caller didn't notice the spot until taking a shower. She confirms she recovered completely from the headache and nausea on 08Feb2021 and the spot was also gone. The patient did not require hospitalization. The outcome for the events was recovered on 08Feb2021. No follow-up attempts are possible. No further information is expected.
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| 72 | 2021-03-30 | vaccination site pain |
Left arm is sore at injection site; This is a spontaneous report received from a sponsored program. ...
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Left arm is sore at injection site; This is a spontaneous report received from a sponsored program. A contactable consumer (patient) reported that a 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284, Expiry date 01Apr2021), via an unspecified route of administration on 19Jan2021 as single dose for COVID-19 immunization. Medical history included Cancer. Concomitant medication included palbociclib (IBRANCE) taken for neoplasm malignant, start and stop date were not reported. It was reported that patient had the first injection yesterday (19Jan2021) and she was doing great. She did not had any kind of reaction from it except her arm was a little bit sore. That was all, no big deal. But she have cancer and she was on old chemo called Ibrance and she did not inform vaccination providers of her taking Ibrance regularly wanted to know if she should have informed them. And was asking that, should she have to tell them and does it matter. When informed about Medical Information department, consumer stated, "That was okay. She mean, she was not going to sit and wait on the phone call any more. She was not having any kind of reaction or anything. Oncologist wanted her to have the shot. So, she guess she would have told. As such no treatment she just massaged it and she have taken Tylenol. No big deal. It was just barely sore. Patient stated, she do not know what they were. She just had to go to her oncologist. She had cancer. They always draw blood. she has no idea what it for was. The outcome of the event was unknown.
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| 72 | 2021-03-30 | redness, rash, hives, itchy skin |
had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; had an anaphylacti...
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had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days; pain in abdomen and face/Abdominal pain; pain in abdomen and face; Generalized pruritus with skin rash; Respiratory distress; Angioedema (not hereditary); a lot of pain after her tooth extraction; Upper airway swelling; Cyanosis; Hoarse voice; Difficulty breathing; Sensation of throat closure; Generalized urticaria (hives); Generalized erythema; Generalized pruritus with skin rash; Localized injection site urticaria; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 15:00 (Lot Number: EN6199) (at the age of 72 years old) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD); osteoarthritis; rheumatoid arthritis (RA); allergy: Environmental; asthma. Concomitant medications included ubidecarenone (COQ10 [UBIDECARENONE]) ongoing; atorvastatin ongoing; nebivolol hydrochloride (BYSTOLIC) ongoing; methimazole ongoing. The patient was taking some medications prior to the event being reported. No prior vaccinations (within 4 weeks). The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than bnt162b2 prior to the event being reported. The patient had not received any other vaccines around the time of bnt162b2 vaccination. Caller would like to know if there was an impact on efficacy if she chooses to take her second dose of the Pfizer BioNTech COVID-19 vaccine at a later date than the recommended 21 days. Caller received her first dose of the Pfizer BioNTech COVID-19 vaccine on 03Mar2021. She stated that on 08Mar2021 she had a tooth extraction and was told by her physician to take Advil. Then on 11Mar2021 caller reported that she had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days. She stated that her physicians were unsure if it could have been a delayed reaction to the vaccine or a reaction to the Advil (which caller stated she had taken all her life) (lot number: 55633, Expiry Date: Feb2023). Caller was scheduled to receive her second dose of the vaccine next week and would like to know if she should take it. She stated one physician told her it was okay to do so while another told her to hold on taking it, so she was confused as to what to do. Reporter seriousness for Anaphylactic reaction was Hospitalization. The patient was in hospital for Anaphylactic reaction from 11Mar2021 to 14Mar2021. The patient stated she received her first COVID vaccine on 03Mar2021, and on 08Mar2021, she had a tooth extracted. Because of that, she was taking Advil on 11Mar2021, she had an anaphylactic reaction to the Advil and an acute hepatitis. And the doctors couldn't give her any answer. They didn't know what caused what and if it was a delayed reaction from the vaccine because it was one week following the vaccine or if it was just coincidental. The patient due next week (scheduled for 23Mar2021) for her second dose and wanted to know if she should she take it. She ended up in the hospital for five days. Date of hospitalization was 11Mar2021. Reason for hospitalization was Anaphylactic reaction. Date of discharge from the hospital was 14Mar2021 (pending clarification). Event "had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days" started from 11Mar2021 18:00. Seriousness Criteria: Hospitalization / Prolongation of hospital, hospitalized Duration of stay was 5d, event not recovered. The event required visit to Emergency Room. Treatment included steroids and fluids IV. "Tooth extraction" started from 08Mar2021 and treatment included Tylenol and Advil. Consumer stated she was still in a lot of pain after her tooth extraction (Mar2021). On 08Mar2021 she had a tooth extraction. After the procedure she had severe pain and she was taking Advil and by Thursday 11Mar2021 she had a lot of pain in abdomen and face. She went to ER 18:00 PM, she was going through a complete reaction. The patient required medical intervention: Corticosteroids, IV fluids. The patient was seen in the Emergency Department. The patient had hospitalized for 5 days. The patient was not admitted to an Intensive Care Unit. In Mar2021, the patient had Upper airway swelling, Respiratory distress, Cyanosis, Hoarse voice, Difficulty breathing (without wheeze or stridor), Sensation of throat closure, Generalized urticaria (hives), Generalized erythema, Angioedema (not hereditary), Generalized pruritus with skin rash, Localized injection site urticaria, Abdominal pain. No Bilateral wheeze/bronchospasm. No Stridor, No Increased use of accessory respiratory muscles, No Recession, no Grunting, no Dry cough, no Sneezing, No Rhinorrhea, No Shock, No Tachycardia, No Capillary refill time > 3 sec, No Decreased level of consciousness, No Loss of consciousness, No Generalized pruritus without skin rash, no Generalized prickle sensation, No Diarrhea, no Nausea, no Vomiting. Tachypnoea: Unknown. Measured hypotension: Unknown. Reduced central pulse volume: Unknown. The events did not require the initiation of new medication or other treatment or procedure. Lab work included Liver function over 10 000 in Mar2021. Patient's outcome following the potential anaphylactic reaction was Recovering. The outcome of the events "had an anaphylactic reaction and acute hepatitis and was hospitalized for 5 days", "a lot of pain after her tooth extraction" was not recovered, of "pain in abdomen and face" was unknown, of the other events was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events anaphylactic reaction, hepatitis acute, and respiratory distress with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 72 | 2021-03-30 | pain of skin |
her skin hurts all over; she was cold during the night; hurts to be touched and pull on pants; This ...
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her skin hurts all over; she was cold during the night; hurts to be touched and pull on pants; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunisation. Medical history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunisation. The patient's concomitant medications were not reported. On an unspecified date, the patient reported, her side effect stating her skin hurts all over, she was cold during the night, hurts to be touched and pull on pants. The seriousness was reported as non-serious. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 72 | 2021-03-30 | rash |
horrible rash on both armpits; This is a spontaneous report received from a contactable consumer (re...
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horrible rash on both armpits; This is a spontaneous report received from a contactable consumer (reporting on herself). A 72-years-old female patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiry date not reported), via intramuscular route of administration in right arm on 06Feb2021 16:00 as a single dose for COVID-19 immunization. Medical history included ongoing autoimmune thyroiditis (Hashimoto's disease) diagnosed 30 years ago. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for autoimmune thyroiditis (Hashimoto's disease) (75mg once a day). It was reported that patient was calling about the Pfizer covid vaccine. She went Saturday (06Feb2021) at 16:00 for her first dose of the shot. Within 3 hours she developed a horrible rash on both of her armpits, still has the rash. She was afraid to get the second dose. Advised to contact hcp. She was in the hospital waiting to get a lung scan, it was outpatient. For treatment she declines any, She was going to her primary doctor at 13:45 today. She was told to schedule her own second appointment which she thought was weird since most people get the second appointment with the first dose. Advised to contact facility. No history of previous immunization with the Pfizer vaccine or any other additional vaccine (within 4 weeks) that was administered on the same date as the Pfizer suspect. Information on lot/batch number has been requested.
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| 72 | 2021-03-31 | redness, itchy skin |
angioedema; Face itching; feel unwell; my face was swelling, dark red; my face was swelling, dark re...
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angioedema; Face itching; feel unwell; my face was swelling, dark red; my face was swelling, dark red/Palms of both hands were swelling and dark red/feet turning red; Palms of both hands were swelling and dark red.; Wheezing; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient (Not pregnant at the time of vaccination) received first dose of bnt162b2 (Batch/Lot Number: EN6198), via an unspecified route of administration in left arm on 03Mar2021 10:45 as single dose for covid-19 immunization. Relevant medical history included: Heart disease, HTN (hypertension), asthma, hereditary factor X deficiency, breast cancer 5 years ago all from an unknown date and unknown if ongoing. The patient was allergies to Lisinopril and povidone-iodine (BETADINE). The patient's concomitant medications were not reported. The patient experienced angioedema, face itching, feel unwell, face was swelling, dark red, dark red/palms of both hands were swelling and dark red/feet turning red, palms of both hands were swelling and dark red, wheezing on 05Mar2021 17:00. The patient felt fine on the 1st and 2nd day post vaccination. Thrilled to finally get 1st dose Pfizer. On 05Mar2021, she began to feel unwell. She looked in mirror, her face was swelling, dark red. Palms of both hands were swelling and dark red. Also feet turning red. Wheezing. Face itching. She was a retired nurse and she knew this was angioedema. Her husband drove her to ED (emergency department). She was given methylprednisolone sodium succinate (SOLUMEDROL) IM and prescription for prednisone. The outcome of events was not resolved. The events resulted in emergency room/department or urgent care. Treatment included: IM methylprednisolone sodium succinate (SOLUMEDROL) in ED and oral prednisone for 3 days. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, has the patient hasn't been tested for COVID-19.; Sender's Comments: Based on temporal association and known drug profile, a contributory role of the suspect drug cannot be excluded in the development of the reported events. Relevant medical history includes allergies to lisinopril and betadine, which suggests potential for drug allergies. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 72 | 2021-04-07 | skin discolouration |
Thumb on left hand turned entirely black, skin died. After seeing Infectious Disease and receiving I...
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Thumb on left hand turned entirely black, skin died. After seeing Infectious Disease and receiving IV antibiotics with no improvement, Dermatology consult was made. After a biopsy, it was diagnosed as Sweet Syndrome. Ongoing steroid treatment, whirlpool treatment of wound.
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| 72 | 2021-04-08 | rash, bruising | Low platelets, body rash, flat red splotches, unexplained bruises and black scabs/ blister on lips |
| 72 | 2021-04-23 | hives |
Horrible hives all over my body 4 days after my 2nd shot.; This is a spontaneous report from a Conta...
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Horrible hives all over my body 4 days after my 2nd shot.; This is a spontaneous report from a Contactable Consumer (patient). A 72-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EL9269, expiration date not reported) via an unspecified route of administration, in right arm on 03Feb2021 at 15:00 (age at the time of vaccination 72-years-old) as single dose for covid-19 immunisation. Medical history included back problems, diverticulitis sometimes. Patient had no known allergies. Historical vaccine included BNT162B2 (product: COVID 19; brand: Pfizer; lot number: Pfizer EL1284; administration date: 13Jan2021; administration time: 03:00 PM; vaccine location: Right arm; dose number: 1) for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication in two weeks included vitamins, calcium, fish oil, probiotics, omeprazole. On 06Feb2021 at 13:00, the patient experienced horrible hives all over the body 4 days after the 2nd shot. The patient went to the doctor or other healthcare professional office/clinic visit as a result of AE. The patient was not tested for COVID post vaccination. Treatment received for the events with Steroid shot, prednisone pills, antihistamine. The outcome of the events was not recovered.
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| 72 | 2021-05-04 | redness, rash, skin burning sensation |
She picked at a little bump and it started to bleed; little bumps on her chest; sunburn; Chest top o...
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She picked at a little bump and it started to bleed; little bumps on her chest; sunburn; Chest top of shoulders, back of shoulders turned bright red/ Her chest, shoulder, and upper part of back turned red; She was burnt, but did not have any blisters. She described her skin feeling like she poured peroxide on an open cut.; Nauseous; The inside of her body did not feel right. She felt like something was attacking the inside of her body.; sun allergy reaction; Rash on the top part of the chest; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 15:00 (Lot Number: EN6202) in the arm as SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took advil [ibuprofen], tylenol regular and vitamins. The patient went on a boat ride two weeks later with minimal exposure to the sun and developed chest, top of shoulders, back of shoulders turned bright red. She put after sun lotion on and it didn't go away. She was told by her pharmacist to take bendryl and use cortisone with aloe. She used topical benadryl gel first and it wasn't helpful. She took oral liquid benadryl and was able to sleep. The patient stated, It felt like "I had an open wound and poured peroxide on it- my entire chest." She couldn't stand to have clothes on her chest. She did not develop any blisters. Her doctor recommended she not get the second dose so she missed the second dose. She believes that she had a reaction to the covid vaccine. She received the first dose of the covid vaccine, and the inside of her body did not feel right. She felt like something was attacking the inside of her body. A couple of weeks later, she went on a boat ride with her friends. Her chest, shoulder, and upper part of back turned red. She was burnt, but did not have any blisters. She described her skin feeling like she poured peroxide on an open cut. She tried treating it with aloe vera and a cloth with cold water. Hydrocortisone 1% with aloe vera made it hurt worse. She took liquid Benadryl and it put her to sleep. She has been reading up on side effects and about people calling to report. She thinks that she had a sun allergy reaction. The redness has still has not gone away. She now has little bumps on her chest. She is going to go to the dermatologist. She thinks that she had this reaction from the covid vaccine. She is 72 years old. She has never had anything happen to her like this before. She is out in the sun often. The day that she took the boat ride, she was only out for a little period. It goes from the upper part of her breast to her shoulder. She is not allergic to the sun, so she is not sure why she had a reaction. Because sun allergies are common, but not often reported, she wanted to call and report about her experience. The inside of her body did not feel right. She felt like something was attacking the inside of her body. It began on the same day she received the covid vaccine, 17Mar2021. It is now recovered completely. It lasted for several weeks, at least two weeks. Her chest, shoulder, and upper part of back turned red. She was burnt, but did not have any blisters. She described her skin feeling like she poured peroxide on an open cut: She clarifies that it is like a redness, like a sunburn. It began on 31Mar2021, two weeks after she received the first dose of the covid vaccine. It is a lot better now. But now she has these little bumps, she picked at a little bump and it started to bleed. She is asking about sun allergies. She is asking what can she do about this. She is asking if she can take anything. Hydrocortisone 1% with aloe vera made it hurt worse. She also used After Tan that had aloe vera in it. After Tan is a lotion made by Banana Boat that is sold over the counter. It is raining cats and dogs outside, so she is not able to go and get the bottle. She took liquid Benadryl and it put her to sleep. Benadryl gel made her skin burn. The patient had rash on the top part of the chest in Mar2021. The outcome of the event did not feel right, shoulders turned bright red and skin feeling like she poured peroxide on an open wound and nauseous was recovering. The outcome of the rest of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 72 | 2021-05-04 | dry skin, itchy skin |
activate autoimmune system ? effect on skin (dry , itchy on scalp/face) and organ (spleen?) -- > bo...
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activate autoimmune system ? effect on skin (dry , itchy on scalp/face) and organ (spleen?) -- > body fluid function: 1) tear gland ( dry eye, posterior capsular opacification)--YAG capsolotomy 2) salivary gland (extreme dry mouth -- > tooth decay --extraction of 3 teeth ; removal of gum abscess 3) reabsorption of fluid in GI (colon?) -- > 16 diarrah/day
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| 72 | 2021-05-10 | vaccination site pain |
Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Cough; loss of appetite...
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Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Cough; loss of appetite; Cataract; 'started feeling really ill'; painful injection site; A 72-years-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9265, Expiration date: unknown), via an unspecified route of administration on 28Jan2021 in left arm at a single dose for covid-19 immunization. The patient's medical history included asthma, nerve injury, chronic nerve damage and blood pressure measurement. Patients concomitant medications included losartan for blood pressure abnormal at the dose of 100 mg per day, atenolol for blood pressure abnormal, albuterol (SALBUTAMOL)) for asthma at the dose of 1.25mg, esomeprazole sodium (NEXIUM) for gastroesophageal reflux disease. On 02Feb2021, she had a cataract implant on the right side. Which was the side her headaches were on. She didn't know if it was from the vaccine or not. Five days later after surgery, on an unspecified date in Feb2021, the patient experienced started feeling really ill. She was pending a procedure on her other eye as well. She got lots of symptoms. The patient experienced tiredness, headache muscle and joint pain, chills, fever, her injection site was painful, and she was feeling unwell. The patient underwent lab tests and procedures which included body temperature which was 101.2. A couple of days after the vaccine she felt well. On 05Feb2021, then all the sudden she just felt tired and couldn't do anything. She was laying and sitting all day. She had no appetite. It had persisted. She didn't have an appetite when she eats. She couldn't taste the food. She didn't feel as bad. She could feel herself getting better. She was taking more vitamin c and more vitamins. On same date, she had a cough. She had been taking Theraflu and lung support for her chest since she developed the cough. She had fever and which was up to 101.2. It kept fluctuating. This morning it was 96. She had muscle and joint every day, but this was triple the pain of her normal pain. She had been drinking a Gatorade. She took nexium for acid reflux, and she had been taking that for a while. That was why she thinks she couldn't taste as much. She got the vaccine because with everything going on, it was the right thing to do. The reporter assessed cataract as medically significant. The outcome of events tiredness, headache, muscle pain, joint pain, fever, feeling unwell was recovering, while chills, painful injection site were recovered, cough and loss of appetite were not recovered and the outcome of started feeling really ill was unknown. She was scheduled for her second dose on 18Feb2021.
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| 72 | 2021-05-11 | skin laceration |
Pneumonia due to COVID-19 virus ED to Hosp-Admission Discharged 4/14/2021 - 4/22/2021 (8 days) ...
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Pneumonia due to COVID-19 virus ED to Hosp-Admission Discharged 4/14/2021 - 4/22/2021 (8 days) Last attending ? Treatment team Maxillary fracture Principal problem Final Summary for Deceased Patient Admission Date: 4/14/2021 Discharge Date: 4/22/2021 Final Diagnosis Principal Problem: Maxillary fracture (CMS/HCC) Active Problems: Pneumonia due to COVID-19 virus Demand ischemia (CMS/HCC) Dyslipidemia Essential hypertension Acute kidney injury (CMS/HCC) Glomerulonephritis, IgA Lactic acidosis Septic shock (CMS/HCC) Cytomegalovirus (CMV) viremia (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Left femoral vein DVT (CMS/HCC) Malnutrition (CMS/HCC) Hypothermia DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Hypoxia [R09.02] Acute respiratory failure with hypoxia (CMS/HCC) [J96.01] Fall, initial encounter [W19.XXXA] COVID-19 [U07.1] COVID-19 virus infection [U07.1] Hospital Course Patient is a 72-year-old female with past medical history of hypertension, hyperlipidemia, recent hospitalization due to CMV viremia and an AKI and myelosuppression. Who presented to the emergency room after a fall in her house on 4/14. She had significant face pain and was hypoxic with an O2 saturation of 68% on room air on presentation. She was then found to be Covid positive. Initially admitted to the medical floor however required increasing amounts of oxygen and was ultimately transferred to the ICU on 4/16. She was maintained on nonrebreather oxygen until the evening of 4/21 when she was intubated and increasing vasopressor requirements. Given her worsening condition, her husband elected to palliatively extubate and pursue comfort care. Time of death was 10:02 AM on 4/22/2021. Disposition of the body: morgue
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| 72 | 2021-05-13 | cellulitis |
This is a spontaneous report from a contactable other HCP (healthcare professional), the patient. A ...
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This is a spontaneous report from a contactable other HCP (healthcare professional), the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: E11283) via an unspecified route of administration on 19Dec2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included "HTH GERD" and sulfa allergy, both from unspecified dates and unspecified if ongoing Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within two weeks of the vaccination) included pantoprazole sodium sesquihydrate (PROTONIX), losartan and anastrazole, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received demerol for an unspecified indication on an unspecified date and experienced allergy (reported as "known allergies: Eli sulfa demerol"). On 08Jan2021 at 12:00 the patient experienced severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain. All events were serious for hospitalization on an unspecified date, for 5 days. All events resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care visit. The events required treatment with antibiotics for 6 weeks. The clinical outcomes of the events severe cellulitis on trunk anterior/ posterior, elevated temp white count pain, fatigue, SOB (shortness of breath) and chest pain were all recovered/resolved with sequel (recovered with lasting effects) on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available the reported events more likely represent intercurrent medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 73 | 2021-01-09 | redness, rash |
Skin beneath the bandaid became very red and raised. The square are under the bandaid where the inj...
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Skin beneath the bandaid became very red and raised. The square are under the bandaid where the injection was given, was completely normal.
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| 73 | 2021-01-14 | hives, rash papular, rash |
3-4?raised red itchy hive on upper FORWARD side of arm close to shoulder. Subsided and then returned...
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3-4?raised red itchy hive on upper FORWARD side of arm close to shoulder. Subsided and then returned. Still there.
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| 73 | 2021-01-14 | injection site pruritus, injection site pain, injection site redness |
Phone call on 1/11: Starting on 1/10 employee developed red area and soreness on injection site on t...
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Phone call on 1/11: Starting on 1/10 employee developed red area and soreness on injection site on the R arm (day #4), denied any fever or chills. It later developed to a pinkish color, itchy and sore not swollen. Provider prescribed Keflex 500mg 3x days. Update on 1/14: employee is feeling much better.
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| 73 | 2021-01-19 | injection site hardening, injection site pain |
1/15/2021 and 1/16/2021 Extremely tired and fatigued and started having heavy night sweats, sleeping...
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1/15/2021 and 1/16/2021 Extremely tired and fatigued and started having heavy night sweats, sleeping 10-11 hours on both nights. 1/17/2021 Chills and temperatures between 99 and 101.2 degrees 1/18/2021 Temperature of 100.1 degrees in the morning with gradual decline to 98.9 degrees in the evening 1/19/2021 and 1/20/2021 Temperature normal 1/13/2021 to 1/15/2021 Injection site "sore" 1/15/2021 Injection site became hard and painful to the point where I was not able to move the arm without pain at the level of 10 or above which of course limited my use of the arm 1/20/2021 Injection site still painful and difficult to lift or move the arm without pain at a level of 4-5.
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| 73 | 2021-01-20 | redness |
Within 5 minutes after leaving the hospital, my lips and left cheek started tingling. When I got hom...
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Within 5 minutes after leaving the hospital, my lips and left cheek started tingling. When I got home, my left cheek was beet red. That went away in a couple of hours, but left jaw up to my ear still feels strange with intermittent tingling in left cheek and lips. Called dr.
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| 73 | 2021-01-20 | skin irritation, itchy skin, rash, redness |
approximately 48 hours after receiving the first Pfizer Covid vaccine I noticed a small area of redn...
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approximately 48 hours after receiving the first Pfizer Covid vaccine I noticed a small area of redness on my left clavicle near my shoulder, it was red and itchy. Just thought it was dry skin and used some Eucerin lotion. Over the next 3-4 days this redness spread across my chest and down toward my breast. It became more red, itchy and irritated and started spreading up my neck. This went on for a few weeks and just thought it was dry skin irritation. When the rash became more raised and looked almost like hives I checked in with our clinic Family Practice doctor as my regular provider was out of the office. It was about time for my second Pfizer Covid vaccine and I hesitated to get another shot with this rash getting worse. Dr. has started me on Mometasone Cream twice daily along with Benadryl and or Zyrtec for the itching. The rash is fading and tolerable as of 1/21/21 but still remains.
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| 73 | 2021-01-20 | injection site redness, itchy skin |
minor itching starting day following inoculation. The last couple of days, the itching has increasin...
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minor itching starting day following inoculation. The last couple of days, the itching has increasing noticeably.. There is a red circle of about three quarters of an inch diameter around the place of inoculation.
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| 73 | 2021-01-20 | injection site swelling, injection site pain | pain and swelling at injection site, nausea and body aches |
| 73 | 2021-01-20 | rash |
weakness, a rush (like adrenalin or B-12 shot effect), rash on forehead, 3 hives on right cheek, two...
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weakness, a rush (like adrenalin or B-12 shot effect), rash on forehead, 3 hives on right cheek, two on right chin, slight breathing issue, slight numbness on sides of tongue and between bottom of nose and top of lips,
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| 73 | 2021-01-20 | hives, itchy skin |
worst case of Hives; Itching all over; This is a spontaneous report from a contactable consumer (pat...
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worst case of Hives; Itching all over; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899, Expiry Date: 31Mar2021), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. Medical history included blood pressure abnormal, thyroid disorder. Concomitant medication included atenolol for blood pressure, hydrochlorothiazide for blood pressure, levothyroxine for thyroid problems.On 09Jan2021, the patient broke out and got the worst case of hives to the Covid 19 vaccination, she was just itching all over and all over. The patient took diphenhydramine hydrochloride (BENADRYL) and everything and nothing was helping. The outcome of events was unknown.
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| 73 | 2021-01-21 | injection site pain |
72 hrs after injection...unbearable pain from sight to the top of the shoulder similar to rotator cu...
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72 hrs after injection...unbearable pain from sight to the top of the shoulder similar to rotator cuff pain. it eased up with continuous throbbing. Then 72 hrs later on Jan.14 same extreme pain as if I had rotator cuff surgery without anesthesia, Then the rest of the days continual throbbing especially in the shoulder area. Using Advil and hot compresses. I am limited as to completely using my arm. I have been unable to work at my daily life.
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| 73 | 2021-01-21 | injection site pain | Right arm (injection site) pain, joint pain |
| 73 | 2021-01-23 | itchy skin | Itching Pain in elbows, shoulders & knees Pain in stomach (not upset) Vertigo |
| 73 | 2021-01-23 | injection site pain, injection site pruritus, injection site warmth, injection site redness, injection site swelling |
Seven days after receiving vaccine, a large area around the injection site became very red with inte...
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Seven days after receiving vaccine, a large area around the injection site became very red with intense itching and burning/stinging. Very warm area to touch.. Slight swelling. Did not seek treatment. Applied cool cloths and symptoms began to improve in 2 to 3 days. Three days after symptoms began (and 10 days after receiving vaccine) redness is nearly gone and only slight itchiness remains.
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| 73 | 2021-01-24 | injection site pain, injection site warmth, injection site redness |
Caregiver stated the patient woke up next day complaining about being achy, feverish, entire body ac...
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Caregiver stated the patient woke up next day complaining about being achy, feverish, entire body aches and no strength. Caregiver stated on 1/23/2021 patient was having same symptoms with loss of appetite and fatigue. On 1/25/2021 caregiver noticed 2x2 red spot around the injection site that warm sore to touch. Caregiver reached out to the PCP and was told to keep an eye on red spot and put a damp warm rag on it.
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| 73 | 2021-01-24 | itchy rash |
Fever for 10 hours, swelling of arm, tenderness and what appears to be a rash that itches still ther...
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Fever for 10 hours, swelling of arm, tenderness and what appears to be a rash that itches still there at 5 days after vaccination.
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| 73 | 2021-01-24 | injection site redness, injection site swelling | Left arm pain, redness & swelling at injection site |
| 73 | 2021-01-24 | redness |
left side of face numb, tingling, redness initially bu gone as of time of call 1/21. Told her to co...
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left side of face numb, tingling, redness initially bu gone as of time of call 1/21. Told her to cont to monitor and get evaluated if did not go away in 24 hours or got worse
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| 73 | 2021-01-26 | injection site pain | Client describes burning at the injection site. |
| 73 | 2021-01-26 | rash | Facia rash |
| 73 | 2021-01-26 | injection site redness, rash, injection site pruritus |
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Rash (other th...
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Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Rash (other than injection site)-Mild
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| 73 | 2021-01-27 | injection site pain |
Nausea and vomiting beginning 12 hours after injection, headache, muscle weakness, painful injection...
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Nausea and vomiting beginning 12 hours after injection, headache, muscle weakness, painful injection site
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| 73 | 2021-01-27 | skin warm |
Started with join pain for a few days, started taking one Aleve a day. The muscles became extremely ...
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Started with join pain for a few days, started taking one Aleve a day. The muscles became extremely sore. Joint pain increased, involving shoulders, hands, legs, arms, knees and hips. Left hand began swelling on January 23rd and continued so I could no longer see my knuckles and it ballooned and it was hot and very painful. The knees were so bad it was almost impossible to stand from a sitting position and walking was stiff. Could not sleep laying down because pain in shoulders and knees would increase. I went to the doctor on the 26th. he prescribed Prednisolone for one week and I am scheduled to see him next Tuesday February 2nd.
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| 73 | 2021-01-27 | itchy skin |
head itched horribly; This is a spontaneous report from a contactable consumer reported for a hersel...
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head itched horribly; This is a spontaneous report from a contactable consumer reported for a herself A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number "end231" via an unspecified route of administration on 13Jan2021 13:00 at SINGLE DOSE for covid-19 immunisation and minoxidil (ROGAINE). vaccine location=Right arm, dose number=1 facility type vaccine: hospital. Medical history was not provided. Concomitant medication included fluorine, xylitol (BIOTENE [FLUORINE;XYLITOL]), cyanocobalamin (B12 [CYANOCOBALAMIN]), colecalciferol (D3), omeprazole (OMEPRAZOL), rosuvastatin (ROSUVASTATIN). The patient on 13Jan2021 reporter that 2 hours after using rogaine, my head itched horribly, outcome of unknown. The patient stated that used Rogaine for over a year with no issues. The action taken was not applicable.
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| 73 | 2021-01-28 | skin burning sensation | Pt. c/o flushing/burning in vaccinated arm, nausea and light headed. |
| 73 | 2021-01-29 | injection site pain |
Site soreness. 24 hours had sharp pain in left chest muscle.lastef over an hour. Hurt to take deep b...
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Site soreness. 24 hours had sharp pain in left chest muscle.lastef over an hour. Hurt to take deep breaths. Them couldn't get warm. Shivering. Felt fevered but no elevated temp registered. Lasted about another hour. Tired/weak after. Noal next day.
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| 73 | 2021-01-29 | hives |
at 16:37 making rounds to check on status of vaccination patients . Patient stated "that her mouth l...
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at 16:37 making rounds to check on status of vaccination patients . Patient stated "that her mouth lower lip and tongue were tingling and numb". Notified EMT (on site) patient moved to area of closer observation, Complete assessment . Patient A & O x 3. denies any c/o SOB or Dyspnea. Color wnl, Notified (CN) who immediately came to site of need. Noted at 16:47 Patient appears to have pink circumoral flushed areas around her mouth. Patient also had noted hives on her left upper bicep area. Discussion with (CN) and Paramedic , decision to give 50 mgs of Benedryl. 4:55 PM 50 mgs Benedry l given IM into right Deltoid. Continual monitoring of patient. 5:19 patient stated "I feel much better". Continual monitoring of patient until 5:25PM. Patient discharged home (per her and her son's wish) . Discussion to call 911 or go to ED if condition worsens or returns. Patient recommend to make primary physician aware of incident as well as to take benedryl prior to second dose of vaccine as well as patient to make clinician aware of this occurrence prior to injection..
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| 73 | 2021-01-30 | rash with redness, itchy skin |
2 days following vaccine some mild pain, next day mild itching and four days later2.5 inches approxi...
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2 days following vaccine some mild pain, next day mild itching and four days later2.5 inches approximately, circular red rash and itching. I applied cortisone cream.
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| 73 | 2021-01-30 | injection site redness | A few days after the inoculation a red circle about 1 1/2 cm appeared at the site of the shot. |
| 73 | 2021-01-30 | itchy skin |
itchy eyes, then itching spread to other areas of body (no rash). face and eyes completely swelled u...
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itchy eyes, then itching spread to other areas of body (no rash). face and eyes completely swelled up. Took oral benedryl (OTC) over course of 3 days.
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| 73 | 2021-01-31 | hives |
Approximately 48 hours after first dose given, pt developed generalized urticaria (hives) There was ...
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Approximately 48 hours after first dose given, pt developed generalized urticaria (hives) There was no angioedema, no anaphylaxis. Symptoms resolved with antihistamine, but recurred on 2/1/21 when she stopped- although very mild recurrence. Pt has h/o hives, intermittent, she describes as related to spicy foods, but more likely idiopathic hives by her history.
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| 73 | 2021-01-31 | hives, itchy skin |
Hives on breasts, under breasts, stomach, chest, lower stomach, on back, under both arms. Went to Ur...
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Hives on breasts, under breasts, stomach, chest, lower stomach, on back, under both arms. Went to Urgent Care, Sunday 01/31/2021 and was prescribed Predisone. Was also told to take Benadryl for the itch
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| 73 | 2021-01-31 | skin tightness |
Not feeling great; Slight headache; Breathing is heavier; Below her breast line is a tightness she c...
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Not feeling great; Slight headache; Breathing is heavier; Below her breast line is a tightness she can't really describe; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: SL3246), via an unspecified route of administration in right arm, on 12Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took varicella zoster vaccine (SHINGLES VACCINE) for immunization and had a little reaction but just the normal things. On Tuesday morning, the patient got the COVID-19 shot and was fine. This morning (15Jan2021), the patient was not feeling great, has a slight headache, her breathing is heavier, and below her breast line is a tightness she can't really describe. The patient asked if these were a side effect of the COVID-19 vaccine and wondering if this is normal. As a treatment for the events, the patient took paracetamol (TYLENOL). The patient asked if she can or should get a test, a COVID-19 test. It has been so many days since having the vaccine, 4 days later, she is wondering if she might have COVID-19. The patient isn't sure and is just asking a question. It is confirmed that she has not had a test or tested positive for COVID-19. The outcome of "Not feeling great" was unknown. The patient had not recovered from the remaining events.
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| 73 | 2021-01-31 | itchy rash |
Pinpoint itchy rash on arms, back, chest and abdomen, Noticed at 2:00 AM, 14 hours after shot give...
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Pinpoint itchy rash on arms, back, chest and abdomen, Noticed at 2:00 AM, 14 hours after shot given. Very tired feeling. Went to ER for treatment on Sat AM, Was told to take Zyrtec and/or Benedryl and make appt with PCP. Rash gone on Monday 02/01/21. Have appt with Dr , PCP, Wed 02/03/21 for follow up. Will discuss having second shot??
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| 73 | 2021-01-31 | itchy skin |
Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjectiv...
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Progress Notes Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/29/2021 Subjective Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience throat tightness, body tingles, itching, eye and ear pressure, dizziness, weakness,chest tightness, sweating, and feeling flushed She denied hives, loss of sensation, SOB. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress and tongue swelling. ALLERGY REVIEW OF SYSTEMS Previous Reactions: PCN Objective Vitals Vitals: 01/29/21 1514 01/29/21 1521 01/29/21 1526 01/29/21 1539 BP: (!) 153/97 (!) 154/116 (!) 167/90 (!) 172/84 Pulse: 59 64 59 55 SpO2: 99% 94% 96% 99% Blood Sugar 97 collected at 1500 Physical Exam No Rashes or Hives noted. No facial swelling , no wheezes. HEENT Pharynx is clear without exduate. No facial or tongue swelling. Lungs CTA all wheeze No SOB. Neck is supple. No swelling is noted. pt is anxious and nervous. No sign of anaphalyxis No stridor, no swelling Assessment/Plan Treatment included: antihistamines Benadryl 25 mg, Pepcid 10 mg Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Mild reaction, improving. Pt refused any further medications or assessment at the ER. Her husband will pick her up.
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| 73 | 2021-01-31 | itchy skin, skin warm, redness |
Redness, heat , swellling ,soreness down whole arm, hot, itching , acheing, tired, arm is still so...
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Redness, heat , swellling ,soreness down whole arm, hot, itching , acheing, tired, arm is still sore. Pt stated Reaction much worse on 2nd Vaccination
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| 73 | 2021-01-31 | itchy skin | Sore arm with soreness and itching, next day headache and nausea |
| 73 | 2021-01-31 | injection site redness | site reaction post 1st dose of Covid vaccine. Elevation and erythema noted at site. |
| 73 | 2021-02-01 | skin peeling |
Having hallucinations at night when sleeping, very scary things. My hands completed shedding, almost...
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Having hallucinations at night when sleeping, very scary things. My hands completed shedding, almost like a snake shedding, front and back down to wrist
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| 73 | 2021-02-01 | injection site pain |
I had injection site area pain, and I found there was a pain with as like bruise on the back side of...
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I had injection site area pain, and I found there was a pain with as like bruise on the back side of left index finger. I don't have any pain at the injection area. About my index finger, It is getting better, but it has still a little pain and a little blue around the second joint area.
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| 73 | 2021-02-01 | rash, redness, itchy skin, skin warm |
Tenderness, warm to touch, red, itchy and then rash on 3rd day after vaccine. Applied ice. Lasted ab...
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Tenderness, warm to touch, red, itchy and then rash on 3rd day after vaccine. Applied ice. Lasted about 6 hrs.
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| 73 | 2021-02-02 | injection site pain |
Medium soreness in upper left arm 4 days after vaccine was administered. Surprised because no sorene...
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Medium soreness in upper left arm 4 days after vaccine was administered. Surprised because no soreness whatsoever the first 3 days.
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| 73 | 2021-02-03 | vaccination site pain, vaccination site swelling |
Patient's primary care provider received a death certificate to be signed for this patient. He spoke...
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Patient's primary care provider received a death certificate to be signed for this patient. He spoke with the patient's husband and son, who reported that the patient had pain and swelling at the vaccine administration site after receiving the vaccine and was feeling unwell after receiving the vaccine. The patient's family reported that they found her unresponsive on 2/2/21 and called 9-1-1. The patient was pronounced dead upon arrival of emergency responders.
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| 73 | 2021-02-03 | injection site redness, injection site warmth, injection site mass | Red, warm, swollen, hard lump at injection site |
| 73 | 2021-02-03 | bruising |
flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ...
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flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ache; changes from her lower extremities freezing and sometimes it was her whole body; changes from her lower extremities freezing and sometimes it was her whole body; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231), via an unspecified route of administration in the right arm on 12Jan2021 at a single dose for covid-19 prophylaxis; apixaban, oral from an unspecified date and ongoing at 5 mg, twice daily as blood thinner medication and atrial fibrillation. Medical history was not reported. Concomitant medication included ongoing dronedarone hydrochloride (MULTAQ) for blood pressure and heart beat, ongoing pravastatin for cholesterol, and dronedarone for blood pressure. For the past couple of days, she had had flu like symptoms. She has had a headache, body aches and chills. It changes from her lower extremities freezing and sometimes it was her whole body. Patient also had a pain in arm. Her left arm was bruised - still black and blue. All of these occurred on 13Jan2021. She did not have a fever. Today (20Jan2021), she was ok. When they went through the check in they asked if patient was on a blood thinner and she was. The patient's husband was wondering if the reactions had anything to do with the vaccine and if the blood thinner medication (Apixaban) she was taking would have caused the bruise. The patient was supposed to get the second vaccine 02Feb2021. Reporter was asking if it is ok to get the second dose. The action taken in response to the event for apixaban was unknown. Outcome of event chills was recovered on 19Jan2021, after 6 days; events flu like symptoms and lower extremities freezing and sometimes it was her whole body was unknown while recovering for other events.
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| 73 | 2021-02-03 | itchy skin, vaccination site pain |
sporadic itching mostly on chest and some on legs and arms; slight sore at the Injection site.; itch...
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sporadic itching mostly on chest and some on legs and arms; slight sore at the Injection site.; itchy eyes; slight redness in the corner of her eyeballs.; This is a spontaneous report from a contactable consumer or other non hcp. A 73-year-old female patient started to receive BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: Unknown), via an unspecified route of administration on 13Jan2021 at 10:00 (at the age of 73-years-old) as a single dose for Covid-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 15Jan2021, the patient experienced itchy eyes, slight redness in the corner of her eyeballs, sporadic itching mostly on chest and some on legs and arms and slightly sore at the injection site. The clinical outcome of the events itchy eyes, slight redness in the corner of her eyeballs, sporadic itching mostly on chest and some on legs and arms and slightly sore at the injection site was resolved on 17Jan2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 73 | 2021-02-03 | injection site pain |
the thermometer that marked 100°F orally (she says that the fever was higher in the night); States ...
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the thermometer that marked 100°F orally (she says that the fever was higher in the night); States she is shrinking. Weight varies; cough; 86 of oxygen saturation/O2 saturation was anywhere between 86-88; pulse was 133/rapid pulse, it was 133/rapid heartbeat; her breathing was above 94; shooting pain/stabbing pain at the injection site/extremely excruciating stabbing pains in her arm with the shot; shivers; headache/splitting headache; freezing; slight breathing difficulty; slight body aches; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284, expiration date unspecified), via an unspecified route of administration on 15Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included high blood pressure diagnosed 15 years ago, maybe; High cholesterol diagnosed 20 years ago, she doesn't know, reflux diagnosed 20 years ago, maybe more, prediabetes and allergy induced asthma which she carries an inhaler, and she has used it maybe three times a year. Patient reported that she was tested and they don't know for sure, but she reported that she may have allergy induced asthma as she has to take, carries an inhaler, and she has used it maybe three times a year, in the fall when leaves are falling down, the leaves get moldy, and she was driving in her car, or walking in a wooded area, she gets tightness, takes her inhaler and was fine, that's the extent, no other circumstances; fall or she had where a plant was blooming outdoors, she gets tightness, and she took her inhaler, and was good for the next year, so sitting in the environment and nothing further materializes, if she takes the inhaler three or two times a year, considering what other people have, she thought this was insignificant. There were no concomitant medications. The patient reported that she got vaccinated this Friday and had nothing but a sore arm afterwards, on 16Jan2021 and was fine all day, evening, all day Saturday. She just had soreness at the site, she had no redness at the site of injection, but the weird part: she doesn't think anyone would believe, 33 hours later, at midnight, she was still up, on her way to bed, and all of a sudden she experienced extremely excruciating stabbing pains in her arm with the shot, it was stabbing, excruciating, and immediately at the same time, she had shivers/shivered and had a splitting headache, was freezing and had to put socks on, and had noticed very slight difficulty breathing, and since it was midnight, she didn't want to wake up her husband, she dozed off, and was up at 0530. She had body aches, slight, it was the least, but the stabbing stopped in her arm. She slept from 12:30 to 05:30, and the shivering and aches stopped, but the headache was still on, so she took a pill for the headache. She took the thermometer that marked 100F orally; she stated that the fever was higher in the night and she assumed with the shivering, she had a greater fever than 100. Also, the oximeter indicated 133 pulse and 86 of oxygen saturation. By 10:00, it all had resolved. She has an oximeter, and since she still had the feeling of difficulty breathing, she put it on, but her pulse was 133, that was when she was feeling better. It was reported that all symptoms were gone except for rapid pulse, it was 133 and the slight breathing, and her 02 saturation was anywhere between 86-88, it varied, and by 10:00, all issues resolved, her heartbeat was down to normal, her breathing was above 94, or whatever, everything was fine, and has been fine since then. Maybe she had fatigue on Saturday and Sunday, on Sunday was like after the flu, after you finish, you have fatigue and was a little out of it, this was on Sunday. On an unspecified date, the patient stated that she was shrinking and weight varies. Patient stated that the only thing she does have, says she has a cough, but because she needs a drink, she was not sick and she gets to drink water. She felt like the reaction she had was in the limit of a severe allergic reaction due to the rapid heartbeat and her difficulty breathing. She would like to know if there was information about these side effects reported so she can determine if she was going to have the second dose of the vaccine. Outcome of events states she was shrinking, weight varies and cough was unknown; and outcome of the rest of events was recovered on an unspecified date.
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| 73 | 2021-02-05 | rash macular, rash, itchy skin | i have a blotchy rash on my arms and legs. that is somwhat itchy. it also is in my head. |
| 73 | 2021-02-06 | injection site swelling, injection site redness, injection site pain | Redness, swelling, aching, pain, in the arm where injection was administered. |
| 73 | 2021-02-07 | injection site swelling, injection site redness, injection site pruritus, injection site warmth |
Large red area on arm near injection site that spread around the arm. Original area was approx 2" x...
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Large red area on arm near injection site that spread around the arm. Original area was approx 2" x 2" and was initially red, slightly swollen and warmer than rest of the area. By day two the area spread down and around the arm to about 1/3 the circumference of my arm. Since starting it is gradually fading but is still visible. The original itching was stopped by the use of an over the counter itch cream. Primary doctor thought I should report since he had not seen this in any of his other patients who had shot #2.
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| 73 | 2021-02-07 | injection site pain |
No reaction until 10pm. Injection site became sore and tender, Had chills during the night. Follo...
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No reaction until 10pm. Injection site became sore and tender, Had chills during the night. Following morning was running 102 degree temperature, heart rate was 107 and blood pressure was 90/60. Took two 650 mg tylenol and temperature was back to normal within 5 or 6 hours. Heartrate never got below 102 until late afternoon and blood pressure was still low at bedtime. Uneventful night and all was normal the following morning. No reaction since.
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| 73 | 2021-02-07 | skin warm |
Pt states they felt eyelids hot and felt a heachache. Pt stayed for additional monitoring. Pt denie...
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Pt states they felt eyelids hot and felt a heachache. Pt stayed for additional monitoring. Pt denies any other c/o. Pt aloc x 4. Resp. unlabored and even. Pt later states her eyelids feel normal and headache went away. Pt d/c home.
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| 73 | 2021-02-07 | redness, itchy skin, hives |
Within a few minutes after receiving the vaccine my arm felt stiff and some soreness. Then it fine a...
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Within a few minutes after receiving the vaccine my arm felt stiff and some soreness. Then it fine after I got home and I moved my arm around. It was fine by the next day. Yesterday I ate some shrimp and within the hour of eating the shrimp, I was talking to my son and my head got hot and my ears got really hot. It was itching on my forehead and the front of my neck. I thought something bite me, I went to bathroom. I had big welts on my neck about the size of the quarter and my ears were really red. I told my son that I must have hives, my son told me to take some Benadryl. It eased up after taking the Benadryl, the itching went away but the welts did not go away right away. I took another Benadryl before I went to bed last night. I was able to sleep good last night, it looked pretty much back to normal today, there is one spot left. Today when I got up I don't know how to explain it and I just didn't feel like my normal self. I felt like nervous and shaking. I didn't feel like eating but I made my self eat. I just feel like something isn't right.
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| 73 | 2021-02-07 | skin infection at injection site |
cellulitis from the shot in left arm; This is a spontaneous report from a contactable consumer repor...
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cellulitis from the shot in left arm; This is a spontaneous report from a contactable consumer reported for herself. This 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 in her left arm at single dose for covid-19 immunisation. Medical history and concomitant medications were none. There were no additional vaccines administered on same date of BNT162B2. The patient previously received a pneumococcal vaccine (reported as pneumonia shot) on unspecified date for immunisation where kind of the same thing happened, she had red, bumped up and itchiness at the injection. she didn't remember if she was diagnosed with cellulitis as it was a long time ago and she has no NDC, Lot, or Expiry for the product. The patient experienced cellulitis from the shot in left arm on 22Jan2021. The event did not require a visit to Emergency Room. She just called the doctor and was given a prescription, the name of the prescription was unknown. The outcome of event was not recovered. Information about lot/batch number has been requested.
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| 73 | 2021-02-08 | hives | Hives on neck and upper chest. |
| 73 | 2021-02-08 | vaccination site swelling, injection site redness, vaccination site warmth | Redness, swelling, and hot at vaccination site approximately 2 diameter |
| 73 | 2021-02-08 | injection site redness, injection site warmth, injection site swelling |
localized injection site reaction: redness, swollen and warm to the touch; localized injection site ...
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localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; This is a spontaneous report from a contactable nurse. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 21Jan2021 at SINGLE DOSE vaccine location: left arm, dose number:1 for covid-19 immunisation. Medical history and concomitant medications were none. The patient experienced localized injection site reaction: redness, swollen and warm to the touch on 23Jan2021 with outcome of not recovered considered as important medical event. The physician recommended Tylenol and cold compress as treatment. The action taken was not applicable. Caller works in an assisted living facility. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported vaccination site events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 73 | 2021-02-08 | injection site pain, injection site redness |
pt stated she developed a painful red area around injection site. Pt has an appt w/ a new PCP on 2/...
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pt stated she developed a painful red area around injection site. Pt has an appt w/ a new PCP on 2/23/2021 and will discuss getting the 2nd dose at this time.
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| 73 | 2021-02-09 | injection site pruritus, injection site redness |
12 hours after receiving vaccine, patient developed sweats, chills, temperature to 101.4, and myalgi...
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12 hours after receiving vaccine, patient developed sweats, chills, temperature to 101.4, and myalgias. Symptoms lasted 48 hours. Over last 24 hours patient has developed redness and itching over the injection site on the right arm.
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| 73 | 2021-02-09 | redness |
COVID-19 vaccine on 2/8/21. Next day had redness and swelling of one side of face. No other reaction...
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COVID-19 vaccine on 2/8/21. Next day had redness and swelling of one side of face. No other reaction. No fever. No pain.
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| 73 | 2021-02-09 | hardening, redness | I had a large grapefruit size red spot come up that was painful and was hard under the skin. |
| 73 | 2021-02-09 | itchy skin |
Itching; Pain in elbows, shoulders and knees; Pain in stomach; Vertigo; This is a spontaneous report...
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Itching; Pain in elbows, shoulders and knees; Pain in stomach; Vertigo; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number not provided), via an unspecified route of administration on the left arm on 22Jan2021 08:30 at SINGLE DOSE for COVID-19 immunization at the Public Health Department. Medical history reported as none. The patient's concomitant medications were not reported. On 23Jan2021 23:45, the patient experienced itching, pain in elbows, shoulders and knees; pain in stomach and vertigo. The patient was not diagnosed with COVID-19 prior and not tested since vaccination. No treatment was received for the events. The patient had not recovered from the events. Information about lot and batch number was requested.
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| 73 | 2021-02-09 | injection site pain |
Vaccine at 12:20 pm. Side effects started out with arm pain and then chills and nausea.the same as w...
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Vaccine at 12:20 pm. Side effects started out with arm pain and then chills and nausea.the same as when had first dose. 4:30 pm -acetaminophen 500mg 10:30pm severe right arm and shoulder pain 8/10. Nausea 11:30 acetaminophen 500 mg. Was trying to not take any medication for fear it would effect negatively the vaccine efficacy. continued nausea Did not sleep first night kept waking groaning in pain/R arm shoulder 5:00 am acetaminophen 500 mg body aches and continued severe arm pain. 10:40 am acetaminophen 500 mg " and " and nausea 11:30 am severe body aches, chills and fever 99* with 500mg Acetaminophen. my Normal temp (96.8) 3:30 pm "
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| 73 | 2021-02-10 | hives |
Pt without contraindications to receive vaccine. Vaccine given at approx. 1125. Patient waited requi...
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Pt without contraindications to receive vaccine. Vaccine given at approx. 1125. Patient waited required 15 min. w/o reaction. Pt remained for husband's 15 minute wait. During this time, patient felt dizzy and nauseousl and generally weak at 1150. Nourishments provided without relief. Rapid response called at 1155. Team arrived assessed patient. VS179/81 82 pulse, O2 - 96%. Dr. from Urgent Care came to check patient. Told to observe patient and repeat VS, patient ok per Dr. VS repeated at 1215 - 185/92, pulse 84, O2 sat 98%. Patient with c/o pressure to chest, chills and hives. Patient remained stable, husband present. 911 called. EMS Station 28 B shift arrived at 1225 and assumed care of patient. 1245 Ambulance arrived Unit 217 assumed care of patient.
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| 73 | 2021-02-10 | injection site swelling, injection site redness, injection site rash | Swelling, redness, small bumps in 2inch area at site of injection. |
| 73 | 2021-02-10 | injection site pain | sharp pain at injection site, body and muscle aches |
| 73 | 2021-02-11 | hives, itchy skin |
beginning with itchy soles of my feet and both palms, and progressing through the day with the addit...
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beginning with itchy soles of my feet and both palms, and progressing through the day with the addition of grotesquely swollen knees and hives on legs, arms, and a few on my back. The hives presented as large welts all very itchy. I applied Calamine lotion and took a Loratadine pill, and the hives and itch subsided dramatically. I also developed flu-like symptoms of malaise and wheezing. At no time did I have a fever nor did my throat swell or close. Saturday, 24 hours after the first Loratadine pill, the hives and swelling reappeared but disappeared within 15 minutes of taking another Loratadine pill. Sunday through today, the swollen knees and wheeze remain but diminished in severity
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| 73 | 2021-02-14 | injection site warmth |
Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the CO...
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Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience lightheadedness and headache, flushed, left deltoid where vaccination given hot to touch, nausea. She denied rash, difficulty breathing, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, rapid progression of symptoms, respiratory distress and skin changes. Patient with flushing, headache, left arm warm to touch, and nausea after first vaccine administration of Pfizer in the 15-minute waiting period. Blood pressure elevated, SpO2 is 98-99% on room air, pulse 68. Patient notes that she has reactions with medications and vaccines. Water provided. After sitting for a few minutes, patient reports that she is no longer lightheaded, headache is almost gone, nausea has resolved. ALLERGY REVIEW OF SYSTEMS: Waves of nausea: Lightheaded with some dizziness, headache: Previous Reactions: Adverse reactions to medications in the past. Objective Vitals Vitals: 02/09/21 1145 BP: (!) 179/63 Pulse: 68 SpO2: 98% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Extraocular Movements: Extraocular movements intact. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: General: No swelling. Right lower leg: No edema. Left lower leg: No edema. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and patient took Tylenol before vaccine administration Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Patient feeling back to normal. BP 152/76 at 1203. All symptoms have resolved. Left deltoid without swelling, redness, rash. Patient ambulating without difficulty. She is cleared to drive home. If she should have symptoms return or worsen, she is to call PCP or go to ER.
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| 73 | 2021-02-15 | itchy skin |
Date and time adverse event started: #1 vaccine cause swelling and pain to injection arm several hou...
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Date and time adverse event started: #1 vaccine cause swelling and pain to injection arm several hours after shot then was better the next day, was itching. #2 vaccine on right arm but it almost immediately caused numbness and tingling to left arm, felt tired. ~2 hours after vaccine, felt generalized pain and exhaustion, headache started, then 2 hours later developed chills and shivering, T 99F, leg cramps, nausea, difficulty swallowing and speech garbled. Numbness, tingling, dysphagia and speech garbled eased up after about 24 hours. She took APAP and icepack to neck to ease headache. Stayed in bed most of the time, didn't sleep well. Headache subsided, continued to have chills and aches. Now has lingering fatigue, today has "ears on fire," chills and nauseous. Brand and lot of vaccine: Pfizer#1lot FL9262, Pfizer#2lot EL9267 (caller stated it is hard to read) Date and time of vaccination: (list both if they received both shots): #1 Pfizer Jan 23, 2021
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| 73 | 2021-02-15 | redness | Three days after vaccine on Feb 1 headache, red and burning face and ears |
| 73 | 2021-02-16 | injection site pain |
Approximately 12 hours after vaccination pain and slight stiffness was noticed in the right upper ar...
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Approximately 12 hours after vaccination pain and slight stiffness was noticed in the right upper arm. No after vaccination treatment was received according to report from client. Shoulder stiffness progressed for the next 2 and 1/2 - 3 days after vaccination resulting in limited mobility, client unable to raise her arm. Client called her physician who advised her to call the HD which she did 2/16/21 at 4:50pm. Client reports having no other symptoms after vaccination and is applying (Icy Hot) patch to shoulder area which seems to be improving her mobility. she is able to raise her right arm and the soreness is improving. Client stated she would call her physician if she does not continue to improve and is agreeable to a call next week to see how she is progressing in her recovery.
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| 73 | 2021-02-16 | injection site pruritus, injection site swelling, injection site redness |
One week after injection, woke to swelling, redness, intermittent itching at injection site, no pain...
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One week after injection, woke to swelling, redness, intermittent itching at injection site, no pain or tenderness. It is now day three with no worsening or improvement.
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| 73 | 2021-02-16 | shingles, blister |
Started having neck and L shoulder pain on 2/6. Continuously got worse and on 2/12 went to PCP. Dx a...
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Started having neck and L shoulder pain on 2/6. Continuously got worse and on 2/12 went to PCP. Dx a pinched nerve. On 2/13 at 2:23pm, my whole L arm broke out in vesicles. Went to ER. Dx with Shingles. Started on Valtrex 1ooomg TID and Prednisone 50mg daily x5 days. V.esicles continued down into my L hand and fingers. Nerve pain continued to be severe. Went back to PCP on 2/16. Started on gabapentin.
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| 73 | 2021-02-16 | shingles |
psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible ...
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psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible palsy, as if her muscle was being pulled like a rubber band; the worse bowel movement. She had to go the bathroom a lot; Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening; muscle cramping and pulling; Her toes would contort and go backwards.; she feels like the left arm is going to do something, its like the last to be pulled; shingles; muscles became tight/contort; minor nausea; Stomach cramps; Gas; Indigestion; became weird in her head, almost like a lightheadedness; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular on 30Jan2021 at 10:00 at a single dose on right arm for COVID-19 immunisation. Medical history included fever, being ill (deathly ill and it lasted for three weeks) and bug bites from an unknown date and unknown if ongoing. There were no concomitant medications. The patient is the type of person that takes a lot for her to take medications. She is allergic to a lot of things; she always has crazy reactions. She can't take morphine. It took her 7 pills to get the right one for high blood pressure. She has the craziest one-day reactions. She received the COVID-19 vaccine on Saturday much against her will, knowing she had COVID but not diagnosed in March. She had a fever, she was deathly ill and it lasted for three weeks. She had a nasal swab done and it came back negative. She doesn't think that was right, she believes she had COVID-19 in Mar2020. Her daughter is younger, and she had the same thing, she couldn't breathe good for 3 weeks. She had pneumonia. She knows she had COVID-19. She was trying to lose weight. She was given her first COVID-19 vaccine by a doctor. Everything was going okay at first. About an hour and a half later, she became weird in her head, almost like a lightheadedness. She can't describe it. She has never taken drugs. She doesn't drink alcohol at all. She has like a virgin body. She states plus she is red headed, which it is known red heads have a harder time with medication. As the day goes on, she just felt lightheaded all the rest of the day. The next day (Sunday, 31Jan2021), she wakes up and it hits her like a ton of bricks. She woke in the morning and seemed to be okay and then it was like she was pregnant and blew up. She started cramping really bad and had gas. Everybody has gas. She was a little nauseated as well. She experienced lots of indigestion, cramping in her stomach like she was going to have a baby or the worse bowel movement. She had to go the bathroom a lot. She had a little bit of nausea. She had nausea pills because she had a gallbladder taken out and she took nausea pills for 2-3 days. She didn't take any medication for any of these symptoms she started to experience on Sunday. However, she did start popping Gas-X. She was taking two Gas-X every 3 or 4 hours. The caller states it helped. She had lots of gas; gas was just coming out of her bottom. She had the gas, cramps, her stomach hurt. She was able to get through it, which that is good. Then Monday, 01Feb2021 was the day she had weird things happen to her that she was kind of concerned about. Her muscles started to draw, that is the best way she can describe it. Her feet would just draw up weird. Her arms and hands would do crazy things and contort or draw up. This hurts because the muscles are like a rubber band pulling. It was weird, and she didn't like it. It wasn't like when she has a horse and has to get up and stand, it wasn't like that at all. Her muscles were tightening up like a rubber band. Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening. She thought to herself, "what is this Parkinson's?". She doesn't even know. She still has some stomach issues, but it is easing up. The gas is still coming out. It wasn't debilitating or anything. She has some minor nausea. What scared her more was the muscle cramping and pulling. Her toes would contort and go backwards. The muscle tightness occurred yesterday, 01Feb2021. It happened all day and was sporadic. Her toes moved in a different way like a rubber band pulling on muscle. Nothing has happened today. Everything was yesterday. Her whole body basically was affected, just different sections at different times. Today, she feels like the left arm is going to do something, it's like the last to be pulled. Her hands and fingers stayed the same. She explains like the upper arm area from her elbow to her shoulder part. She can't even think of what that area is, but it's the part between her elbow and shoulder. She has been doing lots of exercises and moving, hoping the part of her elbow to her should don't atrophy or won't pull. She hasn't told anybody about it. She doesn't like it. It was very frightening. She is scheduled for her second shot and she is scared to death to go back. She mentions her nerves are shot. From stress, she had previously broken out instantly. She thought it was a bug biting her. She never had gone to the doctor but after about 4 weeks, she thought she had these horrible bug bites. She was shaking her clothes and she almost wanted to strip it was so bad. She thought it was severe bug bites. She couldn't figure it out. She finally went to the doctor after a week. It was a Saturday. The doctor told her it was shingles. Explained that it itches a lot. She went on medication. She clarifies she went on acyclovir 800mg, three pills a day. She called her doctor knowing that she had shingles and how scared she is with medicine, the doctor assured her she could get the COVID-19 shot as scheduled. The medicine for shingles (acyclovir) was finished up the Friday before she received the COVID-19 vaccine. She got the shingles shot at 60 but everybody is now saying to get the new shot for shingles which she has never done obviously since she got the shingles. She plans to get the shingles shot in the summer. She is not worried about it. She took 3 pills a day and that was fine. She is fine, meaning every day she did normal things going through the whole process. She states she plans to go to the bank. She asked if anybody has reported the reaction she experienced after receiving the first dose of the Covid vaccine. She received the first dose of the vaccine last Saturday, in which within an hour and a half her "brain got weird, like a psychedelic feeling and it felt like I was getting an injection in the operating room to go to sleep." On Monday she experienced, "horrible palsy, as if her muscle was being pulled like a rubber band." Stated that it wasn't a horse feeling. Her hands and fingers would pull and contort in different positions, in which they would remain tight and stay in that position, and then she would be able to make a closed fist. On Monday night, her left arm contorted (which is not administration arm) and her muscle became really tight from her elbow to her wrist leading to her hand contorting as well. She describes the muscle tension as if a rubber band was being pulled, it would have burst. This muscle pulling hurt, in which she took 3 ibuprofen (ADVIL). She has crazy reactions with almost anything that she takes. She has never smoked or drank. The patient underwent lab tests and procedures which included COVID-19: unknown on an unspecified date and unknown on Mar2020, SARS-COV-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of gas (flatulence), muscles became tight/contort, minor nausea, horrible palsy, as if her muscle was being pulled like a rubber band and shingles. The outcome of the event 'the worse bowel movement. She had to go the bathroom a lot' was not recovered while of the rest of the events was unknown.
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| 73 | 2021-02-17 | hives |
Hives on breasts, under breasts, chest, lower stomach, on back, under both arms; Hives/ a small one ...
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Hives on breasts, under breasts, chest, lower stomach, on back, under both arms; Hives/ a small one on injection site; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262) on her left arm, via an unspecified route of administration on 22Jan2021 14:30 at a single dose for covid-19 immunization. Medical history included arthritis, penicillin allergy, sulphas allergy and Celpholasporins allergy. Concomitant medication included atorvastatin calcium (LIPITOR). The patient previously took sporanox and nitrofurantoin and experienced allergies. It was reported that the patient experienced Hives on breasts, under breasts, chest, lower stomach, on back, under both arms, and a small one on injection site on 29Jan2021 at 10:00PM. The patient received Prednisone twice a day for 5 days as treatment for the events on the emergency room (visit). The outcome of the events was recovering.
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| 73 | 2021-02-17 | rash | Rash started over chest, scalp, neck, and groin area |
| 73 | 2021-02-18 | injection site pruritus, rash, injection site swelling, injection site redness, injection site pain |
10 days after injection red area 3"/2" appeared near area of injection, itchy ,, slightly swollen, s...
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10 days after injection red area 3"/2" appeared near area of injection, itchy ,, slightly swollen, sore to touch .. enlarged area over next 2 days and currently active. topical hydrocortisone, oral cephaphlexin started on day 1, Benadryl gel cap taken first day with no improvement. rash less defined after 2 days but still spreading slowly.
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| 73 | 2021-02-18 | itchy skin, redness, rash |
Delayed reaction after both Pfizer vaccines administered at clinic. Rash from first shot began four ...
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Delayed reaction after both Pfizer vaccines administered at clinic. Rash from first shot began four days later. Chest rash reignited after second shot a week after administration. New area of itchy redness in right armpit and arm. I filed Vsafe daily responses but the service ended before my symptoms erupted. PLEASE ADJUST YOUR VSAFE SYSTEM TO ACCEPT DELAYED REACTIONS.
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| 73 | 2021-02-18 | shingles, skin warm |
On Day 3 after the shot, I experienced a sensation in the back of my left leg that felt like a shing...
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On Day 3 after the shot, I experienced a sensation in the back of my left leg that felt like a shingles-active area (no rash). Next several days, I have been experiencing hot, heavy, and prickly skin. Not hot externally, just the sensation ? like a constant strong hot flash. No fever. No fatigue. No headache.
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| 73 | 2021-02-18 | redness |
She received her first dose of the Pfizer COVID-19 vaccine on 1/7/2021 with the second dose administ...
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She received her first dose of the Pfizer COVID-19 vaccine on 1/7/2021 with the second dose administered on 1/28/2021. She reports that following the second immunization she developed a large red area on the left arm which has since resolved but since less than 1 week after the immunization she has had pain in the left upper arm as well as decreased strength. Pain and decreased strength have not worsened since onset. Pain occurs with movement.
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| 73 | 2021-02-21 | injection site pain |
This is not a critical reaction but want to report in order to help build up the information availab...
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This is not a critical reaction but want to report in order to help build up the information available to healthcare professionals going forward. Morning after chills, neck stiffness, pain back of head left side. Applied heating pad to neck. By late morning I was nauseous , and weak as a kitten. Took a 500 mg Tylenol and slept for about 4 hours. Woke up in a sweat but chills gone and am now able to eat a little bit. Back of head and neck still very sore. The injection site is sore but no rash; right arm seems to have "phantom pain" as well ( I experienced this with Shingles shot in December 2020 too).
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| 73 | 2021-02-21 | hardening |
Vaccine at 945 am Friday Calves of both legs cramped rock hard at 10 pm Friday and remained so for 1...
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Vaccine at 945 am Friday Calves of both legs cramped rock hard at 10 pm Friday and remained so for 18 hours. Had to use heating pad and massage to help feet relax from en pointe position so I could walk to the bathroom. Legs were sore after 18 hours but not cramped . Also massive headache made my eyes light sensitive all day Saturday and Sunday until about 9PM. Extreme exhaustion. Recovering today, Monday. Still tired an s slight residual headache at times but not bad enough for painkiller.
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| 73 | 2021-02-22 | redness, itchy skin |
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual came in Clinic for Covid-19 Vaccine. She began to ...
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"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual came in Clinic for Covid-19 Vaccine. She began to itching and developed redness on her bilateral forearms and shins 5 mins. After receiving vaccine. 1:30 pm vitals were 137/88,89, 20, 98% SATS on RA. Individual stated she has a history of allergies. 1:35 PM 138/88, 90, 20. Individual was given Benadryl 50 mg IM in right deltoid. Vitals at 1:50 pm were 140/90, 89, 20 98 % SATS RA itchy is less intense. At 2:10 pm vitals 140.90, 78, 20, 100% SATS RA with no noted acute distress, redness and itching has decreased in bilateral arms and legs. Individual was discharge home with family. Patient was advised to see allergist and get cleared before receiving second vaccine
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| 73 | 2021-02-22 | injection site bruising, injection site nodule | A lump at injection site that is bruised. Not tender or painful. |
| 73 | 2021-02-22 | itchy skin |
After 15 minutes of the vaccine she left and when she got home had an anaphylactic reaction, had to ...
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After 15 minutes of the vaccine she left and when she got home had an anaphylactic reaction, had to use her Epi-Pen. Did a telemed appointment with her physician who told her to take one dose of the Epi-Pen, Benadryl, Prednisone, Ventolin, and Singulair. These medications have worn off, and wants her to take even more doses of the Prednisone, Benadryl and the inhaler. She is still having symptoms, but improving. She does not itch as badly. Her arm is sore.
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| 73 | 2021-02-22 | injection site redness, injection site warmth |
Red inflamed 5" x 2" hot reaction at injection site. No pain itching or swelling. Temperature of ~10...
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Red inflamed 5" x 2" hot reaction at injection site. No pain itching or swelling. Temperature of ~100 F
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| 73 | 2021-02-23 | injection site pain |
2/6/2020 and 2/7/2020: severe chills/horrible headache--rizatriptan 2/11/2020 through 2/14/2020: sev...
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2/6/2020 and 2/7/2020: severe chills/horrible headache--rizatriptan 2/11/2020 through 2/14/2020: severe abdominal pain; low backahe; headache--aleve and rizatriptan 2/21/2020 through 2/25/2020 severe stiff neck; headache; aleve X4 pills Only a sore arm from the fist vaccine.
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| 73 | 2021-02-23 | injection site pain |
Upset stomach a few hours after injection. Next day Saturday left arm sore at shot area, and contin...
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Upset stomach a few hours after injection. Next day Saturday left arm sore at shot area, and continued upset stomach. Sunday night slight cramping in stomach. Monday AM Full blown cramping , afternoon 99.2 fever, chills, hands cold continued severe cramping. Took Tylenol. Tuesday slight cramping from stomach to rectum, normal temp. Wednesday slight cramping comes and goes. Feeling much better.
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| 73 | 2021-02-23 | vaccination site pain |
we noticed our arms wore sore/right arm soreness following injection; This is a spontaneous report f...
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we noticed our arms wore sore/right arm soreness following injection; This is a spontaneous report from a contactable consumer (patient's husband) reporting for a patient. A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3247, Expire Date: 31May2021), intramuscular (right arm) on 24Jan2021 13:30 at SINGLE DOSE (first dose) for covid-19 immunisation. Medical history included reported as none. The patient did not COVID virus prior vaccination. Patient did not have prior vaccinations within 4 weeks. There were no concomitant medications. The patient experienced arms were sore/right arm soreness following injection on 24Jan2021 before bed. It has improved, it was way better and that she was good. No treatment was given and no lab tests were done. Outcome of the event was recovering. The event did not require emergency room visit or physician office visit.
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| 73 | 2021-02-24 | vaccination site rash, injection site pruritus, vaccination site pain, vaccination site swelling |
Large rash on left arm at vaccination site. Soreness, slight swelling and slight itchiness. Rash cam...
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Large rash on left arm at vaccination site. Soreness, slight swelling and slight itchiness. Rash came on five days after Pfizer COVID 2nd vaccination injection. Rash still present.
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| 73 | 2021-02-24 | injection site swelling, injection site redness, injection site pain |
On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, ch...
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On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, chills, ear ache, pain level 8. Felt sick all over, like having the flu and then whole body ached, not just GI track. Left arm injection site was red, sore to touch, swollen (slightly). Doctor couldn't get vaccination needle into arm muscle the first time and so had to try a second time. Intense cramping of GI track started up again 8:45AM on Feb. 13th. By 4PM Feb. 15th fever 102F, chills, felt freezing cold and had to wrap myself in a heating blanket. Pain level 10, especially in pancreas. Fever broke around 2:30AM Feb. 16th and later when I was up at 8AM I felt very weak, faint, pancreas ached. Pancreatic pain lasted another 3 days. Pancreatic pain stayed around level 5. On Feb. 17th took ibuprophen. Pain level reduced to 1. This was the only time that I took pain medication between Feb. 10th and 17th, because I am conservative about using Ibuprophen, Tylenol, and have a high threshold for pain.
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| 73 | 2021-02-24 | rash, bruising |
Progress Notes Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 ...
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Progress Notes Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 Date: 2/25/2021 Subjective is a 73 y.o. female who was seen at Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience L arm/hand numbness . She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. PMH: none per pt. Not on any medication. She has not been back to her pcp for "several years". No known hx of htn. She does have a bp cuff at home. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/25/21 1118 02/25/21 1136 BP: (!) 172/84 124/82 Pulse: 96 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit or facial asymmetry. Sensory: Sensation is intact. No sensory deficit. Motor: Motor function is intact. No weakness. Coordination: Coordination is intact. Coordination normal. Gait: Gait normal. Comments: +5/5 strength to upper and lower extremities. Equal facial movement. Psychiatric: Mood and Affect: Mood is anxious (slightly). Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Exam is stable/unremarkable. VS improved after monitoring. Pt monitored for 20 minutes. She feels well. More like anxiety than local reaction. Pt aware of what to watch for. Education on monitoring bp at home and recommended that she follow up with pcp sometime next week to get up to date on her physical and follow up on bp records she will have done at home. Electronically Signed 2/25/2021 11:33 AM
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| 73 | 2021-02-24 | redness, itchy skin |
Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely t...
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Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely tired and sore arm that day. Day 2 - tired easily, no stamina. Dizzy and nauseous after showering at3:30 pm. By 10:30, both hands were red and itched. Sometime in the night woke with a very sharp, painful headache. Did not last. No real problem again until Saturday. Nausea at 11:20 am. Sunday I sat all day doing taxes - no symptoms noted. Monday after walking - rapid heart rate and very tired after what is normal activity. By 4:30 I was tingling all over my body. Tuesday night my ankles are swollen for the first time in years. Only happened that nigh. Wednesday morning, the tingling is very strong in my calves. and I had a sharp pain in the area of my Achilles tendon. I believe that the vaccine has exacerbated the neuropathy (undiagnosed) of the bottom of my feet. Today I am reporting because I fell for no reason getting out of a chair, and the tingling is in my legs, arms, shoulders. I had not heard until today that the vaccine could affect the nervous system. The effects are the worst they have been and it has been one week since I had the vaccine. Should I get the second shot? Due March 11,2021.
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| 73 | 2021-02-25 | injection site warmth, injection site redness, injection site pruritus |
Red patch developed on 02/25/2021 at injection site (approx. 2? across) warm to touch and occasional...
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Red patch developed on 02/25/2021 at injection site (approx. 2? across) warm to touch and occasional slight itch. Used cold compress twice to ease down. On 02/26/2021 - Red patch increased in size to 3? across and still warm to the touch.
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| 73 | 2021-02-25 | injection site pruritus, injection site warmth, injection site swelling, injection site redness |
Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain an...
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Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain and inability to support my weight, this lasted for three days with 2nd day being the worst pain and discomfort. Also had a headache for most of the day on the second day. Four days following vaccine I started to notice the injection site was getting itchy, then on day Five it was increasing and started getting red, swollen, hot and itch increased. Day Six it is still itchy, red, hot and swollen. Red site is about the size of an orange. As of Day Six, No fever, headache or other symptoms and knee has returned to normal discomfort.
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| 73 | 2021-02-26 | itchy skin |
9 hours after the shot, my left hand began to itch. That's the arm where I received the vaccination....
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9 hours after the shot, my left hand began to itch. That's the arm where I received the vaccination. I had no redness, rash or swelling, just severe itching. It stopped after I took Benadryl. I had no reaction at all at the vaccination site, just itching in my hand.
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| 73 | 2021-02-26 | injection site pain |
Extremely mild: headache, site injection soreness. Mild: difficulty breathing - required oxygen & ...
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Extremely mild: headache, site injection soreness. Mild: difficulty breathing - required oxygen & sleepiness. Also, antagonized my dry eye problem - requiring drops every couple of hours round the clock instead of just twice a day.
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| 73 | 2021-02-26 | itchy skin | Itching from head to toe; high blood pressure; flushed and warm |
| 73 | 2021-02-26 | hives | Nausea dizziness and hives |
| 73 | 2021-02-26 | injection site redness |
PATIENT BECAME DIZZY, FLUSHED AND SLIGHTLY RED ON ARM AT SITE. GIVEN 25 MG BNENDRYL. SYMPTOMS RESOLV...
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PATIENT BECAME DIZZY, FLUSHED AND SLIGHTLY RED ON ARM AT SITE. GIVEN 25 MG BNENDRYL. SYMPTOMS RESOLVED WITHIN 30 ADDITIONAL MINUTES .
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| 73 | 2021-02-26 | skin burning sensation |
Worsening of neuropathy symptoms: burning in hands, feet, new symptoms: transient burning in other p...
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Worsening of neuropathy symptoms: burning in hands, feet, new symptoms: transient burning in other parts of my body, bad tinnitus in left ear, worsening of chronic neck pain , worsening of dry eye syndrome.
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| 73 | 2021-02-26 | rash |
extreme fatigue,sore guns,canker sores,loss of appetite,diarrhea, rectal bleeding, no smell, no tast...
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extreme fatigue,sore guns,canker sores,loss of appetite,diarrhea, rectal bleeding, no smell, no taste, extreme thirst rash on front of both legs and both arms,night sweats, runny nose
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| 73 | 2021-02-26 | injection site pain |
sore upper left arm 2 days, fatigue 5 days, muscle & joint pain 5 days, diarrhea 4th day rested a...
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sore upper left arm 2 days, fatigue 5 days, muscle & joint pain 5 days, diarrhea 4th day rested and slept for fatigue took Tylenol first 2 days, and ibuprofen thereafter for pain took bismuth subsalicylate for diarrhea
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| 73 | 2021-02-27 | injection site pain | Fever 102.1 headache chills soreness at injection site |
| 73 | 2021-02-27 | injection site pain |
Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Ch...
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Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: DEATH-Severe, Systemic: Heart Attack-Severe
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| 73 | 2021-02-28 | injection site pain | All day. |
| 73 | 2021-02-28 | rash |
I developed a rash (in the evening and continued all night). The instructions I received was to see...
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I developed a rash (in the evening and continued all night). The instructions I received was to seek medical attention. I went to Urgent Care at 8 AM on Feb.25. I was instructed to take one tablet Claritin and then 2 Benedryls in the evening. By 5:30 PM on Feb 25 I was extremely uncomfertible and took two benedryls. Still could not sleep and at 11:30 PM took 2 more benedryls. When I woke up at 7:30 AM on Feb 26, the rash was gone and has been gone since. I was also instructed not to take the second shot. (Which I will not)
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| 73 | 2021-02-28 | injection site pain |
Patient called after getting home that she has pain at the injection site, and a golfball sized amou...
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Patient called after getting home that she has pain at the injection site, and a golfball sized amount of fluid collecting at her elbow.
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| 73 | 2021-02-28 | injection site pain |
Pt. c/o lightheadedness, nausea and burning sensation at site 10 minutes after receiving the vaccine...
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Pt. c/o lightheadedness, nausea and burning sensation at site 10 minutes after receiving the vaccine. Client assessed by EMS and vital signs are B/P 115/80, HR 75, 02 98. After 20 min. of continuous observation client stated that she started to feel better. Pt. advised to stay another 15 min then cleared to go home by EMS.
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| 73 | 2021-02-28 | rash, itchy skin |
States develop generalized rash, itchy 25 hours after receiving first dose of vaccine. Called her pr...
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States develop generalized rash, itchy 25 hours after receiving first dose of vaccine. Called her primary dr. 4 days after first dose of vaccine for continued rash. Was given a round of steroids and claritin by her pcp per patient.
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| 73 | 2021-02-28 | injection site warmth, redness |
Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep becaus...
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Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep because I was just uncomfortable all over. Felt a little light headed. At 7:00 took temp,99.2,- my normal is around 97.7. Right arm was feverish and extremely sore,more so than first vaccine. All that day fever went up to 101.2 by the afternoon. Drank liquids all day. had a headache most of the day with all over joint pain. Never had the flu but think this must be how you feel. Fever broke around 3:00AM on 2/26. Upper arm remains sore, swollen,red and feverish as of today,3/1
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| 73 | 2021-03-01 | itchy skin, hives |
About ten days after vaccination, hives began to show up on my lower abdomen . Since then, hives app...
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About ten days after vaccination, hives began to show up on my lower abdomen . Since then, hives appeared in many areas of my body as well as itching where there are no hives. My eyes are also itchy. The hives and itching become worse when my body heats up during exercise or when covered by warm clothing or blankets. I'm taking 2 Benadryl every six hours, which provides relief but not entirely. This has been going on for 9 days now. I eliminated eggs and Teeccino Dandelion Dark Roast from my diet several days ago and cut my probiotic dosage in half, thinking these might be the culprits, but so far I continue to itch and have hives.
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| 73 | 2021-03-01 | hives, itchy skin |
After 1st dose of Pfizer Covid vaccine Received on 2/25/2, 20 mins later noted mosquito bite size hi...
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After 1st dose of Pfizer Covid vaccine Received on 2/25/2, 20 mins later noted mosquito bite size hive on upper extremities. 6 hours later hives appeared on all extremities but not face or body truck. No airway and facial involvement. Pt states hives are not painful but pruritic. Also has some numbness and tingling. As of today 3/2/2021, all hives resolved. Finished prednisone course today. Taking Benadryl along with prednisone.
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| 73 | 2021-03-01 | injection site pain | Chills, nausea, fatigue soreness and stiff at shot site. |
| 73 | 2021-03-02 | injection site redness, injection site swelling, injection site warmth |
Patient has localized swelling, redness and warm to touch. Entire upper arm where she received the v...
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Patient has localized swelling, redness and warm to touch. Entire upper arm where she received the vaccination. Patient was seen on 03/02/21 by PCP. Patient was recommended to use ice for swelling as well as tylenol /ibuprofen and to call with an update on 03/05/21 or sooner if becomes worse. PCP also used marker to outline to monitor if the redness or swelling increases.
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| 73 | 2021-03-02 | injection site pruritus, injection site swelling, injection site redness | Redness & swelling at the injection site & itchey |
| 73 | 2021-03-02 | injection site swelling, injection site warmth, injection site pain, injection site redness | Swelling and redness, warm and painful to the touch, in 2 inch diameter around injection site |
| 73 | 2021-03-02 | redness |
rt. hand fingers tingling, 15-20 minute later ears turned red, sinuses started aching, shaky week fe...
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rt. hand fingers tingling, 15-20 minute later ears turned red, sinuses started aching, shaky week feeling
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| 73 | 2021-03-03 | injection site redness, injection site swelling |
Overwhelming tiredness for 2 days Fatigue- Slept all through nights A little foggy mind Redness and...
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Overwhelming tiredness for 2 days Fatigue- Slept all through nights A little foggy mind Redness and swelling around site of injection- still demonstrating on third day March 4
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| 73 | 2021-03-03 | vaccination site pain |
food poisoning; First got really sick; nausea/She got sick to her stomach; head colds/feels like com...
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food poisoning; First got really sick; nausea/She got sick to her stomach; head colds/feels like coming down with a cold; Feeling unwell/she wasn't feeling well; Dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever.; sinus problems.; vomiting; Pain injection site; Slight headache; Chills, feels like coming down with a cold; Tired; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: RL3249), via an unspecified route of administration at left arm on 26Jan2021 14:00 (also reported as 17Jan2021 - pending clarification) at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included diabetes, cancer (prior to receiving COVID-19 shot. Stated she was 14 years cancer free), allergy, shingles shot which hurt at the injection site, shrinks every year (Doesn't know exact number, but a little under 5 feet). The patient had no family medical history. Concomitant medication included mometasone furoate (FLONASE [MOMETASONE FUROATE]). On an unspecified date, the patient experienced she got sick to her stomach, food poisoning, "nausea/She got sick to her stomach," "head colds/feels like coming down with a cold," "feeling unwell/she wasn't feeling well," "dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever," sinus problems, vomiting, and first got really sick. On 26Jan2021, the patient experienced tired, slight headache, chills feels like coming down with a cold, and pain injection site. The patient reported that she received the first dose of the Pfizer vaccine and experienced side effects including nausea, head colds, and sinus problems. She was concerned that this may be covid and if it will be safe for her to get the second dose of the vaccine as scheduled. The patient further reported that she first got really sick. Never had the flu and always gets head colds or food poisoning on an unspecified date. After reading material passed out, perhaps she was treating COVID and not a cold or allergy. The patient took first COVID-19 shot on 26Jan2021. Thought everything was fine. The patient was close to bedtime then noticed she wasn't feeling well. Looked at side effects and has like six of them at the same time. Right as she was going to rest, she got sick to her stomach. Never was sick to her stomach except when she was food poisoned. The patient had dry heaved for 40 minutes. Saliva in her stomach was coming up, not food. Felt like it lasted forever on an unspecified date. The patient asked that if she does have COVID, should she take the second shot? Wanted to get tested because Pfizer materials says exactly what her headache and sinus stuff was about. Now she was scared. The patient also reported that she wanted to take the second COVID-19 shot. If she does have COVID, thinks it's not the thing to do right now. It was confirmed she has not had a positive COVID test after receiving the first COVID-19 shot. Should have read material prior to and maybe wouldn't have taken the first COVID-19 shot. Confirmed symptoms she mentioned occurred after the COVID-19 shot. The patient came home from COVID-19 shot feeling fine. Didn't get sick until close to bedtime. Appointment for COVID-19 shot was 2:30PM. Clarified six symptoms previously mentioned: The patient had pain at injection site just two days and was gone. Began shortly after she got home from the COVID-19 shot. Went to lift arm up and it didn't feel good. Began an hour or two after COVID-19 shot. The patient was tired unusually early in the day. Felt like she didn't want to do anything. Couldn't use her left arm. Clarified left arm was injection arm. Tiredness has subsided and only lasted a couple of days. It was further reported that patient never gets headaches. It started after vomiting which didn't last long. It bothered her and then was gone by the time she went to sleep. The patient had chills, feels like coming down with a cold on an unspecified date which subsided right before dinner around 3PM-4PM. The patient had to put on a fluffy robe to keep warm. It was also reported that the patient did not have a fever. It was also reported that shingles shot hurt at injection site where pain lasted a week and a half. Temperature went from 98.6 degrees to 99 degrees. The patient was taking stuff now and monitoring to see if she can see any signs. The patient was feeling unwell on an unspecified date which has subsided except for allergies and she was concerned. The patient also experienced dry heaving: didn't have anything in her stomach on an unspecified date which subsided. Even after she ate yesterday, hasn't had any dry heaving except for night of the COVID-19 shot. The patient underwent lab tests and procedure which included body height: little under 5 feet (doesn't know exact number), temperature: went from 98.6 degrees to 99 degrees, and COVID test: negative (she has not had a positive COVID test after receiving the first COVID-19 shot). Therapeutic measures were taken as a result of sinus disorder which included sinus medication and was squirting Flonase in her nose. On an unspecified date, the patient recovered from slight headache. The patient had not yet recovered from the event nausea and vomiting. The outcome of the events chills, tired, food poisoning, first got really sick, head colds/feels like coming down with a cold, feeling unwell/she wasn't feeling well, dry heaves, sinus problems, and pain injection site were unknown.
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| 73 | 2021-03-04 | injection site redness, injection site swelling | Injection site swelling and redness - today it is eight days since injection and still very red. |
| 73 | 2021-03-04 | itchy skin, redness |
Patient started to itch on left arm and showed slight redness. Gave 25mg of diphenhydramine liquid f...
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Patient started to itch on left arm and showed slight redness. Gave 25mg of diphenhydramine liquid for 1 dose
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| 73 | 2021-03-04 | shingles, rash |
Severe case of shingles in left arm. Electrical shock type pain from left mastoid thru neck, shoulde...
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Severe case of shingles in left arm. Electrical shock type pain from left mastoid thru neck, shoulder, arm to palm, thumb and finger tips. Muscular pain from neck (felt like pinched nerve) thru shoulder to wrist (felt like carpel tunnel). Blooming painful pustule rash from shoulder to wrist on inner arm for one week. Post-herpetic and muscular pain continues through rash scabbing and drying, to date March 6, 2021. This is my second event in 37 years.
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| 73 | 2021-03-04 | injection site redness, injection site warmth, injection site rash, injection site pain |
Warm red mound at injection site, painful if bumped, but arm ok to use. Lasted 3 days, then needle s...
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Warm red mound at injection site, painful if bumped, but arm ok to use. Lasted 3 days, then needle site itchy for 3 days
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| 73 | 2021-03-04 | injection site pain |
tenderness at injection site, low grade fever, aching in all joints-started at 12:30-7;30 3/5/21, 3 ...
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tenderness at injection site, low grade fever, aching in all joints-started at 12:30-7;30 3/5/21, 3 doses of advil,vomiting
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| 73 | 2021-03-05 | injection site redness, injection site mass, hives, injection site warmth, injection site pruritus |
Itching close to the site of the vaccine on the arm, been going on for a day and a half. Hard mass o...
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Itching close to the site of the vaccine on the arm, been going on for a day and a half. Hard mass on arm, redness and skin warm to touch, on the arm under the shot site. There is a hive that measures about 4-5 inches . This happened with the second dose.
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| 73 | 2021-03-05 | injection site rash, injection site pain, injection site swelling, injection site redness | Nausea Vomiting Diarrhea Headache Chills Rash, Pain, Swelling, Redness at site area |
| 73 | 2021-03-05 | rash |
Rash on lower arms 10 minutes post vaccination. Patient had taken diphenhydramine prior to arrival, ...
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Rash on lower arms 10 minutes post vaccination. Patient had taken diphenhydramine prior to arrival, declined cetirizine or additional diphenhydramine. Rash slowly resolved, patient discharged.
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| 73 | 2021-03-06 | rash |
2 am,,went to get out of bed, collapsed because legs wouldnt hold her up. Headache, 2 poilt fever, a...
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2 am,,went to get out of bed, collapsed because legs wouldnt hold her up. Headache, 2 poilt fever, arm rashes shoulder to wrist. Body aches and bad weakness for about a week. Rashes on arm and swollen arm lasted 9 days.
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| 73 | 2021-03-06 | hives, rash with redness | Hives - red/rash around neck, ears, hairline |
| 73 | 2021-03-07 | injection site pain |
3/4 Evening: injection site VERY sore. Too painful To sleep on. Disturbed sleep due to pain. 3/5:...
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3/4 Evening: injection site VERY sore. Too painful To sleep on. Disturbed sleep due to pain. 3/5: Morning; headache, fatigue Evening/overnight: arm still tender 3/6: Morning: fatigue, nausea, headache, lack of appetite, stomach upset. Hot flashes, no fever detected Afternoon: very nauseous, vomiting, headache Evening/overnight: not getting restful sleep 3/7: Morning: mild headache/lack of appetite Evening/overnight: woke in the middle of the night with severe stomach cramps, loose stool, nausea amd vomiting. No fever detected. 3/8 continues to be nauseous, lack of appetite and extreme fatigue.
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| 73 | 2021-03-07 | injection site pain |
Severe breathing distress lasting 3 days Diarrhea 2 days. Injection site pain. Headache joint pAin...
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Severe breathing distress lasting 3 days Diarrhea 2 days. Injection site pain. Headache joint pAin Fatigue
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| 73 | 2021-03-08 | vaccination site pain |
Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the in...
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Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the injection; I have a slight fever of a 100; I feel I am cold, I have the chills; Headache; joint pain; muscle pain unbelievable; nauseous; I was sick all day; symptoms felt like when you are getting the flu and when you get the flu vaccine; tiredness; sweating; This is a spontaneous report from a contactable consumer, the patient. This 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 05Feb2021 (at the age of 73 years-old) for COVID-19 vaccination. Medical history included Parkinson's disease, bulging disc in the back and shoulder, anxiety, thyroid, had very bad case of, was in the hospital for 12 days and they were just supposed to put her on the ventilator, but then started to recover a little bit, was hesitating on taking the shot. But when she called the doctors they said no you can take it, even the neurologist said that you can take it because she had this disease and should be taking it. Historical vaccine included unspecified reaction from an unspecified flu vaccine on an unknown date. Concomitant medications included dexlansoprazole (DEXILANT), levothyroxine, paroxetine for anxiety, carbidopa, levodopa for Parkinson's disease, metoprolol succinate (METOPROLOL ER ACTAVIS) 25 mg, one a day and vitamin D NOS. On 05Feb2021, the patient experienced slight fever of a 100, felt cold, chills, headache, joint pain, muscle pain unbelievable, nauseous and was sick all day. On 06Feb2021, the patient's arm was very sore in the spot where they gave the injection and has no rash, it's not red in that area or any place else, It's just very sore and it hurts in the muscle, this is very sore in the spot where they gave the injection. On an unknown date in 2021, symptoms felt like when you are getting the flu and when you get the flu vaccine just a little more tiredness. Treatment to reduce the fever included acetaminophen (TYLENOL) and is sweating. Treatment was received for chills. The clinical outcome of slight fever of a 100, felt cold, chills was recovered on an unknown date. The clinical outcome of arm very sore in the spot where they gave the injection, headache, joint pain, muscle pain unbelievable, nauseous, sick all day, symptoms felt like when you are getting the flu and flu vaccine, tiredness and sweating was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 73 | 2021-03-08 | redness, vaccination site itchiness |
Site is very itchy.; Arm red and hot; Arm red and hot; This is a spontaneous report from a contactab...
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Site is very itchy.; Arm red and hot; Arm red and hot; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the left arm on 23Jan2021 at 11:30 AM (at the age of 73 years) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, asthma, hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine sodium, hydrochlorothiazide/losartan potassium. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Feb2021 at 16:00 PM, the patient experienced arm red and hot. On an unspecified date the patient experienced the injection site is very itchy. No treatment was given for the events. The clinical outcome of arm red and hot was not recovered. The clinical outcome of injection site is very itchy was unknown. . It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 73 | 2021-03-09 | pain of skin |
1st Pfizer vaccine given Feb 4th; 2nd Vaccine received 9:30 a.m. March 25; Side effect 1: Never ...
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1st Pfizer vaccine given Feb 4th; 2nd Vaccine received 9:30 a.m. March 25; Side effect 1: Never having had nose bleeds I had 8 minor nosebleeds after the 1st vaccine. (chalked it up to "ND dry air). March 24 at 1;30a.m. I awoke to a nose bleed my husband and I could not stop; went to ER and a catheter was placed in my nose after an hour after they could not get it stopped. Catheter was removed next day. Blood pressure 184/96 unusual for me range 120/80. Side effect 2: 10 days after the 2nd vaccine I noticed loss of hearing in my right ear. That has persisted but I have not taken any action on it. My head is tender and I feel more "off balance than normal". Not sure if this coincidence or side effect.
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| 73 | 2021-03-09 | injection site pain |
Covid Pfizer #2 was injected high into my right shoulder (bursa) area instead of the deltoid muscle ...
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Covid Pfizer #2 was injected high into my right shoulder (bursa) area instead of the deltoid muscle area. Unlike shot #1 on 02/16/21, where I could not even feel the needle in my left arm, this injection into my shoulder was immediately painful. As the day progressed, my upper arm had to be massaged to reduce the pain, my wrist and fingers tingled, and I could not use my right arm for normal activities. Overnight, I had difficulty finding a comfortable position for sleeping. I fear a bursitis condition will develop requiring further treatment.
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| 73 | 2021-03-09 | itchy skin, rash |
Fever, itching very bad. Stinging, rash , chills , headache. In bed for a week. Had rash for sever...
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Fever, itching very bad. Stinging, rash , chills , headache. In bed for a week. Had rash for several days.
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| 73 | 2021-03-09 | vaccination site itchiness, vaccination site redness |
Injection site is red, itchy and slightly raised.; Injection site is red, itchy and slightly raised....
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Injection site is red, itchy and slightly raised.; Injection site is red, itchy and slightly raised.; This is a spontaneous report from a contactable consumer (patient, self-reported). A 73-year-old female patient received (who was not pregnant, at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3302 and expiry date was unknown) via an unspecified route of administration, in Arm Left, on 26Jan2021 15:00, as single dose for COVID-19 immunization, at hospital. Patient's medical history was not reported. Concomitant medications were included women's Multi-Vitamin, Calcium and Fish Oil (within two weeks of vaccination). Patient previously took sertraline and citalopram; had allergies with these two medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, Prior to vaccination. Since the vaccination, Patient has not been tested for COVID-19. On 02Feb2021, 23:00, patient experienced Injection site is red, itchy and slightly raised. Patient was not received treatment for the events. Seriousness of the events was reported as non-serious. Outcome of the events was reported as not recovered.
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| 73 | 2021-03-09 | rash | Rash on torso |
| 73 | 2021-03-09 | redness |
When entering into the observation room, the RN noticed that patches of red on the neck and throat a...
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When entering into the observation room, the RN noticed that patches of red on the neck and throat area of the patient. Patient denies any shortness of breath, chest tightness, or wheezing. Denies any tongue swelling. Blood pressure taken. Vital Signs 218/105 94 98% examined. Patient alert and oriented. Patient was observed for 30 minutes.
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| 73 | 2021-03-09 | skin warm, itchy skin |
arm was hot, and chills -sat 03/06/21 itching- Sunday 03/07/21 and it got bad on 03/08/21 pt. stated...
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arm was hot, and chills -sat 03/06/21 itching- Sunday 03/07/21 and it got bad on 03/08/21 pt. stated she took tylenol and benadryl at night Recommendations: Apply a cold compress to the area where you are experiencing itching to provide some comfort, please contact your PCP and let him/her know the symptoms you are experiencing for other recommendations. You stated you are having difficulty breathing so I recommend for you to go to your nearest emergency department just to make sure your airway doesn't close up and they could do a full workup.
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| 73 | 2021-03-10 | injection site redness |
L local red arm @ vaccination site Vitals: B/P: 160/82 HR: 87 Resp.: 12 O2sat: 85% Skin signs: Warm...
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L local red arm @ vaccination site Vitals: B/P: 160/82 HR: 87 Resp.: 12 O2sat: 85% Skin signs: Warm and dry Resp.: Breath Sounds Clear Bilaterally Treatment: Ice Repeat Assessment @15:45 Vitals: B/P: 140/80 HR: 76 Resp.: 12 O2sat: 95% Skin signs: warm and dry Circulation: Cap refill <2sec Resp.: Breath Sounds Bilaterally Treatment: Released home with spouse
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| 73 | 2021-03-10 | itchy rash, rash |
Symptoms include breaking out in small red spots on shoulders and neck at first. Then eventually spr...
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Symptoms include breaking out in small red spots on shoulders and neck at first. Then eventually spread downward to elbow and bend of arms bilaterally . Now has continued on down clients body. Some are under the skin. A few errupt. They are very sore. If they do errupt they have a small white pustule in the center. The rash has now spread completely down abdomen and covered legs also . There is periods that the itching stops with an antihistamine but it doesnt go away. This started on the 7th and has continued..
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| 73 | 2021-03-10 | injection site warmth, hives, injection site pruritus, injection site pain, injection site redness |
This area had remained somewhat sore after the initial soreness the day of and the day after the vac...
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This area had remained somewhat sore after the initial soreness the day of and the day after the vaccination. Red, welp, itching, stinging, burning, "hot" to touch after waking up this morning. Redness patch/area approximately 4" x 3" Took extra dose of my allergy medication and applied Benadryl cream locally At 4:25 (time of this report) the area is not as "red" but still "hot" to touch and itching periodically. Reddish/pink patch still the same measurement
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| 73 | 2021-03-11 | injection site swelling, injection site pain, injection site redness, injection site pruritus |
2nd shot given 2/28/2021, reaction occurred on 3/5/2021. Shot site swelled a little, was sore, red...
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2nd shot given 2/28/2021, reaction occurred on 3/5/2021. Shot site swelled a little, was sore, reddish, hurt and itched. Reddish site was the size of a silver dollar. This lasted 3 days with no other adverse effects.
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| 73 | 2021-03-11 | pain of skin, skin discolouration, rash, itchy skin | Swollen face with small bumps, discoloration on the face, itchy, stings |
| 73 | 2021-03-14 | skin discolouration |
36 hours after shot skin discoloration (brown/red flat patches) developed on both upper inner thighs...
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36 hours after shot skin discoloration (brown/red flat patches) developed on both upper inner thighs and around both armpits. Discoloration has not gone away and after about a week, the discolored areas on both thighs were 'puffy' with some edema. These areas were not itchy nor was there a raised rash - just discoloration. The area around the injection site has no discoloration. For first few days also had some chills and tiredness, but these are gone.
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| 73 | 2021-03-14 | skin tightness |
The right side of my face was numb and felt uneven, my throat felt very dry, tingling in my right si...
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The right side of my face was numb and felt uneven, my throat felt very dry, tingling in my right side of the body. No treatment the symptoms went away within two hours. However, the right side of my face feels tight not numb.
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| 73 | 2021-03-14 | skin reaction, redness | a delayed skin reaction to the vaccine as described here: In web site. |
| 73 | 2021-03-14 | injection site pain |
chills, fever, headache, nausea, weakness, and arm pain at site. Called Dr. spoke with staff and tol...
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chills, fever, headache, nausea, weakness, and arm pain at site. Called Dr. spoke with staff and told it will go away in a couple of day. Stayed in bed all day on the 12th of March and woke up about 8:00 on the 13th and only symptom which I still have today is sore arm at point of vaccination. other meds Lorazepam .05mg,Aspirin 81 mg, Acyclovir 400 mg, Vita D, Vita B12,Align, Estroven. Turmeric, One a day vitamins,Coq10
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| 73 | 2021-03-15 | injection site pain |
First does had soreness of area of injection overnight., no other adverse reaction. Second does had ...
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First does had soreness of area of injection overnight., no other adverse reaction. Second does had the same soreness of area of injection overnight, in addition to bodyacnes and soreness, for about a day and a half. After that I continues to experience fatigue, I go to sleep at night and have difficulty getting up in the morning due to feeling very fatigued. It takes about an hour before I can feel like completing my day. During the day I feel like I need a nap. Before the shot I was able to complete my day as normal.
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| 73 | 2021-03-15 | hives |
Hives, treated with Benadryl pills and ointments, but hives continue to come back daily after one we...
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Hives, treated with Benadryl pills and ointments, but hives continue to come back daily after one week. Saw primary dr today. Starting new course of treatment with Zertec & Pepicid. If that does not work, she prescribed Prednisone.
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| 73 | 2021-03-16 | rash |
Developed rash after vaccine. No trouble breathing. Benadryl 25mg PO x 1 given. Pt discharged home w...
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Developed rash after vaccine. No trouble breathing. Benadryl 25mg PO x 1 given. Pt discharged home with family in stable condition.
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| 73 | 2021-03-17 | hives, rash with redness, rash |
Allergic Reaction within 10 minutes: Large itchy hive on forehead, a red rash on both hands, headac...
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Allergic Reaction within 10 minutes: Large itchy hive on forehead, a red rash on both hands, headache, mild dry cough. After 40 minutes of observation by a hospital nurse, I went home and took an allergy pill, as advised (Benedryl). I am recovered.
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| 73 | 2021-03-17 | injection site rash, injection site pain |
Chills - fever of 100.8 - extreme headache - arm pain and rash by injection site - joint pain throu...
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Chills - fever of 100.8 - extreme headache - arm pain and rash by injection site - joint pain through the whole body - swollen lymph nodes on left side of neck - pain so bad couldn't roll over in bed - fatigue
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| 73 | 2021-03-17 | shingles, rash |
Developed rash on Sunday and Monday 3/14/ turned into full shingles outbreak on left chest and unde...
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Developed rash on Sunday and Monday 3/14/ turned into full shingles outbreak on left chest and under left arm and now back
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| 73 | 2021-03-17 | rash with redness, injection site redness, injection site pruritus, injection site rash, itchy rash |
Slight fever day after vaccine 2nd dose. Red rash appeared 2 days after below vaccination site. Red ...
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Slight fever day after vaccine 2nd dose. Red rash appeared 2 days after below vaccination site. Red and itchy and remains over 2 weeks later
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| 73 | 2021-03-17 | skin reaction | Tongue tingling, face hot, red nose |
| 73 | 2021-03-18 | redness |
Swelling of right hand including sore joints in wrist and fingers. This resolved by 3/1/2021. Hot ...
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Swelling of right hand including sore joints in wrist and fingers. This resolved by 3/1/2021. Hot flashes including drenching sweat , red neck and face and raised blood pressure. This occurred randomly. It was an almost daily event until 3/5/2021. This then reduced to 1 event every 2-3 days until the present. Last occurred on 3/18/2021.
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| 73 | 2021-03-19 | rash, hives |
High blood pressure (190/70) Painful headache due to high blood pressure Heart palpitations Hives on...
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High blood pressure (190/70) Painful headache due to high blood pressure Heart palpitations Hives on left arm above elbow
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| 73 | 2021-03-19 | rash papular, rash, itchy skin, rash with redness |
Skin rash (red, raised) around neck, chest, face. Red, raised and puffy, extremely itchy, tender. ...
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Skin rash (red, raised) around neck, chest, face. Red, raised and puffy, extremely itchy, tender. The rash started in several spots which have then grown in size and merged in a couple of areas. I had one patch of the same rash a couple of weeks after the first vaccination . It lasted a couple of days and wasn't as severe as this time. My internist thinks this is due to the vaccination -- other possibilities (eg bug bite) are not at all likely. Treating with antihistamines and topical cortisone - which are minimally effective so far.
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| 73 | 2021-03-19 | rash | Sore right arm, fever, nausea chills, rash, headache |
| 73 | 2021-03-19 | injection site bruising |
Started with chills and upset stomach. After about 30 minutes felt sick to my stomach, still chills...
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Started with chills and upset stomach. After about 30 minutes felt sick to my stomach, still chills and felt weak. Went to bed with normal covers, spread and an extra quilt. Temperature was 101.0. stayed in bed until noon then went to the couch. Still felt weak and extremely tired. Temp down to 99 but developed a bad headache. Took Tylenol and laid on the couch all day - did not eat still felt queasy. Went to bed around 8:00pm. Got up about 10:00 on Friday and felt almost back to normal and got better as the day went on. I also noticed quite a bruise at the site.
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| 73 | 2021-03-20 | injection site reaction |
3/10 could not stay awake beyond 9PM 3/11 10 AM, tired, nauseous, continued to 8PM when could no lo...
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3/10 could not stay awake beyond 9PM 3/11 10 AM, tired, nauseous, continued to 8PM when could no longer stay awake, slight aching at injection site 3/12 slept 10 hours, continue to feel tired, less energy to present date 3/21/21.
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| 73 | 2021-03-20 | injection site swelling, injection site redness, injection site rash | Swelling and redness and rash at injection site on left arm |
| 73 | 2021-03-21 | itchy skin |
Evening of administered dose sore and itchy arm. Woke up the morning after injection (3/18/2021) had...
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Evening of administered dose sore and itchy arm. Woke up the morning after injection (3/18/2021) had tired feeling of eyes, white of left eye appeared to have bleeding across entire bottom area as well as up both sides, top area remained white in appearanceor bleeding was unresolved in three weeks AS
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| 73 | 2021-03-21 | rash with redness, rash |
Got the vaccine, she had no side effects and about 3/12/201 noticed a major rash from above the elbo...
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Got the vaccine, she had no side effects and about 3/12/201 noticed a major rash from above the elbow, inner aspect of her arm down to her wrist. This was bright red. She put cortisone on it, and now it's brownish and rough in nature. It is 4" above the elbow and probably down to about 2-3" above the wrist, watch area. It runs up the outer aspect of the arm to the elbow. She put cortisone cream on it, the redness and inflammation was there for about 2 days, and now it has changed to the brownish/rough area. She did not go to the doctor, just took the OTC Cortisone cream. It is not itching, it did not itch, just red and inflamed.
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| 73 | 2021-03-21 | skin spots, injection site bruising, itchy skin, bruising, rash |
History of present illness: patientt is a 73 y.o. year old female with a history of hypothyroidism, ...
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History of present illness: patientt is a 73 y.o. year old female with a history of hypothyroidism, hypertension, history of breast cancer status post bilateral mastectomies who presented with complaints of bruising, petechial rash and gum bleeds. She noticed that when she was brushing her teeth this morning, her gums were bleeding and found a pea size hematoma in the bottom of her lip. Denies recent injury or trauma. Denies fevers chills nausea vomiting chest pain shortness of breath cough weakness dizziness lightheadedness. Denies hematuria or blood in stools or dark stools. Patient reports she received her first dose of Covid vaccine on March 2. She noticed a large bruise in her injection site this morning. Denies pain. She reports that her lower extremity started itching last week and she began scratching and knows it is small red dots diffusely distributed in her bilateral lower extremities. Denies starting any new medications. Denies history of HIV or hep C. She reports starting a new topical medication given to her by a dermatologist for dry skin but does not know the name. Denies history of blood disorders. 3/18: Patient diagnosed with idiopathic thrombocytopenia and admitted to medical floor. History of present illness as above. Plt <2; WBC 9.2; Hgb/Hct 13.2/38 3/19: Oncology provider consulted and recommended oral prednisone 100 mg daily, transfusing for any evidence of significant bleeding and considering IVIG if no improvement in platelets after 2 days. After further discussion plan was changed to dexamethasone 40 mg dailys x 4 days and rechecking CBC, transfusing platelets if <2 with a goal of >10. Labs showed plt <2, transfused 1 units, plt increased to 9, transfused additional unit. Plt <2, <2, transfused 1 unit plt, increased to 9, transfused additional unit of plt. WBC 94.6, 10.1, 13.4 (no s/s infection, monitored); Hgb/Hct 13.1/38, 12.8/37, 11.7/33 (decreased throughout day). 3/20: Provider consulted hematology who recommended rechecking platelets in 24 hours and considering IVIG on 3/21. Continued dexamethasone. Platelets increased to 11 after additional plt transfusion on 3/19. WBC 15 (no s/s infection, monitored); Hgb/Hct 11.3/32. 3/21: Platelets found to be <2 with morning labs. Transfused 1 unit of platelets, IVIG ordered by hematologist, and dexamethasone was continued. Plt <2, transfused 1 unit plt, plt increased to 21. WBC 14.2, 17.5 (no s/s infection, monitored); Hgb/Hct 11.3/34, 13.2/38 3/22: Patient feels more comfortable this morning denying any new bleeding symptoms. ITP refractory to treatment with prenisone, high-dose dexamethasone and is status post 1 dose of IVIG. Patient to receive her last dose of dexamethasone today and reassess tomorrow. Additional dose of IVIG planned for 3/22. Plt 2 in the am, increased to 43 in the afternoon. WBC 11.5, 13.7 (no s/s infection, monitored); Hgb/Hct 11.2/33, 12.8/37 Patient is still currently admitted.
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| 73 | 2021-03-21 | injection site pain, injection site pruritus, injection site swelling | Large swelling, very sore with extreme itching at injection site |
| 73 | 2021-03-21 | rash | Rash over body + face swollen |
| 73 | 2021-03-22 | skin warm |
AT 3:00am on Monday 3/15/2021 I woke up with severe headache & body aches. I was disoriented & leth...
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AT 3:00am on Monday 3/15/2021 I woke up with severe headache & body aches. I was disoriented & lethargic. My friend came over took my blood pressure it was 144/75 I was freezing and the room was 80degrees I had absolutely no appetite. My head felt like it was going blow up Next day was Tuesday 3/16/2021 I woke still groggy & bad headache but now I was hallucinating & i was burning up & sweating profusely Next day 3/17/21 still out of sync & very disoriented Thursday 3/18/21 had video dr appt at 1:00pm he told me to ride it out gave me something to sleep & some tramadol for pain Friday 3/19/21 started coming out of it I felt like i was dying if thats what it feels like
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| 73 | 2021-03-22 | rash, redness | Swollen arm with redness and rash Swollen face, throat, feet, hands, flushing Shortness of breath |
| 73 | 2021-03-22 | injection site pain | painful arm that received the vaccine, gas and cramping, headache, fatigue, stiffness |
| 73 | 2021-03-23 | hives, itchy skin | itching and hives 2 days after second injection. Still continuing one week later. |
| 73 | 2021-03-24 | injection site pain |
Pain in shoulder at injection site, especially when exercising, when lying down, and upon exertion. ...
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Pain in shoulder at injection site, especially when exercising, when lying down, and upon exertion. Pain in arm is staying the same and not getting better. Wakes me up and keeps me up occasionally.
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| 73 | 2021-03-24 | skin peeling, injection site bruising, injection site redness |
Patient experienced red bruising at the injection site on 03/05/2021. She visited a Medical Center o...
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Patient experienced red bruising at the injection site on 03/05/2021. She visited a Medical Center on 03/09/2021 and was told she might have an infection. She was prescribed Mupirocin ointment to be applied twice daily as well as Keflex antibiotics. After applying the ointment for several days patient's bruising darkened and began to peel. The antibiotics caused diarrhea for about ten days.
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| 73 | 2021-03-24 | redness |
Pt walked in to vaccination clinic on 2/2/21, reporting to have left upper arm redness, had COVID-19...
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Pt walked in to vaccination clinic on 2/2/21, reporting to have left upper arm redness, had COVID-19 vaccine at outside vaccination site 1/31/2021. Reviewed by provider on site and mild redness of left upper arm. Patient was advised to go to urgent care for further evaluation. Pt was agreeable and left clinic to go to urgent care. Appointment at urgent care was made for 2/2/21 but patient no showed to visit.
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| 73 | 2021-03-24 | itchy rash, rash macular |
Rash/Itching along with rash; red round splotches; This 73- year-old female patient contactable cons...
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Rash/Itching along with rash; red round splotches; This 73- year-old female patient contactable consumer (reported for herself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 13Jan2021 as a single dose for COVID-19 immunization. She has had no other vaccines on the same day or in the past 4 weeks. Relevant medical history included: Stage 3 renal disease. Concomitant medications were not reported. The patient has taken other medications in the past two weeks (not reported). On 14Jan2021, the patient experienced Rash (red round splotches) started within 1 day of vaccination on lower extremities. Itching along with rash. Within a week had spread to torso and back of torso and chest. The patient did not receive treatment for the events. The clinical outcome of the events itchy red rash was not recovered. Information about lot/ batch number has been requested.
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| 73 | 2021-03-24 | hives |
Whole body hives; This is a spontaneous report from a contactable consumer (patient). This non-pregn...
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Whole body hives; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9266) via an unspecified route of administration in the left arm on 11Feb2021 at 16:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP), cholesterol, gout, penicillin allergy, and sulfa allergy, all from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were reported as "yes." The patient previously received oxytetracycline calcium (TERRAMYCIN) from an unknown date for an unknown indication and experienced allergy. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 the patient experienced whole body hives, which were reported as still breaking out on "11Feb2021." The event was reported as non-serious and did not require hospitalization. The event resulted in a doctor or other healthcare professional office/clinic visit. The event was treated with prednisone, cetirizine hydrochloride (ZYRTEC), diphenhydramine hydrochloride (BENADRYL), and famotidine (PEPCID). The clinical outcome of the event was reported as recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.
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| 73 | 2021-03-25 | itchy skin, rash |
Patient reported arm pain, itchy rash and swelling after receiving the vaccine. It has been 3 days a...
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Patient reported arm pain, itchy rash and swelling after receiving the vaccine. It has been 3 days and she doesn't have any resolution of symptoms.
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| 73 | 2021-03-26 | skin laceration |
Pfizer COVID-19 EUA Vaccine Pt received first COVID vaccine 2/25/21. Tested positive for COVID late...
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Pfizer COVID-19 EUA Vaccine Pt received first COVID vaccine 2/25/21. Tested positive for COVID late February. Reported to ED 3/5/21 with near syncope. Patient was seen emergency department laying in bed. The patient had a noticeable scalp laceration to posterior parietal area. After being symptomatic with COVID-19 for a few days, the patient reports getting up at 5:00 a.m. to use the bathroom, feeling lightheaded, then ended up on the floor, she reports sitting on the floor and then hit her head at some point, but was not entirely sure of this timeline. She states she ended up moving to the living room when she noticed that her head was bleeding a lot and her fiance called 911. She reports a history of syncopal episode in 2001 when she had influenza and apparently the story was much the same as this time, but she actually lost consciousness in 2001. Admitted to observation. 3/7: 73-year-old female recent COVID-19 infection admitted on 03/05/2021 for an episode of syncope probably secondary to bradycardia versus volume depletion. Paramedic on arrival at home reported bradycardia with heart rate in the 30s but has been normal since admission. The CT angiogram of the chest done at the emergency room showed bilateral infiltrates compatible with recent COVID-19 infection. No PE. However patient has no respiratory symptoms and O2 saturation is perfectly normal. Urinalysis was suggestive of infection and subsequent culture was positive for E coli and it is pansensitive. She was admitted to hospital for overnight observation. She was commenced on IV Rocephin and azithromycin. The EP cardiologist was consulted and she recommended and echocardiogram and it revealed mild global hypokinesis with LVEF of 45-50% but patient denied any prior history of cardiac problem. On re-evaluation this morning the vital signs remains normal. Patient has not had any episode of bradycardia since she presented to the emergency room. She will be discharged home follow up with the EP cardiologist for further evaluation. Patient does not need outpatient oral antibiotics as IV Rocephin for 3 days should be adequate for uncomplicated UTI.
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| 73 | 2021-03-27 | injection site pruritus, injection site redness | Red itchy ring around injection site |
| 73 | 2021-03-28 | itchy skin |
within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itc...
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within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itch; blood pressure: 178/90; within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itch; This is a spontaneous report from a contactable other health professional (patient). A 73-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 73-years-old, administered in Arm Left on 25Jan2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included one kidney, left was removed due to cancer, no residual cancer, allergic to juniper. The patient was not pregnant. Concomitant medication included ezetimibe (ZETIA), escitalopram oxalate (LEXAPRO), pravastatin (PRAVASTATIN), and probiotics; all taken for an unspecified indication, start and stop date were not reported. Patient reported that, "Within 8-10 minutes of shot, I began to sweat under my arms, my chest and back and head began to itch. EMT took my blood pressure: 178/90, oxygen level was good. They called the EMT Ambulance, and transported me to the medical center > they treated me with IV Benadryl and steroids and I went home within two hours, with no further issues." The events started on 25Jan2021 12:00 PM. The adverse events resulted in Emergency room/department or urgent care, Hospitalization (0 days). The patient received IV Benadryl, steroids and prescription for Medrol for events. The patient underwent lab tests and procedures which included blood pressure measurement: 178/90 on 25Jan2021, oxygen saturation: good on 25Jan2021. The patient recovered on 25Jan2021 14:00. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination. Facility type vaccine was Health Clinic/Facility. At the advice of her allergist she declined to get the 2nd dose of the Pfizer vaccine. Her questions is should she take a the J&J vaccine and wanted to know if Pfizer could give guidance on the matter. Information about lot/batch number has been requested.; Sender's Comments: Based temporal association, the reported events in relation to suspected drug BNT 162b2 cannot be totally excluded. Case will be reassessed pending new information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 73 | 2021-03-29 | hives |
Extremely itchy hives scalp, neck, ears, forearms, ankles and lower legs, abdomen/severe case of hiv...
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Extremely itchy hives scalp, neck, ears, forearms, ankles and lower legs, abdomen/severe case of hives; Occasional wheezy cough; sore throat; runny nose; Occasional wheezy cough; This is a spontaneous report from a contactable consumer, the patient. A 73-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL9269), via an unspecified route of administration, administered in Arm Left on 11Feb2021 at 15:30 (at the age of 73 years old) as SINGLE DOSE for covid-19 immunization; chlorphenamine maleate, dextromethorphan hydrobromide, paracetamol, phenylephrine hydrochloride (ALKA SELTZER PLUS COLD &COUGH FORMULA, Lot number not provided), (reported as 'Alka Seltzer Plus Severe Cough, Mucous, Congestion') orally on 24Feb2021 at 22:00 1 DF single dose (LIQUID GEL CAP) for sore throat runny nose and wheezy cough. Medical history included hypothyroidism, osteoporosis, drug hypersensitivity (Allergy to: Penicillin). Concomitant medication(s) included levothyroxine (LEVOTHYROXINE); atorvastatin (ATORVASTATIN); alendronate sodium (ALENDRONATE). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 24Feb2021 the patient experienced occasional wheezy cough, sore throat, runny nose. On 25Feb2021 The patient experienced extremely itchy hives scalp, neck, ears, forearms, ankles and lower legs, abdomen/severe case of hives. The clinical course as reported by patient is as follows experienced Extremely itchy hives scalp, neck, ears, forearms, ankles and lower legs, abdomen. Possibly reacted to combination of vaccine and 1 gel capsule of Alka Seltzer Plus Severe Cough, Mucous, Congestion Liquid Gel which I took for a sore throat, runny nose and cough. Have never had hives before. Have never had reaction to gel cap. Had NO reaction to vaccine first 13 days. Yesterday had a wheezy cough, runny nose, sore throat. Didn't think due to vaccine. Took gel cap about 10pm 24Feb2021. Within 2 hours had severe case of hives still present over 12 hours later, though lessened. Occasional wheezy cough. New symptom last 2 days. Not sure if linkage. Treatment was given as a result of occasional wheezy cough, sore throat and runny nose. No Treatment was given for hives. The clinical outcome of the hives was recovering while the remaining events wheezy cough, sore throat and runny nose were not recovered.
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| 73 | 2021-03-30 | rash papular, shingles, itchy rash |
has a rash, it is itchy; kind of like the shingles/thinks it may have caused her to have shingles; h...
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has a rash, it is itchy; kind of like the shingles/thinks it may have caused her to have shingles; has a rash, has bumps or pustules; has a rash, has bumps or pustules; it made her sick; This is a spontaneous report from a contactable nurse (patient herself). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 02Mar2021 10:30 (at age of 73-year-old) (Lot Number: EL9262) at single dose for COVID-19 immunisation. Medical history (including any illness at time of vaccination) and family medical History was reported as none. There were no concomitant medications or prior vaccinations (within 4 weeks). The patient stated she got the shot on 02Mar2021 and had a rash at time of the report. Added she was going to get scheduled for the next dose but is asking if she should get it with this rash. Clarified she received the first dose of the Pfizer COVID 19 vaccine 02Mar2021 at 10: 30AM in the left arm. She didn't get the rash right away. All of the sudden a week after the shot she woke up in the night Monday (08Mar2021) with a rash; kind of like the shingles; it was itchy and had bumps or pustules. The rash was located on her upper body; shoulders and arms. Added she could scratch her boot to hell. Stated she was an old nurse and she did a lot of things to try to stop the itching. Added it was so itchy. She treated her rash with Vicks vapor rub; Bag Balm; Greycaine powder to dry it up; and finally put diphenhydramine hydrochloride (BENADRYL) on it. She took aspirin; vitamin C; B12 and zinc. Added but this shot didn't work, it made her sick. Added she thought it may have caused her to have shingles and she had never had shingles before. She had not had the shingles vaccination. Added she was supposed to get the next dose of the Pfizer COVID 19 vaccine in three weeks. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken as a result of 'has a rash, it is itchy, has bumps or pustules'. The outcome of events was not resolved.
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| 73 | 2021-03-31 | vaccination site pain |
Pain at injection site lasting more than 24 hours; fatigue; This is a spontaneous report from a cont...
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Pain at injection site lasting more than 24 hours; fatigue; This is a spontaneous report from a contactable consumer (patient). This 73-years-old not pregnant female patient received,at hosptial, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administered in Arm Left on 08Mar2021 as SINGLE DOSE at age of 73 years for covid-19 immunisation . Medical history included pneumonia from an unknown date and unknown if ongoing (but have since been vaccinated for it 2x in last 4 yrs ), iodine allergy from an unknown date and unknown if ongoing. No other vaccine received in the last four weeks .Concomitant medicatoins includes: OTC vitamins & health aids.The patient experienced pain at injection site lasting more than 24 hours on 08Mar2021 21:00 with outcome of unknown and fatigue on 08Mar2021 21:00 with outcome of unknown. No treatment recevied for the events.No covid prior vaccination: No covid tested post vaccination. Information about lot/batch number has been requested.
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| 73 | 2021-04-04 | redness, hives, itchy skin | hives, itching, redness to head, face, and neck, requiring admit to hospital, discharged |
| 73 | 2021-04-09 | vaccination site pain |
pain over her heart area; pain in the right shoulder where she got the shot; Pain in the right shoul...
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pain over her heart area; pain in the right shoulder where she got the shot; Pain in the right shoulder; pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm; tooth ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN6198, via an unspecified route of administration administered in right arm (shoulder) on 03Mar2021 10:00 at single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure abnormal, thyroid problems, fall (fell a couple of years ago), and trouble with her shoulder (prior to getting the vaccine). She reported that she did have some trouble with her shoulder prior to getting the vaccine. She fell a couple of years ago and the doctor's x-rayed it and thought it was pulling away from the bone. They didn't have to do surgery. She was completely over that and it had resolved before getting the vaccine. Patient has no additional vaccines administered on same date of the Pfizer suspect. Patient has no prior vaccinations within 4 weeks. Concomitant medications included metformin hydrochloride, sitagliptin (JANUMET) taken for diabetes from an unspecified start date and ongoing (been taking it a long time over 20 years); glipizide taken for diabetes, start and stop date were not reported (been taking it a long time over 20 years); losartan taken for blood pressure from an unspecified start date and ongoing (been on it about 10 years, her blood pressure is in between and it doesn't bother her a lot, it is not really high or low); and thiamazole (METHIMAZOLE) taken for thyroid problem from an unspecified start date and ongoing (been on it about ten years). Patient was calling because she had her first Pfizer shot about three weeks ago. About three days after on 06Mar2021, she developed pain in the right shoulder where she got the shot. It has been bothering her up until this time. She also had a pain over her heart area. The pain over her heart area occurred when she was breathing it. That has gone away. She had her second shot today and she was trying to explain to the doctor what happen to the right shoulder. He said the shot had to be in the other shoulder and he put it in the left shoulder in the bone. It hit the bone. She hollered because it hurt so bad. He said no one ever jumped like that before. She jumped because it hurt. She still has the pain in the right shoulder, but she doesn't feel anything in the left where she got it today. She clarified Pfizer shot as COVID19 vaccine. The pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm in Mar2021. She got first and second dose. She got the first dose of COVID19 vaccine on 03Mar2021. Pain in the right shoulder: it felt like her toothache has something to do with the pain in the shoulder. The toothache came on a little later (Mar2021) than the pain in the shoulder. The tooth ache is still ongoing, but it has improved. Pain over heart area: It started at the same time as with the pain in the right shoulder. The pain over the heart stopped about a week ago. She thinks she has recovered completely. She didn't have anything done for the heart pain. She got the second dose today, 25Mar2021, lot number: ER8733, Expiry date: unknown. The outcome of the events 'pain over her heart area and pain in the right shoulder travels down the right arm/it goes down the shoulder and down the arm' was recovered, event tooth ache was recovering, and events 'pain in the right shoulder where she got the shot (vaccination site pain) and pain in the right shoulder' was not recovered.
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| 73 | 2021-04-23 | itchy skin |
Muscle spasm; Lump in a small area that she can rub; Tingling in her arm; Itch; Like a tiny pinched ...
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Muscle spasm; Lump in a small area that she can rub; Tingling in her arm; Itch; Like a tiny pinched nerve; feels like something is biting her in an area that stings; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1686), via an unspecified route of administration, on 21Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included cataract (pending clarification). The patient's concomitant medications included fluticasone propionate/ salmeterol xinafoate (ADVAIR) and unspecified drops. The patient received the first dose of the COVID-19 vaccine on 21Jan2021 and experienced muscle spasm and a lump in a small area that she can rub out within a couple days on 23Jan2021 (within 2 days of the dose being given); little bit of muscle spasms and a slight lump will come up in that area and she can rub it out. The muscle issue isn't still happening as much. The patient wanted to know if the tingling is a common side effect. In Jan2021, the patient experienced tingling in her arm and asked could that be because the vaccine she received was cold. The patient asked how long the vaccine should sit out at room temperature. In Jan2021, it feels like something is biting her in an area that stings, like a mosquito bite, and nothing is there; like a bite feeling and it will itch in that area and she will think what could have bitten her. The feeling like a bite, it is like a tiny pinched nerve or something like a mosquito bite and she will look but nothing will be there. The feeling will be in like one specific area. It began very close to the muscle thing around 2 to 3 days after the vaccine (Jan2021). It happens about once per day. It might skip a day here or there but pretty much its once per day. It is about every day or every day and a half or so. The patient was in a place that was below zero. It was mostly her legs but last night it was in her arms. The patient was scheduled to have the second dose tomorrow (16Feb2021) and she is concerned. The patient had cataract surgery last week, so she had to get her purse she also has her drops in there. That is why she did not get the second dose exactly 3 weeks because she had surgery. The patient kept thinking what that weird thing was, it is like a no-see-um bite. The patient called her primary care about it and her recommendation was to get the shot anyway and let them know. It was fairly mild, and she was just curious. The outcome of "Lump in a small area that she can rub", "Tingling in her arm", and "Itch" was unknown. The patient was recovering from "Muscle spasm". The patient had not recovered from the remaining event.
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| 73 | 2021-05-04 | vaccination site mass, rash with redness |
one localized rash described as red with white lump; heart palpitations; Left breast hurt; Red rash;...
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one localized rash described as red with white lump; heart palpitations; Left breast hurt; Red rash; tingling of the left breast; Foggy different feeling; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received first dose of BNT162B2 (Pfizer COVID19, Solution for injection, Lot number EN6201) via an unspecified route of administration in the left arm on 12Feb2021 at 15:00 for Covid-19 immunisation. The patients medical history included Breast cancer, thyroid cancer, blood pressure and palpitations. The patient had allergic to Z-pak. The concomitant medication includes Synthroid 150mcg 1 tablet by mouth once a day for thyroid cancer. Relevant Family medical history included Shingles shot, she took one a long time ago, like 10 years ago, it gave her ringing in the ear. She had no other vaccines on the same day on in the 4 weeks prior to the first dose. On 12Feb2021, the patient experienced Foggy different feeling, on 13Feb2021 at 16:00, tingling of the left breast, on 14Feb2021 experienced Left breast hurt, heart palpitations and localized rash described as red with white lumps. She had no ER visit. The outcome of the event foggy different feeling, left breast hurt, and white lumps was recovered, whereas of red rash and heart palpitations it was recovering and for tingling of the left breast it was recovered with sequelae. The patient underwent lab test which included blood work whose results were unknown and TSH with results 0.57. She wanted to know if those AEs are from the vaccine and if she is ok to get the second shot. She felt lightheaded for 20 minutes, in the left breast is where she had cancer and it was in situ in the duct, it had not spread for which she received 8 weeks of radiation. She went to bed and noticed that her breast was hurting in the night, but she was too tired to get up at that point, when woke up and took a shower she lifted the left breast and saw a massive, bigger than pancake, rash. It was on the bottom of the breast and it ran down to the stomach, it also had white lumps on it, this just frightened her. There was severe redness before, but that has started to fade, it was still dark brown right now, like she can see outline, but it was going away. Before when there was redness, she could press the spot and it would turn white, it would be red again. When read the instruction that came it says there could be a side effect of a rash, but it would be all over the body not localized. She does not know if the vaccine was responsible for it. Then just quickly she started having heart palpitations on Sunday, just a few, but on Monday it was like a 100 of them. She called doctor, at this point that she also has a history of thyroid cancer in 1982, they removed 2/3rds of her thyroid and since then she has been on Synthroid. When her thyroid was not working properly, she had a TSH done. She got lab work done just to see if it was the thyroid. The doctor said it could be from the shot. The Heart Palpitations were fading, she stopped taking Synthroid for 1 day and it went from 100 palpitations to 50, to like 6-7 now. The heart palpitations were going away and that was after stopping the Synthroid for 1 day. The Light headedness only lasted for 20 minutes but started 5 minutes after getting the shot. She clarified that it was not lightheadedness she means to say that she was a little foggy and had a different feeling. The tingling in the Left Breast began, it was for a couple hours, she thought it was different. Normally she doesn't have that. She has had 6 breast operations, so she has very little feeling in that breast normally. Her left breast began to hurt when she was sleeping, she was too tired to get up and look, she rolled over felt something was wrong. This was at 2-3AM on and it subsided when she took shower and patted all around, she dried it and kept an eye on it, the pain started to go away easily. She did notice that she started to feel a little bit of an itch, but that went away quickly too. She had the rash and lumps, it was during the shower she lifted the breast and saw it. She has a picture to provide. It is Not ongoing, it has started to fade, it is still dark reddish brown, but she can tell it was going away. The heart palpitations started late at 4 or 5 in the evening, she has not had that for years. She knows at one-point TSH was high, but they like to keep it low like this in which the 1/3 of thyroid stays dormant, this is intentional because if it gets too high.
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| 73 | 2021-05-04 | pain of skin, itchy skin, skin burning sensation |
ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, bur...
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ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809 and Expiration date was not reported), via unspecified route in left arm on 09Feb2021at single dose for COVID-19 immunization. Medical history included diabetes and overweight. Patient had an allergic reaction to medication. Clarified products as Bactrim and codeine. With Bactrim she had hives all over and went to ER. codeine made her do the exact same thing as she was now (stinging, burning and itching) and hadn't taken codeine or Bactrim for several years. She confirmed that she had no ndc/lot/exp for either codeine or Bactrim. The patient's concomitant medications were not reported (She takes so many medications). On 09Feb2021, four hours after the covid-19 vaccine, the patient experienced ongoing stinging, burning, and itching sensation on her scalp, face, and back. She states there is no visible rash, but these symptoms are consistent with her reaction to codeine. Have these symptoms been reported. Should she get her second dose that was due on 02Mar2021. It has been a full week. She called her doctor and the nurse asked him. Doctor didn't know if that was a listed side effect and should she get her second shot. Has been taking Benadryl (Wal-dryl Allergy HCi-25mg antihistamine, Exp: Jun2023, Formulation: 25mg capsules, provided: ORG11719008, 50844 and P120784), but that is not helping. Sometimes after taking Benadryl, it's better, but sometimes it will hit real hard again. Does not see very well. only took one capsule and tried not to take it over twice a day. She takes so many medications. Doesn't know what will mix with what. Therapeutic measures were taken as a result of adverse event. The outcome of the events was not recovered.
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| 74 | 2021-01-07 | itchy skin |
Headache; Itchiness; Phlebitis; Looks like little flea bites on her skin. There isn't that many, its...
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Headache; Itchiness; Phlebitis; Looks like little flea bites on her skin. There isn't that many, its mostly on her upper torso and they are sporadically placed.; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported), intramuscularly on the right deltoid, on 27Dec2020 (10:00) at a single dose for COVID-19 immunization at the hospital. Medical history included hypertension; hypothyroidism; was allergic to shellfish probably over the last 20 or 30 years; and was allergic to penicillin and sulfa "many, many years ago". Concomitant medications included HCTZ for hypertension; losartan potassium (COZAAR) for hypertension; levothyroxine sodium (SYNTHROID) for hypothyroidism; amlodipine for hypertension; omeprazole for hypertension; and ongoing lansoprazole (PREVACID). The patient previously took Fluzone Quadrivalent influenza vaccine on 17Oct2020 for vaccination, and had itchiness. On 28Dec2020, the patient had headache; itchiness; phlebitis; and had what looked like flea bites on her skin which were not that many, and was mostly on the upper torso and sporadically placed. The patient had received diphenhydramine (BENADRYL) as treatment for the events. The patient was told that since itchiness was not a part of the normal side effects, the itchiness was considered an adverse reaction and that she could not get her second shot which was scheduled for 16Jan2021. The outcome of the events was recovering for 'headache', 'pruritus' and 'phlebitis'; and was recovered on an unspecified date for 'looked like flea bites on her skin'.
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| 74 | 2021-01-07 | hives | Hives, recurrent after 1 dose dexamethasone and benadryl |
| 74 | 2021-01-12 | redness |
3.) Call back from POA, notified of new skin condition and POC, 2.) Call received from APRN- repor...
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3.) Call back from POA, notified of new skin condition and POC, 2.) Call received from APRN- reported assessment to her, new order for Benadryl 25mg x one dose, medication given, called and left message with POA awaiting return call back 1.) Resident with raised red areas on left arm, did receive Covid-19 Vaccine on 01/05/21, no respiratory difficulties, call out to APRN- to report new skin issue
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| 74 | 2021-01-12 | injection site swelling, injection site redness |
Received COVID vaccination on 01/06/2021 at 8:00 at the COVID vaccinations clinic. About 2:20pm emp...
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Received COVID vaccination on 01/06/2021 at 8:00 at the COVID vaccinations clinic. About 2:20pm employee states that Left arm started aching. Around midnight, employee states that right elbow began to ache as noticed redness and swelling approximately 2-3 inches below injection site. States swelling and redness increased over the course of two days. Friday, the swelling and redness began to improve.
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| 74 | 2021-01-13 | injection site pain |
After we left(approx. 30 min. later) My tongue felt a little swollen, my lips felt a little swollen ...
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After we left(approx. 30 min. later) My tongue felt a little swollen, my lips felt a little swollen and my nose felt numb. The symptoms lasted approx. 1-3 hrs. Mild, no tx sought. The injection site was moderately sore, but dissapaited the next day, by 1PM.
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| 74 | 2021-01-13 | injection site pain |
very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site;...
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very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3246, expiry date not reported), intramuscular on 05Jan2021 13:30 at a single dose in the upper left arm for COVID-19 prophylaxis. There were no medical history and concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient asked if there was any contraindication to getting the second dose. Patient reported having vomiting and shivers the day after receiving the vaccine as well as pain at injection site which was reportedly now resolved. Patient was calling about the Covid-19 vaccine and reported that she received the vaccine this past Tuesday 05Jan2021. She said that she was very sick the next day (06Jan2021). She said that 5 people went with her to get the vaccine and she was the only one who had gotten sick. Patient clarified that she had vomiting throughout the day the next day after receiving the vaccine. She also reported that she had shivers for hours and hours. She said that she had blankets and quilts on her and she could not stop shivering. She said that when she went to the doctor, the doctor thought it was because of the vaccine. Patient wanted to know if she should she take the second shot and if these will happen to her again or not and asked if there are any contraindications. She said that the vomiting started in the morning around 10:00 on 06Jan2021. It lasted a couple of hours until about 13:00 06Jan2021. She said that the shivers were bad, and she had big time shivering and there was nothing she could do to stop the shivering. The shivering lasted from 10:00 06Jan2021 until about 5-6 in the evening 06Jan2021. As the day progressed the pain where they gave her the shot was very bad on 05Jan2021. She said that she had pain at the injection site (pain injection site) on 05Jan2021. She said that it only hurts now if she touches the area. She said that the site previously it hurt without touching it. Patient was very weak and sleepy the next day. She said that she felt very weak and sleepy on 07Jan2021. She said that it lasted throughout the entirety of the day and she fell asleep and felt better today (at the time of the report). She said that today she felt fine. The events did not require emergency room visit but events required physician's office visit. The events were reported as not serious. Therapeutic measures were taken as a result of the events weak and sleepy. The patient recovered from vomiting on 06Jan2021 13:00, from shivers on 06Jan2021, from weak and sleepy on 07Jan2021. The patient was recovering from pain injection site. The outcome of the event sick was unknown.
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| 74 | 2021-01-19 | injection site swelling |
Severe pain. Upper arm where injection was swelled a lot. Could not raise right arm because of pain....
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Severe pain. Upper arm where injection was swelled a lot. Could not raise right arm because of pain. This is day three and pain and swelling still pronounced
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| 74 | 2021-01-19 | rash |
rash on hands--had this happen once last summer after working in garden. She did work in garden thi...
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rash on hands--had this happen once last summer after working in garden. She did work in garden this morning but didn't know if it was that or covid vaccine
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| 74 | 2021-01-19 | redness | redness soreness and swelling |
| 74 | 2021-01-21 | injection site pain |
Pain in arm just below injection site Hurts to lift arm or lift anything. Seems to slowly be getti...
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Pain in arm just below injection site Hurts to lift arm or lift anything. Seems to slowly be getting worse? Definitely is not getting better. I haven't pulled a muscle or such that I'm aware of. Has hurt since the injection, and gradually hurt more.
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| 74 | 2021-01-23 | injection site pain |
Approx 7:00pm on the 22nd of January had a dull headache. The next day had muscle pain, joint pain...
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Approx 7:00pm on the 22nd of January had a dull headache. The next day had muscle pain, joint pain, and chills. Also injection site was sore. Took Advil for pain and aches.
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| 74 | 2021-01-24 | itchy skin, vaccination site pain, hives |
Developed hives on my face, on my head, on top of my back and they also itch in addition to the all ...
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Developed hives on my face, on my head, on top of my back and they also itch in addition to the all over itching; headaches; Pain around my face, my left arm; Developed severe itching from head to toe; I was running a temperature of 102; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; Appetite lost; Chills; soreness more than usual from the shot; Soreness in my arm, my neck; Soreness in my arm, my neck/ pain around her face, her left arm; I got stiff neck, my back, my lower back; Massive weakness; Confusion; terrible sleepiness; Diarrhea; I still don't feel good; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3248, expiration Apr2021) at 6:00AM on 07Jan2021 for Covid-19 immunization. The patient had her first dose on 19Dec2020 and had side effects from it but very few. The patient was worked at COVID rooms to clean rooms in hospital as a housekeeper and so her exposer to the hospital made her in first group to get the vaccine. Medical history included allergies (had anaphylactic shock from Amoxicillin and from Tylenol, she cannot take Tylenol), anxiety, and high blood pressure. Concomitant medications included acetylsalicylic acid (ASPIRIN) on regular basis, bisoprolol fumarate, loratadine (CLARITIN) for allergies, escitalopram for anxiety, mometasone furoate (FLONASE) for allergies, losartan, magnesium, omeprazole, and triamterene. On the first day (07Jan2021) she had soreness more than usual from the shot, soreness in her arm, her neck. She got stiff neck, back, lower back. She had gotten the shot at 6 am, then worked at that time and by the time she got home at noon, she had massive weakness, some confusion, terrible sleepiness and by evening, she developed diarrhea. On the second day (08Jan2021) the pain increased the weakness increased, and she was running a temperature of 102. She could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move pretty much. She could not eat and lost appetite, and she developed the chills on that evening. On the third day (09Jan2021) she was running a temperature of 101 so it had gone down. She still had headaches, and pain around her face, her left arm and developed severe itching from head to toe, and on the next day (10Jan2021) she developed hives on her face, on her head, on top of her back and they also itch in addition to the all over itching. The temperature was gone, she had no temperature when she developed the hives. At the report day, she stated that she had not gone back to work as she broke out in the horrible hives and she still did not feel good. Only cold ice packs on the hives/ itching and no more treatment received for the events. The fever and itching resolved on 10Jan2021, and outcome of all other events was unknown.
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| 74 | 2021-01-24 | injection site pain | injection site pain, fatigue, headache periodically, muscle and joint pain |
| 74 | 2021-01-24 | rash | symptoms of rash and scratchy throat two weeks after injection |
| 74 | 2021-01-25 | injection site pain |
Initially soreness around injection site later followed by vertigo, nausea and vomiting. which reso...
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Initially soreness around injection site later followed by vertigo, nausea and vomiting. which resolved after 48 hours. Dizziness continued and on fourth day I developed body aches, low grade fever (100.9) and nausea. which lasted for three days.
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| 74 | 2021-01-25 | injection site pruritus |
Within 15-minutes of vaccination, the patient reported pruritus at the site of injection. Patient wa...
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Within 15-minutes of vaccination, the patient reported pruritus at the site of injection. Patient was monitored and managed on-site.
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| 74 | 2021-01-26 | injection site swelling |
fever; severe chills/could not get warm; her breathing was deep; drop in blood pressure; mild swelli...
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fever; severe chills/could not get warm; her breathing was deep; drop in blood pressure; mild swelling/Swelling of Left Arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration in the left arm on 11Jan2021 10:00 at a single dose for COVID-19 vaccine (because she's 74 and high risk). Medical history included hypertension. Concomitant medication included irbesartan oral (by mouth) from an unspecified date (maybe 3 years ago) and ongoing at 300 mg once daily (150mg, 2 tablets once a day in the morning) for hypertension as blood pressure medication. The patient received the first dose of vaccine on Monday (11Jan2021) morning (AM) at 10 at the county (public) health department. She had no problem at all until yesterday Tuesday, she experienced mild swelling; the swelling happened in the upper left arm (swelling of left arm) which started on 12Jan2021, this was also the same side that she got her vaccine on, the left arm. On 13Jan2021 she woke up at 4AM [also reported as thirty (30) hours after the shot] in which she started to have severe chills (horrendous chills), could not get warm under the blanket for an hour and a half. It lasted a long time. Her severe chills did stop, she used an electric (heated) blanket. This morning on 13Jan2021 at 8:30, she woke up with the fever, which she was able to reduce with acetaminophen (did take two acetaminophen). Her fever was also gone. She was a little concerned because she thought her breathing was deep too on 13Jan2021. She did some relaxing breathing which helped. It lasted a long time. The patient also experienced a drop in blood pressure on 13Jan2021. Her blood pressure has been running the past few days at 133/80 on 11Jan2021. Today (13Jan2021), she took her blood pressure and it was at 93/50. It went to 87/56 after drinking some salty soup on 13Jan2021 (the bottom number in the blood pressure was going up a little, and the top number was going down a little). Her blood pressure has been normal 133/70 on Jan2021, but this morning it was 90/50 on 13Jan2021. Her blood pressure has been running normal the last couple of days like 133/90 on Jan2021. She was shocked it was lower. She knew they talk about dizziness and weakness, but she didn't experience that. She was concerned about that sudden drop in blood pressure. She did some research and started eating some salty soup and stuff (has been drinking salty soup). Her bottom number went up to 53 on Jan2021. She was concerned about that drop there. She was wondering if that was a side effect of the vaccine (result of the vaccine). She asked if drop in blood pressure was a concern. She had no positive test for Covid before the vaccine. She never had any tested, she's been pretty isolated. She had no antibody test. She has had no issues with vaccine in the past. Therapeutic measures were taken as a result of severe chills/could not get warm, fever, her breathing was deep, and drop in blood pressure. The outcome of swelling of left arm/mild swelling and drop in blood pressure was not recovered; of severe chills/could not get warm was recovered on 13Jan2021 05:30 and fever was recovered on 13Jan2021; and of her breathing was deep was recovering.
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| 74 | 2021-01-26 | redness, hives | hives red welts on face, chest and arms. |
| 74 | 2021-01-26 | vaccination site pain |
soreness in left arm where injection was given; This is a spontaneous report from a contactable cons...
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soreness in left arm where injection was given; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), intramuscular (left arm) from 14Jan2021 18:00 to 14Jan2021 18:00 at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included vitamin D3. The patient previously took hydrocodone and had allergy. The patient experienced soreness in left arm where injection was given on 15Jan2021 09:00. The patient did not receive any treatment for the event. The outcome of the event was not recovered.
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| 74 | 2021-01-26 | itchy skin, hives, redness |
wheals, redness, intense itching to trunk and all extremities. Benadryl was prescribed to control sy...
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wheals, redness, intense itching to trunk and all extremities. Benadryl was prescribed to control symptoms
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| 74 | 2021-01-27 | itchy skin, hives, rash, injection site tingling |
Hives/Rash. Various places on my arms, legs, neck, vaginal area. Itchy. Took Benadryl even 6 hours. ...
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Hives/Rash. Various places on my arms, legs, neck, vaginal area. Itchy. Took Benadryl even 6 hours. Lasted 3 days Tingling in arm in the exact area shot was given started on 3 day after injection. Nausea and diarrhea started on 3rd day after injection
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| 74 | 2021-01-27 | hives |
Patient states right after she received the vaccine, she had a small "coughing spell" for the first ...
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Patient states right after she received the vaccine, she had a small "coughing spell" for the first 15 minutes. The coughing stopped. When the patient went home she noticed hives on her face and upper chest that lasted 1-2 hours and went away on their own.
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| 74 | 2021-01-28 | redness |
both cheeks were very rosy red; This is a spontaneous report from a contactable consumer (patient). ...
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both cheeks were very rosy red; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) via an unspecified route of administration on 14Jan2021 (in the morning) at a single dose as COVID-vaccine, she got it as a protection to her because she's elderly with underlying conditions. Medical history was not reported. Concomitant medications included unspecified five prescriptions which she has been taking for a long time (nothing new). She has had no reaction to medications. Her diet was her normal diet. The patient experienced both cheeks were very rosy red on 14Jan2021 21:30. She wanted to know if experiencing very rosy red cheeks, on both sides, after receiving the Covid vaccine was a normal side effect. She received the first dose of the COVID Pfizer vaccine yesterday morning on 14Jan2021, everything was fine (good) at 7:30 p.m. Then at 9:30 p.m., while she was brushing her teeth, she noticed that both cheeks were very rosy red (her cheeks were rosy red). This morning, her cheeks appeared to be skin tone (skin looked normal). It was gone now; both cheeks were her normal skin tone and everything looked normal now. She didn't eat anything unusual the day of the vaccine. She was wondering if she should go back on 15Feb2021. She was going to ask her doctor and was going to notify her primary care doctor as well if she experiences any redness today or tomorrow. Investigation assessment was noted as no. The outcome of the event was recovered on 15Jan2021.
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| 74 | 2021-01-28 | itchy skin, rash, rash vesicular |
it itches quite a bit/ Itching; pain and discomfort with her arm; pain and discomfort with her arm; ...
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it itches quite a bit/ Itching; pain and discomfort with her arm; pain and discomfort with her arm; couldn't get to sleep; rash looks like little blisters; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date: Nov2021), via an unspecified route of administration on her left arm on 12Jan2021 12:40 at a single dose for her age (COVID-19 immunization). Medical history included blood pressure (abnormal) and surgeries (had so many surgeries but none recently). Concomitant medications included ongoing atorvastatin for more than a year for blood pressure, ongoing amlodipine for more than year for blood pressure, ongoing losartan for more than year for blood pressure and ongoing terazosin from 09Dec2020 for blood pressure. The patient got her first injection on 12Jan2021 Tuesday and the following day (13Jan2021) she broke out with a rash on her right arm, right under her wrist and where you bend arm. She was asking if this a normal or expected side effect. The patient mentioned it was not in the arm where she received the vaccine. The rash was located in four places on her right arm; at the bend; maybe about two inches from where she bends it; a little bit on the outside of the arm and at the inside of her wrist. Last night (14Jan2021) she went to bed at 11PM and couldn't get to sleep until 3:00AM due to the pain and discomfort with her arm. Now (15Jan2021), it itches quite a bit. She put Neosporin (31254-7238-090 Lot 3259L or a 1 2/1 Expiration date Oct2021) on it and it helped but then when it dries up she can feel the itching again and was painful. The rash looks like little blisters. She is planning to get the next dose; she has to call in. Her next dose is due by 02Feb2021. The events did not require a visit to physician or ER. No prior vaccinations (within 4 weeks). The outcome of the events rash looks like little blisters, Pain in arm and it itches quite a bit/ Itching was not recovered and it was unknown for the other events.
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| 74 | 2021-01-29 | skin warm |
Complaint of feeling lightheaded. Denies any other issues or distress. Color is pink, warm to touch....
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Complaint of feeling lightheaded. Denies any other issues or distress. Color is pink, warm to touch. Alert and oriented x3. Sitting in chair. Denies taking medication today. Blood pressure 98/60, pulse 80, respirations 16, oxygen saturation 98%. Monitored for 45 minutes. No complaints of dizziness or lightheadedness at 1300. Client left clinic with no complaints.
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| 74 | 2021-01-31 | rash, rash macular, itchy skin |
Diffuse body rash with red spots on face, chest, back, arms, legs. Increased swelling of bilateral l...
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Diffuse body rash with red spots on face, chest, back, arms, legs. Increased swelling of bilateral legs. Leg swelling first started in the afternoon after the vaccine, followed by diffuse rash with mild itching at night. The rash was on the arms and then spread to the rest of the body The patient had been taking benadryl at night with improvement of her rash . No respiratory complaints
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| 74 | 2021-01-31 | shingles | Fever 101F. Shingles noted on 2nd day. Took Enbrel injection on01/23/2021 |
| 74 | 2021-01-31 | pain of skin, shingles |
exhausted; slept most of day/night; pain in scalp, pimples, bumps; pain in scalp, pimples, bumps; so...
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exhausted; slept most of day/night; pain in scalp, pimples, bumps; pain in scalp, pimples, bumps; sore left eye; blood pressure very high and hard to control; shingles; This is a spontaneous report from a contactable consumer. A 74-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration on 08Jan2021 13:30 at single dose for covid-19 immunisation. Vaccine location was left arm. No other vaccine was received in four weeks. Medical history included hypertension, neuropathy peripheral, asthma/allergies, headache, allergy to medications, food. Concomitant medications included azelastine, fluticasone propionate (FLONASE), metoprolol, gabapentin, levothyroxine sodium (LEVOTHYROXINE). The patient experienced shingles on 08Jan2021 (immediately after she got the shot), exhausted on 09Jan2021 03:30, slept most of day/night on 09Jan2021 03:30, pain in scalp, pimples, bumps on 09Jan2021 03:30, sore left eye on 09Jan2021 03:30, blood pressure very high and hard to control on 09Jan2021 03:30. Patient was treated with Valacyclovir, lisinipril, metropolis, aquafor. The outcome of shingles was unknown. The outcome of exhausted, slept most of day/night, pain in scalp, pimples, bumps, sore left eye, blood pressure very high and hard to control was not recovered.
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| 74 | 2021-02-01 | redness |
Area around her mouth is a little red and it felt itchy; Area around her mouth is a little red and i...
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Area around her mouth is a little red and it felt itchy; Area around her mouth is a little red and it felt itchy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 18Jan2021 at 09:15, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. Yesterday morning (18Jan2021) at 9:15, the patient got her vaccine, and around 04:00 PM (also reported as 04:30 PM), yesterday afternoon, the patient started to rub the area around her mouth. And when she looked it in the mirror, it was a little red and it felt itchy. The patient took diphenhydramine hydrochloride (BENADRYL) which helped a little, just one. And the patient put some diphenhydramine hydrochloride topical cream on it also. The patient was able to sleep last night and woke up this morning and the redness is gone. It's not itchy. The patient seemed to be fine, but she doesn't know if it's from the vaccine or not. It's not one of the typical side effects. The patient asked if it is safe for her to get the vaccine (second dose) or if she needs to ask them. The patient's second dose of vaccine is scheduled on 08Feb2021. The patient recovered from the events on 19Jan2021. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
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| 74 | 2021-02-01 | rash with redness, injection site pain, injection site swelling, itchy skin |
I had a normal pain reaction at site of injection (similar to flu shots) for first three days. Then ...
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I had a normal pain reaction at site of injection (similar to flu shots) for first three days. Then nothing until a week after injection. Then itching started. It has itched for 2 days and there is now an egg sized area with a fine red rash. There are no blisters or hives, and it is annoying rather than painful. I have a history of eczema on my hands. I would not report this if I were not scheduled for a second dose Feb 15. I desperately want to get that vaccine. This may be an expected reaction, but I don't know who to ask but you.
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| 74 | 2021-02-02 | hives |
6 hours after vaccination, patient reported hives all over her body. She took Benadryl by mouth and ...
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6 hours after vaccination, patient reported hives all over her body. She took Benadryl by mouth and applied Benadryl cream. She also reported joint pain. Next morning, hives were slightly better but not gone so patient took more benadryl. Patient also reports feeling a little dizzy this morning especially when she turns around.
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| 74 | 2021-02-02 | injection site rash | Chills. muscle ache, joint pain, rash at injection site, extremely tired |
| 74 | 2021-02-02 | hives |
Patient reported having hives all over body starting 6 hours after vaccination. Patient to Benadryl ...
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Patient reported having hives all over body starting 6 hours after vaccination. Patient to Benadryl by mouth and applied topically. Patient also reported joint pain. Next morning after vaccination, patient said hives were maybe better but about the same. She took more benadryl. Patient also reports some dizziness this morning
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| 74 | 2021-02-02 | vaccination site swelling, vaccination site itchiness, vaccination site redness, vaccination site rash |
arm she received the injection in was red, swollen and itchy/developed a red rash and swelling at th...
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arm she received the injection in was red, swollen and itchy/developed a red rash and swelling at the injection site; arm she received the injection in was red, swollen and itchy/ little itching; developed a red rash and swelling at the injection site/ It has gotten darker and reddish; arm she received the injection in was red, swollen and itchy/developed a red rash and swelling at the injection site/ It has gotten darker and reddish/ red spot; This is spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EL1283; Expiration Date: 30Apr2021) via an unspecified route of administration in the arm right on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis, and retirement. There were no concomitant medications. No additional vaccines administered on the same date of the Pfizer suspect. No Prior Vaccinations within 4 weeks. She stated that she received the first dose 9 days ago and then a few days ago (15Jan2021) she noticed that the arm she received the injection in was red, swollen and itchy. She stated that this morning the symptoms had not changed and she took an naproxen sodium (ALEVE) which made all of the symptoms disappear. She said, "it worked like magic." Caller has felt fine. She was thrilled she could get the Pfizer Vaccine. She was 9 days out, and developed a red rash and swelling at the injection site. She wanted to make sure that was okay. She worked in a dialysis center as a social worker. She was retired. She received the Pfizer COVID vaccine. She did not have the HCP information at this time. She was itchy yesterday too. She really wanted to get the second dose. It has gotten darker and reddish from the first time she noticed it. She felt nothing just a little itching. That was why she looked. She hadn't looked until Friday, so that is when she first saw it. Now it kind of looked like it was the same color, but the swelling was down somewhat. A half an hour ago, she took naproxen sodium (ALEVE). She took that to see if it would help. The itching was okay this morning. It did not itch if she did not scratch it. She did not feel it at all this morning since the naproxen sodium. Yesterday, if she scratched it, it would make it worse. It was much worse Saturday and Sunday. If she did not touch it, it won't itch. She got the vaccine in her right arm. The next time, she would ask for it to be administered in her left arm. She got it because she wanted to be safe. She did not want to get sick, and she is dying to see her grandchildren. She felt perfectly fine. It was not itching now. The red spot might have started earlier (Jan2021) than the 15Jan2021, but that was the first time she noticed it. The itching, swelling, and rash were right near the injection site. It was very mild swelling. These events did not require a visit to emergency room or physician office. Treatment received for the events. The outcome of the events vaccination site erythema and vaccination site rash was not recovered, of other remain events was recovering. She wanted to know if it is okay that she took naproxen sodium after receiving the vaccine. The response is "the interim guidelines note that, antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses is not available at this time. If you are a patient, you should discuss this with your healthcare provider". The patient wanted to know if these symptoms were common this long after receiving the first dose of the vaccine. The response is "let the caller know if the symptoms that she is experiencing do not subside that she should not hesitate to notify her HCP". The patient wanted to know if these symptoms would prevent her from getting the second dose of the vaccine. The response is "reviewed serious allergic reaction symptoms with caller and reiterated that if her symptoms did not go away or became worrisome to not hesitate to contact her HCP as Pfizer could not make a treatment recommendation".
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| 74 | 2021-02-03 | bruising, vaccination site pain |
Pain in left arm and at injection site; Pain in left arm and at injection site; Large bruise; This i...
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Pain in left arm and at injection site; Pain in left arm and at injection site; Large bruise; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received BTN162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: E13246, expiration date was unknown), via an unspecified route of administration on the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the public health clinic/veterans administration facility. Relevant medical history included allergies to Penicillin. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Jan2021, the patient experienced pain in left arm and at injection site and large bruise, which were assessed as non-serious. One week after the injection, she still had pain in left arm and at injection site and also a large bruise. The patient did not receive any treatment for the adverse events. The patient was not recovered from all the events.
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| 74 | 2021-02-03 | injection site pruritus |
Within 15-minutes of vaccination, the patient reported pruritus at site of injection. EMS managed th...
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Within 15-minutes of vaccination, the patient reported pruritus at site of injection. EMS managed the patient's condition on-site.
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| 74 | 2021-02-03 | vaccination site pain |
she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; ...
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she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; fogginess/Foggy brain was described as she was not able to focus very well; Strong chills was not going away almost like a feeling of ice in her veins; Arm ache at the site; She was not able to get work done due to extreme fatigue and foggy brain/It was very disturbing and interfering with ability to do work; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had her first COVID19 vaccine dose. Immediately, on 16Jan2021, she felt very cold and unwell. She also experienced dizziness, headache that started right after the shot, extreme fatigue that started later in the day and fogginess that started right after the shot. Strong chills was not going away almost like a feeling of ice in her veins. She is taking paracetamol (TYLENOL) and ibuprofen for these. The events were not improving. She was just surprised, she was ok with a day's worth, but it was hanging on dizziness (not enough to fall down), but she has to hold onto a rail to go upstairs which was not normal. She doesn't feel like she is real anchored. Headache was described as very bad and is not changing. Foggy brain was described as she was not able to focus very well. She was not able to get work done on Jan2021 due to extreme fatigue and foggy brain. She also experienced arm ache at the site on 06Jan2021 for which the patient expected. It is reducing some, the ache is not as bad as it was while the other things seem to be growing and it is still there. She had to be set aside when she took the shot, because she had these reactions after she got the shot. She had to be watched because of her almost immediate reactions. The patient wants an advice on what to do now, if there is any help for the side effects, and if this will go away. It was very disturbing and interfering with ability to do work. Outcome of the vaccination site pain was recovering while of the remaining events was not recovered.
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| 74 | 2021-02-04 | rash with redness, itchy skin |
Itchy and red rash along stomach area lasting approximately 5 hours. She applied alcohol to the are...
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Itchy and red rash along stomach area lasting approximately 5 hours. She applied alcohol to the area to help relieve itchiness. No other symptoms.
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| 74 | 2021-02-04 | injection site redness, injection site mass |
after receiving vaccine patient had 2 lumps on site ; some redness at the site of injection; experie...
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after receiving vaccine patient had 2 lumps on site ; some redness at the site of injection; experienced some tingling in the face, and head .
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| 74 | 2021-02-05 | injection site pain, injection site swelling |
About 3-4 hrs. after 2nd Covid vaccine, sore arm. Next day: sore arm, bones ached, injection site p...
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About 3-4 hrs. after 2nd Covid vaccine, sore arm. Next day: sore arm, bones ached, injection site pain and swelling, muscle and joint pain, feeling unwell
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| 74 | 2021-02-06 | redness, injection site bruising, itchy skin, cellulitis, skin warm |
From the point of injection in the left deltoid down to the elbow the arm was red, hot, stiff, and s...
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From the point of injection in the left deltoid down to the elbow the arm was red, hot, stiff, and swollen. Patient reported pain as well as itching in the swollen part. Arm was also bruised the size of a half dollar at the injection site. Dr. diagnosed her with cellulitis after immunization and prescribed her amoxicillin 875mg twice daily for 10 days.
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| 74 | 2021-02-06 | redness, hives |
I was very concerned that the vaccine injection was not done correctly, and not done in the right pl...
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I was very concerned that the vaccine injection was not done correctly, and not done in the right place. Instead of doing an IM in the deltoid, the shot was a subq just above the elbow. At first, a large red welt (10 x 8 cm.) appeared soon after. Four days later, when I went to the clinic, it was improved. Photos were taken.
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| 74 | 2021-02-07 | itchy skin |
Fever and chills starting 12 hours after injection. Temperature 101.7 then and now 5 hours later! Un...
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Fever and chills starting 12 hours after injection. Temperature 101.7 then and now 5 hours later! Unable to sleep, restlessness! Lower legs itch. Site is sore! Had been to to not take ibuprofen or Tylenol to help antibodies form! Can I take Benadryl? I had none of these adverse effects with 1st dose!
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| 74 | 2021-02-07 | itchy rash, rash | Rash on body and itching very bad |
| 74 | 2021-02-07 | itchy rash, rash with redness |
Red rash that is about the size of her palm/Rash is red and warm to the touch; Rash itches a lot; Ra...
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Red rash that is about the size of her palm/Rash is red and warm to the touch; Rash itches a lot; Rash is red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunization. The patient had a regular routine appointment to the HCP on Monday. The patient medical history and concomitant medications were not reported. The patient noticed every day she had a red rash that was about the size of her palm. Rash itches a lot. Rash was red and warm to the touch. The patient wanted to know should she be concerned and what to do to get rid of it or should she ignore it. She did not think she was going to die, it just kept continuing. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 74 | 2021-02-07 | vaccination site pain, vaccination site swelling |
Start of an ear infection; Stuffy nose; Sore throat; Headache; Muscle and joint pain; Muscle and joi...
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Start of an ear infection; Stuffy nose; Sore throat; Headache; Muscle and joint pain; Muscle and joint pain; Chills; Dry mouth; White coating all over tongue; Nausea; Unbelievable thirst; Slight swelling at injection site; Injection site pain; Tiredness; swollen tonsils; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1283), via an unspecified route of administration in the right arm on 13Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included Transverse Myelitis ongoing from 2016, neurologic lime disease ongoing from 1992 due to which the patient gets migraines (from 1992), H. Pylori in May2019 and the patient is hard of hearing, ongoing from an unknown date. The patient's concomitant medications included unspecified migraine medication. On 13Jan2021 the patient experienced injection site pain, slight swelling at injection site, tiredness, and unbelievable thirst. On 14Jan2021 the patient experienced headache, muscle and joint pain, chills (which come and go), nausea (which is off and on), dry mouth, and white coating all over tongue. On 15Jan2021 the patient experienced stuffy nose and sore throat. The patient stated she still has tonsils on her right side where she has the earache and they are swollen (from an unknown date in Jan2021). On 17Jan2021 the patient experienced start of an ear infection (earache on the right side). The patient has had no fever and no redness. The patient stated she knows injection site pain is standard for a lot of people. The patient stated on Monday, 18Jan2021 she saw her provider and went over some of this. She stated she would not think that 4 days later she would still be feeling the side effects. The patient was inquiring if this only occurs with the first dose or will it also occur with the second? She is scheduled for the second one on 05Feb2021. The patient asked what was the time frame between injections? The patient was treated for the ear infection Neomycin/Polymyxin Sulfate ear drops and for the tiredness she has been walking around and trying light exercises. The patient turned down other medication as she did not want it to have any effect with the vaccine. The patient asked if there were any recommendations for the nausea and headaches. She stated she does have her migraine medication which she is trying to use to deal with the headaches. The clinical outcome of the injection site pain and slight swelling at injection site was recovered on 14Jan2021 and the white coating all over tongue recovered on 18Jan2021. The clinical outcome of the tiredness and start of an ear infection was recovering. The clinical outcome of the headache, muscle and joint pain, chills, nausea, stuffy nose, sore throat, thirst, and dry mouth was not recovered. The clinical outcome of the swollen tonsils was unknown.
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| 74 | 2021-02-07 | rash |
feeling icky all day; Rash on front and back of nect; chest, and little bit down both arms; Muscle a...
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feeling icky all day; Rash on front and back of nect; chest, and little bit down both arms; Muscle aches; This is a spontaneous report from a contactable consumer(patient).A 74-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3246), via an unspecified route of administration on 12Jan2021 16:45 at single dose, left upper arm for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient had a little bit of muscle aches on 12Jan2021 after the vaccine kind of all day. Other days it came and went. On 19Jan2021 the patient felt icky all day. She got a rash on the front and back of her neck. Rash was also on her chest and a little bit down both arms. She went to a walk-in clinic. Wasn't sure if it would be related to the COVID-19 Vaccine, but was advised to report it. Events required a visit to walk-in clinic. The outcome of the events was unknown.
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| 74 | 2021-02-08 | rash, injection site redness, injection site swelling |
1/30/21 Rash on abdomen and left upper are. 2/1/21 Flu symptoms- muscle aches, low grade fever. 2/...
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1/30/21 Rash on abdomen and left upper are. 2/1/21 Flu symptoms- muscle aches, low grade fever. 2/6/2021- Arm red, hot swollen at injection site
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| 74 | 2021-02-08 | redness, rash macular | Blotchy red irregular, lower arm underside between hand and elbow |
| 74 | 2021-02-08 | hardening, redness, itchy skin |
I have a large 1 1/2 inch diameter red ..slightly swollen but hot to touch. It itches and seems h...
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I have a large 1 1/2 inch diameter red ..slightly swollen but hot to touch. It itches and seems harder than other parts of my arm.
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| 74 | 2021-02-08 | injection site pain |
My mom only had site soreness after her covid vaccine on 1/21 which resolved within a couple days. H...
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My mom only had site soreness after her covid vaccine on 1/21 which resolved within a couple days. However, she died in the early morning hours of 1/25, she was fine the day before, no sign of injury. We found her collapsed on the ground and although we tried cpr she was already dead. She had gone to the hospital on 12/28 for shortness of breath, angina and symptomatic anemia, her ekg was unchanged and blood work normal except for anemia. The cardiologist did not think a cardiac cath was needed. Her shortness of breath improved with a blood transfusion and a dose of lasix (no heart failure).
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| 74 | 2021-02-08 | rash |
started with acute symptoms chills, fever, nausea. aches, and after i started to feel better and th...
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started with acute symptoms chills, fever, nausea. aches, and after i started to feel better and then full body rash from my face down my whole body.
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| 74 | 2021-02-10 | hives | Hives on stomach and back |
| 74 | 2021-02-10 | itchy skin | I already did. Face itching/burning and nausea I had no red face and no discernible hives or rash. |
| 74 | 2021-02-10 | injection site redness | Site: Redness at Injection Site-Mild |
| 74 | 2021-02-10 | skin warm |
Swelling of tongue and face with heat. Waited 30 min it started to subside went home took Benzedrine...
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Swelling of tongue and face with heat. Waited 30 min it started to subside went home took Benzedrine got better. Good so far
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| 74 | 2021-02-10 | hives | acute urticarial occurred 7 days after vaccine unclear if related but no other exposures |
| 74 | 2021-02-12 | hives, rash, itchy skin |
Rash/welts developed over entire body (face, trunk, arms and legs) within 1 hour of receiving vaccin...
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Rash/welts developed over entire body (face, trunk, arms and legs) within 1 hour of receiving vaccine. Itching started that evening. Next day went to PCP who ordered 3 doses of prednisone 20mg and benadryl 25mg every 6 hours PRN. Day 2, rash/welts increased as well as itching. Evening of day 2, rash to legs progressed to purpura, temp of 102.7, chills and extreme pain to bilateral hips which prompted taking to ED and being admitted to progressive care unit.
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| 74 | 2021-02-16 | shingles, redness |
First I noticed some red spots on my left thigh and then the next morning when I got up they had spr...
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First I noticed some red spots on my left thigh and then the next morning when I got up they had spread. Which happened on a Tuesday night and Wednesday morning I called the doctor but I couldn't get in that day so I got an appointment for that Thursday. Every day they were spreading more on my inner and outer left thigh and my left buttock. They didn't go above my waist and they just stayed on my lower left thigh but didn't go up to my stomach and I didn't have any on my stomach. My doctor told me it was shingles.
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| 74 | 2021-02-16 | injection site discolouration, injection site swelling |
I put today's date as the onset of this reaction because it is the first day I actually looked in th...
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I put today's date as the onset of this reaction because it is the first day I actually looked in the mirror at the injection site. I have been wearing layered clothing. There was a large (about 3" diameter) pink spot around the point of injection. I suspect this slightly raised pink spot has been there since Feb. 10, I only noticed it today. My arm is not sore, the pink spot is slightly raised and not warm to the touch. It doesn't concern me at all, however, I received a text from HD asking if I had any side effects, so I decided to respond.
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| 74 | 2021-02-16 | itchy skin |
Itchy skin all over. No rash. Started about 8 hours after injection. Took diphenhydramine and it...
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Itchy skin all over. No rash. Started about 8 hours after injection. Took diphenhydramine and it finally subsided enough to sleep.
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| 74 | 2021-02-16 | itchy rash, rash with redness |
Noted angry red rash on bilateral Achilles heels on 1/30/2021. Rash was very red and itchy. Tx with...
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Noted angry red rash on bilateral Achilles heels on 1/30/2021. Rash was very red and itchy. Tx with Benadryl 25 mg 2-3 times a day and Hydrocort 10 cream as needed. This lasted approximately 1 1/2 weeks. I woke up on 2/13/2021 with pain in both wrist joint, all my finger joints as well as swelling so that I couldn't close my fingers. This is still going on. Today (2/17/2021) I noted joint pain in both my knees and shoulders. I have not had any problem with either my knees or shoulders prior to this.
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| 74 | 2021-02-17 | shingles |
I broke out with shingles; This is a spontaneous report from a contactable consumer reporting for he...
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I broke out with shingles; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number 144414, via an unspecified route of administration in left arm, on 03Feb2021 at 08:45 (at 74 years of age) at single dose for COVID-19 immunization. The patient was not pregnant at the time of the vaccination, she was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Medical history included thyroid disorder from an unknown date. Concomitant medications included thyroid (ARMOUR THYROID), atorvastatin and alendronate sodium. On 05Feb2021 06:00 the patient "broke out with shingles". No treatment was given to the patient for the event. The patient had not recovered yet at the time of the report.
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| 74 | 2021-02-18 | injection site pain |
Adverse effects began immediately on 02/16/2021 after the 1st Pfizer Covid shot at 3.45p. They incl...
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Adverse effects began immediately on 02/16/2021 after the 1st Pfizer Covid shot at 3.45p. They included flushing & face really hot & much higher than normal BP. My BP, usually low, 95/67 pulse 61 that morning rose precipitately to 142 in the parking lot via a nurse who tested me. It subsided to 125 within 30 mins. BUT the next morning, W the 17th, it again rose precipitately from 99/65 pulse 74 at 9am to 141/88 pulse dropped to 66, at 10a, it was 150/88 pulse was 73, at 10.30a it was 156/93 pulse 80 and I called the nurse. Again BP rose to 160/84. I tested my right arm where I rec.d the shot, it was still sore. I suggested going to Urgent Care, the nurse advised the ER. I went to ER & by then my BP lowered to 140 & within an hour I left. I notified my doctor bvia a voice mail to her PA and an email today. Im feeling fine today Feb. 19, 2021 & felt fine yesterday Thursday, Feb 18, 2021. With the unusually high BP I felt shaky. This high of a BP is something Ive never experienced before in my life. It was frightening. My only other near death experience was in 1970 at a Hospital getting a broken tooth repaired bc of a car accident. They gave me an injection of Demerol & I immediately went into shock, perhaps anaphylactic, was given Epinephrine I believe & survived the ordeal & he was able to repair the cracked tooth. I was advised to never have Demerol again. It is such a vivid memory I checked with my doctor prior as I was very concerned about the PEG in the Demerol injection & also in the Pfizer vaccine. She advised that I was at a very low risk for adverse reactions from the Pfizer shot. I preferred Moderna after reading it had 1/2 of the Pfizer adverse reactions reported. I was not so lucky.
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| 74 | 2021-02-18 | redness |
Attended vaccine clinic with friend. After receiving vaccine and moving to observation area, pt repo...
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Attended vaccine clinic with friend. After receiving vaccine and moving to observation area, pt reports noticing? her mouth feels numb and tingly?. Pt has history to surgery for non-cancerous tumor on skull that involved the nerves in the early 2000s resulting in facial asymmetry and some swelling and redness around her left nares. Face inspected and her friend reports that it looks normal for her. Facial asymmetry continues but when assessing face, her friend reports the asymmetry is her norm. VSS BP 166/108, HR-68, Resp 14. She reports that BP goes up. She has no side effects with the first dose but reports feeling ?extremely anxious about coming to get this vaccine?. Arm and leg strength are equal bilaterally. Pt drank water and says she is feeling better by 2:42. She reports no longer feeling tingly but her lips are still numb> 2:52 symptoms resolved with no additional symptoms reported. 3:01 no further s/s reported. Reviewed s/s of reactions vs side effects. Agrees to notify PCP of response after vaccine and also agrees to call 911 with any s/s reaction upon leaving Facility.
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| 74 | 2021-02-21 | redness, rash |
1.Swelling, redness, pain , rash about size of silver dollar. Did not start to appear until about th...
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1.Swelling, redness, pain , rash about size of silver dollar. Did not start to appear until about the 7-8 day. Reaction continued to get worse until day 12. It is now day 15 and much improved but still present. 2. Noticed having some difficulty swallowing on the 3-4 day. Did not have problems with swallowing foods, only when trying to swallow small amounts of liquid , such as accumulated saliva. I had to consciously engage muscles to gulp or get more liquid to get it down. The problem is improved now at day 15.
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| 74 | 2021-02-21 | itchy skin, injection site hives, hives |
shortly after receiving vaccine patient began to feel itchy. patient had urticaria to neck and shou...
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shortly after receiving vaccine patient began to feel itchy. patient had urticaria to neck and shoulders as well as the injection site. patient also states she felt like she had a really dry throat. patient taken to ED for further evaluation and treatment
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| 74 | 2021-02-21 | hives, itchy skin |
side effects started about 8 pm in the evening , my skin started to itch like crazy and broke out in...
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side effects started about 8 pm in the evening , my skin started to itch like crazy and broke out in hives all over my body but not on my face. The next morning i woke up and saw a dermatologist who said if sounded like it was from the injection. prescribed Allegra once a day and Benadryl 4 times a day. the next morning, my bottom lip was swollen. then my face broke out in hives in the evening and with i would wake up it was gone but i did have two puff pockets under my eyes. i called my primary care Dr. My Dr prescribed me the epi pen just incase she needed it. Friday i also had chills By Saturday i stated to improve. I was taking antihistamine and Benadryl together. By Sunday i started to take less of the Benadryl and by Monday i has stopped al together.
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| 74 | 2021-02-23 | itchy skin, hives |
Hives; itching; shortness of breath; This is a spontaneous report from a contactable Other Health Pr...
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Hives; itching; shortness of breath; This is a spontaneous report from a contactable Other Health Professional, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El1284), via an unspecified route of administration on 19Jan2021 at 16:00 (at the age of 74-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had unspecified concomitant medications that were received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021, the patient experienced hives, itching, all over and eventually some shortness of breath. The events resulted in visit to doctor or other healthcare professional office/clinic visit. The patient was treated for the events with prednisone and a variety of (unspecified) antihistamines. The patient was due to get the second dose of vaccination on Tuesday and the patient has been told she can get the second dose if she does it in the hospital under observation, and was requesting assistance in scheduling second vaccine. The clinical outcomes of the hives, itching, and shortness of breath were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 74 | 2021-02-23 | skin laceration |
Kidney infection; Wheezing in chest; her blood pressure is so low right now they can't even transfer...
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Kidney infection; Wheezing in chest; her blood pressure is so low right now they can't even transfer her to the hospital that can actually perform the surgery she needs; became very weak and didn't tell anyone/too weak to get up; mother was swollen from head to toe with edema; mother was swollen from head to toe with edema; fell using her walker on Wednesday/fell again; Laceration of face; having issues with her kidneys and has progressively declined since; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history using her walker. Concomitant medications were not reported. The consumer reported that her mother had the COVID-19 Vaccine on 21Jan2021. She was now hospitalized and was due to have the second vaccine on 11Feb2021 and stated that her mother was completely unstable for the second vaccine. After receiving the COVID-19 vaccine, medically, she seemed fine. Then, she progressively has gotten worse. First EMS was called. This was about less than a week later after receiving the vaccine. Then, she was admitted into the hospital with a kidney infection and she has progressively declined. She has no idea if it was related to the COVID-19 vaccine or not. She initially called regarding the second COVID-19 vaccine. She didn't know what would happen if her mother didn't show up for her second vaccine. She didn't know if she would get on the "never going to get the vaccine" list or what as her mother was just so unstable. On an unspecified date, her blood pressure was so low right now they can't even transfer her to the hospital that can perform the surgery she needs. The reporter stated that she has no idea if this was COVID related or what. She began having problems less than a week later after receiving the COVID-19 vaccine, she mentioned Wednesday. On 27Jan2021, her mother began having issues with her kidneys and has progressively declined since. Consumer stated her mother was swollen from head to toe with edema on an unspecified date and that was how this all kind of started. Her mother became very weak and didn't tell anyone. She fell using her walker on Wednesday and the EMS was called. Her mother told the EMS she wasn't hurt but was just too weak to get up and EMS got her up. Her primary care doctor sent her for an x-ray, and she had some wheezing in her chest. She was given an antibiotic for that. The patient fell again, and the EMS was called and had some face lacerations and stuff, so she was taken to the hospital. Consumer confirmed her mother was admitted into the hospital and was first diagnosed with a kidney infection and it has progressively gotten worse. Outcome of event kidney infection was not recovered; and outcome of the rest of events was unknown. Information on lot/Batch number has been requested.
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| 74 | 2021-02-23 | itchy skin, hives |
uncomfortable all night; itching; hives all over my body/developed giant hives all over her body/the...
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uncomfortable all night; itching; hives all over my body/developed giant hives all over her body/the giant hives were like fire ant bites/developed little hives on the inside of her arms, behind her knees, and on the tops of her feet; This is a spontaneous report from a contactable health care professional nurse, the patient. A 74-years-old female patient (retired nurse) received the first dose of bnt162b2 (BNT162B2, Lot Number EL9262) , via an unspecified route of administration in the right deltoid on 29Jan2021 at 11:00 (at 74 years of age) as a Single dose for Covid-19 Vaccination. The Vaccination Facility was 'movie theater'. No other vaccines were given within 4 weeks. Medical history included hypertension from 2020 ( doctor considered taking her off of blood pressure medicine because her blood pressure is very normal now), Prediabetes (diagnosed with Prediabetes about 3 years ago) and Allergic reaction to bee sting (numerous yellow jacket stings throat felt like it was starting to close, and tongue felt funny. Went to ER and Treated with Zantac and Epinephrine) and lost 55 lbs. (borderline high blood pressure was related to her weight). Concomitant medication included ongoing generic losartan (LOSARTAN) 50 mg, 1x/day for borderline high blood pressure, metformin (METFORMIN) 500 mg, 1x/day for glucose tolerance impaired. On 29Jan2021at 5 PM the patient started having some itching 'felt like she had a mosquito bite but on further investigation she noticed "giant hives all over my body'. She said she took some Benadryl Lot Number: P119923 Expiration Date: Apr2023 and 1 expired Zantac (Lot Number: NL4604, Expiration Date: Nov2019) on 29Jan2021 to help treat giant hives and itching. The giant hives 'kind of subsided' after she took the Benadryl and the Zantac, though she did remain itchy and uncomfortable all night. She said by the morning (30Jan2021) the giant hives were gone. She said that evening (30Jan2021) the giant hives came back again, and the giant hives were all over her body. She said the giant hives were like fire ant bites, she said the giant hives were just awful. She said she had a previously scheduled appointment with her doctor on Monday, 01Feb2021 (prior to developing the giant hives after her first COVID-19 Vaccine dose) but probably would have gone to see her doctor anyway, if she didn't have a prior appointment. She said she had taken pictures of her giant hives, her doctor believes the giant hives she experienced was a reaction the COVID-19 Vaccine's preservatives. She said her doctor still wants her to get the second COVID-19 Vaccine dose. Consumer stated Reported her giant hives were gone by Monday morning (01Feb2021), when she woke up. She stated during Monday (01Feb2021) into Tuesday (02Feb2021) she developed little hives on the inside of her arms, behind her knees, and on the tops of her feet. She said she has a residual itching that is lingering, but not continual. She said she has been taking one generic Zyrtec 10mg tablet per day, Lot Number: NL4604, Expiration Date: Nov2019. The events Hives and Itching was medically significant and uncomfortable was non serious. Treatment was given for itching and hives. Her doctor still wants her to get the second COVID-19 Vaccine dose. Patient second COVID-19 Vaccine dose is scheduled for 19Feb2021. The patient reported her doctor told her it would be a good idea for her to take one Zyrtec, each day, for 3 days before her next COVID-19 Vaccine dose. She said her doctor told her to pre-medicate with Benadryl on the day of her second COVID-19 Vaccine dose. The clinical outcome of Pruritus was recovering while Hives was recovered on 02Feb2021 and the outcome of uncomfortable was unknown. The events Giant hive, hives and itching were considered related to the suspect product.
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| 74 | 2021-02-24 | rash with redness, redness, itchy skin |
2 days after vaccine (2/10/21) patient developed an intensely red rash on extremities that was itchy...
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2 days after vaccine (2/10/21) patient developed an intensely red rash on extremities that was itchy. She self medicated with Allegra. She was seen at the doctor's office. Labs were drawn. No further treatment administered. Patient was seen for follow up visit on 2/25/21 and advised that the rash had resolved on 2/20/21.
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| 74 | 2021-02-24 | hives | Hives on mid to lower body. Benadryl seemed to help. In evening |
| 74 | 2021-02-24 | injection site pruritus, injection site rash |
On second day of receiving vaccine my arm began to get itchy. Upon looking at it, I seem to have a r...
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On second day of receiving vaccine my arm began to get itchy. Upon looking at it, I seem to have a rash about size of a half dollar where the injection was. It is red and extremely itchy. I have put some cortisone cream on the area. Upon searching the internet, I discovered it looks the rashes that have developed with Moderna but no mention of Pfizer so I thought I'd let you know.
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| 74 | 2021-02-24 | pain of skin |
on 2/24/21 noted discomfort starting on scalp on top of head going down to left eyebrow, onto left o...
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on 2/24/21 noted discomfort starting on scalp on top of head going down to left eyebrow, onto left orbit down face on left side of nose, also a fever blister on bottom lip starting 2/22/2021,discomfort continues. have not called M.D. Lysine ointment on lip. no other treatment
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| 74 | 2021-02-25 | rash with redness, hives |
Hives and red rash developed about 3 half hours after vaccination starting with legs and continuing ...
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Hives and red rash developed about 3 half hours after vaccination starting with legs and continuing over entire body. took Benadryl & used Ventolin HFA and went to ER at Hospital . There treated with more Benadryl, famotidine & prednisone (last dose 8:31 pm). released. follow up with primary 2/17/20 continued with hives and rash . Took Benadryl 5-6 times daily first several days. Day 13 only needed one. Also using still Cortizone 10 Crème . Day 15 still have red rash and hives starting to go down.
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| 74 | 2021-02-25 | itchy skin, redness | REDNESS AND ITCHING NO TRETMENT |
| 74 | 2021-02-25 | redness |
cheeks red and burning; cheeks red and burning; upper lip swelling; This is a spontaneous report fro...
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cheeks red and burning; cheeks red and burning; upper lip swelling; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via an unspecified route of administration in the left arm on 12Jan2021 at single dose for covid-19 immunisation. Medical history included allergic to a lot of antibiotics, always get reactions to drugs. Concomitant medications were unknown. The patient previously received ciprofloxacin (CIPRO) experiencing lip swelled, levofloxacin (LEVAQUIN) experiencing lip swelled, Prednisone experiencing burning cheeks. The patient experienced that her cheeks were red and burning, and upper lip swelling slightly, all on 12Jan2021. And it lasted a little over two hours. The patient was asking if it would be safe to take Benadryl before the 2nd dose of the vaccine. Outcome of all events was recovered on 12Jan2021.
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| 74 | 2021-02-25 | shingles |
still a part of her forehead that feels like a live nerve; upper back started hurting/back was very ...
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still a part of her forehead that feels like a live nerve; upper back started hurting/back was very tender and sensitive around the spine area; arm was a little sore; pharmacist had some left over in the vial and gave her that; has post traumatic neuralgia" related to her shingles; Shingles; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 29Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from two contactable consumers via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. Medical history included dental work/specifying a tooth being pulled and an implant (an antibiotic (Amoxicillin)) was used and shingles (7 years ago). The patient's concomitant medications were not reported. It was reported that Pharmacist had some left over in the vial and gave the patient on 28Jan2021. Patient wanted to make sure it was ok. Patient stated "she got shingles on her face, 7 years ago, and had recent dental work done," specifying a tooth being pulled and an implant. She stated she received the first dose of the COVID-19 vaccine last Thursday evening (28Jan2021). On 29Jan2021 and 30Jan2021 (friday and saturday), she mentioned, her "arm was a little sore". On 30Jan2021 and 31Jan2021 (saturday evening and sunday morning) she said her "upper back started hurting" and thought "maybe [she] sat on the couch for too long". On 31Jan2021 (Sunday evening), she added her "back was very tender and sensitive around the spine area" therefore, she "took some tylenol and used a heating pad thinking [she] pulled a muscle". On 01Feb2021 (By Monday) she said her "the back and front were very sensitive" to the point where: when she "touched [her] skin it felt like [she] was touching some live nerves". She explained seeing a physician assistant who "couldn't figure out what was going on" and since it seemed to be getting worst, she thought she could possibly have Shingles. She continued saying she then "went to see an orthopedic doctor who took x-rays and said he doesn't see anything, and it may be the beginning phases of Shingles". She mentioned she has an appointment with her internist today at 4:20. She later mentioned her "brother, who is a doctor, thinks [she] has post traumatic neuralgia" related to her shingles on an unspecified date in Jan2021. She then added there is "still a part of her forehead that feels like a live nerve" to touch, since having Shingles, on 01Feb2021. The outcome of the events was unknown. The outcome of the events was unknown. The information on the Batch/Lot number has been requested.
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| 74 | 2021-02-26 | injection site pruritus | Itch at site, sore arm, insomnia, brain fog, out of breath |
| 74 | 2021-02-26 | hives |
severe hives on back/var/folders/1z/zbry6j8n0r1737cgrdfybb9r0000gn/T/com.apple.mail/com.apple.mail.d...
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severe hives on back/var/folders/1z/zbry6j8n0r1737cgrdfybb9r0000gn/T/com.apple.mail/com.apple.mail.drag-T0x6000023acbc0.tmp.BsUCMb/Attachment-1.jpeg
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| 74 | 2021-02-27 | rash |
Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash....
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Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash. Treatment - bed rest. Outcomes - OK after 4 days.
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| 74 | 2021-02-27 | rash |
Tested positive for COV2T antibodies on 1/18/2021. Starting 1/31/21: Severe fatigue; loss of muscle ...
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Tested positive for COV2T antibodies on 1/18/2021. Starting 1/31/21: Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash. Treatment - bed rest. Outcomes - OK after 4 days.
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| 74 | 2021-02-28 | rash |
Rash (red) all over both arms (from armpit to wrist) (starting from left arm and then both arms). Sy...
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Rash (red) all over both arms (from armpit to wrist) (starting from left arm and then both arms). Symptom getting worse in 1-2 days and then gradually subsided in Day 3 and Day 4.
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| 74 | 2021-02-28 | vaccination site pain |
rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitatio...
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rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitations; quivering in chest and palpitations; lightheadedness; tired; anxious; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of two reports. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on 22Jan2021 at 15:30 at a single dose on left arm for COVID-19 immunisation. Medical history included triglycerides high, obesity, blood clotting issues, thyroid disorder and blood cholesterol abnormal from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, rosuvastatin calcium, aspirin (acetylsalicylic acid) and vitamin D3. The patient experienced rapid heartbeat, headache, quivering in chest and palpitations, lightheadedness, pain in her arm at the injection site, tired on 23Jan2021 and anxious on 22Jan2021. The patient stated that on Saturday (23Jan2021), she noticed pain in her arm at the injection site, a headache, and feeling of like she was quivering in her chest. She was also experiencing palpitations, lightheadedness, and periods of rapid heartbeat. On Monday, the symptoms were a little less but yesterday and today she has had a lot of palpitations, quivery feelings in her chest and rapid strong heart beats. On Saturday, she took an aspirin for headache. On Sunday, she had just a mild headache and by Monday (25Jan2021) it was gone. She wanted to know if these are normal reactions and if she should call the doctor, or what she should do about them. The patient underwent lab tests and procedures which included blood triglycerides: high and body mass index: high on Jan2021; heart rate: rapid on 23Jan2021. Therapeutic measures were taken as a result of headache. The outcome of the events pain in her arm at the injection site and headache was recovered on 25Jan2021, while of the rest was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116966 same reporter/drug, similar events, different patient
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| 74 | 2021-03-01 | injection site swelling, injection site pruritus, injection site mass, injection site redness |
Day 1 and 2 no redness or swelling at site. Slight headache and chills day 1. Day 3 swelling, redn...
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Day 1 and 2 no redness or swelling at site. Slight headache and chills day 1. Day 3 swelling, redness and itching at site. No improvement on day 7. No pain associated or other symptoms. Just red, itchy, and large lump above injection site. Using Benadryl cream on the site.
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| 74 | 2021-03-01 | injection site warmth, rash, injection site pain |
Immediately after vaccination, this individual noticed that the arm was very sore and hot to the tou...
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Immediately after vaccination, this individual noticed that the arm was very sore and hot to the touch. Two days later, they noticed a long, vertical, irregular rash on the arm where the vaccine was administered. The rash has persisted over a week and is still present on 3/2/21. The individual has consulted with her primary care provider who instructed her to keep monitoring it and to notify the Health Department in her county.
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| 74 | 2021-03-01 | itchy skin, bruising |
With first shot, mild itching all over. One Day. With second shot on 2/16- itching, took Benedyl an...
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With first shot, mild itching all over. One Day. With second shot on 2/16- itching, took Benedyl and tylenol. On 21st sore all over, knees, back, shoulders, difficulty rising from seated position. It was as if all my joints were inflamed. Had strange bruise of left thigh, Dificulty walking. Took warm bath, muscle rub, ibuprofin, Pain continued on 10.,muscle spasms. When to ungent Care 2/27. Test Netrophils 61.7,lymphs 30.0, monos 6.0, eos,2.1 baso 0.2, AnC 2.99;Lymphs 1.45, monos 0.29, eos auto 0.10,BASO,001, WBC 4.8, RBC 4.70. HGB 12.7 HCT 39.8, MCV 84.7,MCHC 31.9.RDW<BLOOOD, 14.0,PLT'S AUTO,NA 141, K 4.1,CL 103, CO2 29. CREAT 0.86, GFR 77, BUN 15 , GLUC 112, ESR 23
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| 74 | 2021-03-01 | itchy skin |
With the first vaccine on 1/29/21 I feel slight soreness at injection site and itching all over abou...
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With the first vaccine on 1/29/21 I feel slight soreness at injection site and itching all over about eight hrs after which lasted a day. With the second vaccine on 2/16/21 I felt itching after about six hours for a day and took Benedyl and tylenol. In the 21th I began to be sore all over, my knees, back, shoulders, ached and it was painful to rise from a seated position. It was all my joints were inflamed. I did not have a temperature, my blood pressure went down to 119/55. I am taking warm baths, tylenol, and waiting for the pain to subside. I also feel fatigued. I will call my primary Doc if I don't continue to improve.
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| 74 | 2021-03-01 | skin discolouration |
about 4 hours after the shot I realized my heart was racing and my throat felt ticklish. I also noti...
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about 4 hours after the shot I realized my heart was racing and my throat felt ticklish. I also noticed that the insides of both forearms were a bluish mottled color. Then I started uncontrollable shivering that lasted about 90 minutes. We went to the ER within 15 minutes of symptoms starting.
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| 74 | 2021-03-01 | vaccination site pain |
sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass ou...
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sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass out.; Nausea; Muscle ache; Headache; Second dose arm hurt at injection site; compromised immune status; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), intramuscular at arm left on 13Feb2021 at 10:30 (at the age of 74 years) at single dose for COVID-19 immunization. Medical history included primary biliary cholangitis (PBC, autoimmune condition and was diagnosed 10 years ago), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, diabetes and obesity, all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular at arm left on 24Jan2021 and experienced sore arm. The patient experienced headache and arm hurt at injection site, both on 13Feb2021 at 19:00; heart rate racing, AFib, lightheadedness and dizzy and felt like she would pass out, all on 14Feb2021 at 07:30; nausea, muscle ache, both on 14Feb2021 at 03:00, chills on 14Feb2021 at 15:00 and sweating on 14Feb2021 at 16:00. The patient outcome of the events was recovering.
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| 74 | 2021-03-02 | hives |
Hives; This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old...
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Hives; This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN9581, expiry date: May2021), via an unspecified route of administration on 30Jan2021 (at the age of 74-years-old) at a single dose for COVID-19 immunization. Medical history included diabetes from an unknown date and unknown if ongoing. Concomitant medication included glipizide, metformin, apixaban (ELIQUIS), flecainide, omeprazole, simvastatin, losartan, lorazepam, hydralazine. The patient received the Pfizer COVID vaccine on 30Jan2021 and ended up getting hives from it on 30Jan2021. The event started three hours after the injection. The patient received CLARITIN at 10 mg one pill as treatment. The patient underwent lab tests and procedures which included basic metabolic panel (where they check your creatinine, check your A1C, they check your kidneys and they check your back and stuff) with unknown results. The outcome of the event was recovered on 30Jan2021.
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| 74 | 2021-03-02 | itchy skin | Patient states that she felt "woozy" and itchy left hand. 30 min after vaccine. |
| 74 | 2021-03-02 | rash |
a rash all over [her] body; A swelling face; Being tired; This is a spontaneous report from a contac...
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a rash all over [her] body; A swelling face; Being tired; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, batch/lot number and expiry date unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient experienced a rash all over her body, a swelling face, and being tired on an unspecified date after receiving the first dose of the COVID-19 vaccine. She said that her throat was ok, hadn't itch and she doesn't have a fever. The outcome of the events was unknown. Information about batch/lot number has been requested.
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| 74 | 2021-03-02 | vaccination site redness, vaccination site pain |
tenderness in area of injection; noted blotchy redness, no pain, extending 6 in below shot site; Th...
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tenderness in area of injection; noted blotchy redness, no pain, extending 6 in below shot site; This is a spontaneous report from a contactable consumer who reported for herself. A 74-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL 9263) via an unspecified route of administration on 29Jan2021 at 19:30 (at the age of 74-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included HTN (hypertension), atherosclerosis, hip replacement, TIA (transient ischemic attack) and "INCR" lipids (increased lipids), all from unspecified dates and unspecified if ongoing. The patient had no known allergies to mediations, food or other products. Concomitant medications (received within 2 weeks of vaccination) included nebivolol hydrochloride (BYSTOLIC), lisinopril, calcium citrate (CITRACAL), ezetimibe (ZETIA) and pitavastatin calcium (LIVALO), all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced tenderness in area of injection and noted blotchy redness, no pain, extending 6 in below shot site, both on 29Jan2021 at 23:00, both reported as non-serious. The events did not cause hospitalization. The clinical course was reported as follows: "tenderness in area of injection began hours after injection and increased over 24hrs and began to decease. 52hrs p shot noted blotchy redness, no pain, extending 6 in below shot site. Still there 18hrs later but fading in color." No treatment was received for the events. It was reported that it was unknown whether the patient was recovered. The clinical outcomes of the events tenderness in area of injection and noted blotchy redness, no pain, extending 6 in below shot site were both unknown.
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| 74 | 2021-03-03 | injection site redness, injection site pain, injection site rash |
I had some of the listed side effects. i.e., pain and redness at injection site and fatigue. However...
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I had some of the listed side effects. i.e., pain and redness at injection site and fatigue. However, by Feb 21 noticed swelling under my armpit on the left side as well as somewhat swollen nodes in the left side of my neck. The swelling under my arm became worse over the next two days. When I raised my left arm I felt considerable pain. Over the next 2 days I also had swelling in my left forearm near bend in my elbow. I also had a rash the size of a patch above the injection site. I looked this issue up online and found reports that approximately 16% of women who had received the 2nd Covid shot experienced swelling under the armpit. I contacted my doctor by e mail . I switched from taking tylelnol to advil. All side effects are gone except there is still a little swelling in armpit. I contacted my Doctor and will see her on March 15th if the swelling is not gone.
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| 74 | 2021-03-03 | injection site pruritus, redness |
Severe pain (entire arm) and redness; feverish/temperature fluctuations-highs and lows for her; extr...
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Severe pain (entire arm) and redness; feverish/temperature fluctuations-highs and lows for her; extreme itching at site; lethargy; reporter let person know these events not terribly unusual, vaccinee (sp?) wanted to report because continuing to have this
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| 74 | 2021-03-03 | itchy skin, vaccination site pain, rash macular, redness |
Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right...
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Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right arm; A little headache at the back of the head; Itching; More pain when l lift my arm, my arm pits/Hurting under her arm when she was lifting; Swollen glands; My temperate was 100.8; had difficulty lifting her right arm; Tired, very tired; Tenderness at vaccinate site; More pain when l lift my arm, my arm pits/pain in arm/pain in her right arm/a lot of pain; I feel tugging and redness when I raise my arm, It's not red its blotchy; I feel tugging and redness when I raise my arm, It's not red its blotchy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly at site of right arm on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included (synthroid: Taking for years), prevent urinary tract infection (UTI) (methenamine: started a year and a half ago), vitamin supplementation (Preservision Areds 2 eye vitamins more than a year ago; Vitamin C with Zinc 8-9 months ago), dry eyes (Thera tears: dry eye therapy. she has not been consistent with taking), cholesterol (simvastatin: taking 20 years or more), allergic to Sulfa Drugs and Tetracycline, obesity (had been fighting it for 30 years), removed polyps (had a flat polyp that was a little more dangerous the first time and it was removed; non-cancerous), got the flu (08Jun months later, got the flu, went to the hospital and developed PNA) and eczema (took calcium 1200mg). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid; methenamine for prevent UTI; ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) for vitamin supplementation; ascorbic acid, zinc (VITAMIN C WITH ZINC) for vitamin supplementation; carmellose sodium (THERA TEARS) for dry eyes; simvastatin for cholesterol; calcium for eczema. The patient previously took Flu vaccine (Injection site was left arm, intramuscularly) in Oct2018 and experienced pain in injection site and redness in arm; took the first dose of BNT162B2 with lot number: EL3246, intramuscularly in left arm site at 09:00 on 08Jan2021. Clinical course: After the second dose of vaccination, patient noticed tenderness at vaccinate site at 13:00 and had pain in arm on 28Jan2021, but on 29Jan2021, the pain was worse, and she had difficulty lifting her right arm at 16:00. On 30Jan2021, she started noticing more pain when she lifted her arm, her arm pits, it was hurting under arm when she was lifting. She thought maybe there were swollen glands but did not feel it. her temperate was 100.8, and she took some paracetamol (TYLENOL), by the evening, her temperature was at 98.6 normal. On 31Jan2021, she noticed a lot of pain, itching and redness, redness moved from actual site down her arm about 6 to 7 inches at 14:00. The pain in her right arm was not as bad as it was, but the redness in the area and itching was there, it was hot to touch area on right arm, and she tried cold compresses and took paracetamol. Also, it was hurting under her arm when she was lifting. She experienced something like that before with a Flu vaccine. She noticed when she looked it up, the information states, yes. And it was still going on today, not so much pain, just swelling and redness, looked like what Moderna calls a covid arm. She had no temperature, a little headache on 31Jan2021 at the back of the head and tired, very tired, she was tired from 29Jan2021, and was better from 01Feb2021. She took paracetamol last night, and cold compress. she used to take baby aspirin; she didn't know if it would be a problem. She read not to take paracetamol or ibuprofen before vaccination. She felt tugging and redness when she raised her arm, it was not red its blotchy. She didn' t feel any swelling. The last 7 to 8 months, she was running high blood counts, 12.3 (high) and she had no infection, her doctor was a little nervous, the last one on 15Jan2021, it was down to 10.2 within normal range. Her immune system was very active. She had a flu shot in Oct2018 at age of 72 y/o and by 08Jun months later, she got the flu. She went to the hospital and developed PNA. In 2019 and again this past Aug2020, she had a Colonoscopy where they removed polyps. She had a flat polyp that was a little more dangerous the first time and it was removed. It was non-cancerous. The doctor was just watching it. Last blood results were 2 weeks prior to having first shot on 15Jan2021. The only thing that showed was her Liver enzymes were a little elevated. She was told that if she hadn't gotten the vaccine, it would have been worse, her doctor gave me the zpack. They were calling it a subcutaneous sensitivity, she had eczema, she forgot to mention that. She was taking calcium 1200mg, she forgot to tell her that also. The outcome of events pain in arm, redness and feeling hot was not recovered; of events tiredness, body temperature increased, itching and headache was recovering; of rest events was unknown.
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| 74 | 2021-03-03 | vaccination site pain |
pain in her arm; tired; feeling unwell; This is a spontaneous report from a contactable nurse (patie...
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pain in her arm; tired; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 74 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration (on left arm) on 27Jan2021 13:30 (at the age of 74-years-old), single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the vaccine last Wednesday. Since then she has had pain on her arm mostly on the upper side of the arm. She took Tylenol and it went away. Adds she felt so tired and generally unwell, like the flu. Mentions it is like muscle pain in her left arm that come back whenever she moves around. All of this started on Wednesday. Adds it is not that severe, like if you have the flu. Mentions she does get muscle pain sometimes when she is working around the house but this is different. She is scheduled for the second dose of the vaccine 17Feb2021. She is starting to get worried about taking the second dose of the vaccine if it is going to be like this and wants to ask about that. She received the first dose of the vaccine on 27Jan2021 at 13:30PM in the left arm. That night, Wednesday night she noticed the pain in her upper arm. She took Tylenol and then the morning it went away. Friday it came back and she took Tylenol again and it went away. But when she works or walks around there is pain again. Seriousness not provided. The event pain in her arm was assessed as recovering, other events recovered on 31Jan2021. Information on the lot/batch number has been requested.
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| 74 | 2021-03-04 | injection site pain, injection site bruising, injection site redness |
2nd Shot, 2nd day headache, bad muscle ache, third day slight headache redish injection site, fourth...
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2nd Shot, 2nd day headache, bad muscle ache, third day slight headache redish injection site, fourth day bad headache, indigestion and bad diarrhea. Injection site large red, purple, orange (size 2-1/2 " x 1-1/2" very sore. Today, 3/5; reaction site sore but brusing fading. Feel good. 1st Shot was slightly sore arm. Never had fever, cough, chills or vomitting. *** DID NOT CONTACT DOCTOR; WAS NOT EMERGENCY. Just felt like I had flu but thought I should report bad arm reaction.
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| 74 | 2021-03-04 | itchy skin |
After injection, that night woke up with a blinding headache but it has gone away. Swollen, burning,...
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After injection, that night woke up with a blinding headache but it has gone away. Swollen, burning, itching, soreness and can't sleep on that side.
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| 74 | 2021-03-04 | itchy skin, rash macular |
I received the first Covid shot. After a few days of soreness, it became itchy. Red blotch on arm...
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I received the first Covid shot. After a few days of soreness, it became itchy. Red blotch on arm that itches
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| 74 | 2021-03-06 | itchy rash, hives |
Itchy welts and rash, some in clusters, some individual. Welts mostly on neck, trunk but also arms, ...
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Itchy welts and rash, some in clusters, some individual. Welts mostly on neck, trunk but also arms, leg and face. Worse breakout after 2nd shot
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| 74 | 2021-03-06 | shingles | Shingles |
| 74 | 2021-03-07 | bruising |
1st Covid vaccination received on 2/20/21, Both of the following caused significant bruising on both...
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1st Covid vaccination received on 2/20/21, Both of the following caused significant bruising on both arms - blood draw on 2/26/21 and CT with contrast on 3/2/21. Unusual for me.
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| 74 | 2021-03-07 | bruising |
Client's daughter reports extensive bruising to right arm and increased soreness, starting about 10 ...
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Client's daughter reports extensive bruising to right arm and increased soreness, starting about 10 days post-vaccination. Bruising has continued to grow worse and states her mother "cannot use her right arm." Reports she has been to the ER twice but only pain medication given as treatment. Client denies any other symptoms or skin changes anywhere else.
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| 74 | 2021-03-08 | injection site swelling, injection site warmth, injection site pain |
1st 24 hrs-injection site swelling, hot, pain; 2nd 24 hrs-severe abdominal cramps & diarrhea; next 5...
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1st 24 hrs-injection site swelling, hot, pain; 2nd 24 hrs-severe abdominal cramps & diarrhea; next 5 days-nausea, weakness & fatigue - could not eat or smell or even look at food.
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| 74 | 2021-03-08 | redness |
Light headed and slight fever on day of injection. Since that time, arm is swollen and red and sli...
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Light headed and slight fever on day of injection. Since that time, arm is swollen and red and slightly sore.
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| 74 | 2021-03-08 | skin warm, redness | Localized redness, increased warmth. 5 cm wide by 7 cm long. |
| 74 | 2021-03-08 | redness, injection site pain, skin warm, injection site swelling |
On Sunday around 2:00 p.m. I got cold inside. Around 10:00 p.m. that same day I got a headache and ...
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On Sunday around 2:00 p.m. I got cold inside. Around 10:00 p.m. that same day I got a headache and my arm where I got the shot was swollen in that area and it hurt. On Monday, March 8th my headache was gone and the coldness went away, but my arm was still swollen, sore and red. On Tuesday, March 9th I called the doctor and he told me to put ice on it. When I get other shots my arm swells a little and it is gone in two days along with the redness, but not this time. It is warm to the touch too.
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| 74 | 2021-03-08 | shingles |
One day after receiving the vaccine, the patient developed a rash which was diagnosed as herpes zost...
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One day after receiving the vaccine, the patient developed a rash which was diagnosed as herpes zoster (shingles).
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| 74 | 2021-03-08 | injection site pain |
Soreness at injection site Fever of 100 degrees Chills Body Aches Tiredness At 8:00 pm on March 3 I...
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Soreness at injection site Fever of 100 degrees Chills Body Aches Tiredness At 8:00 pm on March 3 I took 1 full dose (325 MG) aspirin. By the next morning, all symptoms except tiredness were gone. Tiredness remained on March 4, but was gone by March 5th, 2021
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| 74 | 2021-03-08 | redness, itchy skin | itching on cheek and neck, redness (flushing). Evaluated by EMS-Cleared |
| 74 | 2021-03-08 | skin warm, redness |
red, flushed, hot, tender cheeks, face; noticed after removing face mask in car. This was not not...
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red, flushed, hot, tender cheeks, face; noticed after removing face mask in car. This was not noticed at vaccination facility because face was covered with protective mask. Pain in both eyes continued for several hours following.
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| 74 | 2021-03-09 | injection site pain |
11:00 pm - ish: Site of injection began burning which became more intense throughout the night. Cold...
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11:00 pm - ish: Site of injection began burning which became more intense throughout the night. Cold sweats, severe aching and muscle weakness especially in legs, nauseous, severe headache. I tried to drink a little water. Didn't have enough energy and was too cold to get up to get any medication. Slept a little. I was awake early in the morning, but too cold to get out of bed. At 8:30 a.m. I got up and could hardly walk. Dizzy, muscle weakness as if muscles had turned to Jell-O.. Sat down and threw up, mostly dry heaves, which lasted a few minutes. Fitful sleep until 11:00 a.m. when I began to feel better. Drank more water and just rested for a few hours. I ate some applesauce and made a batch of white rice which I ate around 6:00 p.m. Achiness in lower extremities continued until bedtime (10:00 p.m.) when I took a Meloxicam (15 mg) which my GP prescribed for achiness in my neck due to arthritis. I take this drug only when needed and thought it would help the aching in my legs. Maybe it did...maybe it was a coincidence that the achiness was alleviated enough for me to go to sleep. I am almost 100% today. It takes a little longer at my age to fully recover from any illness however slight. I would like to add that I am grateful to be vaccinated.
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| 74 | 2021-03-09 | hives |
Feeling sick/doesn't feel very well; hives (on neck and shoulder); Feverish; Achy; cannot move; This...
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Feeling sick/doesn't feel very well; hives (on neck and shoulder); Feverish; Achy; cannot move; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included "coronavirus" and allergies. The patient's concomitant medications were not reported. On an unspecified date, the patient was feeling sick and developed hives (on neck and shoulder). She wanted to know if she needs to get the second dose since she is afraid to have the side effects again. Patient was feeling feverish and achy, cannot move and doesn't feel very well on an unspecified date. She stated that the place where she received the vaccine had several sites set up. She got the first at one site. She is scheduled for her second dose at another site, but she read or heard it should be done at the same site. She wanted to know if it is safe to have the second shot. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 74 | 2021-03-10 | hives, itchy skin |
10 minutes after injection, reported trouble breathing, tight chest, generalized itching, hives on c...
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10 minutes after injection, reported trouble breathing, tight chest, generalized itching, hives on chest and trunk, swelling of tongue and throat. Epi given to outer thigh, 8L O2 NC placed, Benadryl given IM. 911 called and transported to GS ED via ambulance
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| 74 | 2021-03-10 | redness |
20 minutes after being vaccinated, patient felt,weak,feeling "I'm going to pass out", facial rednes...
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20 minutes after being vaccinated, patient felt,weak,feeling "I'm going to pass out", facial redness, feeling very hot. Remains alert and oriented x3. Brought to EMT monitoring area, VSS 148/72 HR 57 O2 100%, POC 86, very anxious with husband at bedside. EKG,with heart being monitored all within normal ,noted in database for rate as baseline. Cognitively presents anxious with noting calmness after 30 minutes with patient stating "I just feel not right". Has stated that her throat feeling cold. feeling spacey. Vitals have remained stable and offered to be transported to ER if preferred. Both she and husband agreed to be transported to Hospital. Their son was notified of this episode. Transported in stable condition to Hospital.
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| 74 | 2021-03-11 | redness, skin burning sensation |
body was burning up and face became very red. Had no temperature but was extremely hot after on weer...
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body was burning up and face became very red. Had no temperature but was extremely hot after on weer. Now have temporal pain in right hs hand temple with intermittent shooting pains
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| 74 | 2021-03-14 | injection site pain |
Began with left knee and lower leg pain and swelling on 3/2/2021 at approx. 1500. Could barely put ...
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Began with left knee and lower leg pain and swelling on 3/2/2021 at approx. 1500. Could barely put weight on left leg. Placed bag of ice under left knee/lower leg to decrease pain/swelling for 20 minutes. Removed ice and wrapped a heating pad around left knee and went to bed for approx. 11 hours. Awoke at 0230 and almost fell to floor because left leg and knee was very swollen and painful. Left arm was swollen from upper arm to wrist. Whole face also appeared swollen. Denied redness and hardness. Went back to bed and awoke at 0930 - took two Tylenol for left arm soreness where injection was. Swelling slowly subsided throughout the day and she stated that she felt so much better in am of 3/5/2021 (Friday).
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| 74 | 2021-03-14 | redness |
This dose was administered in the wrong location. Resulted in redness, swelling, tenderness and swol...
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This dose was administered in the wrong location. Resulted in redness, swelling, tenderness and swollen lymph nodes under arm.
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| 74 | 2021-03-14 | redness |
lower jaw numbness/felt a little numbing in her jaw on right side; Fatigue; Headache; pain in her fa...
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lower jaw numbness/felt a little numbing in her jaw on right side; Fatigue; Headache; pain in her face/incredible face pain, throbbing; slept most of the two days following the vaccine; face became bright red with swelling and intense in her cheeks and forehead; face became bright red with swelling and intense in her cheeks and forehead; disoriented; dizzy/wooziness; This is a spontaneous report from a contactable consumer herself. A 74-years-old female patient started to receive bnt162b2 (Pfizer-Biontech covid-19 vaccine, Solution for injection lot number: EN5318 and expiration date: unknown) intramuscularly from 29Jan2021 18:10 at single dose for prevent covid. Medical history included stroke from Apr2018 to an unknown date since she had a stroke 3 years ago. Concomitant medication included rivaroxaban (XARELTO) for stroke 30 mg, once a day. The patient previously took diphtheria vaccine. Caller states she spoke to safety agent and gave them all of her information. Caller states she received the first dose of the Pfizer COVID vaccine Friday at 6:15 pm. Caller states after waiting the recommended 15 minutes at the vaccination facility after receiving the first dose caller states four minutes later she began to experience lower jaw numbness that lasted a few seconds 29Jan2021. Caller states her face became bright red with swelling and intense in her cheeks and forehead In Jan2021. Caller states these symptoms were only in her face and no where else. Caller states she was taken back to the vaccination facility and the nurse monitored her every ten minutes for about 30 minutes until she cooled down and then she was sent home. Caller states during this time she was disoriented and dizzy In Jan2021. Caller states the next day she experienced pain in her face and to this day she still gets some pain but no more redness in her face. Caller states she is scheduled for the second dose on 19Feb2021. Caller states she read somewhere online that if you had a severe allergic reaction to the first dose you should not receive the second dose. She stated that within roughly five minutes of receiving the vaccine that she began to experience a numbing in the chin and the surrounding area. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She also experienced wooziness and a dizziness. She said the experience subsided in approximately 40 minutes of its onset. She is scheduled to receive the second dose on the 19th of Feb, but has some concerns about receiving it due to her experience. The patient had Fatigue, Headache in 29Jan2021. She clarifies her slight headache pain came back with the fatigue, reports it comes and goes. Her headache is off and on. After about 5 minutes of waiting she felt a little numbing in her jaw on the right side. Then 2 minutes later her face got bright, bright red, like there was real heat coming from it. She also had swelling in her face. It was very strange. She is asking if it is safe to get the second dose which is scheduled for 19Feb2021. This reaction lasted about 40 minutes. Her face was all flushed and burning hot red. It took a couple of hours for her face to come back to her normal color. After this faded, she reports she was left with incredible face pain, it was throbbing. She was extremely fatigued and is still fatigued, she can do very little. She is managing to cook. She slept most of the two days following the vaccine. The outcome of the events Numbness recovered on 29Jan2021,red face recovered in 2021, event pain in her face/incredible face pain, throbbing recovered in 31Jan2021, event Fatigue was recovering and other events unknown.
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| 74 | 2021-03-15 | hives | Hives, 5 days after vaccination |
| 74 | 2021-03-15 | itchy skin, rash papular |
Raised rash on left arm. Rubbed Benitryl morning and night. Seems to be fading at this time. Very s...
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Raised rash on left arm. Rubbed Benitryl morning and night. Seems to be fading at this time. Very sore and sometimes itchy
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| 74 | 2021-03-15 | redness |
The patient began experiencing numbness on the right side of her face about 10 minutes after her vac...
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The patient began experiencing numbness on the right side of her face about 10 minutes after her vaccine was administered into her right arm. She reported that the right side of her face felt like it was red and swollen. She endorsed some drooping of her right eye. She was able to communicate fully, denied shortness of breath, difficulty breathing, and difficulty swallowing. She denied irritation at the vaccine site or any new rashes. Her only known allergy is to shellfish and iodine, which cause nausea and vomiting. The patient waited for about 25 minutes following the administration of the vaccine. Her symptoms did not begin to improve and it was recommended to contact EMS. The patient refused to call EMS and instead contacted her physician and left the facility.
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| 74 | 2021-03-16 | shingles | Developed pain in left side. Went to urgent care and diagnosed as shingles |
| 74 | 2021-03-17 | rash, rash with redness, itchy rash, injection site rash, injection site pain, injection site redness, injection site swelling |
sore red and swollen 2 days later upper arm at injection site became a large red itchy rash then 2 d...
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sore red and swollen 2 days later upper arm at injection site became a large red itchy rash then 2 days after that a red rash over my whole body
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| 74 | 2021-03-18 | injection site rash, rash vesicular, itchy rash, rash |
Appearance of painful, pruritic vesicular rash around injection site ~ 24 hours after 2nd COVID vacc...
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Appearance of painful, pruritic vesicular rash around injection site ~ 24 hours after 2nd COVID vaccination; visiting nurse thought it resembled shingles, offered valtrex, but patient declined. Rash has been resolving and pain has been improving, but as of last visit in our office on 3/12/21 was still present.
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| 74 | 2021-03-18 | pain of skin |
Joint ache, head and neck ache, skin ache, chills, slight fever. Started night of second shot, Mon...
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Joint ache, head and neck ache, skin ache, chills, slight fever. Started night of second shot, Monday, stopped about 24 hours laterTuesday. Started again third night, Wednesday, stopped next morning. Started again Thursday night and is continuing on Friday (today). Secondary starts are not as strong as first night but are still very uncomfortable and do not allow for a good night?s sleep. Have been taking aspirin and Advil.
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| 74 | 2021-03-18 | shingles |
Shingles; This is a spontaneous report from a contactable consumer. A 74-year-old female patient re...
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Shingles; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in the right arm, on 23Jan2021 (Batch/Lot Number: EN9581; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunization. Medical history included rosacea, rash and CLL (chronic lymphocytic leukaemia); patient has history of CLL (leukemia) in remission for 6 years. Concomitant medications included hydroxychloroquine taken for rash, start and stop date were not reported; and doxycycline taken for rosacea, start and stop date were not reported. The patient experienced shingles (herpes zoster) (non-serious) on 13Feb2021. The patient underwent unspecified lab tests and procedures which patient did earlier in Jan and stated that "all of it was fine". The outcome of event was unknown. Therapeutic measures were taken as a result of shingles included Valtrex. No follow-up attempts are possible. No further information is expected.
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| 74 | 2021-03-18 | vaccination site pain |
Sore injection site; joint aches; Chills; headache; nausea; vomiting; muscle pain; listless; fever; ...
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Sore injection site; joint aches; Chills; headache; nausea; vomiting; muscle pain; listless; fever; no appetite; Not feeling well; still tired; sleeping a lot; Very fearful of taking the second shot; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 (Lot Number: EM0910) as single dose for covid-19 immunization. Medical history included mild chronic obstructive pulmonary disease, asthma, bronchitis, sinus infection and sulfa allergy from unknown dates. The patient previously took and experienced allergies to acetaminophen, montelukast sodium, hydroxyzine, budesonide-formoterol fumarate and pseudoephedrine hcl. On 09Feb2021, at 01:00, the patient experienced sore injection site with outcome of unknown; joint aches with outcome of unknown; chills with outcome of unknown; headache with outcome of unknown; nausea with outcome of unknown; vomiting with outcome of unknown; muscle pain with outcome of unknown; listless with outcome of not recovered; fever with outcome of unknown; no appetite with outcome of unknown; not feeling well with outcome of unknown; still tired with outcome of not recovered; sleeping a lot with outcome of not recovered; very fearful of taking the second shot with outcome of not recovered. No treatments were given for the events. Details were as follows: the adverse events included sore injection site, joint aches, chills, headache, nausea, vomiting, muscle pain, listless, fever, no appetite, not feeling well, all in that order. Worst side effects were gone by the third day; she was still tired, sleeping a lot and was listless. The patient was also very fearful of taking the second shot. The events resulted in doctor or other healthcare professional office or clinic visit on an unspecified date.
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| 74 | 2021-03-18 | vaccination site pain, vaccination site swelling |
Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breast...
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Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breasts are very sensitive and sore; Breasts are sensitive/Her breasts are very sensitive and sore; Swelling in her calves, her left and right arms; Swelling in her calves, her left and right arms/her hand was swollen, and her whole arm was like a log, it has been very uncomfortable; Her arm is very, very sore at the site of injection/Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; Her joints in her elbows, wrists, and ankles are hurting/lot of joint pain; Nauseous; lymph nodes were affected and swelling; Tired; Swelling everywhere; Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; uncomfortable; This is a spontaneous report from Social Media by a contactable consumer (patient). A female patient of 74-year-old received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via unspecified route of administration in right arm on 05Feb2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included chronic kidney disease from an unknown date in 2012. The concomitant medication was not reported. The patient stated that have not had any other recent vaccinations or started any new medications. The patient reported that on an unknown date Feb2021, soreness in arms, she has had swelling in her calves, her left and right arms. She said her arm is very, very sore at the site of injection, her breasts are very sensitive and sore, nauseous and later went away, had a lot of joint pain and swelling everywhere, her lymph nodes were affected and swelling, her right arm where vaccine was given her elbow was still swollen and sore below injection and also specified that swelling where arm is connected to elbow. It was also reported that hand was swollen, and her whole arm was like a log, it has been very uncomfortable on an unknown date in Feb2021. The patient has been tired on an unknown date in Feb2021 and patient worried about recovery of events. The patient stated that lymph nodes took 2-3 days, which started Sunday (as reported). It was reported that patient was still in sore, the breasts are super sensitive, which was weird. The patient also had strange shooting pains in her right arm that are shooting through it. The patient left arm was sore, but not as sore as her right. She said her knuckles were cracking when her hands move, and her right wrist was very sore but that was not so bad now. The patient stated that she thought these events were due to her good immune system. The joints were still sore, her elbows, all of the upper part of her body were also sore. The patient also reported that she was told older people don't have much reactions, but she certainly had. The patient had not seen doctor for the events. The patient took acetaminophen (LOT M045G, EXP Dec2023) as a treatment medication for the events. The outcome of the events nauseous was recovered on an unknown date in Feb2021, for the events swelling everywhere, uncomfortable, tired, lymph nodes were affected and swelling, breasts are sensitive/her breasts are very sensitive and sore was unknown while for rest of the events was not recovered
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| 74 | 2021-03-19 | injection site redness, injection site swelling, injection site pain, injection site pruritus |
Injection site soreness, redness, swelling, and itch onset day after injection. Improving with cold ...
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Injection site soreness, redness, swelling, and itch onset day after injection. Improving with cold compress, Tylenol, and Allegra starting day 3 after injection.
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| 74 | 2021-03-21 | shingles |
Four days after receiving Covid 19 Pfizer vaccine I developed a severe case of shingles on left tors...
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Four days after receiving Covid 19 Pfizer vaccine I developed a severe case of shingles on left torso.
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| 74 | 2021-03-22 | rash, itchy skin |
Hot, itchy rash all over body (abdomen, arms, legs, head, inguinal region). Prescribed prednisone an...
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Hot, itchy rash all over body (abdomen, arms, legs, head, inguinal region). Prescribed prednisone and triamcinolone cream.
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| 74 | 2021-03-22 | injection site pruritus, injection site swelling, injection site redness |
swelling, redness, and itching at the site - body pain, lethergy, - started about 4 hours after inj...
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swelling, redness, and itching at the site - body pain, lethergy, - started about 4 hours after injection and lasted another 36 hours
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| 74 | 2021-03-23 | itchy rash, rash |
Approximately 3 days after receiving the 1st dose of Pfizer vaccine the patient developed a pruritic...
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Approximately 3 days after receiving the 1st dose of Pfizer vaccine the patient developed a pruritic rash that started on the abdomen and torso and became widespread the following day. After applying aloe gel on day 6 it resolved.
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| 74 | 2021-03-23 | injection site pain |
Patient is a 74 year old y.o. female with history of atrial fibrillation, hypothyroidism who present...
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Patient is a 74 year old y.o. female with history of atrial fibrillation, hypothyroidism who presents with acute onset early this a.m. nausea vomiting and change in mental status. History was obtained from the husband as patient is minimally responsive to verbal stimuli at this time. He states she was in her usual state of health until when she awoke this morning. Yesterday in usual state of health that she did have her 2nd COVID vaccine with the Pfizer variant. He states that day she was in her usual state of health with some mild arm pain on the left where she received the vaccine. This morning she awoke with a headache, fever, chills however was ambulating and conversing appropriately. She had no appreciable focal deficits at that time per the husband. She ate breakfast however she subsequently began vomiting. She progressed to a change in mental status with minimal responsiveness. She would say 1 or 2 words and that was it. They then presented emergency department. Diagnosed with severe sepsis, acute encephalopathy, acute meningitis, liver shock, autoimmune hepatitis, ascending cholangitis, acute pancreatitis.
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| 74 | 2021-03-23 | skin irritation, redness | Redness and pinchy feeling in her face. Given allegra and watched for 30 minutes post injection. |
| 74 | 2021-03-24 | injection site hardening, injection site pain, injection site pruritus, injection site swelling, injection site redness |
First day, excruciating pain over my entire body, could hardly get out of bed, chills, hot flashes, ...
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First day, excruciating pain over my entire body, could hardly get out of bed, chills, hot flashes, nausea, extreme tiredness that sleep did not help. Also, hot flashes during night. took Tylenol. Second day, pains were mostly gone, but nausea and a sore arm where the injection was given, and dizziness, and tiredness. But if I would lie down, I couldn't sleep. Later that day my injection site was swollen, redness (about size of an orange) sore to the touch and itched, and was hard. The third day my injection sites pain went further to my left breast, up to my shoulder. It had spread and was now a light pink. A small amount of dizziness.
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| 74 | 2021-03-24 | rash |
I received the vaccine at 11:30 on the morning of Feb 26. I noticed a rash on the inside crook of b...
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I received the vaccine at 11:30 on the morning of Feb 26. I noticed a rash on the inside crook of both of my elbows and across my chest on Sunday Feb 28 when I woke up. It not itch or burn. It was just red and splotchy. Monday morning it was somewhat faded but down my forearms and the tops of my hands and fingers. It continued to lightly appear and fade on and off for about a week. I called my doctor and he said if it gets worse to come in but to go ahead and get the second dose. I am scheduled to receive it at 11:30 tomorrow, Friday, March 26, at Hospital.
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| 74 | 2021-03-24 | injection site swelling, injection site redness, injection site warmth, injection site pain |
Injection site is red, swollen, warm to touch, and sore. More muscle soreness than previous days si...
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Injection site is red, swollen, warm to touch, and sore. More muscle soreness than previous days since injection three days ago.
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| 74 | 2021-03-24 | rash, redness, itchy skin |
Rash on my chest which I still have from 1st shot. Now I have a rash on my left arm . Wrist to elbow...
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Rash on my chest which I still have from 1st shot. Now I have a rash on my left arm . Wrist to elbow and above my elbow. I also have a rash on my left thigh. These spots are very itchy and red. I have called my doctor to find out what I can do for this rash but haven?t heard back yet.
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| 74 | 2021-03-25 | rash with redness, skin warm | Hands, bilaterally erythematous and hot to touch. One-25 mg Benadryl was given at 2:25. |
| 74 | 2021-03-25 | redness, skin irritation |
On 3/15/21 I in morning I noticed that my left leg was red at ankle about one third up my leg. I al...
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On 3/15/21 I in morning I noticed that my left leg was red at ankle about one third up my leg. I also had mild edema at the ankle.
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| 74 | 2021-03-25 | itchy skin |
The day after the shot I began a flare-up of psoriasis, an ongoing condition. By evening it had esca...
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The day after the shot I began a flare-up of psoriasis, an ongoing condition. By evening it had escalated to the point that my eyes were swollen shut. I had a fierce itching and burning of my face. I asked my husband if he would take me to the emergency room. He then suggested that he remembered having prednisone tablets. Without them I know I would have gotten much worse. I couldn't get in to see my dermatologist until another day later. They gave me a 40ml steroid shot. It called everything down but took another week to subside. I've had a similar reaction to the Fluzone shot back in Sept, 2020.
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| 74 | 2021-03-30 | hives, itchy skin |
Hives; Itching; This is a spontaneous report from a contactable consumer or non-hcp (patient). A 74-...
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Hives; Itching; This is a spontaneous report from a contactable consumer or non-hcp (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in arm left on 03Feb2021 at 13:50 (at the age of 74-years) as single dose for COVID-19 immunization. Medical history included, thyroid disorder from an unknown date and unknown if ongoing, cardiac disorder from an unknown date and unknown if ongoing. Patient's Medical History (including any illness at time of vaccination) included Allergy to Amoxicillin. She has been diagnosed with that for a long time. She doesn't have the product to provide NDC, lot, and expiry. She hasn't had Amoxicillin since the first time when it made her sick. Concomitant medication(s) included levothyroxine taken for thyroid disorder from an unspecified start date and ongoing; metoprolol taken for cardiac disorder from an unspecified start date and ongoing (started taking it probably three years ago. She was not sure if Metoprolol was for her blood pressure. Her heart was beating very fast and this pill regulates it); alendronate sodium taken for bone health from an unspecified start date and ongoing; aspirin was taken for an unspecified indication from an unspecified start date and ongoing; Vitamin d was taken for an unspecified indication from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced itching on 04Feb2021 at 18:00 and hives on 05Feb2021 at 04:00. Course of events as follows: She broke out in hives bad. She still has them. She got the shot on 03Feb2021 and still has hives. On the fourth her hands started itching. On Friday the fifth she broke out a little and still had the itch. Then on the sixth it got worst. Then on the seventh she couldn't stand it anymore and went to the outpatient clinic. She was still broken out and was going to the doctor that afternoon. The hives are still there and expanding. She did get Prednisone at the outpatient clinic. It is the fifth day of taking it and it hasn't helped. It is 20mg and she takes two tablets a day. Prednisone is in a pharmacy vial. She doesn't have NDC, lot, or expiry to provide. She has misplaced the vaccine card. She doesn't have NDC, lot, or expiry to provide for the vaccine. The outcome of events were not recovered. Description of Product Complaint: Description of complaint: While providing adverse event for COVID19 Vaccine caller the hives are still there and expanding. She got Prednisone (20mg, count size: 10 pills) at the outpatient clinic. It was the fifth day of taking it and it hasn't helped. It was 20mg and she takes two tablets a day. Prednisone was in a pharmacy vial. She doesn't have NDC, lot, or expiry to provide. She was about to take last pill and won't have any left to send. Packaging was sealed and intact Information about lot/batch number has been requested.
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| 74 | 2021-03-30 | injection site pain, injection site swelling |
mouth sores; slightly swollen upper lip; swelling/pain injection site; swelling/pain injection site;...
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mouth sores; slightly swollen upper lip; swelling/pain injection site; swelling/pain injection site; fatigue; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EKU176, Brand: Pfizer, Expiration date: Unknown) via an unspecified route of administration in right arm on 18Jan2021 14:00 as single dose for covid-19 immunisation. Medical history included bronchiectasis, degen scoliosis, fibromyalgia, peptic esophogitus and swollen lymph nodes for 24 hrs, fatigue and headache for 4-5 days for first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL1284, Brand: Pfizer, Expiration date: Unknown) via an unspecified route of administration in right arm on 02Jan2021 11:00 as single dose for covid-19 immunisation. There was special history of allergies reported. Concomitant medication pantoprazole sodium diclofenac sodium 40 mg, Misoprostol (50-200) (ARTHROTEC) and lisinopril for unspecified indication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On an unspecified date in Jan2021, the patient experienced mouth sores, slightly swollen upper lip, swelling/pain injection site, fatigue and headache. The patient hasn't been tested PCR for COVID-19 post the vaccination. Therapeutic measures were not taken as a result of events. The outcome of the events were not recovered.
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| 74 | 2021-03-31 | vaccination site pain |
a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the si...
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a little tired; passed out; weakness; disorientation when walking; headache; nausea; hand on the side that she got the vaccine was cold; Second dose: pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2, dose 2, via intramuscular, administered in right arm on 16Mar2021 10:00 AM (Lot Number: EN6204; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. Vaccination facility type was hospital. Medical history included eczema from 2017, she had eczema all over her back and arms and had mild allergies to mold and juniper. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 at the age of 74-year-old on 23Feb2021 at 10:00AM (lot number: EN6198, Expiry: Jun2021) intramuscular injection in left arm and experienced pain at injection site and couldn't sleep. The patient also took Prolia shots for arthritis. The patient experienced headache, nausea, pain at injection site and hand on the side that she got the vaccine was cold on 16Mar2021, passed out, weakness and disorientation when walking on 17Mar2021, a little tired on 18Mar2021. The clinical course included: The patient was calling about the second vaccine that she got on 16Mar2021 (Tuesday). She was calling about the after effects. They were quite huge. She had a headache, nausea, weakness, and disorientation when walking. Stated she obviously had pain at the site of injection. Stated some of it was her own fault, and at first she felt fine. On the same day that she got her second dose of the covid vaccine, she had a glass of wine and was not too hungry. She ate a little that evening. The next morning she passed out. Clarified that she had two glasses of wine, not one. Caller's daughter was a doctor. Caller referd to her daughter as doctor daughter. Stated that she told her daughter about what happened. Her daughter told her it was because she was dehydrated. Her daughter told her that it was called vagus something or another. Her daughter was not there with the caller. Her daughter called it vagus something, she does not remember. Her daughter told her that it had to do with inflammation and her immune system. Caller stated she also has arthritis. Her daughter told her that she was stupid for drinking wine after receiving the second dose of the covid vaccine and not eating a full meal. Whenever she passed out and fell, she did not hurt herself but it was a wake up call. She realized she was vulnerable. She was calling because she did not know why no one told her to drink a lot of water after receiving the vaccine. She got a Prolia shot in July and the nurses told her to drink a lot of water. She was asking why the nurses who gave her the covid vaccine are not saying that to people. Her daughter told her to call the doctors office about this, and she told her daughter that it was over with now, she's 95%, she was a little tired on 18Mar2021. She was unconscious for 15 seconds per her husband. Her husband was shouting her name, and she did not hear anything. She wanted to call and report that the nurses should tell people to drink water. One more thing, her daughter told her that the covid vaccine was slowly released. About 10 hours after receiving the second dose of the covid vaccine her hand on the side that she got the vaccine was cold. She got the vaccine about 10AM, and about 10PM at night is whenever her hand got cold. She had pain at the injection site where she had the first dose of the vaccine too. She had more pain at injection site after the second dose of the vaccine. It was not awful, but only if she pressed on it. Clarified that she gets Prolia shots twice a year for her arthritis. Luckily whenever she started to get dizzy, she braced her self, whenever she fell, she did not fall from an upright position. She was crouched over, and fell against trays that fell with her. Her doctor daughter told her that inflammation was because of her immune system. One other thing was that she has been stung in the past and had extreme reactions from yellow jackets in the 90's. She thought her immune system was sensitive. One other things related to her autoimmune from 3 years ago. She moved to a city in 2012. Everyone told her after 5 years she would develop allergies. In 2017, she had eczema all over her back and arms. It was not just like a topical thing where she scratched and itched, it was under her skin. She went to a dermatologist and he took a biopsy, but the results just said eczema. She went to an allergist, he finally found a space on her underarms where he could do a test. The test showed that she had mild allergies to mold and juniper. Juniper is a tree that they have there, she has one in her back yard. Her allergy was very mild. She tried everything, and in 4 months it went away. Now she just latherers her skin with coconut oil. Her diagnosis that this autoimmune issue was related her immune response from the yellow jacket reaction is a self diagnosis. A doctor had never told her this, this was coming from her own self. Clarified that she is calling about the second dose of the pfizer covid 19 vaccine. Headache: It was not a bad headache, it was more like pressure all across the top. Whenever she went to sleep, the headache started. She got the second dose of the covid vaccine on 16Mar2021. She had a little bit of a headache this morning. A cup of coffee with milk made it better. Nausea: It started whenever she did not want to eat dinner. She could tell her stomach was not right. The nausea and headache started together about 12 hours after her vaccine at 10:00 PM. Weakness: She noticed weakness on the next day whenever she got up to use the bathroom. Clarified as the early morning of 17Mar2021. Her weakness was about 90 percent resolved. Disorientation when walking: Clarified that her disorientation was in reference to walking only right before she fell. She was not mentally disoriented. Mentally she knew that she was not doing well. Second dose: pain at injection site: The pain only lasted for about 2-3 hours. It was now absolutely minimal. She would have to press on it to feel anything. Her hand on the side that she got the vaccine was cold: She got the second dose of the covid vaccine around 10:00 AM, and noticed her hand was cold about 5:00 PM., about 7-8 hours later. Whenever she went to bed, she was cold. She thought that it resolved by the next morning. The morning after receiving the second dose of the covid vaccine, she passed out: She passed out about 8:15 AM. The outcome of the events headache, nausea, weakness, pain at injection site was recovering. The outcome of the events disorientation when walking and her hand on the side that she got the vaccine was cold was recovered on 17Mar2021. The outcome of the other events was unknown.
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| 74 | 2021-03-31 | pain of skin, vaccination site pain |
doesn't feel that well; It hurt there at where the needle went in, in the beginning; something is ha...
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doesn't feel that well; It hurt there at where the needle went in, in the beginning; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205), via an unspecified route of administration, administered in the left arm on 03Mar2021 (at the age of 74 years old) at a single dose for COVID-19 immunization. Medical history included lumbar spine infusion (operations on spinal cord) from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that the patient needed the call handler to speak slowly, she doesn't feel that well. She had the first dose of BNT162B2 last 03Mar2021 and the second dose will be on 23Mar2021. She said something was happening to her arm but it was not where the needle went in, that is not where it is. It hurt there at where the needle went in, in the beginning but now it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone. She hopes it was not a blood clot. She has been looking at the website and they say people could have blood clots and she does not know if this was a blood clot, she can't hardly lift her arm, it was the left side that the shot was in because her right side is partially paralyzed due to effect of lumbar spine infusion and so when she tried to get up sometimes she can hardly lift that arm and so she didn't know what to do if she should call the primary care doctor to see if she has a clot but she read it and it says to call this number if you are having compactions and she been on hold over and hour and a half. It was hurting and the feeling like she couldn't hardly raise the arm or get any kind of strength in it. She knew in Europe they have had few people who have had blood clots, and she thought could that be a sign of a blood, like blood not moving through her veins like it is supposed to. It is not moving it has not made it to her heart yet. She says it is associated with the product, this is the only thing she has had in her arm she knows it is the product. She said her birthday just passed. She turned 75 years old but when the issue started in her arm she was 74 years old. It did not start the first week, the first week it was just sore around where the shot went in but then last week it started happening where it was hurting down her arm and she was getting close to the second shot which she doubts she will have but it is the 23rd which is next week. She used to be 5'2" but the operations on her spinal cord, she guesses she might be 4''10 now. She does not know because she can't hold her head up straight because the doctor that fused it, she indented it instead of it being more out and because of that her head is forward and down. It was also reported that she hasn't been to the doctor she only goes to pain management for him to check out her body and everything and renew prescriptions. The outcome of the events was unknown.
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| 74 | 2021-04-03 | vaccination site pain |
She had a little bit of a sore arm on the first one; This is a spontaneous report received from a co...
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She had a little bit of a sore arm on the first one; This is a spontaneous report received from a contactable consumer (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL8982, EL9262and Expiration date: 20May2021), via intramuscular route of administration in the Arm Left on 22Jan2021 12:30 as single dose for COVID-19 immunization. Patient medical history: Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity included: She is overweight. This past year, started in Jun2020, she lost 30 pounds, but she is still overweight. Prior Vaccinations (within 4 weeks) was none. AE following prior vaccinations was none. No previous history of immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional Vaccines Administered on Same Date of the Pfizer Suspect. Family medical history was none. The patient's concomitant medications included Thyroid and Cholesterol medication. On 22Jan2021, the patient had left arm soreness. It was reported that on 22Jan2021 17:00, the patient had a little bit of a sore arm on the first one. It was just a little bit that night and day, but not at all on the second dose. She takes Thyroid and Cholesterol medication and they don't have anything to do with it. No further details provided. She received her second dose on 12Feb2021 at 10:00 am (expiration date: 21May2021). She has had no reaction whatsoever and the site this time around was not even sore. A friend said that she read somewhere if you had no reaction it means the first shot did not give you any antigens. The patient would like to know if that was why she didn't have any reaction to the second shot. No ER or physician's office visit required. No Investigation Assessment. No relevant tests were done. The outcome of the event was recovering.
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| 74 | 2021-04-07 | rash, vaccination site rash |
spreading rash and hives starting at injection site; spreading rash and hives starting at injection ...
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spreading rash and hives starting at injection site; spreading rash and hives starting at injection site; spreading rash and hives starting at injection site and spreading to all arms and legs within 20 minutes; hives spread over entire body/Hives were breaking open and leaking pus and blood.; having trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 30Mar2021 09:30 (Batch/Lot Number: EP6955) as single dose, for covid-19 immunization at Doctor's office/urgent care. Medical history included asthma, heart (disorder) and known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included aciclovir (ACLOVIR), sucralfate (CARAFATE) and asthma medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN6203) on 08Mar2021 at 09:00 in the left arm for COVID-19 immunization at a Doctor's office/urgent care. On 30Mar2021 at 19:30, the patient experienced rapidly spreading rash and hives starting at injection site and spreading to all arms and legs within 20 minutes, hives spread over entire body and began having trouble breathing. Hives were breaking open and leaking pus and blood. The hives were size of a dime rash started approx. 11 hours after injection. The patient was given IV steroids and antihistamines and 2 breathing treatments. The patient has not been tested for COVID-19 since the vaccination. The events resulted in Emergency room/department or urgent care visit and assessed as life threatening illness with immediate risk of death from the events. The outcome of the events was recovering.
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| 74 | 2021-04-15 | injection site pain |
Strong Fatigue. Chills in fingers and toes, headache in back of neck, muscle pain in arms and should...
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Strong Fatigue. Chills in fingers and toes, headache in back of neck, muscle pain in arms and shoulder, soreness at injection site, slight vision impairment lasting 24 hours
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| 74 | 2021-04-23 | itchy skin |
my arm was very itchy for 3-4 days/Itchy on arm where she bends her elbow; Arm soreness is in left a...
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my arm was very itchy for 3-4 days/Itchy on arm where she bends her elbow; Arm soreness is in left arm, which received the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 74-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9265, expiration date not reported) via an unspecified route of administration in left arm on 11Feb2021 around 11:00 am (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included patient was allergic to Ibuprofen and gets swollen eyes. Can't take any medications with Ibuprofen in it. Hasn't taken Ibuprofen in years. Has no NDC/Lot/Exp to provide. Patient had no family medical history. Patient did not receive any other vaccines within four weeks prior to the vaccination. No additional vaccines were administered on same date of Pfizer suspect. Reportedly, there were no other products. No investigation assessment. There were no relevant tests. On 11Feb2021, patient experienced arm soreness is in left arm, which received the COVID-19 Vaccine and on 12Feb2021, started itching where she bends her arm across her elbow about six inches. Had no rash. Was very itchy that day and then it decreased a little. Itching went on for three to four days. Patient was little better in the morning. It was very itchy. Wants to know if that is an allergic reaction. Patient was scheduled for second dose on 03Mar2021, but she doesn't want to get the second COVID-19 Vaccine. Heard all sorts of stories. Patient asked how much she is protected if she just received one shot. Patient asked if you get a reaction can you take Benadryl after getting the vaccine. Patient also asked for his son who has a Penicillin allergy. He was supposed to get his first vaccine tomorrow. He is 45, is it ok to get the vaccine. No further details provided. The case was reported as non-serious. There was no PQC present. Patient was recovered from itching on 16Feb2021 and was recovering from arm soreness.
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| 74 | 2021-04-26 | vaccination site redness |
She still has a red plaque on her arm today, there is a swelling with it; There was a little pony kn...
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She still has a red plaque on her arm today, there is a swelling with it; There was a little pony knot where the injection was, and it was red; it is like elongated about 2 inches, an inch and a half to 2 inches long and maybe 3 quarters of an inch wide; Swelling of the node; It's just a little puffy now but there is like a little knot, It's not tender but it's just too red."; This is a spontaneous report from a contactable consumer (patient sister). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN5318) via an unspecified route of administration at upper part of her right arm on 10Feb2021 as a single dose for COVID-19 immunisation. Medical history included thyroid removed and blood pressure. Patient takes 5 or 6 of concomitant medications (cannot pronounce half of them), takes blood pressure medication and medication for she had a thyroid removed. On 10Feb2021, the day after the shot there was a little pony knot where the injection was, and it was red and thought that's okay but it had stayed red and the area, the whole width of it is like elongated about 2 inches, an inch and a half to 2 inches long and maybe 3 quarters of an inch wide. On an unspecified date in 2021, patient still had a red plaque on her arm today, there was a swelling with it. It has been 9 days since the shot, and were wondering (incomplete sentence). The swelling of the node was probably, she had it on Wednesday so probably she had the swelling on Thursday a little on Friday. It's just a little puffy now but there is like a little knot. It's not tender but it's just too red. Patient was not treated for events. Outcome for the events were unknown. Second dose was scheduled on 03Mar2021.
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| 74 | 2021-04-26 | vaccination site pain |
chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness...
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chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness to my heart; She also had tenderness in muscle where site of vaccine was; headache; Left arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 27Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation (Age at vaccination 74 years) . Medical history included atrial fibrillation from 2019 (AFib was diagnosed a couple of months before Dec2019) , chronic obstructive pulmonary disease from Dec2019 , medical device implantation (Watchman device inserted), anaemia , oesophagogastroduodenoscopy , oesophageal stenosis, obesity. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) from Jul2019 to an unspecified stop date; metoprolol (METOPROLOL) taken for heart rate irregular from Nov2019 to an unspecified stop date. The patient previously took bnt162b2 for covid-19 immunisation on 06Jan2021. The patient also took aspirin (E.C.) and experienced haemorrhage. The patient experienced feeling occasional pain and tightness to my heart on 30Jan2021 with outcome of not recovered , chest pain on an unspecified date with outcome of not recovered , she also had tenderness in muscle where site of vaccine was on 28Jan2021 with outcome of recovering , headache on 28Jan2021 with outcome of recovering , left arm pain on 28Jan2021 with outcome of recovered. No follow-up attempts are possible. No further information is expected.
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| 74 | 2021-04-26 | vaccination site pain |
sore left arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old fem...
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sore left arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female received first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6198) via unspecified route of administration in left arm on 27Feb2021 at 01:15 PM as single dose for COVID-19 immunisation. Medical history included glaucoma, diffuse large B-cell lymphoma (DLBCL), thyroid nodules. Concomitant medication included levothyroxine, vitamin D Nos [VITAMIN D], tocopherol (VITAMIN E), curcumin, acetylsalicylic acid (ASA), fenofibrate (NORTRICOL) (medications in two weeks). No other vaccine in four weeks. On 27Feb2021 at 03:00 PM, patient experienced sore left arm. No covid prior vaccination, Patient has not tested COVID post vaccination. The case was considered as nonserious. The outcome of event was recovering. No follow-up attempts are possible. No further information is expected.
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| 74 | 2021-04-30 | vaccination site pain |
slight pain in her arm; her arm was feeling heavy; right where she got the vaccine, just a little, t...
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slight pain in her arm; her arm was feeling heavy; right where she got the vaccine, just a little, there was pain; arthritis; it was not a big swollen, but she saw it in the shower this morning and when she leant on it or presses on it she felt something there; nerve problems; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in left arm on 01Apr2021 11:30 (Batch/Lot number was not reported) at the age of 74 years old as single dose for covid-19 immunisation. Medical history included pain from back and neck surgery she had predating treatment with the vaccine. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 11Mar2021 11:30 am in her left arm at the age of 74 years old for covid-19 immunisation and didn't feel anything different. The patient received the second dose on 01Apr2021 at 11:30 am in her left arm. Reported the first dose she didn't feel anything different. This time she didn't feel anything different until this morning. Added her arm was feeling heavy (Apr2021), she thought maybe she needed to exercise it, and she slept on that side mostly. She reported she was having a slight pain in her arm. Mentioned she also had arthritis and nerve problems (Apr2021). Added it was not swollen, but right where she got the vaccine, just a little, there was pain (Apr2021). She was asking should she just exercise it. Added it was not a big swollen, but she saw it in the shower this morning and when she leant on it or presses on it she felt something there (Apr2021). Added it was young and it had not scattered out yet. She thought the slight pain in her arm started a few days after the second dose of the vaccine, about 05Apr2021, and now it was better than when she first noticed it. Mentioned she was concerned about getting the vaccine because of her other problems but her doctor told her to go ahead and get it. The outcome of the event slight pain in her arm was recovering, of the other events was unknown. Information about lot/batch number has been requested.
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| 74 | 2021-05-07 | pain of skin, blister |
Shingles on face; I could get acne breakout with that/it is gonna around the eyes was only the eyeli...
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Shingles on face; I could get acne breakout with that/it is gonna around the eyes was only the eyelid and it was on region on my eyelid; it started down my forehead and blistered.; top of my scalp near the crown there is little tenderness still. It was really tender.; She touched my hair and I didn't jump out if my skin but it hurts.; This is a spontaneous report for herself. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included pulmonary hypertension from an unknown date, arthritis from an unknown date, and rosacea from an unknown date. Concomitant medications included atenolol taken for an unspecified indication, start and stop date were not reported; enalapril maleate (LOTRIAL [ENALAPRIL MALEATE]) taken for an unspecified indication, start and stop date were not reported; guanidine taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported, and other vitamins over the counter start and stop date were not reported. The patient experienced shingles on face; I could get acne breakout with that/it is gonna around the eyes was only the eyelid and it was on region on my eyelid on Mar2021 with outcome of unknown, it started down her forehead and blistered on Mar2021 with outcome of unknown, top of her scalp near the crown there is little tenderness still. it was really tender on Mar2021 with outcome of unknown, and she touched her hair and she didn't jump out if her skin but it hurts on Mar2021 with outcome of unknown. As treatment, the patient received valacyclovir, that is for 7 days, 1000mg Once a day. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information the reported events more likely represent intercurrent medical conditions which were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Investigators, as appropriate.
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| 74 | 2021-05-07 | rash, itchy skin |
a measles like rash on her chest, arms and midriff developed; itchy; a measles like rash on her ches...
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a measles like rash on her chest, arms and midriff developed; itchy; a measles like rash on her chest, arms and midriff developed; rash on her chest, midriff, arms, and bottom of legs; She states that she experienced a headache and a sore arm; She states that she experienced a headache and a sore arm; This is a spontaneous report from a contactable consumer (the patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206; expiration date was not reported), via an unspecified route of administration Arm right on 06Mar2021 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER2613; expiration date was not reported), via an unspecified route of administration on 27Mar2021 (at the age of 74-years-old) as single dose for covid-19 immunization. The patient's medical history Included High Blood Pressure. Concomitant medications included diphenhydramine hydrochloride(BENADRYL) for rash; coal tar, dimeticone, zinc oxide(ECZEMA CREAM) for Itching; Metoprolol Tartrate; SIMVASTATIN; LOSARTAN; POTASSIUM CHLORIDE (KLOR CON) for potassium dropped; Amlodipine Besilate; hydrochlorothiazide for high blood pressure. On 11Apr2021, the patient noticed a measly like rash on her chest, midriff, arms, and bottom of legs, measles and it was very itchy, On 28Mar2021 Headache recovered on 2021, on 27Mar2021 a sore arm recovered on 28Mar2021. The patient instructed to took Benadryl for a week and if the rash persists to come in to the office for an examination and also eczema cream in addition to taking the Benadryl for the itching. Outcome of the events rash on her chest, arms and midriff developed (rash), itchy was not recovered, measles outcome was unknown, headache and a sore arm outcome was recovered. The patient received the second dose on 27 MAR 2021. She experienced a headache and a sore arm for day and a half after the vaccine. Then last week she also had a headache for two days in a row, but that could be due to the change in the weather, she doesn't know what that is. She said that a week and a half ago a rash, a measles like rash on her chest, arms and midriff developed. She wasn't sure if it was because she was working outside, or related to the vaccine. She did find a couple of ticks on her. She called the local farm bureau and they said no, it wasn't from the ticks because the ticks would of burrowed their head into the skin. It was probably because she was outside. The patient has been taking Benadryl do to the fact that she has been outside and she has been very itchy. Everything is in bloom right now, but she was wearing long pants and long sleeves with gloves. The patient's itching is horrible. The patient night before up all night took Benadryl. She got a cream her husband use to used for eczema, it was an anti-itch cream, and she also used Aveeno eczema cream that has calamine lotion in it. The patient hasn't gone and seen her doctor yet because she felt better two days later and thought it was subsiding. The patient might be because she takes a shower and then she is alright for a couple of hours because of all the creams she is using. The last night she was up till 3 am because of the itching. She stated that she knows you are not suppose to take other peoples medication but she had Prednisone 10 mg in the house, from her husband when he would have eczema flare ups, and she took that at 3 in the morning. She said that her doctor thought there has been too much time from when she got the vaccine for it to be related so she googled and it said that people can get a measles like rash, and read something about being on their toes, but hers wasn't on her toes. Her rash was just her chest, arm, part of her legs and midriff. She stated that she is nervous, and she lost her husband a year ago on 28 APR and she doesn't know, if it is just nerves/stress or if it due to the reaction. The patient when she went to go get the vaccine they had asked her if she ever had reaction to a vaccine and she said a year ago when she had the pneumonia shot, she got cellulitis 2 inches above and 2 inches below the injection site. Her doctor thought it was cellulitis and she had to take antibiotics for a week. She stated that she had to wait longer then the normal 15 minutes because of her previous reaction so they made he wait for 30 mins when she got the covid vaccine. The first shot did not hurt at all. She asked that because she said that the second vaccine hurt immediately, it was discomforting. She thought she hit a nerve. She said it was like someone ran a nail down all the way down to her elbow. She doesn't know if she hit a nerve or what, but it was very painful. Clarified her headache started Sunday night after the vaccine and went away Monday. The patient thought the rash might be shingles, but then she was like no, that is only suppose to be on one side of a body. She stated that she needs to get the new shingles shot because the one that she had years ago isn't good anymore. She hasn't had new shingles immunization yet because she had to get the COVID shot. She doesn't know if the itching started because she saw the ticks or not but it started immediately. She states that she got the ticks off of her and shook her hair out. She states that she took Benadryl, she didn't have the fast acting Benadryl she had the 24 hour relief Benadryl. She went to the store and got fast acting Benadryl and has been taking them ever since Monday. She took Benadryl 25mg two only at night. Lot S200513 exp. May 2023. The patients second dose received on 27Mar2021 on right arm with lot number ER2613. She was told to get the vaccine in the dominant arm which is her right arm. She used to always get vaccines in her left arm because you were suppose to get it in her nondominant arm because of the movement. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Follow-up #1(PRD 22Apr2021): This is a spontaneous report from a contactable consumer. This 74-year-old female consumer (patient) reported for herself that: updated new events Headache: (From: 28Mar2021 To: 2021), sore arm: (From: 27Mar2021 To: 28Mar2021), a measles like rash on her chest, arms and midriff developed. Updated Concomitant Products Metoprolol, hydrochlorothiazide, simvastatin, Losartan, Klor-Con, Amlodipine for high blood pressure, she states that the last bone density test she had her numbers were good but her doctor put her on this prophylactically. Critical Calcium supplement maximum plus for bone density. The patient's blood pressure medication and vitamins but they haven't changed since she has been going to her current doctor for 5 or 6 years. No follow-up attempts are needed. No further information is expected.
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| 75 | 2021-01-07 | hives | MILD URTICARIA Narrative: |
| 75 | 2021-01-09 | rash papular, rash with redness, rash |
Friday evening 1/8 - Saturday evening 1/9 Mild raised rash on upper inside lip. Saturday 1/9 Rash on...
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Friday evening 1/8 - Saturday evening 1/9 Mild raised rash on upper inside lip. Saturday 1/9 Rash on chest above breast extending to shoulders. Very red raised on left side. Mild on right side and center. Put hydro cortisone otc cream on it. Sunday 1/10 Rash very faint. No treatment Today. Mouth better.
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| 75 | 2021-01-14 | rash, itchy skin |
Had rash 2 days after the injection of COVID 19 vaccine. Continued to have rash on both legs and ba...
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Had rash 2 days after the injection of COVID 19 vaccine. Continued to have rash on both legs and back. Came to clinic and was told to discontinue the Advil PM. Benadryl 25mg given OTC as needed for rash and itching along with Benadryl cream
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| 75 | 2021-01-14 | injection site tingling |
Patient reports tingling in Left arm following vaccine administration. Tingling went from site of in...
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Patient reports tingling in Left arm following vaccine administration. Tingling went from site of injection down arm to 4th and 5th fingers on left hand. Declines any headache, dizziness, numbness. Can feel touch to hand/fingers
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| 75 | 2021-01-15 | injection site pain | Soreness at injection site, mild headache |
| 75 | 2021-01-18 | injection site pain |
injection site pain, very tired kept falling asleep, headache, bad muscle and joint pain, feeling un...
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injection site pain, very tired kept falling asleep, headache, bad muscle and joint pain, feeling unwell and wanting to sleep all day
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| 75 | 2021-01-19 | rash | Jaw swelling, rash on legs and chest onset 1/15/2020 |
| 75 | 2021-01-20 | skin warm, redness |
By 7 p.m. my face was as red as Rudoph's nose! It was also very hot. I took a Benadryl tablet, wa...
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By 7 p.m. my face was as red as Rudoph's nose! It was also very hot. I took a Benadryl tablet, washed my face with cold water, and went to bed. The following morning, I had burst blood vessels on both cheeks. These are resolving.
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| 75 | 2021-01-20 | hives |
Started as hives developed into large red welps on buttocks, neckine and in hair. On shoulder and ...
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Started as hives developed into large red welps on buttocks, neckine and in hair. On shoulder and stomach aera.
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| 75 | 2021-01-21 | redness |
Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe B...
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Immediately after injection, my face and body turned RED. Nothing else. Just RED. I thought maybe BP, but never had that happen before. I was anxious as I have anxiety disorder! But my face was RED and TIRED looking. I asked staff what wrong. No swelling at that time! 4:40 PM. That nite, my heart started POUNDING HARD all night, not stop. Ativan not help. I slept, weird dreams, wake up and still heart pounding. 8 am --- got up and hands, arms, extremities SWOLLEN!! Heart still pounding, Felt like allergic to MSG or nitrates or preservatives or too much salt. Felt weird.. Not faint-- just weird. Tired from the pounding heart. Not fatigued. I did have sore arm, but it was NOT an issue. My hands, toes were red.
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| 75 | 2021-01-21 | rash |
Pts daughter called, pt received Pfizer vaccine on 1/6/2020 and 6 days after pt developed a mild ras...
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Pts daughter called, pt received Pfizer vaccine on 1/6/2020 and 6 days after pt developed a mild rash around her mouth. Pt tried Benadryl 25 mg and applied tropical Aquaphor on rash but did not get better. But few days ago the rash had got worst. Pt also feels like there is some kind of swelling and tightness. Per daughter, no white discoloration or puss. The rash is only on the outside of the mouth and not inside. No other symptoms besides the rash (no shortness of breath, dizziness, or difficulty speaking...) Rx Benadryl 25 mg tid and send Prednisone 20 mg od and Famotidine 40 mg od, and Hydrocordozone topical 2-3 times a day
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| 75 | 2021-01-21 | shingles | Several days after first dose of Covid-19 vaccine, she developed shingles of her left frontal face. |
| 75 | 2021-01-22 | injection site pain |
01/15 Evening of injection developed headache; took 1 Aleve at 9:30 pm. Went to bed at 10:00 pm an...
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01/15 Evening of injection developed headache; took 1 Aleve at 9:30 pm. Went to bed at 10:00 pm and woke at 3:00 am on 1/16 with headache and nausea. At 7:00 am and all day remained in bed with headache, nausea (unable to eat or drink until evening when I had water, 1 scrambled egg and 1 piece of toast), fatigue. My arm was mildly sore at injection site. On 1/17 nausea, chills resolved. Headache better. Fatigue better but remained for about 3 days.
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| 75 | 2021-01-23 | injection site pruritus, injection site rash, shingles, injection site swelling, injection site redness |
Vaccine area became red and slight puffy on 01/20/2021 and of arm 01/23/2021 back near neck area on...
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Vaccine area became red and slight puffy on 01/20/2021 and of arm 01/23/2021 back near neck area on right began to itch. a cluster of bumps appeared. By end of day they had spread and become red and inflamed. Went to urgent care and his diagnosis was shingles. prescribed Valacyclovir 500 mg tablets for 7 days/ 3x daily I had taken the first covid 19 vaccine on the 20th . Dr said i should report this occurance. my next vaccine is scheduled for 02/0
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| 75 | 2021-01-25 | hives |
About 1pm after receiving the vaccine I broke out in hives 2 on my left arm, around 3pm in hives one...
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About 1pm after receiving the vaccine I broke out in hives 2 on my left arm, around 3pm in hives one on my face, about 4pm I got 2 hives on neck. The next day I broke in 2 hives one on each leg. Then I broke out 2 (hives) on wrist. Today 01/26/2021 2 more hives one of wrist and one on the back on my hand. They start out little red circles about the size of a dime, then grow to the size of quarter or dollar. On 01/21/2021 I went to the ER (Virtual Hospital). They looked at the hives, and told me it was an allergic reaction to the vaccine. They gave me Benadryl. They also gave me the number to VAERS to make a report.
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| 75 | 2021-01-26 | rash |
Progress Notes 1/26/2021 Patient: ...
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Progress Notes 1/26/2021 Patient: Date: 1/26/2021 a 75 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience scratchy throat. She denied difficulty breathing, difficulty swallowing and throat tightness. This provider was notified of patient reaction and she was then assessed in the emergency bay area. ALLERGY REVIEW OF SYSTEMS: Patient denies facial swelling, chest tightness, shortness of breath, wheezing and dizziness Previous Reactions: Patient reports a history of previous reaction after receiving an allergy shot many years ago. She is unsure of entire course of events but states she did need medical treatment including a shot. Objective Vitals Vitals: 01/26/21 1412 01/26/21 1439 BP: 135/78 137/63 BP Location: Right arm Patient Position: Sitting Pulse: 90 80 SpO2: 95% 98% Blood Sugar 88 collected at 1415 Physical Exam Vitals signs and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: She is well-developed. She is not ill-appearing or diaphoretic. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Pharynx: Oropharynx is clear. No pharyngeal swelling or oropharyngeal exudate. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No tachypnea or respiratory distress. Breath sounds: Normal breath sounds and air entry. No stridor or decreased air movement. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert and oriented to person, place, and time. Gait: Gait (with cane assist) normal. Psychiatric: Speech: Speech normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy. Patient was observed for 65 minutes s/p injection. She states only symptom of itchy throat improved. Patient accompanied to building exit . Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash)
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| 75 | 2021-01-26 | vaccination site warmth, vaccination site swelling, vaccination site pain, vaccination site redness, vaccination site hardening |
injection site is swollen; redness at injection site; redness at the injection site and it hurts to ...
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injection site is swollen; redness at injection site; redness at the injection site and it hurts to touch; injection site was also warm to the touch; was warm to the touch and it is hard; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular in left arm on 06Jan2021 11:00 at single dose for COVID-19 immunization. Medical history was reported as none. The patient previously had Flu vaccine around the beginning of October. The patient got the vaccine last Wednesday 06Jan2021, the patient noticed recently that the injection site is swollen, there is redness at the injection site and it hurts to touch. It was also warm to touch. She thinks it started yesterday and she did not realize it she just knew there was something involved there. Today she noticed it was warm to touch and it was hard. The patient said that it did not hurt when she got the vaccine. She is basically healthy and takes a world of supplements. The events were experienced in Jan2021. The facility where the most recent COVID-19 vaccine was administered was in the residence community. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
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| 75 | 2021-01-27 | vaccination site pain |
The only thing I have with the first injection is soreness at injection site; This is a spontaneous ...
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The only thing I have with the first injection is soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3248, via unspecified route of administration in the left arm on 15Jan2021 (15:30) at single dose for COVID-19 immunization. Patient medical history included high blood pressure (HBP). Concomitant medications included latanoprostene bunod (VYZULTA 0.024%), losartan at 25 mg, and oxybutynin (5 mg ER) for unspecified indications. Patient is not pregnant at the time of vaccination. The patient reported that the only adverse event she had after first injection was soreness at injection site on 15Jan2021 at 3:30 pm. No treatment was received for the event. Outcome of the event was recovered on unspecified date in Jan2021.
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| 75 | 2021-01-28 | rash, shingles |
I have popped up with a rash that looks a lot like shingles/it broke out into rash around my stomach...
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I have popped up with a rash that looks a lot like shingles/it broke out into rash around my stomach and my back below the waist no actually above the waist.; I have popped up with a rash that looks a lot like shingles; It is painful; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. Medical history included broke some bones and not ongoing; and fell. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). There was no investigation assessment. Patient stated that she had the Pfizer shot on 12Jan2021. Yesterday or maybe the day before she had popped up with a rash that looked a lot like shingles. She saw on the website it can produce rashes. She was going to go to her dermatologist. It was painful in Jan2021. Last night and maybe yesterday it broke out into rash around her stomach and her back below the waist no actually above the waist. She was just trying to figure out if it is from the vaccination or if she should go to dermatologist. Patient stated she did see where it can cause rashes. In fact, it did not cause all over your body but since this is one specific area. She thought maybe it was something known and they could tell her what she need to do. Possibly the 15th or 16th. She knew she had it on 16th but she may got a little bit of. It started on 15Jan2021. Patient stated she had not done anything for the rashes. She didn't know what to do. She was going to physical therapist because she fell in August and broke some bones. But she was fine now. She was not taking any medication other than vitamins. Outcome of events were unknown.
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| 75 | 2021-01-28 | rash |
Low grade fever; Chills; Rash; This is a spontaneous report from a contactable healthcare profession...
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Low grade fever; Chills; Rash; This is a spontaneous report from a contactable healthcare professional. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included urinary tract infection (UTI). Patient stated she was on an antibiotic for a UTI before having the vaccine. No other vaccine in four weeks. No COVID prior vaccination. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Patient stated that she broke out with a rash across chest and legs approximately 24 hours (on 11Jan2021) after having the vaccine. Patient states she had a low grade fever and chills 4 days post covid-19 vaccination (on 14Jan2021). The events resulted in doctor or other healthcare professional office/clinic visit The patient received treatment for the events. The patient was given a steroid shot by dermatologist. Patient was tested for COVID test post vaccination (covid test type: Nasal Swab) which showed negative result. The outcome of the events was not recovered. Information on the batch/lot number has been requested.
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| 75 | 2021-01-28 | skin discolouration, injection site pain |
Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chil...
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Started with injection site Hurting, Developed tiredness, light headache, hurting all over, had chills for 3 nights fever range from 100 degrees up to 103.8, had nauseau and vomited one day, my face- looked a little swollen and cheeks were pink, was in bed mostly for 13 days. Called My Doctor after about 4 days , he prescribed MethyIIPredisolone 4 mg tablets, seems to bring fever down and stop chills, still feeling really bad, went to Urgent Care and they did Covid Test which was Negative, had virtual call with their doctor , and they prescribed a "Z Pak" Did not stated feeling better until 13 day. When taking Predisone, I started having chest pains, when I only had 4 more pills to take. Had to take 2 Nitro and discontinued Predisone. Still weak and tired.
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| 75 | 2021-01-29 | injection site pain | Pfizer-BioNTech COVID-19 Vaccine EUA injection site soreness |
| 75 | 2021-01-31 | rash, itchy skin, itchy rash, rash macular, rash with redness, redness |
Rash (itchy, burning, splotchy, light red to chest at night) for the past 4 nights. Only occurring ...
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Rash (itchy, burning, splotchy, light red to chest at night) for the past 4 nights. Only occurring at night, also developed redness like "rosacea" to her face and last night itching to the palms of her hands. Took Benadryl last night with resolution of the symptoms. Has had itching to B legs, noticed "burning pain" to legs, putting a pillow between her legs seemed to help. First night of rash was the worst. Denies wheezing, SOB, throat tightening, problems swallowing, drooling, lip swelling.
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| 75 | 2021-02-01 | itchy skin, redness |
Angioedema type of reaction: Itching of both eyes. Itching , redness, and slight swelling of cheeks...
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Angioedema type of reaction: Itching of both eyes. Itching , redness, and slight swelling of cheeks, elbows, knees, knuckles of both hands about 48 hours post vaccine. I have had this type of reaction previously - unknown trigger, not related to a vaccine. I took one benadryl dose, and called my PCP office. The nurse took the info, and advised me to take another benadryl if needed, and to call her back in 1 hr. I called her back reporting that the reaction had subsided. She game the same advise and told to make sure to call back if needed.
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| 75 | 2021-02-02 | injection site pruritus | Itchy at injection site. |
| 75 | 2021-02-03 | vaccination site pain |
4/10 Injection site pain; Patient possibly received an unreconstituted dose of the vaccine; Patient ...
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4/10 Injection site pain; Patient possibly received an unreconstituted dose of the vaccine; Patient possibly received an unreconstituted dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date: Mar2021), intramuscularly on the right deltoid on 30Dec2020 (14:00) at a single dose for COVID-19 immunization at the nursing home (not a military facility). Medical history included allergic rhinitis; gastroesophageal reflux disease (GERD); chronic obstructive pulmonary disease (COPD); anemia; hypertension (HTN); hyperlipidemia; anxiety; glaucoma; and vitamin deficiency. The patient's concomitant medications were not reported. On 30Dec2020 (14:00), the patient had possibly received an unreconstituted dose of the vaccine. On an unspecified date, the patient had injection site pain of 4/10. The patient had received paracetamol (TYLENOL) as treatment for the injection site pain. The outcome of the events, 'injection site pain' and 'possibly received an unreconstituted dose the vaccine', was unknown.
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| 75 | 2021-02-04 | rash |
BILATERALLY RASH ON LOWER EXT 4 DAYS POST VACCINATION, CONTINUED THRU TODAY. NO PAIN OR ITCHING ASSO...
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BILATERALLY RASH ON LOWER EXT 4 DAYS POST VACCINATION, CONTINUED THRU TODAY. NO PAIN OR ITCHING ASSOCIATED WITH RASH, NORMAL SKIN TEMPERATURE. NO C/O DIB, SOB, OR CHEST PAIN.
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| 75 | 2021-02-04 | skin discolouration, redness |
severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tirednes...
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severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tiredness; muscle aches; a little swelling in her face; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK5730) intramuscularly on arm left on 09Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included heart problems from May1966 and ongoing (heart problems/She had open heart surgery at that time and had stents put in a couple of times since then), bone spurs and arthritis in her feet. Concomitant medications were none. Patient used to receive unspecified injections in her feet because she has bone spurs and arthritis in her feet. Patient experienced heart pains in Jan2021, dizziness on 10Jan2021, not feeling quite right on 10Jan2021, severe chills on 11Jan2021, fever on 11Jan2021, nauseated in Jan2021, threw up in Jan2021, tiredness in Jan2021, muscle aches in Jan2021, a little swelling in her face in Jan2021, weakness in Jan2021. The outcome of the events was unknown. Patient received her first Pfizer vaccine on 09Jan2021. Patient explains she has had adverse reactions to the vaccine ever since she received it. Patient confirms she took the vaccine on Saturday, 09Jan2021. On Sunday, 10Jan2021, she started having a little bit of dizziness and feeling just not quite right. Sunday night, she went to bed and woke up at around 3:30 a.m. with severe chills and a fever. Her fever was a little over a 100. She states it took about 2 hours to get her chills under control. She took 2 Tylenol at that time. That day (11Jan2021) she ran fever off and on all day. The next day (12Jan2021), she seemed to be better. She had a low-grade fever, but she was better. She was just kind of tired from the day before. But then, that night, she ended up with the same thing again- she woke up at 4am with chills. Her fever had gone up 101.7, and she ended up taking 2 Tylenol and so forth. She got up that morning around 10 am, and was nauseated. She threw up that morning. She felt really bad. She was experiencing tiredness, muscle aches. (At this point it was about Tuesday (12 Jan) or Wednesday (13 Jan). There was one day during the day, she felt better, but a day went by and she ended up having the chills and fever again. Every time her fever kept going up. Her fever this particular night was 102 something. About Wednesday night, when she had the chills and fever, her fever went up to 103.8. That next morning, she called her doctor's office and tried to get an appointment. She could not get an appointment with the office. Her office ended up doing a televist and sending her a Prednisone pack to take for the reaction that it seemed she was having. She started the prednisone pack which seemed to take the fever down and the chills ended up stopping. Caller clarifies further she believes she has recovered from the fever and chills. The Prednisone pack seemed to kind of make those symptoms go away. However, she still felt really bad. This went on all weekend again. Tuesday of this week, (19Jan2021), she still felt really bad. She called her doctor again and her doctor wouldn't see her because of the symptoms she is having after receiving the COVID-19 vaccine are the same symptoms of the actual COVID-19 virus. She clarifies further the adverse effects of the shot are also same ones as the COVID-19 virus. Her doctor suggested she either go to the Emergency Room or to an Urgent Care. Patient called the Urgent Care and they were able to do a COVID test on her to check and see if she did have COVID-19. She confirms this test was on Tuesday, 19Jan2021. The results came back negative. However, they did another swab test. The patient is unsure what the second swab test was for but was told it would be a couple days before they would have the results of this test. At this point, they put her on a Z-pak. Patient mentions she has heart problems. She has nitroglycerin for any problems that she has. She started having some heart pains when she was down to about 3 tablets of that Prednisone pack she was taking. When she took one of the Prednisone tablets, within 30 minutes of taking it, she started having chest pains. She clarifies it started in her throat and went down to her chest. She took 2 nitroglycerin's to get her feeling back to normal/better. Caller doesn't provide NDC, Lot number or expiration date for the Nitroglycerin she took when probed. Patient mentions her cheeks had been pink. She doesn't really know but she may have a little swelling in her face. She can't figure that out herself. She was experiencing dizziness and weakness. Today is the first day which is the 13th day after receiving the vaccine, she has felt like trying to get this stuff together and her thoughts together to try and figure out what is going on with her. She tried calling her primary doctor and this urgent care and she couldn't get anybody to see her. Patient got her Prednisone pack filled at (Pharmacy name), (Address details) The prescription was issued to her on Thursday, 14Jan2021, but she didn't start taking the pack until Saturday. On Saturday, that's when her fever had went up to 103 and she knew she needed to take the Prednisone pack. They are 4mg tablets and she started out taking 6 tablets the first day and then her dose decreased every day. NDC: 164793723369, Lot: 20K0041P, she believes the second digit is a zero and not a "D", Expiry date: Aug2022. Z-pak: patient states she no longer has the box, therefore she is not sure of the dose and how it was prescribed. She makes the comment she believes the first day it was 2 tablets. NDC: Unknown, Lot: 7996030, Expiry: Feb2022. She clarifies she did not take Tylenol as stated earlier. She took Kirkland's brand, Acetaminophen. They are 500mg tablets. She provides the following product information: Lot: 2GE1779B. The last digit is either a "B" or an 8/, Expiry date: May2015; patient clarifies she knows they just bought this bottle, but she thinks her husband put his extra pills in the wrong bottle. No further details were provided or obtained in regard to this statement. The patient wants to find out about this and what is going on with her. To her understanding and her reading information, she is scheduled to take her next shot 27Jan2021. She is not supposed to take it then, correct? Investigations: patient confirms she had a COVID-19 test done (she is not sure what type of test- PCR, Antibody, etc), they swabbed her nose and the results came back negative. She had a second test done, where they swabbed her nose again, but she hasn't got the results back. She isn't sure what that test is for. Vaccination Facility Type was Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. Did any AE(s) require a visit to: Emergency Room was No, she is trying to keep herself out of the hospital. Physician Office? Her doctor would not see her but offered a virtual visit. She did go to the Urgent Care. Prior Vaccinations (within 4 weeks): Caller states she went to the foot doctor on 22Dec2021 (pending clarification). She was given injections in her feet because she has bone spurs and arthritis in her feet. Patient does not know exactly what kind of injection it was. She confirms she has no name, ndc, lot and expiry date for the injections she received. Patient asks the call handler, what should she have done on this? She was lost. She read the information that was provided to her and she doesn't feel there was sufficient information on what to do if you had a reaction. She guesses the best thing she can be told is to call #. She didn't know it was a # emergency. She didn't know what she was supposed to do. It was hard for her to get any information out of anybody as to what to do. The outcome of the events was unknown.
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| 75 | 2021-02-06 | itchy skin | Itching-Hydroxyzine-Itching Starting to relieved |
| 75 | 2021-02-07 | rash, itchy skin |
Body rash affecting arms, thighs, chest and back. Rash started approximately at 11:30pm 2/7/2021 whe...
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Body rash affecting arms, thighs, chest and back. Rash started approximately at 11:30pm 2/7/2021 when in bed. Strong itch woke me up. Began taking Benadryl (Diphenhydramine HCI 25mg 1capsule at 2:30am 2/8/21 and continuing every 4-6hrs. Itchy feeling continues but is milder. Rash is still evident.
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| 75 | 2021-02-07 | itchy rash, rash, rash with redness |
Extremely itchy red rash with tiny raised bumps on chest & around breasts beginning about 28 hours a...
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Extremely itchy red rash with tiny raised bumps on chest & around breasts beginning about 28 hours after injection. Topical Ciclopirox & Benadryl ointment did not help. Took one Benadryl tablet at bedtime on Feb. 1 which calmed the itching. Discontinued Ciclopirox on Feb. 1. Began treatment with Triamcinolone evening of Feb. 2. Red rash began to fade around Feb. 4. Continuing to use 1 Benadryl tablet per day and Triamcinolone since then.
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| 75 | 2021-02-08 | itchy skin |
Arm was itching approximately an hour after receiving vaccine and continues to date. At 9 pm low gra...
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Arm was itching approximately an hour after receiving vaccine and continues to date. At 9 pm low grade fever and headache. Took Tylenol. At 6 am on 2-9-2021 headache persisted so again took Tylenol. Headache is a dull ache. No fever.
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| 75 | 2021-02-08 | injection site swelling, rash, injection site pain |
Diarhea, vomiting, chills, sweats, mild rash all over the body, injection site pain and swelling, mu...
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Diarhea, vomiting, chills, sweats, mild rash all over the body, injection site pain and swelling, muscle soreness.
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| 75 | 2021-02-09 | rash |
nauseated; Rash/all over her body/I woke up in a rash and yesterday it was worst; allergic reaction ...
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nauseated; Rash/all over her body/I woke up in a rash and yesterday it was worst; allergic reaction to something because she just woke up in a rash it didn't itch; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249) injected via an unspecified route of administration in the left arm, on 22Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included blood pressure (disorder). Concomitant medications included losartan for blood pressure, montelukast, estradiol (ESTROGEN), metoprolol, esomeprazole, rosuvastatin calcium (ROSUVA). Patient got the COVID vaccine on Friday (22Jan2021), Saturday (23Jan2021) started breaking out in a rash, all over her body. She woke up in a rash and yesterday (24Jan2021) it was worst and she was nauseated; she was having allergic reaction to something because she just woke up in a rash it didn't itch (Jan2021). This was her first dose of the vaccine. She didn't get the vaccine from her doctor, she called into the hospital, the hospital was giving them out on Friday (pending clarification). She was wondering if there is any way she can get something for the rash. Patient did not have treatment for the events. Outcome of rash was not recovered, outcome of other events was unknown.
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| 75 | 2021-02-10 | rash |
Approximately 35 red spots about 1/4 inch each with a pinhead sized head appeared across stomach and...
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Approximately 35 red spots about 1/4 inch each with a pinhead sized head appeared across stomach and reaching around to back on right and left sides of trunk. Spots were observed at bedtime, Not sure when they first appeared. No itching. Roof of mouth and gums were sore later in the night and mild headache occurred. Spots started disappearing on their own over the course of a week.
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| 75 | 2021-02-10 | injection site swelling, itchy skin, redness |
At 9:30 PM after the injection her back started itching all over, and looked in the mirror and her b...
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At 9:30 PM after the injection her back started itching all over, and looked in the mirror and her back looked like she had the measles. Left arm down to her wrist she could not move, immobile. She had to use her right hand to move her left arm, but the pain was intense. The area where the shot was was swollen. She took Benadryl and Ibuprofen and went to bed. The next morning about 9:00 AM the itching had stopped and she was able to move, could not pick it up, but gradually during the day it was back to normal. The area on her back went up to her neck, but the red marks are still on her back, just under the skin. They do not itch. She does have a lot of reactions to medicines, see list. Her entre back from her neck to almost her waist was covered with the rash.
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| 75 | 2021-02-10 | bruising, injection site bruising, itchy skin |
None major. Occasional itch shoulder Last night found bruise on left leg. This morning looked a...
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None major. Occasional itch shoulder Last night found bruise on left leg. This morning looked at injection site , found bruise.
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| 75 | 2021-02-10 | rash |
On day 2 I had a low grade fever On day 10: High blood pressure 205/77 for over an hour. ...
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On day 2 I had a low grade fever On day 10: High blood pressure 205/77 for over an hour. Difficulty breathing; A fast heartbeat(90); Dizziness; Chills; Uncontrollable shaking for over an hour. Rash on face for less than an hour Starting on day 11: Blood pressure gradually reduced to my normal level over days Headache continued for several days
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| 75 | 2021-02-15 | skin warm |
Profound fatigue and generalized soreness most severe on days 2 and 3 after vaccination, but lasting...
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Profound fatigue and generalized soreness most severe on days 2 and 3 after vaccination, but lasting seven days. No fever or chills. Arm sore, warm and swollen, but not red. It is the severity of the reaction and its duration that prompts this submission.
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| 75 | 2021-02-15 | redness | facial erythema - worsening of her rosacea |
| 75 | 2021-02-17 | skin discolouration, redness, rash |
Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue...
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Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; Very bad rash blue red swollen on thigh; headache; high bp/ had a BP 173/113; short of breath; couldn't sleep; restless; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Ten minutes after she reported having a headache, which she ignored. 2 hours later, very high blood pressure (BP), short of breath (SOB) and restless occurred. All night on 25Jan2021 and the next day on 26Jan2021, the patient couldn't sleep, short of breath, restless. The patient called PCP and was told to go to the ER. She did and had a BP 173/113, SOB. She was admitted, CT scan was ok. She had very bad rash blue red swollen on thigh. Heart enzymes was normal. She was discharged two days later referral to a dermatologist. The outcome of events was unknown. Information on the batch number has been requested.
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| 75 | 2021-02-21 | injection site warmth, injection site pruritus, injection site redness | Hot, red, itchy front of upper arm from injection site to elbow |
| 75 | 2021-02-21 | rash, itchy skin | Itch rash on face and neck |
| 75 | 2021-02-21 | redness |
flush in face, shakiness. facial redness noted. Pt has numerous allergic rxn hx: 5x worsening. sent...
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flush in face, shakiness. facial redness noted. Pt has numerous allergic rxn hx: 5x worsening. sent to ED for evaluation and montioring. BP 141/76 HR 84 02 97
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| 75 | 2021-02-22 | itchy skin | Body and lip itching after 2nd dose of vaccine- required medication intervention. |
| 75 | 2021-02-22 | injection site pain, redness, itchy skin |
Had my 2nd dose last Saturday, Feb. 20, at Hospital, Toledo, Ohio. Had both injections in my left a...
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Had my 2nd dose last Saturday, Feb. 20, at Hospital, Toledo, Ohio. Had both injections in my left arm. Noticed my left arm was sore at the injection site and now my arm is red and a bit swollen from my shoulder to my elbow, plus a little itchy but no rash. Was taking Tylenol and icing it until my friend told me not to ice it.
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| 75 | 2021-02-22 | injection site pain |
generalize aching, chills with no fever, pain at the site of injection, headache, lasting for one d...
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generalize aching, chills with no fever, pain at the site of injection, headache, lasting for one day. Tylenol helps with the symptoms.
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| 75 | 2021-02-23 | skin discolouration, injection site swelling, skin warm, itchy skin |
2/19 woke up with pain in right arm, swelling at site, hot to touch, reddish discoloration, stinging...
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2/19 woke up with pain in right arm, swelling at site, hot to touch, reddish discoloration, stinging, itchy, and noted right above the swollen are three red areas size of tip of my pinky. (these redish spots same on my first vaccination). A few hours after I took my temp and was 99.1. I double checked and 99.1. I took one Motrin for fever and couple hours no fever. Today 2/24= Lump swelling decreased and warm to touch. I have been applying Hydrocortisone Cream 1% for mild itching.
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| 75 | 2021-02-23 | rash macular, blister, itchy skin, hives |
Hives; Itching; She had cracking creases with serous fluid coming out of both hands; She was covered...
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Hives; Itching; She had cracking creases with serous fluid coming out of both hands; She was covered big blisters; blotches; Her hands were so swollen after getting the dose of the vaccine that she couldn't get them closed; This is a spontaneous report from a contactable nurse, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 05Feb2021 at 12:20 (at the age of 75-year-old) as a single dose for COVID-19 vaccination. Medical history included reverse total shoulder replacement on 26Jan2021, cardiomyopathy from an unknown date, and type 2 diabetes mellitus from an unknown date. There were no concomitant medications. The patient previously received her shingles shot (MANUFACTURER UNKNOWN) and flu shot (MANUFACTURER UNKNOWN); both in Oct2020 for immunization and had no reactions. On 05Feb2021 at 16:00, the patient experienced hives and itching. On 05Feb2020, the patient had blotches, blistering, swollen hands, and cracked creases with serous fluid coming out of the hands. The clinical course was as follows: She had absolutely no problem at the time of the injection, no soreness with it she was fine and then she had welts starting with 2-3 then all over her body, that were itching terribly. They stared on the left wrist, both hands. The patient took diphenhydramine hydrochloride (BENADRYL); but it did not help. The patient then went to the emergency room (ER). By the time she got to the ER, the hives moved up to her abdomen and she was covered in big blistery looking raisings and few small raises on her trunk and arms. The hives were concentrated from her fingers to her elbow, and then there were other blotches on her elbows to her fingers that were real concentrated. She stayed at the hospital for 3 hours, but she was not admitted. At the ER, she received pantoprazole (PROTONIX), diphenhydramine hydrochloride, hydroxyzine (ATARAX) and prednisone (MANUFACTURER UNKNOWN). The patient also stated that her hands were so swollen after getting the dose of the vaccine that she couldn't get them closed and she had cracking creases with serous fluid coming out of both hands. The swelling went down a little bit the next day; but she still had the blotches. She said the itch was tolerated. However, the blistering started again. Her doctor put her on a sliding scale of prednisone and diphenhydramine at 25 mg every 6 hours. The clinical outcome of the swelling hands was recovering; while that of the blotches and blisters were not recovered. The clinical outcomes of the hives, itching, and cracked creases with serous fluid coming out of the hands were unknown. The patient assessed the events to be medically significant as she had never experienced anything like this.; Sender's Comments: Considering the temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of the reported events cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 75 | 2021-02-23 | itchy rash, rash, skin burning sensation |
I had no reaction until the day after the shot, when a rash broke out on my chin. The following day ...
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I had no reaction until the day after the shot, when a rash broke out on my chin. The following day the rash has spread to include my whole face. It's small red spots that itch and burn a little
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| 75 | 2021-02-23 | injection site pain |
Vaccine administration error: Undiluted vaccine was given. Patient was monitored from 1/20/21 to 2/...
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Vaccine administration error: Undiluted vaccine was given. Patient was monitored from 1/20/21 to 2/4/21. Injection site pain, tiredness and headaches were the only symptoms reported by patient.
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| 75 | 2021-02-24 | rash, rash with redness |
Generalized red rash starting on the right fore arm (Immunized on right arm) and then the rash sprea...
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Generalized red rash starting on the right fore arm (Immunized on right arm) and then the rash spread to whole body with in 24 hrs. Benadryl did not provide any benefit. Started on steroids.
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| 75 | 2021-02-24 | injection site pain |
Mild reaction lasting 48 hours - achy arm at injection site, brain fog, congestion, slight sore thro...
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Mild reaction lasting 48 hours - achy arm at injection site, brain fog, congestion, slight sore throat, fever: 98.9-99.9, fatigue
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| 75 | 2021-02-24 | injection site nodule, injection site warmth, injection site redness |
Patient developed a nodule with redness and warmth at injection site about 5 minutes after receiving...
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Patient developed a nodule with redness and warmth at injection site about 5 minutes after receiving their second dose of COVID-19 vaccine. The reaction subsided after patient received a dose of oral diphenhydramine. and released from the vaccine clinic without requiring any further intervention.
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| 75 | 2021-02-25 | injection site redness, injection site reaction |
After vaccine, the next day 3-4am woke up with horrible headache, slight fever, sweaty. injection si...
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After vaccine, the next day 3-4am woke up with horrible headache, slight fever, sweaty. injection site raised and red and still is, also has trouble keeping liquid or food in. Still gets fleeting headaches and sweats ever morning.
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| 75 | 2021-02-25 | rash |
Mild rash on forearms approximately 10 minutes after injection. Subsided/cleared 10 minutes later. ...
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Mild rash on forearms approximately 10 minutes after injection. Subsided/cleared 10 minutes later. Issue potentially occurred with first dose but difficult to determine based on resident skin color. Gave low dose (6.25mg diphenhydramine) 30 minutes prior to the dose on 2/26 in the event there was a adverse reaction with 1st dose.
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| 75 | 2021-02-25 | rash, itchy rash |
rash - two pink itchy spots on neck and lower jaw - no other rash - present for several days without...
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rash - two pink itchy spots on neck and lower jaw - no other rash - present for several days without spread at time of evaluation
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| 75 | 2021-02-27 | injection site pain |
Had no pain in arm or redness for the first 10 days. Developed severe pain in my arm from the injec...
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Had no pain in arm or redness for the first 10 days. Developed severe pain in my arm from the injection sight up to my ear and neck. The pain in my neck stayed for 9 days with pain to my arm that was terribly painfull. Now I still have an ache in my neck and arm that is mild but also feels very tired like if you had a neck injury from nerve pain
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| 75 | 2021-02-27 | redness, itchy skin |
Patient received the Covid-19 vaccine. She reports symptoms of Other: Itchy face flushed, foggy feel...
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Patient received the Covid-19 vaccine. She reports symptoms of Other: Itchy face flushed, foggy feeling pressure in the head I have observed Patient having red face itchy face foggy pressure in the head. Vital signs: 0843 BP 170/80 HR 96 RR 18 Pulse Ox 98% 0846 BP 182/80 0857 BP 168/84 HR 88 RR 16 Pulse Ox 97% 0910 BP 180/90 HR 88 RR 16 Pulse Ox 97% 0925 BP 200/90 HR 88 RR 16 Pulse Ox 97% Treatment/intervention Monitored offered water Benadryl 25 mg po @ 0850 by an RN, Benadryl 25 mg po @ 0914 by an RN 0925 patients BP continued to be out of normal range patient stated that she took her BP medications this am. Face still flushed. 0925 ambulance called to transport patient to the ED. 0925 ambulance her report given.
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| 75 | 2021-02-27 | rash |
Severe headache, took tylenol, lasted approx 24 hrs. Chills, bundled up and slept eventually, lasted...
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Severe headache, took tylenol, lasted approx 24 hrs. Chills, bundled up and slept eventually, lasted approx. 10 hrs. 3 days later red rash started on left arm from inj. site almost to elbow and width of arm. Have taken 2 benadryl. Still have rash. It's Sunday 02/28/2021
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| 75 | 2021-02-28 | injection site redness, injection site pain |
At 9:30 A.M. on 2/23, I noticed that I had a slight headache. My left arm was, as I had expected, p...
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At 9:30 A.M. on 2/23, I noticed that I had a slight headache. My left arm was, as I had expected, painful and red near the injection site. As the day progressed, I became aware of more reactions: chills, body aches, increasing headache, arm pain, and changes in my temperature (I usually have a temperature of 97.6, but measured 96.6 and in the evening, 100.4). I felt listless and nauseous by dinnertime. By the morning of 2/24, nothing was improved, so I took 2 Tylenol, which I repeated 7 hours later and 7 hours after that. By the morning of 2/25, I began feeling better and stopped the Tylenol. My symptoms gradually continued to improve through 2/28.
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| 75 | 2021-02-28 | injection site pain |
Injection site pain, Chills, 102 fever 24 hours for 3 days, headache, tiredness, muscle pain, joint ...
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Injection site pain, Chills, 102 fever 24 hours for 3 days, headache, tiredness, muscle pain, joint pain, feeling unwell
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| 75 | 2021-02-28 | injection site bruising, injection site redness, injection site pruritus |
Pfizer-BioNTech COVID-19 Vaccine EUA 2" diameter red and itchy area around injection site and 3" lon...
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Pfizer-BioNTech COVID-19 Vaccine EUA 2" diameter red and itchy area around injection site and 3" long by 1/4" wide red line from injection site to arm pit, that lasted 1 week. Also, 101 temp, some chills, light headache, upper teeth hurt (like in sinus infection) and tired that lasted 1 day.
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| 75 | 2021-03-01 | rash, rash papular, itchy skin |
Generalized body rash involving areas from neck to knees. Red raised areas with itching. Still prese...
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Generalized body rash involving areas from neck to knees. Red raised areas with itching. Still present on day 2. Went to ER in early evening on March 1, 2021. RX given for Pepcid and Kenalog. Dx: Allergic reaction to Covid-19 vaccine.
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| 75 | 2021-03-01 | itchy skin |
Itchiness in various parts of my body. No rash; no hives; no redness. Started 18 hours after the v...
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Itchiness in various parts of my body. No rash; no hives; no redness. Started 18 hours after the vaccine
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| 75 | 2021-03-01 | redness, rash, rash macular |
Lethargic; Flu like symptoms; Lower part of my leg, I have little bit rash, a redness; Lower part of...
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Lethargic; Flu like symptoms; Lower part of my leg, I have little bit rash, a redness; Lower part of my leg, I have little bit rash, a redness; I have few spots on my right forearm; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 75 years, on 22Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing and anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medication included dronedarone hydrochloride (MULTAQ) at 400mg, twice daily and apixaban (ELIQUIS) at 5mg, two times daily. The patient stated, "Both my husband and I took the Covid the first shot on 22Jan2021 which was week ago today. I noticed about 4 days later (Jan2021) like I started feeling you know flu like symptoms but they were mild, if I took two an Extra strength Tylenol it went away. You know what I mean. So that one for about may be one, two may three days and that was it. I was very lethargic. The only thing I did notice that on both my legs from the ankles of about midways I have you know my leg, the lower part of my leg, I have little bit rash, a redness. It does not itch, it was not hard to the touch. My body temperature was normal. It was little red or pinkish to a little bit of red. Now, I noticed tonight that I have few spots on my right forearm. Like I said we have shot on 22nd, everything was fine, no immediate reaction or anything else and everything is okay. I just you know I feel fine but is this normal?" The patient stated, "No, they are healthy and safe about 20-25 minutes. Everything was fine and then let us go and I said couple of days later it hasn't progressed, it is very, it is on both of my lower legs from ankles midway up my legs and I noticed couple of spots on my left forearm but it hasn't gotten any worst and it hasn't gotten spread on any place other than right forearm." The patient also stated, "You mean the rash or any other the symptoms. We have the shot Friday, Saturday, Sunday, Monday. I was say this past Tuesday, around 26th (further not clarified)." The patient stated, "It was there on my legs. It hasn't moved. It hasn't gotten any worse and it is only on front it is not back on my legs. The only thing I noticed tonight that it is couple of spots on my right forearm." The consumer stated, "No, I went to see my doctor the other day for her to take look at it. I went to see PA at my doctor's office, I saw her and she said if it doesn't get worse it would probably go away." The patient also stated, "The only thing that I had done right before the Covid Vaccine. I had injection in my knee of amniotic fluid for a torn meniscus but that should not affect it." The patient underwent lab tests and procedures which included body temperature: normal on an unspecified date. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.
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| 75 | 2021-03-01 | injection site pain | Sever pain in arm at injection site. Also nausea & weakness. |
| 75 | 2021-03-01 | redness |
Severe allergic reaction; wheezing; felt right through her chest like through her right side kind of...
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Severe allergic reaction; wheezing; felt right through her chest like through her right side kind of going into her left; it was weird like she could feel going into her body/ suddenly felt strange sensation in her chest; heart started beating really fast/ heart started beating very rapidly; face was all red/ face growing red and swelling slightly; face was all red/ face growing red and swelling slightly; breathing was becoming labored; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3248, NDC/UPC number and expiry date were unknown), via an unspecified route of administration in the right arm on 12Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. The vaccine facility type was reported as the "doctor's office/urgent care." Relevant medical history included high blood pressure, but it was controlled blood pressure/hypertension; asthma, for which she was not taking medication at the time of the report, because it was under control; non allergic rhinitis; pre diabetes; and a little overweight. The patient further stated that she had just general medical history, which she had everything under control. Concomitant medications included lisinopril, montelukast sodium (SINGULAIR), atorvastatin (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), and metformin. The patient previously took to iodine, doxycycline, erythromycin, and azithromycin, for which the patient had known allergies to all of it. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. She was not tested for COVID-19 post vaccination. The patient stated that on 12Jan2021 at 10:30, she had adverse reactions to the Pfizer vaccine; she had severe allergic reaction within about 30 minutes and then they call the paramedic she ended up and they gave her a shot, which she did not know if it was prednisone. It was further reported that she took her inhaler too as they said she was wheezing, which she didn't really feel in her lungs. The patient just felt that what happen was she went to the car as they said to wait 15 minutes as written, and she always follow the rules and the whole thing they said, she waited 30 minutes, so she went down side of her car then she figured that she could just drive off drive home. So, she was in car sitting or waiting for the last 30 minutes and all of a sudden she felt right through her chest like through her right side kind of going into her left; it was weird like she could feel going into her body, then suddenly her heart start beating really fast, and then she pulled down the vizor and looked in the rearview mirror and her face was all red, so she go back to the site. That's how she transpired and then, that's how the reaction was. It was further reported that the patient waited 15 minutes in the office, then went to car to wait additional 15 minutes, and suddenly felt strange sensation in her chest and her heart started beating very rapidly. She pulled down the visor in car and saw her face growing red and swelling slightly and her breathing was becoming labored. She had read on side effects on information she was given on departure stating symptoms of an allergic reaction. She returned to the facility at which time she was treated. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. The patient had no investigation assessment. Therapeutic measures were taken as a result of all the events, which included that the patient was given a shot of 125 mg of methylprednisolone sodium succinate (SOLU-MEDROL), but another report said they gave her prednisone so they were kind of conflicting in the report, but it was a shot, and also cetirizine (ZYRTEC) and famotidine (PEPCID), and her inhaler for wheezing. The patient recovered from all the events on an unspecified date.
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| 75 | 2021-03-01 | hives, redness, rash with redness |
The patient has red raised erythematous patches abdomen chest neck arms and upper thighs. Upper back...
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The patient has red raised erythematous patches abdomen chest neck arms and upper thighs. Upper back not affected but the lower back is. Allergic reaction to COVID-19 vaccine - Primary Hives Urticaria, unspecified
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| 75 | 2021-03-01 | itchy skin |
itching tongue face lips, mild swollen tongue and lips, neck pain, hoarse voice, cough, pale. Pr...
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itching tongue face lips, mild swollen tongue and lips, neck pain, hoarse voice, cough, pale. Progressively worse in order listed over 10 minutes. Chewable benadryl 12.5 mg x 4 given. Pt reported improved symptoms within 10 minutes and was asymptomatic at 30 minutes.
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| 75 | 2021-03-02 | itchy skin |
During monitoring period post Pfizer COVID-19 vaccine, pt experienced itching on back and spreading ...
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During monitoring period post Pfizer COVID-19 vaccine, pt experienced itching on back and spreading "all over". Medications Ordered/Given Per Protocol: Benadryl 25mg by mouth.
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| 75 | 2021-03-02 | itchy skin |
Patient complaint of tickle/ itchiness in throat and was anxious and jittery at 1253. Then she had g...
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Patient complaint of tickle/ itchiness in throat and was anxious and jittery at 1253. Then she had generalized itchy fore head ,bilateral eyes, throat and ears. Vital signs within normal. Patient was placed in recumbent position and was given apple juice. Patient stated all symptoms resolved at1312 and was discharged home.
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| 75 | 2021-03-02 | itchy skin |
it showed a "CRP value" of 11.5 which is usually below 0.29 which shows inflammation; loss of appeti...
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it showed a "CRP value" of 11.5 which is usually below 0.29 which shows inflammation; loss of appetite; Nausea; breathing problems; mild fever; Muscle ache; Joint ache; Rapid heart rate up to 130; Itchy skin; roof of mouth itching; eyes were also really sore; This is a spontaneous report from a contactable Other HCP (patient). A 75-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6201), via an unspecified route of administration in the right arm on 11Feb2021 at single dose for COVID-19 immunisation. Medical history included ongoing asthma initially diagnosed at 21 years old, ongoing arthritis diagnosed 10-15 years before but she thinks she had it since she was 35, multiple joint replacements, past pneumonia. The patient's concomitant medications were not reported. The patient previously received methotrexate 25mg a week orally for arthritis but she quit taking it about 3 months before in preparation of getting the vaccine. The patient previously received the first dose of bnt162b2 on unspecified date (lot EL8982) at single dose for COVID-19 immunisation in the right arm. The patient experienced mild fever on 12Feb2021 with outcome of recovered on 14Feb2021, roof of mouth itching on 11Feb2021 with outcome of recovered on 11Feb2021, muscle ache on 12Feb2021 with outcome of recovered on 12Feb2021, joint ache on 12Feb2021 with outcome of recovering, breathing problems on 12Feb2021 with outcome of recovering, rapid heart rate up to 130 on 12Feb2021 with outcome of recovering, itchy skin on 11Feb2021 with outcome of recovered on 11Feb2021, it showed a "crp value" of 11.5 which is usually below 0.29 on 15Feb2021 with outcome of unknown, nausea on 12Feb2021 with outcome of recovered on 13Feb2021, loss of appetite on 13Feb2021 with outcome of recovered on 13Feb2021, eyes were also really sore on 11Feb2021 with outcome of recovered on 15Feb2021. An EKG performed on 15Feb2021 as pending results. The event of breathing problems was serious due to disability. The events mild fever, roof of mouth itching, muscle ache, joint ache, rapid heart rate up to 130 and itchy skin were medically significant. The patient reported that initially, the roof of her mouth started itching. It literally happened as soon as she had the vaccine. She took a Benadryl. She didn't have a skin irruption, but did have itchy skin. The next day, she had a low grade fever. She had muscle and joint aches. She had no rash, but a little nausea. She had breathing problems. She had asthma issues and wheezing after the vaccine. That is how she described her breathing issues. She had a rapid heart rate. It went up to 130. It could of been because of fever, her breathing, or pain. There was a period of days then it resolved. On 15Feb2021, she feels almost human. She had routine arthritis lab drawn on 15Feb2021. They showed a CRP level of 11.5 which shows inflammation. She normally was below 0.29 which was within normal limits. That was an extreme difference. That was a lot of inflammation. The patient had to get her nebulizer out to breathe. She has taken Tylenol a couple of times. Her lab work was essentially normal. The CBC and chemical panel was okay. The patient thoughts the fever was important because she has been immunocompromised for years by Methotrexate. She has had pneumonia before with no fevers. Her eyes were also really sore. They bothered her. She already had to use eye drops. That was 11Feb2021 it was gone on 15Feb2021 but it kind of lasted a few days. Her muscles were better, but her joints still hurt some. But her joints always hurt some. She has had multiple joint replacements. The muscles in her legs were severe Friday and Saturday. Her muscles aren't hurting now, but her joints were but that was kind of normal. Her peak flow was way down on 14Feb2021. It was at 250. She did finally get it up to 350 by using her nebulizer. Her best effort normally is 450. Her peak flow was down quite a bit. She has been having breathing changes for a year. They were not sure what it was about. It could be an acute episode of something. On unknown date (next morning as reported), her pulse was 90-100. Now her heart rate was only elevated with activity. Her heart rate was down in the 70s, but when moving it was in the low 100s. With activity it was still up. It was hanging out in the 70s except exercising. She considers walking across the room exercising. All her other labs were in within normal limits. The patient wanted to know if the inflammatory response was secondary to the vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 75 | 2021-03-03 | injection site redness |
8 days after 2nd Covid shot, right arm swollen, very red in and around the area of shot about 5" dow...
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8 days after 2nd Covid shot, right arm swollen, very red in and around the area of shot about 5" down/around from injection area.
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| 75 | 2021-03-03 | redness, cellulitis | Cellulitis left arm - red and swollen, 2 pulmonary embolism, right tibial blood clot |
| 75 | 2021-03-03 | rash maculo-papular, rash | Maculopapular rash arms, legs, chest |
| 75 | 2021-03-03 | rash macular, rash, itchy skin, vaccination site rash, vaccination site itchiness |
maybe she is getting Ebola; blotching; arms were itching/ it was her right arm that she got the shot...
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maybe she is getting Ebola; blotching; arms were itching/ it was her right arm that she got the shot; had blotches on her arm, it was only the arm she got the shot in; rash/like there were ants all over her back, head, legs, under her breast and under her arms in between legs; Itching/ like there were ants all over her back, head, legs, under her breast and under her arms in between legs; This is a spontaneous report from a contactable consumer (patient). This 75-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiration date: May2021) via an unspecified route of administration in the right arm on 01Feb2021 at single dose for covid-19 immunisation. Medical history included hear disorder, sulfa allergy, allergic to iodine, being shrinking she was 5'4" the last time she looked at it but she has shrunk, she was not sure but she thought she was currently shorter than 5'4". The patient would like to know if it has sulfa and iodine in BNT162B2. Concomitant medications included insulin, blood pressure medication and heart medication. The patient received first dose of vaccine and experienced a rash and itching on 02Feb2021. The patient was broke out, she had a rash since she had the shot, it was like there were ants all over her back, head, legs, under her breast and under her arms in between legs. The doctor gave her Hydroxyzine for the itch and she just wanted to know, she was leery of going to get the second dose, she wanted to know was the second dose going to make it worse. The patient was scheduled to go for the second one 22Feb2021. She said the first day she got it she was fine, there was nothing, she was waiting for something to happen then she started with the rash. She was taking her blood pressure medication and insulin but she noticed that on the inside of her, on the top of the head was itching, it was the next day, and then toward the evening under her arms were itching and then between her legs and ankles and it was her right arm that she got the shot in and it started blotching. She showed it to the nurse at the office and she told the nurse maybe she was getting Ebola. She had blotches on her arm, it was only the arm she got the shot in. She still had the blotches she still had quite a few. She can still see them but they were getting lighter. Under her breast was still bugging her. She confirmed the itching and rash began the next day, after the first vaccine dose. It had improved since her doctor gave the pills to stop the itching. She was able to sleep, before she couldn't sleep she had to get up and take showers but since he had given the medicine it was improved and she had used salve, it was Cortisone but her under the bra it still itched where it was pressuring. She was going to have a labs taken to see if there was anything different. She took insulin and heart medication since forever and she even stopped to see, she said it was probably a bad thing but she stopped taking her heart medication to see if it was interacting, she stopped taking her insulin and her heart rate went up, everything was still the same, now she went back and started taking the insulin and heart medication again. Outcome of the event maybe she is getting Ebola was unknown, of the other events was recovering.
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| 75 | 2021-03-05 | vaccination site itchiness, vaccination site swelling, vaccination site redness |
Red rectangular area near vaccination spot appeared on 3rd day after 2nd vaccination. Area was itchy...
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Red rectangular area near vaccination spot appeared on 3rd day after 2nd vaccination. Area was itchy and swollen for three days. Area is about 4x5 inches. Today is 8th day after vaccination and itching and redness seem to be going away.
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| 75 | 2021-03-07 | itchy skin, redness |
At 12:30a.m. I awoke after the shot to shooting pain on the left side of my head that would last for...
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At 12:30a.m. I awoke after the shot to shooting pain on the left side of my head that would last for seconds and continue every few minutes. My arm was hurting a lot also, but I expected that. I took an Ibuprophen but it continued now coming every 10 minutes. My son told me to take 3 ibuprofen at a time every 4 hours that allowed me to go back to sleep. When I awoke I continued the ibuprofen but in the afternoon I was getting the shooting pains in my left ear. SO I continued the ibuprofen. On Sunday m72 hours after the shot my arm was so swollen and red with pain and itching. I called my doctor and she said to take ibuprofen and come in if it is not better on Monday.
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| 75 | 2021-03-07 | vaccination site pain, rash, itchy skin, redness |
Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms;...
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Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms; Headache; Diarrhea; Chills; Tenderness where the shot area is; Joint pain; Really bad flu; A little bit of a rash from it because my skin is all red from itching; A little bit of a rash from it because my skin is all red from itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN5318), via an unspecified route of administration on 02Feb2021 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol and eye disorder. Concomitant medication included atorvastatin, ubidecarenone (COQ-10), colecalciferol (VITAMIN D3), cyanocobalamin (VITAMIN B12), monascus purpureus (RED YEAST RICE) and unspecified OCUVITE for the eyes. On 02Feb2021 at 14:30, within 15 minutes of the vaccination, the patient was itching really bad (itchy in the ears, scalp, neck, chest, arms). The patient was kept in observation after the vaccination for an hour and was treated with diphenhydramine (BENADRYL) which did not seem to help. The patient drover home and went to bed. Her physician suggested that she see an allergist. The allergist was not sure what was in the vaccine and requested the patient ask her doctor for another referral. On 02Feb2021, the patient also experienced headache; diarrhea; chills; tenderness where the shot area was. On 03Feb2021, the patient woke up with cold sweats, like cold wet perspirations and chills again. On an unspecified date in Feb2021, the patient experienced joint pain and felt like she had a really bad flu, developed a little bit of a rash because the skin was all red from the itching, which she couldn't stop. The patient reported that she was treated for the events with diphenhydramine and paracetamol (TYLENOL). She questioned whether there were other reports of itchiness. The clinical outcome of "within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms", headache, diarrhea, chills, cold sweat was not resolved; while "tenderness where the shot area is", joint pain, really bad flu, "a little bit of a rash from it because my skin is all red from itching" was unknown.
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| 75 | 2021-03-07 | blister, rash, shingles |
Rash, blisters, and discomfort of Shingles outbreak on the left buttocks. Diagnosed at Dr. visit 2/1...
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Rash, blisters, and discomfort of Shingles outbreak on the left buttocks. Diagnosed at Dr. visit 2/17/2021; Treated with Medication for 7 days. Discomfort has improved but remains somewhat uncomfortable. Rash and blisters have diminished but are still visible.
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| 75 | 2021-03-08 | hives |
3/3/2021 6pm approximately Angioedema (Face) Hives (between the eyes & forehead) Extreme Fatigue 3/...
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3/3/2021 6pm approximately Angioedema (Face) Hives (between the eyes & forehead) Extreme Fatigue 3/9/2021 Swelling going down Drinking a lot of water & resting
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| 75 | 2021-03-08 | hives |
Fever of 103, chills, body aches, headache, nausea, several large, red welts (hives??). Lasted about...
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Fever of 103, chills, body aches, headache, nausea, several large, red welts (hives??). Lasted about 40 hours, symptoms decreasing after about 30 hours.
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| 75 | 2021-03-08 | rash | Purification rash to trunk |
| 75 | 2021-03-09 | rash |
Patient had generalize rash on arms and abdomen 1-2 days after vaccination that gradually resolved o...
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Patient had generalize rash on arms and abdomen 1-2 days after vaccination that gradually resolved over a few days.
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| 75 | 2021-03-09 | itchy skin |
nausea, muscle and joint aches, chill, headache, insomnia, dizziness, itchiness, swollen glands, bra...
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nausea, muscle and joint aches, chill, headache, insomnia, dizziness, itchiness, swollen glands, brain fog, rosacea,
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| 75 | 2021-03-09 | hives, itchy skin |
patient had 2nd vaccine on 2/26/21. she called the office on 3/1/21 and stated that she had hives/we...
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patient had 2nd vaccine on 2/26/21. she called the office on 3/1/21 and stated that she had hives/welts with extreme itching. she states she had diarrhea and was nauseous. she was taking Benadryl and Caladryl lotion for the itchiness. she stated at that time she was feeling better as the day went on. she called back the office on 3/3/21 and stated that she still had the hives and itching and that the Benadryl helped. she also stated that she was not willing to leave the house to go out to the pharmacy for any meds that might have been prescribed.
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| 75 | 2021-03-10 | skin burning sensation, blister |
One week after the vaccine, the pain was intense on my left side of neck, my left arm was weak and ...
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One week after the vaccine, the pain was intense on my left side of neck, my left arm was weak and had burning pain and my scalp was on fire. Four days later, the blisters appeared.
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| 75 | 2021-03-11 | rash, itchy rash, skin burning sensation |
Fever of 101 degrees for 3 days, The day after the fever left I woke up with a severe rash all over ...
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Fever of 101 degrees for 3 days, The day after the fever left I woke up with a severe rash all over my body on day 4 after the shot. The rash was severe with itching and stinging all over my body; including stomach, chest, upper back and lower back. buttocks. I went to urgent care. The Nurse Practitioner said it was a chemical rash from the COVID-19 shot. She gave me two shots and medication. The rash has gotten better but became localized on certain areas of my body including my arms and limbs. Itching and burning still occurring. Calamine lotion helped.
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| 75 | 2021-03-12 | itchy rash, rash with redness |
2:00 p.m. day of injection - suddenly very tired; 6:00 p.m. heart pounding; 7:00 p.m. blood pressure...
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2:00 p.m. day of injection - suddenly very tired; 6:00 p.m. heart pounding; 7:00 p.m. blood pressure spiked to 181/93 (headache); 9:00 p.m. blood pressure dropped to 112/53 - then chills, muscle/joint pain, felt very unwell 3/7/2021 - small red itchy spot appeared on belly 3/9/2021 - full blown itchy red rash on belly
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| 75 | 2021-03-13 | injection site swelling, injection site redness, injection site pruritus, injection site hardening |
1st vaccine on 02/03/2021 left arm, had no side affects. 2nd vaccine on 02/24/2021, on second day, ...
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1st vaccine on 02/03/2021 left arm, had no side affects. 2nd vaccine on 02/24/2021, on second day, injection site got red, swollen, had hard knot, and deep itch at injection site right arm. On third day started getting brain fog, had hard time concentrating and felt extremely tired. Redness, swelling, hard knot, and deep itching has gone away. Still have a bit of brain fog but getting better. Knee joints are hurting. I got most of my energy back. It took 9 days for redness and swelling to go down. I did not seek treatment for symptoms.
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| 75 | 2021-03-13 | itchy rash |
Itchy rash all over body. Not totally terrible but uncomfortable and bothersome. Taking some Benadry...
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Itchy rash all over body. Not totally terrible but uncomfortable and bothersome. Taking some Benadryl the last couple of days. Still hasn't gone away as of 3/14/21. Never experienced this before and there have been no other changes in my life, i.e. food, soap, clothing, etc. that could be allergens. All I can think of is the vaccinations. Will go to a doctor soon if possible. Just thought I should report this.
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| 75 | 2021-03-14 | rash macular |
I experienced prickly heat to my face and neck, red splotches on my face and a racing heartbeat last...
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I experienced prickly heat to my face and neck, red splotches on my face and a racing heartbeat lasting only about ten minutes. It began to subside and I took Benadryl 25mg about fifteen minutes later with no additional symptoms. Nothing else was different about my morning routine but felt this was worth reporting since it may have been from the vaccine about 19 hours previously. It felt severe at the time but began resolving before I attempted to contact medical personnel.
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| 75 | 2021-03-14 | rash papular, vaccination site mass |
Red bump on my forehead; it feels like kind of sore when I touch it; Red bump on my forehead; it fee...
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Red bump on my forehead; it feels like kind of sore when I touch it; Red bump on my forehead; it feels like kind of sore when I touch it; She is getting red bumps today on the part where she got injected; Sore arm; I get this pain in my pointer finger in my right hand; A little weakness in my right leg; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was 75-years-old) as a single dose for covid-19 immunisation. Medical history included high blood pressure, osteoporosis and overactive bladder. The patient concomitant medications were not reported. The previously had first dose (first shot) of BNT162B2 for covid-19 immunisation and had sore arm. It was reported that she is getting red bumps today (on 07Feb2021) on the part where she got injected. The consumer stated after second shot also, I had no symptoms except for sore arm on an unspecified date in Feb2021. The only thing that I noticed which was from second shot and which was really crazy is, once in a while I get this pain in my pointer finger in my right hand and that was it, it comes and it goes. But today, and in the last couple of days I noticed a little weakness in my right leg, but today when I went to work somebody said what is that big red bump on your forehead and I looked and there was a big red circle, there was a bump, like a real bump on my forehead. I didn't hide it, I didn't even think if it was allergic as I only had a banana before I went to work and a cup of coffee which I have lot of time. I am wondering if this bump that I have on my forehead which looks ridiculous and it is a big red bump, like a tumor bump, it feels like kind of sore when I touch it, is from the vaccine because I haven't had anything but the vaccine." Consumer stated, "Main thing I am concerned about is the big red bump on my forehead." Treatment: Consumer stated, "I never had that before, it is very slight. The main thing was the bump on my head that came today and I didn't have it when I left the house. I didn't hit my head or anything. I just took two Tylenol and an allergy pill in case if it was some kind of allergy." The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 75 | 2021-03-14 | rash | Severe rash |
| 75 | 2021-03-15 | injection site redness, injection site pain, injection site swelling |
1st time no effect. 2nd time swollen and redness and pain at injection site. The shot stung bad goin...
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1st time no effect. 2nd time swollen and redness and pain at injection site. The shot stung bad going in. Excruciating pain in lower back. Drank lots of water, took Liquid Ibuprofen Children's liquid 2 tablespoons every 6 hours. Heating Pad on lower back. Still have effect two day later but not as bad. Swelling going down but still red. . and used heating pad.
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| 75 | 2021-03-15 | redness |
?Pfizer-BioNTech COVID-19 Vaccine My upper lip began to swell about 5 hours after the injection ...
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?Pfizer-BioNTech COVID-19 Vaccine My upper lip began to swell about 5 hours after the injection and after a while turned into a terrible cold sore. I haven't had a cold sore in many, many years and have only gotten one if I have been in the sun too long or have a high fever. I called the doctor on call the following morning and asked for a prescription of acyclovir. Starting it that late resulted in not stopping the progression of the cold sore. Also had runny nose (haven't had a cold since masking started last year), and a red swollen arm..still red and swollen two days later and a terrible headache (started the day after injection and still bad today which is two days after).
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| 75 | 2021-03-15 | hives |
On her right inner wrist area she developed a hive; This is a spontaneous report from a contactable ...
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On her right inner wrist area she developed a hive; This is a spontaneous report from a contactable consumer (patient's husband). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jan2021 (batch/lot number: EL8982) at a single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The first experience was with the first dose. On her right inner wrist area, she developed a hive, just one. The hive appeared a couple hours after the first vaccine. The hive stayed there for 3 to 4 hours and then dissipated. Outcome of the event was recovered on 14Jan2021.
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| 75 | 2021-03-16 | rash |
99.9 fever, fatigue, rash on lower extremities fever and fatigue gone in 24 hours Rash being treated...
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99.9 fever, fatigue, rash on lower extremities fever and fatigue gone in 24 hours Rash being treated with Eucerin cream and hydrocortisone 1% cream mixture. Gradually improving after 6 days. NO STEROIDS as per CDC caution.
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| 75 | 2021-03-16 | rash |
Follow-up: spoke with Pt who states that some of the rash remains but has much improved, she applied...
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Follow-up: spoke with Pt who states that some of the rash remains but has much improved, she applied some topical Benadryl over it, and has had no itching since. the rash eventually spread from the arm to the shoulder and part of her collar bone, but has not progressed further. *mild headache and aches she only experienced the day of the shot and they only lasted a few hours. Advised: to call us with any questions. If she experience return of symptoms or worsening f/u with physician
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| 75 | 2021-03-17 | injection site pain, injection site hardening, injection site warmth, injection site redness |
Patient received her first dose of pfizer x 2 weeks ago Number of days post vaccine: 14 days Initia...
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Patient received her first dose of pfizer x 2 weeks ago Number of days post vaccine: 14 days Initial reaction was noted on day 2 after vaccine. Redness and pain to site resolved after a 3 days. Symptoms to arm has returned with an increase in pain to the right arm of 6/10 on a pain scale. Has been taking Tylenol and use of cold compresses without any effect. Reports of an induration, area red and warm to touch. Limited range of motion; able to move arm with pain but unable to lift any object.
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| 75 | 2021-03-17 | rash, vaccination site warmth |
Rash on my chest; I guess the rash joined one another on my chest, inside my legs and both my upper ...
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Rash on my chest; I guess the rash joined one another on my chest, inside my legs and both my upper arms; Cough; My left arm where I got the shot that arm, it was feverish, it was very hot; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2, lot no. EL9262, via an unspecified route of administration (left arm) on 24Jan2021 at a single dose for COVID-19 immunization at a hospital facility. They gave her a dose that was recommended. Medical history and concomitant medications were not reported. The patient reported a reaction that she had to her first vaccine. It was Pfizer BioNTech COVID-19 Vaccine EUA and she had that on 24Jan2021 and she had a little cough the following day (25Jan2021) which she did not have before and then she didn't recover from the cough but she woke up on the 27th with a little bit of rash on her chest and she just kind of ignored it but within four hours she had not just a rash, she had she guessed the rash joined one another on her chest, inside her legs and both her upper arms. She started taking Benadryl and it took about 125 mg of the Benadryl over 30 hours before she was able to get rid of the rash. It happened three days later at her house. She treated herself with Benadryl. She was not experiencing any kind of breathing problems or anything that she was alarmed about. She only took Benadryl 25 mg when she first saw it because the rash was not severe but within four hours even after she took the 25 mg, the rash became very severe and her left arm where she got the shot that arm, it was feverish, it was very hot on Jan2021. She didn't know next step with her second dose. She felt like rash was severe. Her rash took over 30 hours and taking 125mg Benadryl to get rid of it. So, she didn't know how to prepare or what to expect. She was due to get it on 14Feb. The patient recovered from rash generalized on Jan2021, not recovered from cough, while outcome of other event was unknown.
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| 75 | 2021-03-18 | shingles |
Developed rash of shingles 5.days after vaccine.; This is a spontaneous report from a contactable co...
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Developed rash of shingles 5.days after vaccine.; This is a spontaneous report from a contactable consumer (patient) reported for herself. This is a spontaneous report from a contactable consumer or other non hcp. A 75-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269, Expiry date: unknown), via an unspecified route of administration on 16Feb2021 at 10:30 am (at the age of 75-years-old) at single dose on Right arm for covid-19 immunisation. Medical history included hypertension and AV block left heart. Allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included amlodipine besilate (NORVASC), atorvastatin, aspirin (ASPIRIN [ACETYLSALICYLIC ACID]). The patient previously took first dose of BNT162B2 (lot number: EL3249, Expiry date: unknown) on 26Jan2021 at 10:00 AM (at the age of 75-years-old) on right arm at single dose for covid-19 immunisation. The patient developed rash of shingles 5 days after vaccine on 21Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The Patient received antivirals medication and pain medicine as treatment. The patient underwent lab tests and procedures which included covid test: negative on 22Feb2021. The patient was not recovered from the event.
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| 75 | 2021-03-20 | vaccination site pain |
3 hours after injection, experienced pain and tenderness at injection site; facial flushing that per...
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3 hours after injection, experienced pain and tenderness at injection site; facial flushing that persisted for 3 days; This is a spontaneous report from a contactable 75-year-old non-pregnant female nurse (patient) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 05Feb2021 at 09:15 am at single dose for covid-19 immunization on left arm. The patient's medical history included hypothyroidism, breast cancer and known allergies: Shrimp, cilantro, contrast dye, gadolinium. Concomitant drugs included Levothyroxine sodium, ciclosporin (RESTASIS), multiple vitamins. On 05Feb2021, 3 hours after injection (12:00 PM), the patient experienced pain and tenderness at injection site, facial flushing that persisted for 3 days. Benadryl 25mg taken every 4 hours for 2 days for flushing. The laboratory test included temperature taken and WNL (within normal limits) 97.2 during flushing period. The outcome of the events was recovered. Information about Lot/Batch number is requested.
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| 75 | 2021-03-20 | pain of skin |
A stinging, raw sensation when clothing is rubbing against the upper, inner arm from the arm pit dow...
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A stinging, raw sensation when clothing is rubbing against the upper, inner arm from the arm pit down the arm approx 3 inches on my RIGHT arm. I have visited my family Dr twice (03/01/2021, 03/11/2021) and an orthopaedic surgeon (03.04.21021) dealing with nerves once. Neither could help me.
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| 75 | 2021-03-20 | vaccination site pain |
Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen ...
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Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen lymph nodes that hurts like crazy; Swollen lymph nodes that hurts like crazy; arm got sore; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 31May2021), via an unspecified route of administration on 03Feb2021 (at the age of 75 years) as single dose for covid-19 immunisation; potassium chloride (KLOR-CON M10), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included ongoing type 2 diabetes and ongoing high blood pressure. Concomitant medications included metformin; atorvastatin; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). Consumer stated she got her Covid inoculation last Wednesday and in Feb2021, she was experiencing symptoms, adverse reactions. She had injection site pain still, muscle pain, her lungs are fine but when she breathe her front and back of her chest hurts. She had chills. She did not think she had a fever but she was definitely feeling unwell and the most difficult thing was swollen lymph nodes that hurts like crazy. She cannot read this too well. Lot was 2CI or EI EL3302 expires 31May2021. Her arm got sore but today she really started may be yesterday experiencing this muscle pain and the lymph stuff going on. Consumer stated she had no treatment. The last time her doctor gave her this new medication because she had run out of her potassium. It was called Klor-con M10 tablet. For lab work, consumer stated she did not know but right before she went there they took some blood and when the doctor gave her the Klor thing, she had a violent reaction to it. she threw up and had a lot of diarrhea and she have not taken it since. Results of lab work was unknown. The action taken in response to the events for potassium chloride was unknown. Outcome of events was unknown. Information about lot/batch number has been requested.
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| 75 | 2021-03-20 | vaccination site pain |
Slight pain in left arm of injection site/Sore; This is a spontaneous report from a contactable cons...
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Slight pain in left arm of injection site/Sore; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL9262) via an unspecified route of administration, at the age of 75-year-old, administered in Arm Left on 21Jan2021 10:15 AM, as SINGLE DOSE for covid-19 immunisation. Medical history included allergy to Penicillin and derivatives. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. The patient experienced slight pain in left arm of injection site/sore for 24hrs in 2021. The patient did not receive any treatment in response to the event. Outcome of the event was unknown.
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| 75 | 2021-03-20 | redness, itchy skin |
The day following my 2nd vaccine my arm started swelling and was red and painful. It has now been 4...
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The day following my 2nd vaccine my arm started swelling and was red and painful. It has now been 4 days and continues to get more redness and now itches. Taking Benadryl for itching.
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| 75 | 2021-03-20 | injection site pain, redness |
injection site pain; massive redness; swelling; bad headache; muscle and joint pain; muscle and join...
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injection site pain; massive redness; swelling; bad headache; muscle and joint pain; muscle and joint pain; tiredness; feeling unwell; This is a spontaneous report received from a contactable consumer. A 75-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on Right arm on 04Feb2021 02:45 PM at single dose.Patient Medical history included arthritis, hypertension, osteopenia. Historical vaccine included first dose of bnt162b2 via an unspecified route of administration (lot number: EL9265) on left arm on 14Jan2021 04:30 PM at Single Dose for COVID-19 immunisation. Concomitant medication included Amlodipine Besylate 2.5mg, Citalopram 10, captopril (METOPRIL). On 04Feb2021 22:30 patient experienced injection site pain, massive redness, swelling, bad headache, muscle and joint pain, muscle and joint pain, tiredness, feeling unwell after vaccination. patient was not pregnant, No treatment received for AE, patient had not Covid tested post vaccination, patient had allergies to Codine. Outcome of events was recovering. Information on the lot/batch number has been requested.
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| 75 | 2021-03-21 | itchy skin |
Slight pain in left arm of injection site/Sore; Tiny pimple-like bumps on entire scalp, very itchy; ...
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Slight pain in left arm of injection site/Sore; Tiny pimple-like bumps on entire scalp, very itchy; Tiny pimple-like bumps on entire scalp, very itchy; Fatigue; This is a spontaneous report from a contactable (consumer). This non-pregnant 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the left arm on 12Feb2021 at 00:45 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to penicillin and derivatives from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number EL9262) in the left arm on 21Jan2021 at 10:15 (at the age of 75-years-old) as a single dose for COVID-19 immunization and experienced slight pain in left arm of injection site/sore. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient reported that on 16Feb2021 at 16:00 she experienced slight pain in left arm of injection site, sore for 24hrs; tiny pimple-like bumps on entire scalp, further reported as very itchy; and fatigue which lasted 24hrs. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of slight pain in left arm of injection site/sore, tiny pimple-like bumps on entire scalp, very itchy, and fatigue were unknown. It was also reported that since vaccination the patient had not been tested for COVID-19.
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| 75 | 2021-03-21 | rash, itchy rash |
The morning after the injection an itchy rash was on my chest. Saw a dermatologist a few days later...
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The morning after the injection an itchy rash was on my chest. Saw a dermatologist a few days later and a cream was prescribed. The rash continued and in time spread throughout my upper torso. Extreme itching also continues. Went back to dermatologist and was prescribed a new cream and cortisone pills. That was today March 22, 2021
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| 75 | 2021-03-22 | hives |
Extremely tired kept falling asleep all day of shot; slept thru the night and most of next day; hive...
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Extremely tired kept falling asleep all day of shot; slept thru the night and most of next day; hives on left side of neck (received shot in left arm) diarrhea all day after shot; arm slightly sore. Did not feel sick; just had these reactions.
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| 75 | 2021-03-22 | hives |
Patient had adverse reaction with selling of the tongue, lips tingling, and hives. After taking Bena...
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Patient had adverse reaction with selling of the tongue, lips tingling, and hives. After taking Benadryl, patient's symptoms resided within an hour.
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| 75 | 2021-03-22 | rash, hives, itchy skin |
rash, hives, itchiness 20 min after receiving vaccine. Gave 50mg Benedrylorally per protocol. ater ...
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rash, hives, itchiness 20 min after receiving vaccine. Gave 50mg Benedrylorally per protocol. ater 30 min observation, discharged to home in stable condition (with driver)
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| 75 | 2021-03-22 | injection site swelling, injection site hardening, injection site pain, injection site warmth, injection site pruritus |
~24 hours after injection, injection site became swollen, sore and itchy, and experienced extreme fa...
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~24 hours after injection, injection site became swollen, sore and itchy, and experienced extreme fatigue and joint pain lasting ~48 hours. Over following 3 days, arm swelling expanded to ~5" diameter with hard center and warm to touch, sore and itchy. Still swollen on Day 4 but beginning to resolve. Fatigue and joint pain resolved by end of Day 3.
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| 75 | 2021-03-23 | rash, itchy skin |
Rash/breakout all over face and neck - very itchy. Vaccine was given Saturday, side effects started ...
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Rash/breakout all over face and neck - very itchy. Vaccine was given Saturday, side effects started Monday.
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| 75 | 2021-03-24 | vaccination site pain, vaccination site swelling, rash |
all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, d...
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all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, dry, itchy; injection site pain and was swollen a lot; little dizziness; nausea; Muscle pain more on back side of shoulder towards neck-unbearable pain; headache; neck disfigured; rash; injection site pain; brain fog big time - disorientated, felt like brain getting damage; I'm desperate; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: solution for injection, Lot no: EN5318) via intramuscular at left arm on 19Feb2021 at 03:10 (at the age of 75-years-old) at single dose for covid-19 immunisation (at hospital). Patient medical history not reported. Concomitant medications included levothyroxine; 0.075 mg once daily for hypothyroid since 20 years; ongoing and trazodone 100 mg 1 tab daily since 20 years; ongoing. On 19Feb2021 the patient experienced injection site pain and was swollen a lot, little dizziness, nausea, muscle pain more on back side of shoulder towards neck-unbearable pain, headache, all face including eyes swollen and red, all face including eyes swollen and red, skin got creepy, dry, itchy, brain fog big time - disorientated, felt like brain getting damage, she was desperate, skin got creepy, dry and itchy. my face and neck was disfigured that don't want my children and grant children see my face. Rash-swelling, itchy and flaky skin, got a little better on 01Mar, but I still have creepy skin, flackey, itchy around eye and eyelids were swollen and dry and felt like have stones rolling in my eyes and my brain fog was very bad. I want to know if my skin will ever get better. Patent took vit-d and all the vit. Covid. Patient received treatment as OTC, Tylenol, ibuprofen, aleve. No covid prior vaccination. The reporter reported seriousness criteria as non-serious. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 75 | 2021-03-25 | injection site swelling |
Swelling at injection site. 183/99, HR 77, R. 70, 98.6. Pt. observed with swelling at injection si...
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Swelling at injection site. 183/99, HR 77, R. 70, 98.6. Pt. observed with swelling at injection site. Elevated BP has history. Transported to a Hospital for further evaluation.
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| 75 | 2021-03-26 | rash, rash with redness, itchy rash |
About four days after I receive the first Pfizer vaccine I got a bright red itchy rash on my throat ...
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About four days after I receive the first Pfizer vaccine I got a bright red itchy rash on my throat lower left jaw and into my neck area, it was difficult to touch it finally went away I tried an expired Halog ointment on which expired in 2017. I only use that once, it left the skin dry on my lower jaw for several days.
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| 75 | 2021-03-30 | itchy rash, hives |
This is a spontaneous report from a Pfizer-sponsored program, COVAX Support. A contactable consumer...
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This is a spontaneous report from a Pfizer-sponsored program, COVAX Support. A contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 05Mar2021 13:00 at a single dose for COVID-19 immunisation. Medical history included blood pressure (abnormal), depression, both hips replaced and allergic to sulfur. Concomitant medications included ibuprofen, blood pressure and depression pill. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization and experienced mild arm soreness. The patient received her second Pfizer COVID vaccine on 05Mar2021 at 1 PM. The following morning on 06Mar2021 she woke up at 6:30 AM with an itchy rash on her buttocks and hips. She took diphenhydramine (BENADRYL) and it subsided but came back later and started spreading to her thighs, chest, arms, stomach, and back. She was taking Benadryl to treat it and wanted to know what else to do. She was covered with a rash and itching and going crazy, they were welts like little welts kind of hives; It is itching all over; It didn't go away, it was itching all through the day. It just kept getting more and more in covers like her knees up to her butt, her butt was all covered, her lower back was covered and her arms were getting it now that just keep travelling. It is all around the area, it's travelling everywhere my legs, my arms and my chest. The patient had the 2nd dose yesterday (05Mar2021). She experienced little soreness on her arm and rashes starting to spread all over to her body after the vaccine. Outcome of the events going crazy and little soreness on her arm was unknown while not recovered for the other events. Information on the lot/batch number has been requested.
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| 75 | 2021-03-30 | redness |
Tongue tingling; arm swollen; severe headache; tired; Arm still swollen red; This is a spontaneous r...
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Tongue tingling; arm swollen; severe headache; tired; Arm still swollen red; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (Solution for injection, Batch/Lot number: EL1283) via an unspecified route of administration in right arm on 20Jan2021 14:00 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Heart palpitations, arthritis, obese. Concomitant medication included valsartan (DIOVAN), levothyroxine sodium (SYNTHROID), sertraline hydrochloride (ZOLOFT), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]). The patient previously took omnicef and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced tongue tingling arm swollen, severe headache, tired. Arm still swollen red two weeks later on 20Jan2021 at 02:00 PM. Prior to vaccination, the patient was not diagnosed with COVID-19. The treatment of the adverse events was OTC Benadryl. The patient underwent lab tests and procedures which included nasal swab: negative on 30Jan2021. The outcome of the events was recovering.
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| 75 | 2021-03-30 | itchy skin |
left arm sore; left arm has a large lump like a 50 cent piece; left arm itching; This is a spontaneo...
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left arm sore; left arm has a large lump like a 50 cent piece; left arm itching; This is a spontaneous report from a contactable consumer (patient reported herself). A 75-year-old female patient received BNT162B2 (Pfizer Covid shot, Formulation: Solution for injection, Batch/lot number: Not Provided, Expiry Date/NDC number: Not Provided) via an unspecified route of administration on 25Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left arm sore, left arm has a large lump like a 50 cent piece and left arm itching. Caller stated that she received her first shot on 25Jan2021 and that her arm was sore which went away in a few days. Stated that she received the second shot early on 09Feb2021 because she was scheduled to have surgery. Stated that the spot where she received it is sore, has a large lump like a 50 cent piece and is itching. Stated that she went to the doctor and he put her on Benadryl and Zyrtec over the counter for allergies. Wanted to know if it will be safe to go and have surgery if she had this going on. Stated it was sore and she had terrible itching. Wanted to know if she was on the right track. Stated that she would start testing for surgery on Monday. Wanted to know Pfizer's opinion and if had others are calling with same. Clarified that it was for the left arm for both shots. Clarified that it was for Pfizer Covid shot. Outcome of the events was unknown. Information about lot/batch number has been requested.
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| 75 | 2021-03-30 | rash with redness, itchy skin |
lichenoid reaction from pemphigus foliaceous; Lichenoid dermatitis; They are itchy; she had outbreak...
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lichenoid reaction from pemphigus foliaceous; Lichenoid dermatitis; They are itchy; she had outbreaks on both of her nipples and also on her pubic area; The reaction would start as small raised areas that would eventually form white pustules in the middle of it and if left alone; If it got scratched off, a scab would come; It was all over her body in sporadic area; The old outbreaks that turned into dry skin patches, she is getting little bumps in them; there are red marks in various places; This is a spontaneous report from a contactable consumer (patient) and contactable physician. A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 17Feb2021 at single dose for COVID-19 immunization. Medical history included stenosis, acid reflux from an unknown date and unknown if ongoing. Concomitant medication(s) included valaciclovir hydrochloride (VALACYCLOVIR HCL) taken for herpes simplex, levothyroxine sodium (SYNTHROID) 5x a week taken for thyroid, marijuana (MARIJUANA) taken for sleep, minocycline hydrochloride (MINOCYCLINE HCL) 15mg 2x a day, methylprednisolone acetate (METHYLPREDNISOLONE [METHYLPREDNISOLONE ACETATE])4mg 2x a day, famotidine (FAMOTIDINE ACID REDUCER) 20mg, vitamins, fexofenadine hydrochloride (ALLEGRA), and 2% mupirocin;sucralfate. On 18Mar2021, patient experienced an outbreak on her face. On Friday (19Feb2021), patient went to a dermatologist and she was prescribed with topical and oral steroids. She described her outbreak to be a lichenoid reaction from pemphigus foliaceous (from pathology report). Patient said that she had outbreaks on both of her nipples and also on her pubic area. The reaction would start as small raised areas that would eventually form white pustules in the middle of it and if left alone, it would go away but leave a mark like a cigarette burn. She said her outbreaks are getting smaller and smaller. She has pictures. She went to dermatologist and two pathology tests were taken at two different times. After 5 days, she took a steroid. After taking the medication for a week the outbreak continued and worsened. She got new outbreaks in semi large areas. The outbreak would come as a single bump that looked like a mosquito bite. Then a mini pustule would come up. If it got scratched off, a scab would come. It was all over her body in sporadic area. She had outbreak in pubic hairs, both nipples, various spots on her arms, legs, back, and buttock. They are itchy. The old outbreaks that turned into dry skin patches, she was getting little bumps in them. If it was a small spot it may be a little bump and in cluster. They are not coming to a pustule head, but they are itching. There are little bumps in general or in cluster spots there would be maybe one or too little bumps that itch. They come up and go away and then come back again. They look like remanence of a cigarette burn. They are circular and there are red marks in various places. Patient was prescribed an antibiotic for the immune reaction because of pustules. The antibiotic was Minocycline HCL. She took 50mg twice a day, 12 hours apart. She didn't take any calcium or magnesium with it. She didn't drink milk or anything with it because of calcium. The events lichenoid reaction from pemphigus foliaceous and Lichenoid dermatitis was considered as serious due to medically significant. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 75 | 2021-03-30 | redness, vaccination site pain |
no arm pain at injection site until following morning; my face became warm and beet red; my face bec...
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no arm pain at injection site until following morning; my face became warm and beet red; my face became warm and beet red; experienced incredible thirst; intermittent nausea and lethargy; intermittent nausea and lethargy; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient (non pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, in Arm Left on 02Feb2021 12:00 (12:00 PM) (age at vaccination 75 Years) as single dose for covid-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included known allergies to penicillin, NSAIDS, doxycycline, lidocaine and prednisone. Concomitant medication(s) included atorvastatin at 10 mg; calcium citrate (CITRACAL [CALCIUM CITRATE]); bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]); ubidecarenone (COQ-10) and Magn (as reported). Pateint reported that "on 02Feb2021 at 12:00 PM, Shortly after receiving first dose my face became warm and beet red, didn't realize until I'd gotten to my car and taken off my mask, at which time I also experienced incredible thirst. Other symptoms that day (02Feb2021), Wednesday and today have been intermittent nausea and lethargy, no arm pain at injection site until following morning (03Feb2021), okay now." No treatment was received for the events. This case is reported as non-serious. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Outcome "no arm pain at injection site until following morning" was recovered while other events was recovering. No follow-up attempts are possible. No further information is expected.
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| 75 | 2021-03-30 | itchy skin |
pain; swelling; itching; This is a spontaneous report from a contactable consumer or other non hcp. ...
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pain; swelling; itching; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 19Jan2021 10:45 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. Medical history included HTN (hypertension), osteoporosis and Allergies to sulfa. Concomitant medication(s) included macrogol 3350 (MIRALAX); metoprolol; hctz; donepezil; alendronate sodium (ALENDRONATE) all was taken for an unspecified indication. The patient previously took hydrocodone and experienced allergies. on 27Jan2021 05:00 patient experienced pain, swelling, itching. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, was the patient did not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. Outcome of the events was not recovered.
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| 75 | 2021-03-31 | hives |
Angioedema (Face); Hives (between the eyes & forehead); Extreme Fatigue; This is a spontaneous repor...
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Angioedema (Face); Hives (between the eyes & forehead); Extreme Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 at 15:30 at single dose in left arm for COVID-19 immunisation at the age of 75-year-old. Lot number was EM9810. Medical history included possible atrial fibrillation, allergy to sulfa. Past drug history included allergy to antibiotic drugs, Betoptic, Motrin, Iodine, Nickel, Latex, Ragweed, Mold, Grass, Cat, Bee. The patient was not pregnant. On 03Mar2021 at 18:00 approximately, the patient experienced angioedema (Face), Hives (between the eyes and forehead), Extreme Fatigue. The patient was not treated for the events. The patient was recovering from the events. In 2017, IgG Anti-IgE resulted elevated. It was unknown if the patient had Covid before vaccination. The patient was not tested for Covid after vaccination. No follow-up attempts are possible. No further information is expected.
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| 75 | 2021-04-01 | rash | Rash all over the body |
| 75 | 2021-04-02 | vaccination site pain |
arm where she received the injection is really hurting bad to the elbow/felt sore on her arm where t...
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arm where she received the injection is really hurting bad to the elbow/felt sore on her arm where the first dose was placed in and it is like on side and right on her elbow; arm where she received the injection is really hurting bad to the elbow/felt sore on her arm where the first dose was placed in and it is like on side and right on her elbow; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3248), first dose via an unspecified route of administration, administered in Arm on 29Jan2021, single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, Sjogren's, Lung problems, from an unknown date. The patient had a flu shot and experienced sore on her arm. Concomitant medications included mycophenolate mofetil hydrochloride (CELLCEPT); insulin (INSULIN); sitagliptin phosphate (JANUVIA). Patient experienced her arm where she received the injection is really hurting bad to the elbow, she took Tylenol and she would like to know if she can put heat on the site to decrease the pain. The outcome of the event was unknown.
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| 75 | 2021-04-17 | redness, bruising, cellulitis |
cellulitis; Bacterial skin infection; right arm where I got the injection turning all red and swolle...
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cellulitis; Bacterial skin infection; right arm where I got the injection turning all red and swollen; arm swelling; bursitis; Muscle pain; joint pain in elbow; the bruise have been flamed; Feeling hot; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 75-years-old, via an unspecified route of administration in right arm on 13Mar2021 at single dose for COVID-19 immunization. Medical history included diabetic type 2 for probably 13-14 years, sleep apnea for 20 years (2001), arthritis in 2005 (probably 12-14 years), and blood pressure abnormal (reported as blood pressure). Concomitant medications included metformin, sertraline, alprazolam, sitagliptin (JANUVIA), oxybutynin, insulin glargine (LANTUS), lisinopril for blood pressure abnormal (reported as blood pressure), and cortisone for arthritis. The patient received the vaccine on 13Mar2021 in the afternoon and within 24 to 30 hours, the next day (14Mar2021), her right arm, where the vaccine was administered turned all red and swollen and her elbow also hurt. She went to the emergency room because she felt it was a reaction to the vaccine. They told her that it was a bacterial skin infection, an adverse effect of an initial encounter to the vaccine, arm swelling and bursitis caused by that, muscle pain and join pain in elbow and then she guessed it was like cellulitis. They gave her ROCEPHIN at the emergency room and then a couple days later, it wasn't getting any better and it was all the way down to her wrist. She went to immediate care center and received an antibiotic. She was also given 2 more prescription of antibiotics and told that it had to be administered with the antibiotics to get rid of the reactions. It has finally pretty much cleared up with the antibiotics if they hadn't put her in an immediate care and put her on intravenous medications. They were really concerned because it was going to get into sepsis or something. At first, the patient thought that it was just inflamed, then it was skin infection and then adverse effect from the initial encounter of the vaccine. She had been on the antibiotics for 10 days when it finally cleared, but the elbow was still sore and it hurts a lot, but the fluid was drained by an orthopedic doctor. She was given 2 different types of antibiotics plus a shot into her buttocks. It's a little sore because she was informed that "the bruise have been flamed" on Mar2021. When she went to emergency, first they give her 1 gm ROCEPHIN and then switched antibiotic to DURICEF and to BACTRIM DS, and advised to continue monitoring and if swelling and redness was progressive or worse, then go to emergency room again. She went to emergency room on 16Mar2021, the medicine given was doxycycline and then she was seen by an orthopedic physician today where the fluid was drained from her elbow but swelling and redness was progressively getting worst and she was feeling hot on Mar2021. So, she went to the immediate care. Overall, consistent to cellulitis of right upper arm strongly includes to go to the ER but the patient had something else and had to go right then. And then, she was given 1 gm ROCEPHIN and then switched to DURACEF and BACTRIM. She came back to the ER on the same day. It was kind of 2 things, like the redness and skin infection which currently was cellulitis. Doxycycline was what they told her to get, that's what they gave her at the emergency room, doxycycline hyclate. And then said to follow-up with her primary care which she did and that was on 17Mar2021. She looked at it and then they told her to see an orthopedic surgeon and she saw him on the 18Mar2021. They just thought that the antibiotics, that's why he gave her 2 different prescriptions plus the shot in the buttocks because he said if this will not be cured with the antibiotics, she'll end up in a hospital. And then it was raft and it took her 10 days to recover. And he marked little black dots to show where wasn't and if it goes beyond that then call us because it was spreading. The outcome of the events bruise and feeling hot was unknown, not recovered for joint pain, and recovered on 24Mar2021 for all other events. The events required emergency room visit/ physician office visit.
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| 75 | 2021-05-07 | rash, itchy skin |
Tiredness; Tightness in her left leg that felt like a tunicate was left on; Chills on her left side ...
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Tiredness; Tightness in her left leg that felt like a tunicate was left on; Chills on her left side from her foot to her neck; Sore Left Arm; Chills; Wasn't feeling herself; Rash on the left side of her face; itchy; face felt like it was hot; Rash on the left side of her face; itchy; face felt like it was hot; Rash on the left side of her face; itchy; face felt like it was hot; This is a spontaneous report received from a contactable nurse (Patient herself). A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via unknown route of administration on 03Apr2021 (Lot Number: ER8729, Expiry date: Jul 2021) as single dose for COVID-19 immunization. The patient medical history was breast cancer. The patient historical vaccine included BNT162B2 on (LOT:EJ1686 Expiration: 31MAR2021) on 13 Mar 2021 for COVID-19 immunization. The patient had no family history. The patient concomitant medications were not reported. The patient experienced chills on 04Apr2021, sore left arm on 13Apr2021, Rash on the left side of her face; itchy; face felt like it was hot on Apr2021, chills on her left side from her foot to her neck: on 17Apr2021, Tiredness on an unknown date and tightness in her left leg that felt like a tunicate was left on 17Apr2021, wasn't feeling herself Apr2021. The patient stated she wanted to send pictures of her rash on her face that her dermatologist diagnosed last Tuesday as a Covid Vaccine side effect. She had the first dose of the vaccine on 13Mar2021 and the second dose on 03Apr2021. They were both done at (withheld). With the first, she had no side effects, other than a sore left arm. The second she had a sore arm and a couple of chills at first. Then two weeks post second vaccination she wasn't feeling herself, and she went to see a primary about that, but that wasn't a definite that it was side effects from the vaccine. Then, the following week on a Thursday she got a rash about the same time but it was getting itchy so she decided someone should look at it. At first she thought it was from her mask, but it was only on the left side of her face. Caller states she wrote a message to her doctor about not feeling well but she didn't connect all of the other symptoms. She went to her primary for the chills on her left side from her foot to her neck and just not feeling like herself. She had a tightness in her left leg that felt like a tunicate was left on. Her face felt like it was hot. States it was really very weird and she was very tired. The tiredness comes and goes. States she was doing interviews yesterday for a long time, virtual interviews and by 12 noon she felt so tired and took a nap and felt out of sorts. She Didn't show her the rash because she thought it was just from her mask and she wasn't a dermatologist. Didn't mention it to her primary. States she tried to cancel the appointment but said she needed to come see her anyway. Thursday she had another appointment so she called the dermatologist when it started to itch and she said to the office, should she be worried. At first, said no time, and reported to doctor and fit her in at 13:30 and she looked at it and said it is really impressive for being 2 weeks old and thinks it is Covid vaccine related. Didn't know if she should report it or not. Maybe it is something. Was thinking the Covid rash was extensive. She still has the tiredness. It reminds her of the tiredness she had after radiation for breast cancer. States it wasn't during the radiation, but 4-5 weeks later and lasted about a month. States the tiredness is not from a lack of sleep, it is like a veil comes over her. States if she has taken 10 naps in her whole life, that is a lot for her and that didn't help. Treatment: Gel for the Rash; states for her leg issue the doctor ordered an MRI to rule out a back or disc problem. States she didn't put it together, one said it might be and another side not sure. At first she was offered the Moderna and she changed when they offered the Pfizer, because of the breast issues from the Moderna. Curious to see at some point if point if other people are experiencing rashes on their faces. Caller states she didn't know what type of rash was common, she assumed it was more of a bodily rash. Tetanus back in the Fall or maybe July thinks last July, she had GI stuff and her physician wasn't particularly believing it was from that. The event tiredness wsa assessed as serious (Medically significant), and tightness in her left leg that felt like a tunicate was left considered serious (Disability). The all other events were assessed as non-serious. The patient had physicians room visit (PCP and dermatologist) and not had emergency room visit. The causality assessment was unknown for all events. The outcome of the event rash on the left side of her face; itchy; face felt like it was hot and tiredness was not recovered, The outcome of all other events was recovered. Additional information requested.; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect vaccine BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 75 | 2021-05-07 | shingles, rash macular, rash |
rash on her scalp; flat macular rash; on her scalp the vesicles were breaking out basically; Pain in...
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rash on her scalp; flat macular rash; on her scalp the vesicles were breaking out basically; Pain in her throat one side, injection on the right side, just in the right peritonsillar fossa; very foggy; trouble sleeping; numbness; paresthesia; Shingles; Rash around her eye; Sore throat; Earache; This is a spontaneous report from a patient. A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot Number: EN6201) as a single dose (at the age of 75 years) for covid-19 immunization. The patient's medical history included lung Cancer from Aug2010 to Oct2010 (lung cancer survivor and had 35 days of treatments, 20Sep2010 was her last day of treatment. She says the end date for this condition was mid Oct2010, she has inoperable lung scarring, it's not COPD, more like a seasonal allergy, when she runs into an URI they up the prednisone to stop the spasms. She clarifies that URI stands for upper respiratory infection; ongoing sleep obstructive sleep apnea (patient uses a CPAP. She says she has had this condition prior to 2010, since the early 2000's), polymyalgia rheumatica from 2019 and ongoing,ongoing hypothyroidism (had this condition for 30 years probably) , hypertension from Feb2021 and ongoing; gastrooesophageal reflux disease (since the 1990's), chemotherapy and radiation (chemotherapy and radiation 10 years ago), postmenopausal and inoperable lung scarring from an unknown date and unknown if ongoing. Concomitant medication included prednisone (PREDNISONE) taken for polymyalgia rheumatica from; budesonide, formoterol fumarate (SYMBICORT) taken for lung neoplasm malignant; salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) taken for lung neoplasm malignant; omeprazole (PROTONIX [OMEPRAZOLE]) taken for gastrooesophageal reflux disease; levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing; calcium carbonate, vitamin d nos (CALCIUM + VIT D) taken for postmenopause from an unspecified start date and ongoing; ascorbic acid (VIT C) taken for postmenopause; hydrochlorothiazide (HYDRODIURIL) taken for hypertension from Feb2021 to an unspecified stop date. The patient received the first dose of BNT162B2 (lot:EL9262) in the left arm on 21Jan2021 at the age of 75 years for Covid-19 immunization. The patient experienced shingles, rash around her eye, sore throat, earache on 29Mar2021; numbness, paresthesia and trouble sleeping on 31Mar2021; very foggy on 03Apr2021; very foggy was reported as worsened/ trouble sleeping was reported as worsened, rash on her scalp, flat macular rash, on her scalp the vesicles were breaking out basically, pain in her throat one side, injection on the right side, just in the right peritonsillar fossa on an unspecified date. It was further reported that 5 and a half weeks later (after the vaccine) she developed shingles. She said it just recently came to her attention and might be related to the vaccine, but she was not sure if it was or not. She said she has not had the shingles vaccine, she had chemotherapy and radiation 10 years ago and never had any issues so she never got the vaccine for shingles. Patient is on a dose of gabapentin 800mg for the shingles, she has had a lot of difficulty with the dose and the shingles, She said she was little bit fuzzy, but that's probably because of the gabapentin, not the vaccine. Patient also mentioned she had a sore throat, it involves the right forehead, scalp, neck, she has an earache. She said the earache and the sore throat have passed but she still has the issue around her eye, a rash. She said the numbness and paresthesia started, she didn't pay much attention to it, then 2 days later she thought she should see the doctor. She says she saw a rash on her scalp, she didn't see the vesicles right away, she saw a flat macular rash. She says on her scalp the vesicles were breaking out basically. She says the sore throat has been interfering with her sleep, she can't use her CPAP, it got to disabling because she can't use her CPAP. She was very foggy. Trouble sleeping was medically significant moving into disabling because she was really foggy, more foggy as she goes along. She says the foggy is medically significant moving towards disabling, that up until today it was medically significant. She said for her throat she had to gargle a lot, it didn't go away with Tylenol. Tylenol NDC, lot, and expiration date not provided. She says the earache was there, it was annoying. She said the trouble sleeping was related to the shingles, she can't say the vaccine did it. The patient underwent lab tests and procedures included bloodwork on 02Apr2021 and everything came back normal. She said that was to test her kidney function following the HydroDiuril. She said the HydroDiuril was changed from 25mg to 12.5mg. She says she also had a screen of her inflammation markers of her lungs and that that was normal. She says both tests were done on 02Apr2021, that was the last ones, not the first ones done. The patient went to her doctor and ophthalmologist and was prescribed Valtrex. She does not know the dose and frequency, she says it is an antiviral for shingles. She says the gabapentin was for the pain for the paresthesia. The gabapentin was fluctuating, they keep increasing it due to discomfort, and she was up to 800mg in divided doses. She said she also was given eye drops, triple antibiotic polymixin. She had neomycin and another one, that it was the same as the ointment triple antibiotic for abrasions. She used that 3 times a day in her right eye. She also took a cortisone preparation eye drops and that they are also 3 times a day in her right eye. She says her ophthalmologist put her on a second course of Valtrex, she does not know the dose or frequency, saying that it varies according to her primary care physician. She says the total is 800 mg in divided doses. She says she is doing 200, 200, 400, she is trying to get off of it but that doesn't work so they are going to be increasing it. The organ involvement included respiratory and Dermatological/Mucosal. The patient was recovering from the events shingles and rash around her eye, recovered from sore throat, earache on 19Apr2021, not recovered from the events numbness, paresthesia, very foggy, trouble sleeping, and unknown outcome for all the other events.
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| 75 | 2021-05-10 | bruising |
On 3/23/21 pt had SOB so went to went to the Hospital ER. She had lab work, CT, Chest Xray, ECG 12 ...
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On 3/23/21 pt had SOB so went to went to the Hospital ER. She had lab work, CT, Chest Xray, ECG 12 lead. DX is pneumonia of right lower lobe of the lung. She was given Augmentin and released after 7 hours and told to FU w/ PCP. On 3/31/21 pt went to see her PCP due to having SOB. She was given a Covid Test which was negative. She was sent home and told to breath deeply and hopefully this symptom would go away. On 4/18/21 she went back to the Hospital ER for SOB. Pt was admitted with acute DVT and other blood clots as well as pleural effusion of the right lung. They did US on legs and Chest X-Rays. They found fluid around her right lung which they drained. She was prescribed Eliquis. Pt was discharged on 4/21/2021 and was told to FU w/ PCP. On 4/24/21 pt went back to the Hospital ER, because she had a bruising/blood clots in the groin area. She had 3 blood clots on the left side and one on the right side. They told her the bruising was from the Eliquis and they did a US. She was told she had the same blood clots that she had during her hospital stay and they were right where they were before. She was discharged. On 4/29/2021 she went back to her PCP due to SOB. She told her PCP about the DVT that was bothering her. She was sent to another Hospital. She had a stat Chest X-Ray- results were that her lungs were stable with inflammation around the right lung. She was told to FU w/ PCP in July 2021 and go back to ER if she had another episode w/ SOB.
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| 75 | 2021-05-13 | rash, hives |
Extreme rash/welts over entire body from head to feet; Extreme rash/welts over entire body from head...
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Extreme rash/welts over entire body from head to feet; Extreme rash/welts over entire body from head to feet; This is a spontaneous report from two contactable consumers (patient and patient husband). A 75-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW6200), via an unspecified route of ad-ministration on 24Feb2021 at 10:00 AM in the left arm at single dose for COVID-19 immunisation. The patient age at vaccination was 75 Years. Facility where COVID-19 vaccine was administered was at the other. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Epstein barr viraemia. Concomitant medications included olmesartan medoxomil (BENICAR) taken for blood pressure measurement and levothyroxine sodium (SYNTHROID) taken for an unspecified indication. Historical vaccine included first dose of BNT162B2 (Lot Number: EL9263), on 03Feb2021 at 09:00 AM in the left arm at single dose for COVID-19 immunisation. On 04Mar2021, the patient experienced extreme rash/welts over entire body from head to feet. Reporter stated, she went to her internist on Friday as a result of the rash that she developed, it's a very serious rash basically from her head to her toes and he put her on Benadryl which did not help and then he gave her Medrol pack which she started yesterday and getting two days worth of the Medrol pack which does not seem to be helping yet. Reporter added, we would like to know, going online we could see this is somewhat not rare side effect any other medication or treatment she should be receiving or what is the experience with respect to the side effect how long does it last. Multiple blood work, they were all within normal limits. Date of Lab work was approximately 3 weeks ago. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19, since the vaccination. The patient underwent lab tests and procedures which included blood test: normal on an unknown date 2021 (all within normal limits). Therapeutic measures were taken as a result of extreme rash/welts over entire body from head to feet with Benadryl & Medrol Pak. Outcome of the events was not recovered. Health authority comment: none. More follow-up information has been requested.
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